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Cutting-edge Advancements Clinical Diagnosis OphthalmologyTimes.com follow us online: Special Reprt NEWER ICLS MAY reduce CATARACT formation rate Surgery May 2016 Vol. 41, No. 8 Drug therapy Perfecting capsulotomy Novel disposable tool could provide several advantages compared with femtosecond laser VIDEO This video shows the final design of the disposable intraocular nanopulse technology (Zepto) inserting through a 2.2-mm incision and performing a 5-mm capsulotomy in a cadaver eye. Go to bit.ly/1SFHhoh Oviedo, Spain :: cataract formation has been associated with the first phakic IOLs introduced into the marketplace. However, newer models seem to be on the way to solving that problem, said Jose F. Alfonso, MD, PhD. Because implantable collamer lenses meet a need in the refractive surgery arena for patients with high refractive levels, they have been gaining in popularity. (Video courtesy of Mynosys) ( See story on page 22 : Cataract ) Clinical Diagnosis Tell us at ASCRS Booth 1523. Growing up with glaucoma into adulthood By Cheryl Guttman Krader; mies created with either the femtosecond laser or Reviewed by David F. Chang, MD a manual technique,” Dr. Chang said. miami :: what happens to children The technology consists of a control console and treated for glaucoma as they grow older? a disposable handpiece containing the capsulotomy Los Altos, CA :: The short answer is that life goes on. Precision pulse capsulotomy tip. The tip is comprised of a 6-mm silicone suction Just like other kids, they want to be (PPC) performed using novel disposable intraocular cup and the cutting element—a 5-mm nitinol capsuactive, get an education, have a career, lotomy ring. Using just a small amount of vacuum, nanopulse technology (Zepto, Mynosys) may be a date, get married, and have children. step forward toward the ideal capsulotomy, accord- the suction cup apposes the anterior capsule to the But even if their glaucoma has been cutting element and also shields surrounding tising to David F. Chang, MD. effectively cured, the impact lingers. “PPC is an exciting new method that like a fem- sues from the energy delivery. “They have anatomical things that have A retractable push rod extends to stretch the captosecond laser could quickly and reliably create a followed them, and they have other perfectly circular capsulotomy with a precise di- sulotomy tip into an elongated shape so that it can baggage that has followed them,” said ameter,” said Dr. Chang, private practice, Los Altos, enter through a sub-2.2-mm clear corneal incision. Alana L. Grajewski, MD. Though the © 2016 Abbott Medical Optics Inc.CA, | www.AbbottMedicalOptics.com | PP2016MLT0048 “The nitinol used for the capsulotomy ring is a and clinical professor of ophthalmology, Unianatomical issues have been well studshape memory alloy, which means that it can be versity of California, San Francisco. “However, PPC ied, literature on the psychological-socollapsed to allow insertion through a small corhas advantages of being lower cost and able to be cial burden of childhood glaucoma on used without disruption of the conventional sur- neal incision and then will rebound back from the children and families is limited, and deformation to its native circular shape and diamgical sequence. these quality-of-life issues should be eter,” Dr. Chang explained. “As another bonus, PPC also seems to create a examined more formally. ( See story on page 14 : Pediatric glaucoma ) capsulotomy with a stronger edge than capsuloto- ( Continues on page 9 : Capsulotomy ) CUTTING-EDGE ADVANCEMENTS CLINICAL DIAGNOSIS OphthalmologyTimes.com FOLLOW US ONLINE: Special Reprt NEWER ICLS MAY REDUCE CATARACT FORMATION RATE SURGERY May 2016 VOL. 41, NO. 8 DRUG THERAPY Perfecting CAPSULOTOMY Novel disposable tool could provide several advantages compared with femtosecond laser VIDEO This video shows the final design of the disposable intraocular nanopulse technology (Zepto) inserting through a 2.2-mm incision and performing a 5-mm capsulotomy in a cadaver eye. Go to bit.ly/1SFHhoh OVIEDO, SPAIN :: CATARACT formation has been associated with the first phakic IOLs introduced into the marketplace. However, newer models seem to be on the way to solving that problem, said Jose F. Alfonso, MD, PhD. Because implantable collamer lenses meet a need in the refractive surgery arena for patients with high refractive levels, they have been gaining in popularity. (Video courtesy of Mynosys) ( See story on page 22 : Cataract ) Clinical Diagnosis GROWING UP WITH GLAUCOMA INTO ADULTHOOD MIAMI :: WHAT HAPPENS to children treated for glaucoma as they grow older? The short answer is that life goes on. Just like other kids, they want to be active, get an education, have a career, date, get married, and have children. But even if their glaucoma has been effectively cured, the impact lingers. “They have anatomical things that have followed them, and they have other baggage that has followed them,” said Alana L. Grajewski, MD. Though the anatomical issues have been well studied, literature on the psychological-social burden of childhood glaucoma on children and families is limited, and these quality-of-life issues should be examined more formally. ( See story on page 14 : Pediatric glaucoma ) By Cheryl Guttman Krader; Reviewed by David F. Chang, MD LOS ALTOS, CA :: PRECISION PULSE CAPSULOTOMY (PPC) performed using novel disposable intraocular nanopulse technology (Zepto, Mynosys) may be a step forward toward the ideal capsulotomy, according to David F. Chang, MD. “PPC is an exciting new method that like a femtosecond laser could quickly and reliably create a perfectly circular capsulotomy with a precise diameter,” said Dr. Chang, private practice, Los Altos, CA, and clinical professor of ophthalmology, University of California, San Francisco. “However, PPC has advantages of being lower cost and able to be used without disruption of the conventional surgical sequence. “As another bonus, PPC also seems to create a capsulotomy with a stronger edge than capsuloto- mies created with either the femtosecond laser or a manual technique,” Dr. Chang said. The technology consists of a control console and a disposable handpiece containing the capsulotomy tip. The tip is comprised of a 6-mm silicone suction cup and the cutting element—a 5-mm nitinol capsulotomy ring. Using just a small amount of vacuum, the suction cup apposes the anterior capsule to the cutting element and also shields surrounding tissues from the energy delivery. A retractable push rod extends to stretch the capsulotomy tip into an elongated shape so that it can enter through a sub-2.2-mm clear corneal incision. “The nitinol used for the capsulotomy ring is a shape memory alloy, which means that it can be collapsed to allow insertion through a small corneal incision and then will rebound back from the deformation to its native circular shape and diameter,” Dr. Chang explained. ( Continues on page 9 : Capsulotomy ) Because getting it right the first time is better than getting there first. q @MCRNLTBGLNQD • modmed RCM™ – LDCHB@KAHKKHMFLDDSRGHFGKXODQRNM@KHYDC RDQUHBDOQNBDRRDR@MCSDBGMNKNFXSNGDKOXNTPTHBJKXFDS paid what you deserve • modmed PM™ –OQ@BSHBDL@M@FDLDMSSG@SBNMMDBSR SGDEQNMS@MCA@BJNEjBDR • modmed EMA™ –SGDBKNTCA@RDCLNAHKD@MC RODBH@KSXRODBHjB$'1RXRSDL Introducing your modmed Ophthalmology™ suite: Innovators pave the road to the future. The rest just follow. That’s why we took a different approach. We began as a specialtyRODBHjBBNLO@MXENBTRDCNMCQ@RSHB@KKXBG@MFHMFSGD$'1 F@LD MCMNVVDKKMNVVDQDQD@CXSNSQ@MRENQLSGDBKHMHB@K jM@MBH@K@MCNODQ@SHNM@K@RODBSRNEXNTQOQ@BSHBD www.modmed.com I 561.880.2998 2NLDSHLDRSGHMJHMFENQV@QCQDPTHQDR sideways thinking. MAY 2016 2014 :: Ophthalmology Times editorial advisory board 3 Official publication sponsor of EDITORIAL ADVISORY BOARD Chief Medical Editor Peter J. McDonnell, MD Wilmer Eye Institute Johns Hopkins University Baltimore, MD Anne L. Coleman, MD Joan Miller, MD Jules Stein Eye Institute, UCLA Los Angeles, CA Massachusetts Eye & Ear Infirmary Harvard University Boston, MA Ernest W. Kornmehl, MD Harvard & Tufts Universities Boston, MA Associate Medical Editors Robert K. Maloney, MD Dimitri Azar, MD Los Angeles, CA University of Illinois, Chicago Chicago, IL Ashley Behrens, MD Wilmer Eye Institute, Johns Hopkins University Baltimore, MD Elizabeth A. Davis, MD University of Utah Salt Lake City, UT Ophthalmology Times’ vision is to be the leading content resource for ophthalmologists. Robert Osher, MD Through its multifaceted content channels, Ophthalmology Times will assist physicians with the tools and knowledge necessary to provide advanced quality patient care in the global world of medicine. Kuldev Singh, MD Jonathan H. Talamo, MD Stanford University Stanford, CA Harvard University Boston, MA Joshua D. 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Hersh, MD Joel Schuman, MD University of Medicine & Dentistry of New Jersey Newark, NJ NYU Langone Medical Center New York, NY LASIK & LASEK Titanium Applanator Julia Haller, MD Michael Snyder, MD Robert D. Fechtner, MD Johnston* Re pl ac eme nt Oculoplastics/ Reconstructive Surgery Samuel Masket, MD David R. Guyer, MD New York, NY (1996–2004) p Oregon Health & Science University Portland, OR Neeru Gupta, MD Ophthalmology Times is a physician-driven media brand that presents cutting-edge advancements and analysis from around the world in surgery, drug therapy, technology, and clinical diagnosis to elevate the delivery of progressive eye health from physician to patient. Randall Olson, MD University of Cincinnati Cincinnati, OH Anterior Segment/Cataract Cornea/External Disease Ophthalmology Times Mission Statement An ter io ea orn fC r View O : Jo 05-7003 r te Af nL so hn a Fl IK AS pp pA Fla lan a ium tan i T tor s Desig ned To Apply Equa l Outward Poster ior Pressure To T he L A S I K Flap Fo r E ve n Eg re ss O f F l u i d T o C o n s i s t e n t l y E n h a nce T h e S e at i ng & He a l i ng O f T he Flap To T he S t rom a l B e d . A l so, Designed To Apply Poster ior P ressure To Ephthelial Cells Dur ing L A SEK For More Even Distribution Of Cells. s Special Concave Posterior Lens Surface Designed To Be Pressed Onto The LASIK Flap To Outwardly Flatten The Central Cornea To Resolve Striae, Enhancing Centration And Control Over The Distribution Of Applanated Tissue. s Unique Transparent Applanation Lens Offers Clear Visualization Allowing Full View Of The Applanated Surface Through A Microscope. Special Convex Anterior Lens Surface Eliminates Reflection, And Has A 9mm Orientation Ring For Perfect Centration And Confirmation Of The Applanated Surface. s Easily Applied To The Flap Without Interference From The Speculum, Eyelids, Or Nasal Bridge For Unencumbered Access Around The Clock. Designed To Prevent Striae With A Minimum Of Time & Surgical Skill. s Ideal For Treating Post-Operative Striae, And Refloating & Repositioning The Flap To Insure Consistent Post-Operative Optical Clarity And Performance. s Reusable, Autoclaveable, Made In The U.S.A., Guaranteed For Life, Available For A 30-Day Surgical Evaluation Without Obligation. Ophthalmology Times Industry Council John Bee Bob Gibson Aziz Mottiwala Rhein Medical Inc. President and CEO Topcon Medical Systems Inc. Vice President of Marketing Allergan Vice President of Marketing, U.S. Eye Care Alastair Douglas Andrew Jones Alcon Laboratories Inc. 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First St. Duluth, MN 55802-2065 800/346-0085 FAX: 218/740-7223, 218/740-6576 4HE"IRTHOF6ENUSDETAIL3ANDRO"OTTICELLI 1093 Rev.D AJAG 4 MAY 2016 contents 22 46 28 39 38 Surgery Clinical Diagnosis Practice Management 8 SINGLE TREATMENT FOR BILATERAL GLAUCOMA? 16 IN-OFFICE THERAPY MAY OFFER MGD RELIEF 39 FOR WHOSE CONVENIENCE: PRACTICE OR PATIENT? Laser therapy reduces IOP, lowers patient reliance on medication In This Issue 6 EDITORIAL What’s Trending See what the ophthalmic community is reading on OphthalmologyTimes.com 1 5 reasons why physicians still have the best profession http://bit.ly/1SuNelS 2 DJ ophthalmologists in surgery Patients must play role in care; surgeons need systematic treatment approach 44 MARKETPLACE Digital App by day, mixing music by night targets inflammation http://bit.ly/1YxENK7 4 Why pediatric ophthalmologists don’t go to late-night parties http://bit.ly/1NLQDKZ 46 AFTER-HOURS Video Introducing the Ophthalmology Times app for iPad and iPhone. Download it for free today at OphthalmologyTimes. com/OTapp. http://bit.ly/1T07hb4 3 New ocular allergy drug’s MOA So-called patient conveniences may not be all that helpful after all eReport Sign up for Ophthalmology Times’ weekly eReport at http:// bit.ly/XjksXX. To learn how patient movement can affect FLACS, go to http://bit.ly/1T08qiM (Video courtesy of Sonia Yoo, MD) Facebook Like Ophthalmology Times at Facebook.com/OphthalmologyTimes It’s all in You make every move with the utmost care and consideration. Shouldn’t you choose your phacoemulsification system that way too? How do you phaco? Tell us at ASCRS Booth 1523. INDICATIONS AND SAFETY INFORMATION AVAILABLE IN THE BOOTH COMPACT INTUITIV and WHITESTAR SIGNATURE are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. © 2016 Abbott Medical Optics Inc. | www.AbbottMedicalOptics.com | PP2016MLT0051 6 MAY 2016 :: Ophthalmology Times editorial MAY 2016 ◾ VOL. 41, NO. 8 CONTENT My drug of choice: Dopamine What attracts the attention of neurons in ophthalmologists By Peter J. McDonnell, MD director of the Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, and chief medical editor of Ophthalmology Times. He can be reached at 727 Maumenee Building 600 N. Wolfe St. Baltimore, MD 21287-9278 Phone: 443/287-1511 Fax: 443/287-1514 E-mail: [email protected] FOR SOME TIME, I find myself looking at my smartphone with a frequency that is frankly disconcerting. In committee meetings, lectures, sporting venues, social events, and other settings, my eyes and fingers find themselves gravitating to that little rectangular device. The screen comes to life when my fingerprint is recognized and some bit of data, a text or email message, a news headline or other snippet of information is delivered to me. TAKING IT ALL IN It turns out that our senses present our brains with too much input for us to attend to it all. The process of picking what deserves our attention is called “attentional orienting,” and this is “like tuning a radio to a specific frequency.” Susan Courtney, PhD, a professor of psychological and brain sciences at my university, monitored the brains of subjects using a PET scanner. When her subjects saw an object that had rewarded them in the past, they focused their attention in on it, and “a part of their brains involved in attention became flushed with dopamine . . . Our brains pull us back to things that rewarded us in the past.” Scientists call this “reward conditioning” and the PET scan images show dark pixels in the brain slices that apparently represent dopamine being squirted into certain regions. Those neurons are getting their little fixes from the neurotransmitter that makes them happy. Kind of like a bunch of ophthalmologists at “happy hour” on a Friday evening after a long week of helping people see and documenting in their electronic health records. Hence, my tendency to keep checking my phone is explained. There are three other items that cause the neurons of ophthalmologists to focus attention and garner their rewards of dopamine molecules, just like the dolphins at water parks receiving their fish snacks after their jump through rings of fire. Those include: ‘This phone habit of mine is not like a chemical dependency— it is a chemical dependency.’ Sometimes, there is good news. Sometimes, great news. Occasionally, the news is disappointing. And sometimes there really isn’t any news worth seeing. Then I put the device down, only to find myself looking back at it within a few minutes. Some people are critical of this habit. They say that looking at a phone all day means you are not fully engaged with your surroundings and not living in the moment. But I have found it very, very difficult to stop. Now I know why. This phone habit of mine is not like a chemical dependency—it is a chemical dependency. Or so says recent research published in Current Biology.1 My attention was garnered in an article about this work entitled “Why You Can’t Stop Checking Your Phone.”2 1. Femtophaco lasers 2. Syringes filled with anti-VEGF agents 3. Each and every issue of Ophthalmology Times Q References 1. Anderson BA et al. The role of dopamine in value-based attentional orienting. Current Biology. 2016;26:550-555. 2. Why You Can’t Stop Checking Your Phone. Johns Hopkins Magazine. Vol. 68, Spring 2016. 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Pursuing the promise of new therapies in ophthalmics to address patients’ unmet needs. Just watch. Visit Shire-Eyes.com ©2015 Shire US Inc., Lexington, MA 02421 S06675 07/15 8 MAY 2016 :: Ophthalmology Times surgery Modality approaches bilateral glaucoma in single treatment Laser therapy gives patients access to strategy that reduces IOP, lowers reliance on drugs By Ahad Mahootchi, MD, Special to Ophthalmology Times get tissue, as well as less destructive to tar* get and adjacent tissue. MP allows for a 39.3 treatment effect with> 33% IOP reduction at 18 months, out the inflammation n = 38 patients and destructive effect > 61% medication reduction (2.1 to 1.3) associated with con> 73% success rate with 1.3 sessions 31.1 tinuous wave laser. 28.0 I prefer to perform 27.4 27.1 26.2 26.6 25.8 MicroPulse TSCPC for about 3 minutes total, or about 90 seconds in each hemisphere, in Baseline 1 day 1 wk 1 mo 3 mos 6 mos 12 mos 18 mos patients with darker colored irises. The *Tan A, Chockalingam M, Aquino M, Lim Z, See J, Chew P. Micropulse treatment duration transscleral diode laser cyclophotocoagulation in the treatment of refractory m ight increase to glaucoma. Clin Experiment Ophthalmol. 2010;38:266–272. 100 to 110 seconds per hemisphere in a (FIGURE 1) Evidence that the laser therapy is effective even in the most difficult cases is demonstrated in a recent prospective interventional blue eye. case series by Tan et al. (Figure courtesy of Ahad Mahootchi, MD) Because the MicroPulse TSCPC has a favorable safety profile A NOV EL T R E AT MEN T The probe powered by the laser may look simi- it is widely applicable. I have used it for a wide I contacted these researchers to see what they lar to traditional transcleral cyclophotocoagu- range of cases, ranging from mild to end-stage, thought the durability of MicroPulse TSCPC may and have yet to find a patient type in which be. Dr. Tan and colleagues reported to me that lation (TSCPC). However, there is nothing similar in regard it is not a viable option. Even in uveitis-prone many of the patients they followed in the study to patient selection or postop experience to the patients I have not stirred up iritis. were still doing well 5 and even 6 years after Evidence that MicroPulse TSCPC is effec- a single treatment (personal communication). patient or physician. It may look like the laser cyclodestructive procedures of yester-year when tive even in the most difficult cases is demonI have performed MicroPulse TSCPC now in performing this 3-minute procedure. That is strated in a recent prospective interventional 75 cases with a full range of glaucoma, from case series by Tan et al.2 where the similarity ends. mild to severe, using varying treatment endPatients recover vision in minIn a series of 40 eyes of 38 points. In some cases, the goal was to achieve utes and are free of pain and consecutive patients with re- lower pressure, while in others, patients exLaser therapy that inflammation. The ciliary body fractory glaucoma, mean IOP pressed a desire to reduce their reliance on approaches bilateral laser treatment does not ablate was reduced from 39.3 ± 12.6 costly glaucoma drops. Regardless, the preglaucoma in a single the ciliary body. The mechanism mm Hg at baseline to 31.1 ± defined treatment endpoint has been achieved treatment provides is believed to enhance uveo13.4 mm Hg at 1 day, 28.0 ± in 73 of these cases. greater efficacy for scleral outflow in addition to Ultimately, MicroPulse TSCPC may supplant 12.0 mm Hg at 1 week, 27.4 ± the practice and affecting outflow.1 12.7 mm Hg at 1 month, 27.1 ± many current intermediary approaches to glaumore convenience for 13.6 mm Hg at 3 months, 25.8 ± coma. It is easier to perform than a valve proAlthough seemingly counterpatients. 14.5 mm Hg at 6 months, 26.6 cedure or a trabeculectomy, and has a much intuitive, MicroPulse is not sim± 14.7 mm Hg at 12 months, more favorable safety profile. ply a reduction in laser power It can easily be a first-line therapy for peoand 26.2 ± 14.3 mm Hg at 18 or a way to adjust the interval; rather, MicroPulse is a different way of ap- months (p < 0.001 at all time points (Figure 1). ple who cannot afford or do not want to use Before investing in a P3 probe for my clinic, plying laser—both more specific to the tarContinues on page 9 : Single treatment T TAKE-HOME NUHS Prospective Clinical Study IOP (mmHg) hough medical therapy is the typical first line-treatment strategy in glaucoma, there is much interest in developing therapy approaches that effectively lower IOP while reducing the need for drop therapy. Incisional surgical options typically remain a consideration for end-stage disease, while the largest need in glaucoma management is an approach for the majority of patients with mild-to-moderate glaucoma. In particular, laser therapy offers a viable strategy for these patients, although not all platforms for delivery are equal. The MicroPulse P3 (MP3) probe powered by the Cyclo G6 laser (Iridex) is a powerfulyet-gentle treatment for a range of patients, equally applicable to wide assortment of glaucoma types. This modality represents a new way to treat glaucoma that results in pressure reductions while lessening patients’ reliance on medical therapy. MAY 2016 :: Ophthalmology Times surgery CAPSULOTOMY ( Continued from page 1 ) To make the capsulotomy, very low energy electrical impulses are delivered to the cutting ring. This causes a rapid and momentary increase of temperature, leading to vaporization of water molecules that are trapped between the cutting ring and the capsule. The result is instantaneous mechanical cleavage of the capsule membrane around the entire circumference of the ring in about 4 ms. “There is no heating of the tissue with this technique, and it is not cautery, which would create a capsulotomy with a weaker edge,” he said. Once the capsulotomy is made, the suction is released, and the device is withdrawn from the eye along with the excised capsule disc. PPC performance has been evaluated in several studies. Results from a series of investigations conducted by Dr. Chang with Nick Mamalis, MD, and Liliana Werner, MD, PhD, in human cadaver eyes and in vivo in rabbit eyes highlighted the safety and efficacy of the novel tool for creating round, complete capsulotomies [Ophthalmology. 2016;123:255-264]. Serial slit lamp examination in the animal eyes showed no differences comparing eyes that underwent PPC and fellow eyes in which capsulotomy was done using manual continuous SINGLE TREATMENT ( Continued from page 8 ) drops, yet it is also a successful adjunctive option when drop therapy does not achieve the target pressure. It is more widely applicable than laser trabeculoplasty; it can also be used at the time of cataract surgery, although unlike some of the MIGS category, it can be reimbursed as a stand-alone procedure. The availability of MicroPulse TSCPC has allowed us to design a treatment algorithm for bilateral treatment of glaucoma, which would not be possible with other treatments, because of visual morbidity. When I have a patient with bilateral glaucoma, I will bring him or her to the operating room and use a very low dose combination of Fentanyl, Versed, and Propofol to induce a mild anesthetic state without ophthalmic blocking for the 6 minutes it takes to apply the treatment. We have found that we can avoid using a block at all. As a result, patients are The technology consists of a control console and a disposable handpiece containing the capsulotomy tip. The tip is comprised of a 6-mm silicone suction cup and the cutting element—a 5-mm nitinol capsulotomy ring. (Image courtesy of Mynosy) curvilinear capsulorhexis (CCC) with respect to corneal edema, anterior chamber inflammation, capsular fibrosis, or capsule opacification. “We also used a thermocouple to measure temperature change at the iris and corneal endothelium during the PPC and found negligible increases in both duration and magnitude,” Dr. Chang said. The capsulotomies created with the nanopulse technology were found to be perfectly circular and free of tags. Intraoperative MiyakeApple videos obtained during a study using paired human cadaver eyes showed minimal zonular movement during the procedure that was no different than that occurring during manual CCC. Imaging of human cadaver capsulotomies with scanning electron microscopy showed the capsule edges had the same smooth appearance of those created by manual CCC. In collaboration with Vance M. Thompson, MD, John P. Berdahl, MD, and Joel M. Solano, MD, a comparative study in paired human cadaver eyes evaluated rim strength of capsulotomies created using the PPC technology, a femtosecond laser, or manual CCC [Ophthalmology. 2016;123:265-274]. The PPC capsulotomies were consistently the most resistant to tearing when capsulotomy edge retractors attached to force transducers were used to stretch the edge. “The finding that the PPC capsulotomy edge was significantly stronger was intriguing,” Dr. Chang said. ■ able to leave the recovery area in 15 minutes or less. They return to normal activities immediately after that. The postoperative recovery area is never congested when using the lowdose anesthesia. nient for patients. This is not just a new way to perform the same treatments that are performed with standard continuous wave laser, it gives patients access to a safe and effective treatment strategy that reduces IOP and lessens dependence on medical therapy. ■ CONCLUSION About one-half of patients who respond to treatment do so within 2 weeks. After the first couple of cases, I realized that inflammation was significantly reduced compared with other procedures and laser treatments, and so it was unnecessary to see patients back on the first post-treatment day. As a result, the need for follow-up examinations is based on how badly the visual field is at baseline. If the field is not terrible, (as most mild-to-moderate cases are) there is a bit more latitude in bringing the patient back for follow-up. This treatment modality has proven to be an effective addition to practice. Addressing bilateral glaucoma in a single treatment—one that does not depend on patients’ compliance— is more efficient for practice and more conve- DAVID F. CHANG, MD E: [email protected] This article was adapted from Dr. Chang’s presentation at the 2015 meeting of the European Society of Cataract and Refractive Surgeons. Dr. Chang is a consultant for Mynosys. References 1. Radcliffe N, Vold S, Kammer JA, et al. MicroPulse trans-scleral cyclophotocoagulation (mTSCPC) for the treatment of glaucoma using the MicroPulse P3 Device. Presented at the American Glaucoma Society annual meeting, 2015. 2. Tan AM, Chockalingam M, Aquino MC, Lim ZI, See JL, Chew PT. Micropulse transscleral diode laser cyclophotocoagulation in the treatment of refractory glaucoma. Clin Experiment Ophthalmol. 2010;38:266272. AHAD MAHOOTCHI, MD P: 813/779-3338 E: [email protected] Ahad Mahootchi, MD, is medical director of The Eye Clinic of Florida, Zephyrhills, FL. He is a consultant and speaker for Iridex. 9 Making Allergic Conjunctivitis Treatment a Priority Marguerite B. McDonald, MD, FACS, and John D. Sheppard, MD, MMSc We make treating allergic conjunctivitis a priority by making sure our patients get BEPREVE® (bepotastine besilate ophthalmic solution) 1.5%, for severe itch due to allergic conjunctivitis, and ALREX® (loteprednol etabonate ophthalmic suspension 0.2%), for multiple signs and symptoms of seasonal allergic conjunctivitis. Ocular allergy affects up to 20% of the US population—more than 60 million Americans.1,2 Yet in spite of its prevalence, ocular allergy is underrecognized.1,2 Why? Perhaps because perennial or seasonal ocular allergies are not blinding. Despite the fact that perennial or seasonal ocular allergies are not blinding, we as ophthalmologists need to recognize allergic conjunctivitis as an important condition to diagnose and treat appropriately. Conjunctivitis can result in symptoms that may contribute to discontinuation of contact lens wear and interference with surgical outcomes.3-5 BY NO MEANS BENIGN When allergic conjunctivitis inflames the ocular surface, fluid can accumulate in the subconjunctival space. Repeated cycles of inflammation can cause chalasis, subconjunctival hemorrhages, and inhibition of the normal distribution and collection of tears. When patients with allergic conjunctivitis rub their eyes, they INDICATION IMPORTANT SAFETY INFORMATION BEPREVE® (bepotastine besilate ophthalmic solution) 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. • ALREX® (loteprednol etabonate ophthalmic suspension 0.2%) is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of the ocular structures. ALREX® is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids. • Prolonged use of ALREX® is associated with several warnings and precautions, including glaucoma with optic nerve damage, defects in visual acuity, cataract formation, secondary ocular infections, exacerbation or prolongation of viral ocular infections (including herpes simplex), delay in wound healing and increase in bleb formation. • If this product is used for 10 days or longer, intraocular pressure should be monitored. The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification. • Ocular adverse reactions occurring in 5-15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2%-0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia. IMPORTANT SAFETY INFORMATION • BEPREVE® is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients. • BEPREVE® is for topical ophthalmic use only. To minimize risk of contamination, do not touch the dropper tip to the eyelids or to any surface. Keep the bottle closed when not in use. • BEPREVE® should not be used to treat contact lens-related irritation. Remove contact lens prior to instillation of BEPREVE®. Lenses may be reinserted 10 minutes after BEPREVE® administration. • The most common adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions occurring in 2%–5% of patients were eye irritation, headache, and nasopharyngitis. INDICATION ALREX® (loteprednol etabonate ophthalmic suspension) 0.2% is indicated for temporary relief of the signs and symptoms of seasonal allergic conjunctivitis. can introduce microbes to the ocular surface, which can lead to other ocular complications. IMPACT ON SURGERY A poor quality tear film from ocular surface diseases such as allergic conjunctivitis can affect the accuracy of preoperative biometry, which in turn affects IOL power selection in cataract surgery.6 Without repeatable, confirmable biometry in our patients, we set ourselves up for refractive surprises and postoperative complaints. A patient with allergic conjunctivitis will reveal markedly increased tear levels of proinflammatory cytokines— inflammatory mediators that can negatively impact postsurgical healing.5 In addition, the itch associated with allergic conjunctivitis can provoke eye rubbing, which not only perpetuates the inflammatory process but can also lead to postoperative LASIK flap dislocation.7 Ocular allergy is also a risk factor for regression and haze after PRK and can disqualify a patient from LASIK until symptoms resolve.4,5 Following LASIK surgery, patients with ocular allergies are more likely to develop Sands of the Sahara, or diffuse lamellar keratitis.8 DIAGNOSIS The most common ocular allergy complaints are itching and redness, followed by tearing, lid swelling, and a grey-white stringy mucous. A history of severe ocular itching, or a seasonal itching pattern, almost always indicates allergic conjunctivitis. Patients can have a variety of signs, such as injection, chemosis, conjunctival chalasis, lid droop, and red, thickened lids. There is a wealth of information on examination of the everted upper tarsus: conjunctival hyperemia, papillae in the acute phase, follicles in the chronic phase, conjunctival ulcerations in extreme cases, and conjunctival scarring in chronic cases. RELIEF OF SEVERE OCULAR ITCH For acute-phase problems, a selective therapeutic agent with a fast onset of action such as BEPREVE® (bepotastine besilate ophthalmic solution) 1.5% is a good choice. We also appreciate the comfort BEPREVE® provides to patients. In a 6-week, double-masked, randomized, placebo-controlled trial in which 861 patients received BEPREVE® or placebo, 92% of BEPREVE®-treated patients indicated that they experienced no discomfort (grade 0) on a 0 to 3 ocular comfort scale in an analysis of >6400 assessments of both eyes.11 to understand that as their eyecare practitioner, we are aware of the therapeutic options available to treat their condition and have chosen to prescribe BEPREVE® or ALREX® carefully. MULTISYMPTOM RELIEF Figure 1 BEPREVE® is a selective Blocker of histamine (H1). BEPREVE®, a selective H1 blocker (Figure 1), offers relief in minutes, and has demonstrated efficacy in severe ocular itch.9 In two double-masked, randomized, placebo-controlled trials, 68% of BEPREVE®-treated eyes (n = 104 eyes) in patients with severe ocular itch achieved complete relief of ocular itch vs 3% of placebo treated eyes (n = 98 eyes) in minutes (P ≤ 0.001).10 Marguerite B. McDonald, MD, is a Clinical Professor of Ophthalmology at NYU Langone Medical Center in New York, NY, an Adjunct Clinical Professor of Ophthalmology at Tulane University Health Sciences Center in New Orleans, and a cornea/refractive surgery/anterior segment specialist with Ophthalmic Consultants of Long Island in Lynbrook, NY. Dr. McDonald is a consultant to Bausch + Lomb; the content of this article is sponsored by Bausch + Lomb. John D. Sheppard, MD, MMSc, is President and Managing Partner of Virginia Eye Consultants, Clinical Director of the Thomas R. Lee Ocular Pharmacology Center, and Professor of Ophthalmology, Microbiology and Molecular Biology at Eastern Virginia Medical School, and a Medical Director of the Lions Eye Bank of Eastern Virginia in Norfolk, Virginia. Dr. Sheppard is a consultant for Bausch + Lomb; the content of this article is sponsored by Bausch + Lomb. If the patient presents with more of a chronic phase, is already on an antihistamine/mast cell stabilizer, or has multiple symptoms of seasonal allergic conjunctivitis, we prescribe ALREX® (loteprednol etabonate ophthalmic suspension 0.2%).12 We recommend ALREX® for patients with seasonal allergic conjunctivitis because it reduced inflammation and allergic response quickly and effectively and has demonstrated efficacy in itching, burning/stinging, discomfort, foreign body sensation, tearing, and redness. In two double-masked, placebocontrolled, six-week environmental studies conducted during pollen season (N = 268), ALREX® QID was superior to placebo QID in treating the signs and symptoms of seasonal allergic conjunctivitis. ALREX® provided reduction in bulbar conjunctival injection and itching, beginning approximately 2 hours after instillation of the first dose and throughout the first 14 days of treatment.13,14 In addition, in the two 42-day clinical trials, 1 out of 133 patients treated with ALREX® experienced an IOP elevation ≥ 10 mm Hg compared to 1 out of 135 patients treated with placebo.12 ACCESSIBILITY Thanks to copay assistance programs from Bausch + Lomb, eligible patients can limit their copay on either their BEPREVE® or ALREX® prescriptions. Often, we can print coupons while patients are still in the office by going to Bausch.com. Ask your Bausch + Lomb Sales Representative for more information. Sometimes a patient or pharmacist will inquire about a generic version of BEPREVE® or ALREX®. We let them know that there is no generic equivalent for either medication. Patients need Please see Full Prescribing Information for BEPREVE® and Brief Summary of Prescribing Information for ALREX® on following pages. REFERENCES 1. Rosario N, Bielory L. Epidemiology of allergic conjunctivitis. Curr Opin Allergy Clin Immunol. 2011;11:471-6. 2. Bielory L, Katelaris CH, Lightman S, et al. Treating the ocular component of allergic rhinoconjunctivitis and related eye disorders. MedGenMed. 2007;9(3):35. 3. Blaiss MS. Allergic rhinoconjunctivitis: burden of disease. Allergy Asthma Proc. 2007 Jul-Aug; 28(4):393-7. 4. Yang HY, Fujishima H, Toda I, et al. Allergic conjunctivitis as a risk factor for regression and haze after photorefractive keratectomy. Am J Ophthalmol. 1998 Jan;125(1):54-8. 5. Bielory BP, O’Brien TP. Allergic complications with laser-assisted in-situ keratomileusis. Curr Opin Allergy Clin Immunol. 2011 Oct;11(5):483-91. 6. Montes-Mico R. Role of the tear film in the optical quality of the human eye. J Cataract Refract Surg. 2007;33:1631-5. 7. Padmanabhan P, Aiswaryah R, Abinaya Priya V. Post-LASIK keratectasia triggered by eye rubbing and treated with topography-guided ablation and collagen cross-linking — a case report. Cornea. 2012;31(5):575-80. 8. Boorstein SM, Henk HJ, Elner VM. Atopy: a patient-specific risk factor for diffuse lamellar keratitis. Ophthalmology. 2003 Jan;110(1):131-7. 9. BEPREVE [package insert]. Tampa, FL: Bausch & Lomb Incorporated; 2012. 10. Meier EJ, Torkildsen GL, Gow JA, et al; for Bepotastine Besilate Ophthalmic Solutions Study Group. Integrated phase III trials of bepotastine besilate ophthalmic solution 1.5% for ocular itching associated with allergic conjunctivitis. Allergy Asthma Proc. 2012;33:265-274. 11. Data on file. Clinical study report CL-SAF 040507-P. NDA 22-288. Ista Pharmaceuticals, Inc. October 27, 2008. 12. ALREX [package insert]. Tampa, FL: Bausch & Lomb Incorporated; 2013. 13. Dell SJ, Lowry GM, Northcutt JA, et al. A randomized, double-masked, placebo-controlled parallel study of 0.2% loteprednol etabonate in patients with seasonal allergic conjunctivitis. J Allergy Clin Immunol. 1998 Aug;102(2):251-5. 14. Shulman DG, Lothringer LL, Rubin JM, et al. A randomized, double- masked, placebo-controlled parallel study of loteprednol etabonate 0.2% in patients with seasonal allergic conjunctivitis. Ophthalmology. 1999;106(2):362-369. 15. Kato M, Nishida A, Aga Y, et al. Pharmacokinetic and pharmacodynamic evaluation of central effect of the novel antiallergic agent betotastine besilate. Arzneimittelforschung. 1997;47(10):1116-1124. 16. Hawkins DW, Bussey HI, Trisant LM. Hypertension. In: Dipiro T, ed. Pharmacotherapy: A Pathophysiologic Approach. Stamford, CT: Appleton & Lange; 1997:195-218. 17. Crismon ML, Dorson PG. Schizophrenia. In: Dipiro T, ed. Pharmacotherapy: A Pathophysiologic Approach. Stamford, CT: Appleton & Lange; 1997:1367-1394. 18. Data on file. Bepreve® Integrated Summary of Safety. NDA 22-288. ISTA Pharmaceuticals, Inc. October 18, 2008. ®/TM are trademarks of Bausch & Lomb Incorporated or its affiliates. ©2016 Bausch & Lomb Incorporated BEP.0018.USA.16 BRIEF SUMMARY OF PRESCRIBING INFORMATION This Brief Summary does not include all the information needed to use Alrex® (loteprednol etabonate ophthalmic suspension 0.2%) safely and effectively. See full prescribing information for Alrex. Alrex ® loteprednol etabonate ophthalmic suspension 0.2% Sterile Ophthalmic Suspension Rx only INDICATIONS AND USAGE ALREX Ophthalmic Suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis. CONTRAINDICATIONS ALREX, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. ALREX is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids. WARNINGS Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids should be used with caution in the presence of glaucoma. Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. PRECAUTIONS General: For ophthalmic use only. The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated. If this product is used for 10 days or longer, intraocular pressure should be monitored. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate. Information for Patients: This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the suspension. If redness or itching becomes aggravated, the patient should be advised to consult a physician. Patients should be advised not to wear a contact lens if their eye is red. ALREX should not be used to treat contact lens related irritation. The preservative in ALREX, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least ten minutes after instilling ALREX before they insert their contact lenses. Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma tk assay, or in a chromosome aberration test in human lymphocytes, or in vivo in the single dose mouse micronucleus assay. Treatment of male and female rats with up to 50 mg/kg/day and 25 mg/kg/day of loteprednol etabonate, respectively, (1500 and 750 times the maximum clinical dose, respectively) prior to and during mating did not impair fertility in either gender. Pregnancy: Teratogenic effects: Pregnancy Category C. Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (85 times the maximum daily clinical dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (15 times the maximum daily clinical dose). Oral treatment of rats during organogenesis resulted in teratogenicity (absent innominate artery at ≥5 mg/kg/day doses, and cleft palate and umbilical hernia at ≥50 mg/kg/day) and embryotoxicity (increased postimplantation losses at 100 mg/kg/day and decreased fetal body weight and skeletal ossification with ≥50 mg/kg/day). Treatment of rats with 0.5 mg/kg/day (15 times the maximum clinical dose) during organogenesis did not result in any reproductive toxicity. Loteprednol etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of ≥5 mg/kg/day. Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from the start of the fetal period through the end of lactation, a maternally toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased growth and survival, and retarded development in the offspring during lactation; the NOEL for these effects was 5 mg/kg/day. Loteprednol etabonate had no effect on the duration of gestation or parturition when administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period. There are no adequate and well controlled studies in pregnant women. ALREX Ophthalmic Suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when ALREX is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. ADVERSE REACTIONS Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. Ocular adverse reactions occurring in 5-15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2% - 0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia. Other ocular adverse reactions occurring in less than 5% of patients include conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae, and uveitis. Some of these events were similar to the underlying ocular disease being studied. Non-ocular adverse reactions occurred in less than 15% of patients. These include headache, rhinitis and pharyngitis. In a summation of controlled, randomized studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (≥10 mm Hg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo. Among the smaller group of patients who were studied with ALREX, the incidence of clinically significant increases in IOP (≥10 mm Hg) was 1% (1/133) with ALREX and 1% (1/135) with placebo. DOSAGE AND ADMINISTRATION SHAKE VIGOROUSLY BEFORE USING. One drop instilled into the affected eye(s) four times daily. Revised: August 2013. Bausch & Lomb Incorporated, Tampa, Florida 33637 ©Bausch & Lomb Incorporated Alrex® is a registered trademark of Bausch & Lomb Incorporated Based on 9007904-9005504 US/ALX/15/0004 Issued: 02/2015 BEPREVE® (bepotastine besilate ophthalmic solution) 1.5% HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BEPREVE® (bepotastine besilate ophthalmic solution) 1.5% safely and effectively. See full prescribing information for BEPREVE®. BEPREVE® (bepotastine besilate ophthalmic solution) 1.5% Initial U.S. Approval: 2009 -------------RECENT MAJOR CHANGES-------------Contraindications (4) 06/2012 --------------INDICATIONS AND USAGE-------------BEPREVE® is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis. (1) -----------DOSAGE AND ADMINISTRATION---------Instill one drop into the affected eye(s) twice a day (BID). (2) ----------DOSAGE FORMS AND STRENGTHS-------Solution containing bepotastine besilate, 1.5%. (3) -----------------CONTRAINDICATIONS----------------Hypersensitivity to any component of this product. (4) -----------WARNINGS AND PRECAUTIONS---------t 5 PNJOJNJ[FUIFSJTLPGDPOUBNJOBUJPOEPOPU touch dropper tip to any surface. Keep bottle tightly closed when not in use. (5.1) t #&13&7&TIPVMEOPUCFVTFEUPUSFBUDPOUBDU lens-related irritation. (5.2) t 3 FNPWFDPOUBDUMFOTFTQSJPSUPJOTUJMMBUJPOPG BEPREVE. (5.2) ------------------ADVERSE REACTIONS---------------The most common adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions which occurred in 2-5% of subjects were eye irritation, headache, and nasopharyngitis. (6) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated. at 1-800-3230000, or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch. See 17 for PATIENT COUNSELING INFORMATION Revised: 10/2012 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Contamination of Tip and Solution 5.2 Contact Lens Use 5.3 Topical Ophthalmic Use Only 6 ADVERSE REACTIONS 6.1 Clinical Trial Experience 6.2 Post-Marketing Experience 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis and Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 17.1 Topical Ophthalmic Use Only 17.2 Sterility of Dropper Tip 17.3 Concomitant Use of Contact Lenses FULL PRESCRIBING INFORMATION The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation. Other adverse reactions occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis. 1 INDICATIONS AND USAGE BEPREVE® (bepotastine besilate ophthalmic solution) 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. 2 DOSAGE AND ADMINISTRATION Instill one drop of BEPREVE into the affected eye(s) twice a day (BID). 3 DOSAGE FORMS AND STRENGTHS Topical ophthalmic solution containing bepotastine besilate 1.5%. 4 CONTRAINDICATIONS Bepreve is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients [see Adverse Reactions (6.2)]. 5 WARNINGS AND PRECAUTIONS 5.1 Contamination of Tip and Solution To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. 5.2 Contact Lens Use Patients should be advised not to wear a contact lens if their eye is red. BEPREVE should not be used to treat contact lens-related irritation. BEPREVE should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of BEPREVE. The preservative in BEPREVE, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of BEPREVE. 5.3 Topical Ophthalmic Use Only BEPREVE is for topical ophthalmic use only. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. *Sections or subsections omitted from the full prescribing information are not listed 6.2 Post Marketing Experience Hypersensitivity reactions have been reported rarely during the post-marketing use of BEPREVE. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure. The hypersensitivity reactions include itching, body rash, and swelling of lips, tongue and/or throat. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C: Teratogenicity studies have been performed in animals. Bepotastine besilate was not found to be teratogenic in rats during organogenesis and fetal development at oral doses up to 200 mg/kg/day (representing a systemic concentration approximately 3,300 times that anticipated for topical ocular use in humans), but did show some potential for causing skeletal abnormalities at 1,000 mg/kg/day. There were no teratogenic effects seen in rabbits at oral doses up to 500 mg/kg/day given during organogenesis and fetal development (>13,000 times the dose in humans on a mg/kg basis). Evidence of infertility was seen in rats given oral bepotastine besilate 1,000 mg/kg/day; however, no evidence of infertility was observed in rats given 200 mg/kg/ day (approximately 3,300 times the topical ocular use in humans). The concentration of radiolabeled bepotastine besilate was similar in fetal liver and maternal blood plasma following a single 3 mg/kg oral dose. The concentration in other fetal tissues was one-third to one-tenth the concentration in maternal blood plasma. An increase in stillborns and decreased growth and development were observed in pups born from rats given oral doses of 1,000 mg/kg/day during perinatal and lactation periods. There were no observed effects in rats treated with 100 mg/kg/day. There are no adequate and well-controlled studies of bepotastine besilate in pregnant women. Because animal reproduction studies are not always predictive of human response, BEPREVE® (bepotastine besilate ophthalmic solution) 1.5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 8.3 Nursing Mothers Following a single 3 mg/kg oral dose of radiolabeled bepotastine besilate to nursing rats 11 days after delivery, the maximum concentration of radioactivity in milk was 0.40 mcg-eq/mL 1 hour after administration; at 48 hours after administration the concentration was below detection limits. The milk concentration was higher than the maternal blood plasma concentration at each time of measurement. It is not known if bepotastine besilate is excreted in human milk. Caution should be exercised when BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is administered to a nursing woman. 8.4 Pediatric Use Safety and efficacy of BEPREVE (bepotastine besilate ophthalmic solution) 1.5% have not been established in pediatric patients under 2 years of age. Efficacy in pediatric patients under 10 years of age was extrapolated from clinical trials conducted in pediatric patients greater than 10 years of age and from adults. 8.5 Geriatric Use No overall difference in safety or effectiveness has been observed between elderly and younger patients. 11 DESCRIPTION BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of BEPREVE contains 15 mg bepotastine besilate. Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha -2-pyridylbenzyl]oxy]-1piperidine butyric acid monobenzenesulfonate. The chemical structure for bepotastine besilate is: Bepotastine besilate is a white or pale yellowish crystalline powder. The molecular weight of ® bepotastine besilate is 547.06 daltons. BEPREVE ophthalmic solution is supplied as a sterile, aqueous 1.5% solution, with a pH of 6.8. The osmolality of BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is approximately 290 mOsm/kg. Each mL of BEPREVE® (bepotastine besilate ophthalmic solution) 1.5% contains: Active: Bepotastine besilate 15 mg (equivalent to 10.7 mg bepotastine) Preservative: benzalkonium chloride 0.005% Inactives: monobasic sodium phosphate dihydrate, sodium chloride, sodium hydroxide to adjust pH, and water for injection, USP. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Bepotastine is a topically active, direct H1receptor antagonist and an inhibitor of the release of histamine from mast cells. 12.3 Pharmacokinetics Absorption: The extent of systemic exposure to bepotastine following topical ophthalmic administration of bepotastine besilate 1% and 1.5% ophthalmic solutions was evaluated in 12 healthy adults. Following one drop of 1% or 1.5% bepotastine besilate ophthalmic solution to both eyes four times daily (QID) for seven days, bepotastine plasma concentrations peaked at approximately one to two hours post-instillation. Maximum plasma concentration for the 1% and 1.5% strengths were 5.1 ± 2.5 ng/mL and 7.3 ± 1.9 ng/mL, respectively. Plasma concentration at 24 hours post-instillation were below the quantifiable limit (2 ng/mL) in 11/12 subjects in the two dose groups. Distribution: The extent of protein binding of bepotastine is approximately 55% and independent of bepotastine concentration. Metabolism: In vitro metabolism studies with human liver microsomes demonstrated that bepotastine is minimally metabolized by CYP450 isozymes. In vitro studies demonstrated that bepotastine besilate does not inhibit the metabolism of various cytochrome P450 substrate via inhibition of CYP3A4, CYP2C9, and CYP2C19. The effect of bepotastine besilate on the metabolism of substrates of CYP1A2, CYP2C8, CYP2D6 was not studied. Bepotastine besilate has a low potential for drug interaction via inhibition of CYP3A4, CYP2C9, and CYP2C19. Excretion: The main route of elimination of bepotastine besilate is urinary excretion (with approximately 75-90% excreted unchanged in urine). 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term dietary studies in mice and rats were conducted to evaluate the carcinogenic potential of bepotastine besilate. Bepotastine besilate did not significantly induce neoplasms in mice receiving a nominal dose of up to 200 mg/kg/day for 21 months or rats receiving a nominal dose of up to 97 mg/kg/day for 24 months. These dose levels represent systemic exposures approximating 350 and 200 times that achieved with human topical ocular use. The no observable adverse effect levels for bepotastine besilate based on nominal dose levels in carcinogenicity tests were 18.7 to 19.9 mg/kg/day in mice and 9.6 to 9.8 mg/kg/day in rats (representing exposure margins of approximately 60 and 20 times the systemic exposure anticipated for topical ocular use in humans). There was no evidence of genotoxicity in the Ames test, in CHO cells (chromosome aberrations), in mouse hepatocytes (unscheduled DNA synthesis), or in the mouse micronucleus test. When oral bepotastine was administered to male and female rats at doses up to 1,000 mg/kg/day, there was a slight reduction in fertility index and surviving fetuses. Infertility was not seen in rats given 200 mg/kg/day oral bepotastine besilate (approximately 3,300 times the systemic concentration anticipated for topical ocular use in humans). 14 CLINICAL STUDIES Clinical efficacy was evaluated in 2 conjunctival allergen challenge (CAC) studies (237 patients). BEPREVE (bepotastine besilate ophthalmic solution) 1.5% was more effective than its vehicle for relieving ocular itching induced by an ocular allergen challenge, both at a CAC 15 minutes postdosing and a CAC 8 hours post dosing of BEPREVE. The safety of BEPREVE was evaluated in a randomized clinical study of 861 subjects over a period of 6 weeks. 16 HOW SUPPLIED/STORAGE AND HANDLING BEPREVE® (bepotastine besilate ophthalmic solution) 1.5% is supplied in a white low density polyethylene plastic squeeze bottle with a white controlled dropper tip and a white polypropylene cap in the following size: 5 mL (NDC 24208-629-02) 10 mL (NDC 24208-629-01) STORAGE Store at 15º – 25ºC (59º – 77ºF). 17 PATIENT COUNSELING INFORMATION 17.1 Topical Ophthalmic Use Only For topical ophthalmic administration only. 17.2 Sterility of Dropper Tip Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents. 17.3 Concomitant Use of Contact Lenses Patients should be advised not to wear a contact lens if their eye is red. Patients should be advised that BEPREVE should not be used to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of BEPREVE. The preservative in BEPREVE, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of BEPREVE. Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 Under license from: Senju Pharmaceutical Co., Ltd. Osaka, Japan 541-0046 ®/TM are trademarks of Bausch & Lomb Incorporated or its affiliates © 2012 Bausch & Lomb Incorporated. US/BEP/13/0028 4/13 14 MAY 2016 :: Ophthalmology Times clinical diagnosis Pediatric glaucoma can have impact beyond clinical effect Multifaceted approach takes into account psychological, social burdens as children age By Nancy Groves; Reviewed by Alana L. Grajewski, MD MIAMI :: hat happens to children treated for glaucoma as they grow older? The short answer is that life goes on. Just like other kids, they want to be active, get an education, have a career, date, get married, and have children. But even if their glaucoma has been effectively cured, the impact lingers. “They have anatomical things that have followed them, and they have other baggage that has followed them,” said Alana L. Grajewski, MD. While the anatomical issues have been well studied, literature on the psychological-social burden of childhood glaucoma on children and families is limited, and these quality of life issues should be examined more formally, she said, noting that this is one goal of the Childhood Glaucoma Research Network (CGRN), an international group she helped found several years ago. Providers need more information on the relationship between the care burden and other effects of childhood glaucoma, such as depression in caregivers and visually impaired children, she said. “It should be an essential part of our holistic approach to the management of glaucoma,” said Dr. Grajewski, director, Samuel and Ethel Balkan Pediatric International Glaucoma Center, Bascom Palmer Eye Institute, and professor of ophthalmology, University of Miami Miller School of Medicine. She observed that glaucoma experts who have treated very young children and then continued to follow them for years are uniquely positioned to understand the importance of such a multifaceted approach. As part of a longstanding patient-parent-provider relationship, they have become familiar enough to be invited to graduations and weddings and may have fielded questions from now-grown patients on the risks of inherited glaucoma in the next generation. W Children who have been undergoing treatment or follow-up for years can also share their experiences with newly diagnosed patients and may be more persuasive than doctors, parents, or coaches in getting them to take necessary precautions, such as using protective eyewear for sports. “They know the drill. They’re much more IMPACT BE YON D sensitized to knowing that something can hapCLINIC A L FACTOR S There is also an unmet need for instruments to pen to their eyes,” Dr. Grajewski said. At some point, patients will “graduate” from identify the impact of childhood glaucoma bethe care of pediatric providers, yond the strictly clinical effects. but young adulthood presents “We’re looking for ways to its own concerns, such as decidevaluate this in a more construcAfter childhood ing whether to have children. tive fashion: the process, the glaucoma has “What do we tell them about experience, and the outcome been treated, genetic testing and the risk for of the care,” Dr. Grajewski exophthalmologists their children?” Dr. Grajewski plained. “All of this you hope expect to follow asked. “They may think that they will reduce the physical, psypatients for years, and their parents went through chological, social, and economic monitoring them for so much due to the glaucoma consequences of childhood glaua host of anatomical that they don’t want to subject coma for the affected individual problems that can children of their own to the same and the caregiver.” affect their vision. thing. It’s our job to be sensiThrough her experience treattive to those things and maybe ing pediatric glaucoma, Dr. Grastart looking at those issues in jewski has realized that a teambased approach is most effective and efficient advance or before they leave our care.” She also noted, however, that the managein providing appropriate care for young patients ment of pediatric glaucoma can diverge sigand their caregivers. At the Samuel and Ethel Balkan Interna- nificantly in different countries. It may be uncommon—for any number of tional Pediatric Glaucoma Center, glaucoma specialists partner with experts in pediatric reasons—for children to return to a physician corneal and retinal diseases and amblyopia or clinic for follow-up visits after their disease as well as geneticists and genetic counselors has been treated, and in some places growto address children’s needs as they change ing up visually impaired can present many hardships. ■ through the years. “All of use who take care of kids see where having grown up with something that needs monitoring constantly does affect them, although not necessarily adversely,“ Dr. Grajewski said. “They look back on that experience and make decisions based on it.” TAKE-HOME SUPPORT GROUPS Dr. Grajewski also recommends support groups for young glaucoma patients, tailored to different age groups so that they can talk more freely about the most relevant topics. Middle-school students, for instance, may want to trade tips about make-up and dating, topics their ophthalmologist would never think of or feel comfortable discussing. ALANA L. GRAJEWSKI, MD E: [email protected] This article was adapted from Dr. Grajewski’s presentation at Glaucoma Subspecialty Day during the 2015 meeting of the American Academy of Ophthalmology. She did not indicate any proprietary interest in the subject matter. DUAL-SEGMENT PUMP TECHNOLOGY + Precise fluidics + Pulsatile-free + Quick vacuum rise + Versatile performance PERFORMANCE IN EVERY DETAIL 6XSHULRUFKDPEHUVWDELOLW\WKURXJKVXSHULRUHQJLQHHULQJ†,1,2 That’s the Centurion (HFW ® Only the Centurion Vision System features Active Fluidics™ technology created to: ® ȏ5HGXFHΖ23XFWXDWLRQWKURXJKRXWWKHSURFHGXUH1,2 • Dynamically adjust to maintain chamber stability1,2 • Enhance surgeon control1,2 Contact your Alcon representative to schedule a demonstration and experience the Centurion (HFWIRU\RXUVHOI ® For important product information, please see adjacent page Centurion ® VISION SYSTEM Advancing CATARACT SURGERY © 2015 Novartis 7/15 CNT15039JADi-A † As compared to the INFINITI® Vision System, bottle gravity system. /RUHQWH5)DQQH\'ΖQMHY96KDULI.DVKDQL34XDQWLFDWLRQRIRFFOXVLRQEUHDNVXUJHLQSHULVWDOWLFEDVHGSKDFRHPXOVLFDWLRQV\VWHPV$6&56$62$6\PSRVLXPDQG&RQJUHVV$SULO%RVWRQ86$ 1LFROL00LOOHU.'LPDODQWD5/RNH'-XOHV6WHLQ(\HΖQVWLWXWH8&/$Ζ236WDELOLW\0HDVXUHPHQWDQG&RPSDULVRQ%HWZHHQ*UDYLW\)HGDQG$FWLYHO\&RQWUROOHG3KDFRHPXOVLFDWLRQ6\VWHPV CENTURION® VISION SYSTEM IMPORTANT PRODUCT INFORMATION CAUTION:)HGHUDO86$ODZUHVWULFWVWKLVGHYLFHWRVDOHE\RURQWKHRUGHURIDSK\VLFLDQ$VSDUWRIDSURSHUO\PDLQWDLQHGVXUJLFDO HQYLURQPHQWLWLVUHFRPPHQGHGWKDWDEDFNXSΖ2/ΖQMHFWRUEHPDGHDYDLODEOHLQWKHHYHQWWKH$XWR6HUW®Ζ2/ΖQMHFWRU+DQGSLHFHGRHV not perform as expected. INDICATION: The Centurion®9LVLRQ6\VWHPLVLQGLFDWHGIRUHPXOVLFDWLRQVHSDUDWLRQLUULJDWLRQDQGDVSLUDWLRQRIFDWDUDFWVUHVLGXDO FRUWLFDOPDWHULDODQGOHQVHSLWKHOLDOFHOOVYLWUHRXVDVSLUDWLRQDQGFXWWLQJDVVRFLDWHGZLWKDQWHULRUYLWUHFWRP\ELSRODUFRDJXODWLRQDQG intraocular lens injection. The AutoSert®Ζ2/ΖQMHFWRU+DQGSLHFHLVLQWHQGHGWRGHOLYHUTXDOLHG$FU\6RI® intraocular lenses into the H\HIROORZLQJFDWDUDFWUHPRYDO7KH$XWR6HUW®Ζ2/ΖQMHFWRU+DQGSLHFHDFKLHYHVWKHIXQFWLRQDOLW\RILQMHFWLRQRILQWUDRFXODUOHQVHV7KH AutoSert®Ζ2/ΖQMHFWRU+DQGSLHFHLVLQGLFDWHGIRUXVHZLWKWKH$FU\6RI®OHQVHV612:)61$'61$7WKURXJK61$7DVZHOODV approved AcrySof®OHQVHVWKDWDUHVSHFLFDOO\LQGLFDWHGIRUXVHZLWKWKLVLQVHUWHUDVLQGLFDWHGLQWKHDSSURYHGODEHOLQJRIWKRVHOHQVHV WARNINGS: Appropriate use of Centurion®9LVLRQ6\VWHPSDUDPHWHUVDQGDFFHVVRULHVLVLPSRUWDQWIRUVXFFHVVIXOSURFHGXUHV8VHRI ORZYDFXXPOLPLWVORZRZUDWHVORZERWWOHKHLJKWVKLJKSRZHUVHWWLQJVH[WHQGHGSRZHUXVDJHSRZHUXVDJHGXULQJRFFOXVLRQFRQGLWLRQV EHHSLQJWRQHVIDLOXUHWRVXɝFLHQWO\DVSLUDWHYLVFRHODVWLFSULRUWRXVLQJSRZHUH[FHVVLYHO\WLJKWLQFLVLRQVDQGFRPELQDWLRQVRIWKHDERYH DFWLRQVPD\UHVXOWLQVLJQLFDQWWHPSHUDWXUHLQFUHDVHVDWLQFLVLRQVLWHDQGLQVLGHWKHH\HDQGOHDGWRVHYHUHWKHUPDOH\HWLVVXHGDPDJH *RRGFOLQLFDOSUDFWLFHGLFWDWHVWKHWHVWLQJIRUDGHTXDWHLUULJDWLRQDQGDVSLUDWLRQRZSULRUWRHQWHULQJWKHH\H(QVXUHWKDWWXELQJVDUHQRW RFFOXGHGRUSLQFKHGGXULQJDQ\SKDVHRIRSHUDWLRQ7KHFRQVXPDEOHVXVHGLQFRQMXQFWLRQZLWK$/&21® instrument products constitute a FRPSOHWHVXUJLFDOV\VWHP8VHRIFRQVXPDEOHVDQGKDQGSLHFHVRWKHUWKDQWKRVHPDQXIDFWXUHGE\$OFRQPD\DHFWV\VWHPSHUIRUPDQFHDQG create potential hazards. AES/COMPLICATIONS:ΖQDGYHUWHQWDFWXDWLRQRI3ULPHRU7XQHZKLOHDKDQGSLHFHLVLQWKHH\HFDQFUHDWHDKD]DUGRXVFRQGLWLRQ that may result in patient injury. During any ultrasonic procedure, metal particles may result from inadvertent touching of the ultrasonic WLSZLWKDVHFRQGLQVWUXPHQW$QRWKHUSRWHQWLDOVRXUFHRIPHWDOSDUWLFOHVUHVXOWLQJIURPDQ\XOWUDVRQLFKDQGSLHFHPD\EHWKHUHVXOWRI ultrasonic energy causing micro abrasion of the ultrasonic tip. ATTENTION:5HIHUWRWKH'LUHFWLRQVIRU8VHDQG2SHUDWRUȇV0DQXDOIRUDFRPSOHWHOLVWLQJRILQGLFDWLRQVZDUQLQJVFDXWLRQV and notes. 16 MAY 2016 :: Ophthalmology Times clinical diagnosis In-office therapy may offer MGD relief Patients must play a role in care; surgeons need a systematic treatment approach By Vanessa Caceres; Reviewed by Richard S. Davidson, MD DENVER :: THOUGH IN-OFFICE treatments for meibomian gland dysfunction (MGD) can be helpful, patients also need to know that they must take a role in managing this chronic condition, said Richard S. Davidson, MD. Ophthalmologists must also systematically and consistently follow a treatment plan for patients with MGD to provide relief, explained Dr. Davidson, associate professor and vice chairman, University of Colorado Health Eye Center, Denver. A solid treatment approach for MGD is crucial because the condition may well be the leading cause of dry eye, Dr. Davidson said. These patients often experience discomfort, and they make up a significant chunk of office visits. “We probably all cringe on certain days when we see another burning, itching patient,” he said. Additionally, an unhealthy ocular surface different compared with baseline at 3 years, Dr. Davidson said. can affect surgical outcomes. BlephEx is another treatment for patients At-home treatment has been the mainstay for MGD, and this has included warm compresses, with MGD and consists of a medical-grade disposable micro-sponge that is eyelid scrubs and gland expresapplied to the edge of eyelids sion performed by the patient, and lashes. The device removes Dr. Davidson said. Surgeons have debris and exfoliates eyelids. However, these treatments several in-office The treatments last about 6 to come with their own challenges, treatments available 8 minutes, and patients must including poor compliance, infor meibomian gland maintain good eyelid hygiene adequate heat levels, and padysfunction. and return for treatment every tients only able to self-express 4 to 6 months. the upper portion of the gland. “In theory, it looks pretty These challenges have led to several in-office treatments for blepharitis that good, but there is no data to show it’s beneficial,” Dr. Davidson said. Dr. Davidson outlined. A fourth device is a thermoelectric heat pump One such device that helps with making the diagnosis is an interferometer (LipiView, Tear- (MiBo ThermoFlo, MiBo Medical Group) that Science) that takes precise liquefies the meibum and facilitates the expresmeasurements of tear film sion of gland secretions. Heat is applied to the thickness, takes dynamic outside of the lids, breaking down hardened CENTURION® VISION SYSTEM meibomian imaging, and material inside the glands. The treatment takes IMPORTANT PRODUCT INFORMATION allows the user to quan- up to 12 minutes each eye. One study showed CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician. As part of a properly maintained surgical tify lipid level of tear film. improvement in 73% of patients who had had environment, it is recommended that a backup IOL Injector be made available in the event the AutoSert® IOL Injector “This is helpful for an- previous Lipiflow, Dr. Davidson said. Handpiece does not perform as expected. Yet another MGD treatment is intense pulsed alytical patients because INDICATION: The Centurion®9LVLRQ6\VWHPLVLQGLFDWHGIRUHPXOVLFDWLRQVHSDUDWLRQLUULJDWLRQDQGDVSLUDWLRQRIFDWDUDFWVUHVLGXDO you can show them a num- light, for which there is a paucity of published cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar data for ophthalmic indications, he said. ber,” Dr. Davidson said. coagulation, and intraocular lens injection. The AutoSert® Ζ2/ ΖQMHFWRU +DQGSLHFH LV LQWHQGHG WR GHOLYHU TXDOLHG AcrySof® intraocular lenses into the eye following cataract removal. The AutoSert® IOL Injector Handpiece achieves the However, some research has shown a reThe treatment arm of functionality of injection of intraocular lenses. The AutoSert® IOL Injector Handpiece is indicated for use with the AcrySof® ® duction in artificial tear usage, a decrease in LipiView is Lipiflow, which lenses SN6OWF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof OHQVHVWKDWDUHVSHFLFDOO\LQGLFDWHGIRU use with this inserter, as indicated in the approved labeling of those lenses. applies heat to the inner the Ocular Surface Disease Index score, and WARNINGS: eyelids. The device liq- a reduction in lid margin edema and vascuAppropriate use of Centurion® Vision System parameters and accessories is important for successful procedures. Use of low uefies meibomian gland larity. Patients must return for maintenance YDFXXPOLPLWVORZRZUDWHVORZERWWOHKHLJKWVKLJKSRZHUVHWWLQJVH[WHQGHGSRZHUXVDJHSRZHUXVDJHGXULQJRFFOXVLRQ FRQGLWLRQVEHHSLQJWRQHVIDLOXUHWRVXɝFLHQWO\DVSLUDWHYLVFRHODVWLFSULRUWRXVLQJSRZHUH[FHVVLYHO\WLJKWLQFLVLRQVDQG contents and facilitates the treatments every 6 months to a year. FRPELQDWLRQVRIWKHDERYHDFWLRQVPD\UHVXOWLQVLJQLFDQWWHPSHUDWXUHLQFUHDVHVDWLQFLVLRQVLWHDQGLQVLGHWKHH\HDQGOHDG Finally, Dr. Davidson addressed intraductal release of secretion from WRVHYHUHWKHUPDOH\HWLVVXHGDPDJH*RRGFOLQLFDOSUDFWLFHGLFWDWHVWKHWHVWLQJIRUDGHTXDWHLUULJDWLRQDQGDVSLUDWLRQRZSULRU to entering the eye. Ensure that tubings are not occluded or pinched during any phase of operation. The consumables used meibomian gland probing, in which one study the meibomian glands. The in conjunction with ALCON® instrument products constitute a complete surgical system. Use of consumables and handpieces treatment lasts about 12 reported 96% of the 25 patients included had RWKHUWKDQWKRVHPDQXIDFWXUHGE\$OFRQPD\DHFWV\VWHPSHUIRUPDQFHDQGFUHDWHSRWHQWLDOKD]DUGV immediate post-probing relief. However, the minutes. AES/COMPLICATIONS: ΖQDGYHUWHQWDFWXDWLRQRI3ULPHRU7XQHZKLOHDKDQGSLHFHLVLQWKHH\HFDQFUHDWHDKD]DUGRXVFRQGLWLRQWKDWPD\UHVXOWLQ treatment can be painful, he added. A couple of studies have patient injury. During any ultrasonic procedure, metal particles may result from inadvertent touching of the ultrasonic tip Dr. Davidson noted one drawback that may analyzed Lipiflow results, with a second instrument. Another potential source of metal particles resulting from any ultrasonic handpiece may be the result of ultrasonic energy causing micro abrasion of the ultrasonic tip. including one with 40 eyes hurt in-office treatments for MGD is cost and ATTENTION: in 20 patients that found reimbursement. ■ Refer to the Directions for Use and Operator’s Manual for a complete listing of indications, warnings, cautions that meibomian gland seand notes. cretion scores increased at 1 month and lasted for 3 years. RICHARD S. DAVIDSON, MD Advancing The same study found E: [email protected] CATARACT SURGERY that tear break up time inThis article was adapted from Dr. Davidson’s presentation at Cornea Subspecialty creased from baseline to Day during the 2015 meeting of the American Academy of Ophthalmology. He did not © 2015 Novartis 7/15 CNT15039JAD-A 1 month but was not that indicate any proprietary interest in the subject matter. TAKE-HOME A dedicated team focused solely on eye care professionals. An innovative pipeline designed to improve the way you treat. A shared passion for advancing the field of ophthalmics. With our unique approach and concierge customer care, Sun Ophthalmics offers the promise of new beginnings in the ophthalmic landscape. Be a part of our growing team of world-class professionals. Rise with us at SunOphthalmics.com/Careers. Brightening the future of eye care Sun Ophthalmics is a subsidiary of Sun Pharmaceutical Industries Ltd. © 2016 Sun Ophthalmics. All rights reserved. SUN-OPH-FRA-003-1 03/2016 18 STATE-OF-THE-ART Special Report ) INNOVATION IN IOLS HOW NEW ‘EVOLVING’ IOL FORMULA MAXIMIZES LENS ACCURACY IOL power (D) ADVANCES CONTINUE TO PROGRESS FOR PERFORMANCE OF INTRAOCULAR LENS IMPLANTS Ladas Super Formula represents novel step forward in IOL calculations Axial le ngth ( In developing the “Ladas Super tion and this? How can they deFormula,” the first question we velop intuition?” Once we could visualize these asked was: “How do we capture the best aspects of each formula, formulae in 3-D, we decided to while minimizing their drawbacks?” use this methodology to compare IOL formulae with each We looked at these forother, isolate them and mulae as the algebraic join them together, and equations that they were. what we ended up with We wondered what we was the “Ladas Super could do by simply graph- By leveraging Formula” (see Figure 1). ing these formulae into 3-D mathematical modeling, clinicians T he L ada s Super three dimensions. James Gleick, the au- are able to understand Formula is a novel approach of taking the thor of Chaos: Making a modern IOL formulae ideal portions of curNew Science, said that like never before. take-home “graphic images are the key” and “it’s masochism for a mathematician to do without pictures … [Otherwise] how can they see the relationship between that mo- rent IOL formulae and stitching them together to create one amalgamated surface and corresponding formula. Continues on page 20 : Formula r (D) l powe Cornea Axial le ngth ( mm) r (D) l powe Cornea IOL power (D) I n the modern landscape of ophthalmology, there is an abundance of IOL calculation formulae. This often leads to a clinical dilemma when it comes to choosing the most appropriate option. Thus far, there did not exist a perfect formula for all situations, including extremities of keratometry and axial length. Since there was no “one” formula, surgeons resorted to using multiple formulae without a framework to do so. mm) IOL power (D) By Aazim A. Siddiqui MD, Uday Devgan MD, and John G. Ladas MD, PhD, Special to Ophthalmology Times Axial le ngth ( mm) r (D) l powe Cornea (FIGURE 1) A. Ladas Super Surface in its raw form B. A somewhat amalgamated Ladas Super Surface C. Fully coalesced Ladas Super Surface (All figures courtesy of Aazim A. Siddiqui, MD) Validated for use with the UltraSertTM Preloaded IOL Delivery System* ProVisc® OVD is validated for use with the ORATM System EXCEPTIONAL PERFORMANCE EVERY STEP OF THE WAY. 1-3 Your technologies and techniques have evolved. It’s time to rethink your OVDs. Trust the industry-leading DuoVisc® OVD system to deliver the powerful combination of: • Viscoat ® OVD with chondroitin sulfate for superior endothelial protection and retention1-3 • ProVisc clarity ® OVD for mechanical protection, space maintenance and 4 Advanced-technology compatibility Talk to your Alcon sales representative to learn how the DuoVisc® OVD System can exceed your evolving needs. DuoVisc ® VISCOELASTIC SYSTEM © 2016 Novartis 2/16 US-VIS-16-E-0525 Advancing CATARACT SURGERY For important product information, please see adjacent page. * Speak to your Alcon representative about the appropriate version of UltraSertTM to use with ProVisc 1. Vasavada A, Ong M, Cordova D, Hartzer M. Protective effect ophthalmic viscosurgical devices (OVDs) against hydrogen peroxide-induced oxidative damage to corneal endothelial cells: an in-vitro model. Presented at American Society of Cataract and Refractive Surgeons; April 3-8, 2009; San Francisco, CA. 2. Petroll WM, Jafari M, Lane SS, Jester JV, Cavanagh HD. Quantitative assessment of ophthalmic viscosurgical device retention using in vivo confocal microscopy. J Cataract Refract Surg. 2005;31(12):2363-2368. 3. Lindstrom RL, Ong M. Protective effect of OVDs against hydrogen peroxide-induced oxidative damage to corneal endothelial cells: in vitro model. Presented at ASCRS; 26 Mar 2011; San Diego, CA. 4. DuoVisc® Package Insert. MAY 2016 :: Ophthalmology Times 20 Special Report ) STATE-OF-THE-ART FORMULA ( Continued from page 18 ) R E A L-LIFE EX AMPLES The Ladas Super Formula automatically eliminates the surgeon’s need to mull over various formulas or adjustments. It relies on peerreviewed literature to incorporate the needed formulae and adjustments to reach the best results to date, and localizes to the correct region on the Ladas Super Surface for every individual patient. Any previously described formula and any future formula can be incorporated into the algorithm. Examples of the Ladas Super Formula in action are shown in Figures 2A, 2B, and 2C with a variety of eyes that a surgeon might come across on a daily basis. Figure 2A shows the formula performing with a relatively short eye. The Ladas Super Formula INNOVATION IN IOLS recognizes that the patient has a short eye, and decides to choose the appropriate formulae and adjustments to yield the most accurate result. Figure 2B is a similar example but showcases a more generic eye that resembles eyes many surgeons encounter in their operating rooms on a regular basis. Figure 2C showcases a slightly longer eye. The Ladas Super Formula sees these eyes and decides to incorporate necessary adjustments the formulae need to calculate the most accurate result. The Ladas Super Formula can be accessed free of charge at www. iolcalc.com where it is in beta testing. Surgeons are able to perform lens calculations and provide postoperative data to further hone the accuracy of the formula. With the Ladas-Siddiqui graph, surgeons have the ability to compare multiple formulae to determine where they resemble and differ from each other at entire ranges of corneal power and axial DUOVISC® OVD IMPORTANT PRODUCT INFORMATION DESCRIPTION: DUOVISC® Viscoelastic System is designed to give two Viscoelastic materials with different physico-chemical properties that can be used differently and/or sequentially to perform specific tasks during a cataract procedure. DUOVISC® Viscoelastic System consists of VISCOAT® Ophthalmic Viscosurgical Device and PROVISC® Ophthalmic Viscosurgical Device. CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician. DESCRIPTION: VISCOAT® (Sodium Chondroitin Sulfate – Sodium Hyaluronate) Ophthalmic Viscosurgical Device INDICATIONS: VISCOAT® OVD is indicated for use as an ophthalmic surgical aid in anterior segment procedures including cataract extraction and intraocular lens (IOL) implantation. VISCOAT® OVD maintains a deep anterior chamber during anterior segment surgeries, enhances visualization during the surgical procedure, and protects the corneal endothelium and other ocular tissues. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. WARNINGS: Failure to follow assembly instructions or use of an alternate cannula may result in cannula detachment and potential patient injury. PRECAUTIONS: Precautions are limited to those normally associated with the surgical procedure being performed. Although sodium hyaluronate and sodium chondroitin sulfate are highly purified biological polymers, the physician should be aware of the potential allergic risks inherent in the use of any biological material. ADVERSE REACTIONS: VISCOAT® OVD has been extremely well tolerated in human and animal studies. A transient rise in intraocular pressure in the early postoperative period may be expected due to the presence of sodium hyaluronate, which has been shown to effect such a rise. It is therefore recommended that VISCOAT® OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of surgery to minimize postoperative IOP increases. Do not overfill anterior chamber. ATTENTION: Please refer to the directions for use for a complete listing of indications, warnings and precautions. DESCRIPTION: PROVISC® (Sodium Hyaluronate) Ophthalmic Viscosurgical Device INDICATIONS: PROVISC® OVD is indicated for use as an ophthalmic surgical aid in the anterior segment during cataract extraction and intraocular lens (IOL) implantation. Ophthalmic viscoelastics serve to maintain a deep anterior chamber during anterior segment surgery allowing reduced trauma to the corneal endothelium and surrounding ocular tissues. They help push back the vitreous face and prevent formation of a flat chamber during surgery. PRECAUTIONS: Postoperative increases in intraocular pressure have been reported with sodium hyaluronate products. The IOP should be carefully monitored and appropriate therapy instituted if significant increases should occur. It is recommended that PROVISC® OVD be removed by irrigation and/or aspiration at the close of surgery. Do not overfill anterior chamber. Although sodium hyaluronate is a highly purified biological polymer, the physician should be aware of the potential allergic risks inherent in the use of any biological material; care should be used in patients with hypersensitivity to any components in this material. Cannula assembly instructions should be followed to prevent patient injury. ADVERSE REACTIONS: Postoperative inflammatory reactions such as hypopyon and iritis have been reported with the use of ophthalmic viscoelastics, as well as incidents of corneal edema, corneal decompensation, and a transient rise in intraocular pressure. It is therefore recommended that PROVISC® OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of surgery to minimize postoperative IOP increases. Do not overfill anterior chamber. ATTENTION: Please refer to the directions for use for a complete listing of indications, warnings and precautions. DuoVisc ® VISCOELASTIC SYSTEM Advancing CATARACT SURGERY (FIGURE 2) A. The Ladas Super Formula Interface. An example with a short eye B. An example with a standard eye. C. An example with a somewhat long eye. length. By doing so, surgeons can isolate regions of the formulae where a clinical dilemma may occur. Surgeons can then target areas that require the most improvement. With this graph, surgeons can not only compare IOL power differences between formulae, but also various input parameters, such as anterior chamber depth (ACD). Such a task would have taken thou- sands of eyes to decide upon on a better formula for a given eye. A LadasSiddiqui graph is shown in Figure 3, where the Ladas Super Formula is compared with the SRK/T formula. EVOLUTION OF LADAS SUPER FORMULA The key behind the Ladas Super Formula is its potential to limitlessly improve. The way surgeons go about MAY 2016 :: Ophthalmology Times 21 Special Report ) STATE-OF-THE-ART INNOVATION IN IOLS (FIGURE 3) The Ladas-Siddiqui graph. A graphical representation that highlights areas where the Ladas Super Formula and the SRK/T formula differ from each other by more than 0.5 D. improving any formula is to optimize it. Thomas Olsen, the inventor of the “Olsen Formula,” has emphasized certain points regarding the optimization of a formula. Optimization is formula-specific and other variables, such as ACD, can be used to “optimize” a formula—as is shown in his paper on second eyes.1 To improve the Ladas Super Formula, we are splitting the Ladas Super Surface into tiny “grid boxes,” which optimizes actual patient data. We have developed an algorithm that incorporates and analyzes outcome data and adjusts the surface in all aspects. We have recruited multiple major cataract and refractive surgery groups to supply outcome data to aid the optimization process. Data from these groups is tracked and used to adjust and optimize the Ladas Super Surface accordingly. Figures 4A and 4B illustrate the progress made by highlighting the number of eyes we already have for optimization purposes within each grid box. This “real-world” data helps the Ladas Super Formula evolve and gives it a dynamic edge, which no previous formula had before, to further refine IOL calculations. In Figures 4A and 4B, we have provided a distribution of the data already collected over the given ranges of corneal power and axial range from various user groups. We can see there exists a certain preponderance of eyes in a particular region of the surface. As we cover every unit of the Ladas Super Surface, we will continue to optimize and perfect it. The more eyes we are able to gather, the more refined the Ladas Super Formula gets. We are crowd-sourcing additional data so we can move up to a 100,000-plus eyes and eventually 1 million or more eyes. Surgeons can contact the authors with the contact information at the end of this article i f t he y a re interested in participating. es Number of ey ≤ 0.5 D Difference > 05 D Difference Axial Length (mm) Super Formula versus SRK/T D) r( Axi al l al eng th ( e ow p e orn mm C ) (FIGURE 4A) The Manhattan Graph. A graphical representation of the optimization efforts so far where the Z-axis represents number of eyes that have been collected thanks to the participation of user groups. (FIGURE 4B) A bird’s-eye view of the Manhattan graph. IMPORTA NCE OF ACD IN IOL CALCULATIONS The issue of ACD is an important one when it comes to IOL calculations. Parameters, such as axial length and corneal power, have always been related to the calculation of ACD. By using these methods, we separate the ACD from the modern IOL formulae, and figure out the similarities and differences in various ways ACD is calculated in these formulae. This methodology is applied not only to simple IOL calculations, but also to post-refractive IOL calculations and to accommodating IOLs. For post-refractive IOL calculations, we essentially can split the ACD from the vergence calculation of the formulae. We then apply a double K method to treat the ACD and vergence calculation separately. It is generally believed that the ACD calculation is the most critical step in the calculation of IOL power, especially in small eyes with short axial lengths. By leveraging 3-D mathematical modeling, we are able to understand modern IOL formulae like never before. We also are able to take the best pieces of all formulae and amalgamate them to create a single, ideal surface and consequently derive the Ladas Super Formula. The key functionality of the Ladas Super Formula concept lies in its innate dynamism, which leaves room for development of optimization techniques. It is a “living” formula that is constantly evolving and becoming more accurate as it progresses. By collaborating with a number of user groups and incorporating actual patient data, we can adjust every grid box of the Ladas Super Surface and further enhance its accuracy. ■ Reference 1. Olsen T. Use of fellow eye data in the calculation of intraocular lens power for the second eye. Ophthalmology. 2011;118:1710-1715. doi: 10.1016/j. ophtha.2011.04.030. Epub 2011 Jul 2. AAZIM A. SIDDIQUI, MD P: 703/856-0801 E: [email protected], JOHN G. LADAS, MD, PHD P: 301/928-1448 E: [email protected] UDAY DEVGAN, MD E: [email protected] The authors have an ownership interest in the Ladas Super Formula and Ladas Super Surface and its associated methodologies and processes. MAY 2016 :: Ophthalmology Times 22 Special Report ) STATE-OF-THE-ART INNOVATION IN IOLS Newest ICLs associated with low incidence of cataract formation Prevalence higher in older patients with high refractive errors, older phakic IOL models By Lynda Charters; Reviewed by Jose F. Alfonso, MD, PhD OVIEDO, SPAIN :: CATARACT FORMATION HAS been center. The mean patient age was associated with the first phakic IOLs introduced 31.2 years (range, 18 to 50 years). into the marketplace. However, newer models The mean spherical refractive error seem to be on the way to solving that prob- was -7.27 (range, -26.5 to 12.5 D). Of the 3,420 eyes, 1,531 were lem. The latest models, the Visian Implantable Collamer Lenses (ICL) (mod- implanted with the V4 phakic IOL, els V4b and V4c, STAAR Sur- 1,108 with the V4b model, and 781 gical), did not result in cata- with the V4c model. The mean folract development in any eyes low-up times, respectively, were 6 in which they were implanted. years (range, 1 to 12 years), 2 years Because ICLs meet a need (range, 1 to 3 years), and 6 months in the refractive surgery arena (range, 3 to 24 months), according Dr. Alfonso for patients with high refrac- to Dr. Alfonso, associate professor at the University tive levels, they have been gainof Oviedo, School of ing in popularity from more than Medicine, and head of just their effectiveness. The implantation of ICL V4c (pictured above) did not cause any the Cornea and Lens In addition, they are safe, precataract formations. (Photo courtesy of Jose F. Alfonso, MD, PhD) Department, Fernándictable, and provide stable vision Implantation of the dez-Vega Universitary for patients with high levels of mynewest Implantable reported that central vaulting that exceeded Institute, Oviedo, Spain. opia, hyperopia, and astigmatism. Collamer Lens phakic He reported that cataracts devel- 90 μm protects against cataract development. However, the downside has been intraocular lenses (V4b However, 150 μm is recommended because oped in 21 (0.61%) of 15 patients development of clinically relevant and V4c) did not cause with the V4 phakic IOL. No cata- of decreased vaulting over time. In a previous cataracts in 2.1% of patients in less cataract formation in racts developed in eyes that received study, Dr. Alfonso and colleagues reported a than a year following implantation highly myopic patients. the other two phakic IOL models. direct relationship between low vaulting and and in 2.7% before the 3-year mark, Seven (47%) of the 15 patients cataract formation, with all patients who deaccording to FDA data. The culprit in the development of anterior subcapsular were younger than 40 years of age and eight veloped cataracts having less than 100 μm of cataracts seems to be the contact between the (53%) were 40 years and older (mean age, 39.43 vaulting (Graefes Arch Clin Exp Ophthalmol years). The mean spherical equivalent in these 2010;248:1827-35). phakic IOL and the natural crystalline lens. With phakic IOLs with high refractive power, patients was -10.1 D. In three (14%) eyes, the phakic IOL power was the peripheral vaulting becomes an issue in less than -10.5 D, in four (19%) eyes cataract development, and Dr. Alfonso advised between -10.5 and -13.5 D, and in surgeons to consider this in patients who are 14 (67%) eyes higher than -13.5 D. highly myopic. In addition, patient age seems to be a factor The mean vault distance in these eyes was 103 μm. The mean time in cataract formation, with older patients develto cataract development was 4.2 oping cataracts more often than younger ones. The authors of this study concluded, “Imyears postoperatively. The investigators published plantation of the [ICL] phakic IOL led to a very their findings in the Journal of low incidence of cataract formation. The prev— Jose F. Alfonso, MD, PhD Cataract and Refractive Surgery alence of cataract was higher in patients who were older, had high refractive errors, and had (2015;41:800-805). The relationship between cataract develop- older phakic IOL models.” ■ In light of this, Jose Alfonso, MD, PhD, and colleagues, conducted a retrospective, nonran- ment and vaulting has been of interest to surdomized, clinical study in which they evalu- geons. Previous studies have found that there ated the performances of three phakic IOLs, is substantially less vaulting in patients who JOSE F. ALFONSO, MD, PHD the V4, V4b, and V4c models, in 3,420 eyes of are older. A 2003 study by Gonvers and assoE: [email protected] 1,898 patients who underwent surgery in one ciates (J Cataract Refract Surg 2003;29:918-924) Dr. Alfonso did not indicate any proprietary interest in the subject matter. take-home ‘Previous studies have found that there is substantially less vaulting in patients who are older.’ Once-Daily PAZEOTM Solution 24 HOURS OF OCULAR ALLERGY ITCH RELIEF IN ONE DROP Once-Daily PAZEO™ Solution for relief of ocular allergy itch: The first and only FDA-approved once-daily drop with demonstrated 24-hour ocular allergy itch relief1 Statistically significantly improved relief of ocular itching compared to PATADAY® (olopatadine hydrochloride ophthalmic solution) 0.2% at 24 hours post dose (not statistically significantly different at 30-34 minutes)1 Statistically significantly improved relief of ocular itching compared to vehicle through 24 hours post dose1 Study design: Two multicenter, randomized, double-masked, parallel-group, vehicle- and active-controlled studies in patients at least 18 years of age with allergic conjunctivitis using the conjunctival allergen challenge (CAC) model (N=547). Patients were randomized to receive study drug or vehicle, 1 drop per eye on each of 2-3 assessment days. On separate days, antigen challenge was performed at 27 (±1) minutes post dose to assess onset of action, at 16 hours post dose (Study 1 only), and at 24 hours post dose. Itching scores were evaluated using a half-unit scale from 0=none to 4=incapacitating itch, with data collected 3, 5, and 7 minutes after antigen instillation. The primary objectives were to demonstrate the superiority of PAZEO™ Solution for the treatment of ocular allergy itch. Study 1: PAZEO™ Solution vs vehicle at onset of action and 16 hours. Study 2: PAZEO™ Solution vs vehicle at onset of action; PAZEO™ Solution vs PATADAY® Solution, PATANOL® (olopatadine hydrochloride ophthalmic solution) 0.1%, and vehicle at 24 hours.1-3 PAZEO™ Solution: Safety Profile Give your patients 24 HOURS OF OCULAR ALLERGY ITCH RELIEF with once-daily PAZEO™ Solution1 Well tolerated1 The safety and effectiveness of PAZEO™ Solution have been established in patients two years of age and older1 The most commonly reported adverse reactions, occurring in 2% to 5% of patients, were blurred vision, dry eye, superficial punctate keratitis, dysgeusia, and abnormal sensation in eye1 Once-daily dosing1 INDICATION AND DOSING PAZEO™ Solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis. The recommended dosage is to instill one drop in each affected eye once a day. IMPORTANT SAFETY INFORMATION As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle to prevent contaminating the tip and solution. Keep bottle tightly closed when not in use. Patients should not wear a contact lens if their eye is red. PAZEO™ Solution should not be used to treat contact lens-related irritation. The preservative in PAZEO™ Solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red should be instructed to wait at least five minutes after instilling PAZEO™ Solution before they insert their contact lenses. The most commonly reported adverse reactions in a clinical study occurred in 2%-5% of patients treated with either PAZEO™ Solution or vehicle. These events were blurred vision, dry eye, superficial punctate keratitis, dysgeusia, and abnormal sensation in eye. For additional information on PAZEO™ Solution, please refer to the brief summary of the full Prescribing Information on the following page. References: 1. PAZEO™ Solution Package Insert. 2. Data on file, 2011. 3. Data on file, 2013. From Alcon, committed to providing treatment options for patients. Olopatadine is licensed from Kyowa Hakko Kirin Co., Ltd. Japan ©2015 Novartis 6/15 PAZ15093JAD MAY 2016 :: Ophthalmology Times 24 Special Report ) STATE-OF-THE-ART INNOVATION IN IOLS Weighing pros, cons of IOL implantation in pediatric cataract Study with children under age of 2 finds equal rate of glaucoma but more posterior synechiae By Vanessa Caceres; Reviewed by Abhay Vasavada, MS, FRCS AHMEDABAD, INDIA :: BRIEF SUMMARY PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7%. For topical ophthalmic administration. The following is a brief summary only; see full prescribing information for complete product information. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Contamination of Tip and Solution As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle to prevent contaminating the tip and solution. Keep bottle tightly closed when not in use. Contact Lens Use Patients should not wear a contact lens if their eye is red. The preservative in PAZEO solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least five minutes after instilling PAZEO before they insert their contact lenses. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. In a randomized, double-masked, vehicle-controlled trial, patients at risk for developing allergic conjunctivitis received one drop of either PAZEO (N=330) or vehicle (N=169) in both eyes for 6 weeks. The mean age of the population was 32 years (range 2 to 74 years). Thirty-five percent were male. Fifty-three percent had brown iris color and 23% had blue iris color. The most commonly reported adverse reactions occurred in 2-5% of patients treated with either PAZEO or vehicle. These events were blurred vision, dry eye, superficial punctate keratitis, dysgeusia and abnormal sensation in eye. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There are no adequate or well-controlled studies with PAZEO in pregnant women. Olopatadine caused maternal toxicity and embryofetal toxicity in rats at levels 1,080 to 14,400 times the maximum recommended human ophthalmic dose (MRHOD). There was no toxicity in rat offspring at exposures estimated to be 45 to 150 times that at MRHOD. Olopatadine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal Data In a rabbit embryofetal study, rabbits treated orally at 400 mg/kg/ day during organogenesis showed a decrease in live fetuses. This dose is 14,400 times the MRHOD, on a mg/m2 basis. An oral dose of 600 mg/kg/day olopatadine (10,800 times the MRHOD) was shown to be maternally toxic in rats, producing death and reduced maternal body weight gain. When administered to rats throughout organogenesis, olopatadine produced cleft palate at 60 mg/kg/day (1080 times the MRHOD) and decreased embryofetal viability and reduced fetal weight in rats at 600 mg/kg/day. When administered to rats during late gestation and throughout the lactation period, olopatadine produced decreased neonatal survival at 60 mg/kg/day and reduced body weight gain in offspring at 4 mg/kg/day. A dose of 2 mg/kg/day olopatadine produced no toxicity in rat offspring. An oral dose of 1 mg/kg olopatadine in rats resulted in a range of systemic plasma area under the curve (AUC) levels that were 45 to 150 times higher than the observed human exposure [9.7 ng∙hr/mL] following administration of the recommended human ophthalmic dose. Nursing Mothers Olopatadine has been identified in the milk of nursing rats following oral administration. Oral administration of olopatadine doses at or above 4 mg/kg/day throughout the lactation period produced decreased body weight gain in rat offspring; a dose of 2 mg/kg/ day olopatadine produced no toxicity. An oral dose of 1 mg/kg olopatadine in rats resulted in a range of systemic plasma area under the curve (AUC) levels that were 45 to 150 times higher than the observed human exposure [9.7 ng∙hr/mL] following administration of the recommended human ophthalmic dose. It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when PAZEO is administered to a nursing mother. Pediatric Use The safety and effectiveness of PAZEO have been established in pediatric patients two years of age and older. Use of PAZEO in these pediatric patients is supported by evidence from adequate and well-controlled studies of PAZEO in adults and an adequate and well controlled study evaluating the safety of PAZEO in pediatric and adult patients. Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity Olopatadine administered orally was not carcinogenic in mice and rats in doses up to 500 mg/kg/day and 200 mg/kg/day, respectively. Based on a 35 μL drop size and a 60 kg person, these doses are approximately 4,500 and 3,600 times the MRHOD, on a mg/m2 basis. Mutagenesis No mutagenic potential was observed when olopatadine was tested in an in vitro bacterial reverse mutation (Ames) test, an in vitro mammalian chromosome aberration assay or an in vivo mouse micronucleus test. Impairment of fertility Olopatadine administered at an oral dose of 400 mg/kg/day (approximately 7,200 times the MRHOD) produced toxicity in male and female rats, and resulted in a decrease in the fertility index and reduced implantation rate. No effects on reproductive function were observed at 50 mg/kg/day (approximately 900 times the MRHOD). PATIENT COUNSELING INFORMATION H".804+B439&2.3&9.43@);.8*5&9.*3989434994:(-)7455*7 tip to eyelids or surrounding areas, as this may contaminate the dropper tip and ophthalmic solution. HB43(42.9&39E8*4+B439&(9C*38*8@);.8*5&9.*39834994<*&7 contact lenses if their eyes are red. Advise patients that PAZEO should not be used to treat contact lens-related irritation. Advise patients to remove contact lenses prior to instillation of PAZEO. The preservative in PAZEO solution, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted 5 minutes following administration of PAZEO. Patents: 8,791,154 ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA © 2015 Novartis. 6/15 PAZ15093JAD IOL IMPLANTATION IN children under the age of 2 does not always lead to a higher rate of glaucoma, but posterior synechiae can be more common, said Abhay Vasavada, MS, FRCS. Pediatric cataract surgeons most frequently consider the safety associated with various treatments for pediatric cataract, said Dr. Vasavada, director, Iladevi Cataract and IOL Research Centre, Ahmedabad, India. Some studies, such as the Infant Aphakia Treatment Study, have examined this topic. Though investigators have focused on unilateral cataract, there is still a need to analyze safety and outcomes in bilateral cataract. Aphakic glasses can work well, but patients and their families are seeking alternatives. “There’s nothing wrong with glasses, but now that lifestyles are changing, those glasses are becoming a handicap,” he said. IOL implantation On the surface, it may was associated with seem that contact lenses would be another treat- more inflammation ment option. However— and slightly more contact lenses in many visual obscuration in parts of the world are 120 children age 2 or expensive and actually younger undergoing impractical—they need bilateral cataract a lot of support, Dr. Va- surgery. However, the rate of glaucoma was savada said. For these reasons, more similar compared with surgeons in centers out- an aphakic group. side of the United States are considering IOL implantation. There has been some hesitation because of concern about the development of glaucoma. take-home TAKING A CLOSER LOOK In his research, Dr. Vasavada wanted to take a closer look at outcomes and safety for the treatment of bilateral cataract in patients under the age of 2. The prospective, randomized, study analyzed results for up to 5 years and looked at complications. The study included 60 eyes with hydrophobic single-piece IOL implantation and 60 eyes with aphakia. Dr. Vasavada performed all surgeries. To help motivate parents and their children Continues on page 25 : Pros, cons MAY 2016 :: Ophthalmology Times 25 Special Report ) STATE-OF-THE-ART INNOVATION IN IOLS Improving cataract surgery cases in eyes with pseudoexfoliation Attention to IOL selection among strategies for optimizing success By Cheryl Guttman Krader; Reviewed by Leonard M. Bley, MD BROOK LY N, N Y :: EYES WITH pseudoexfoliation syndrome terial of the enVista IOL will help limit these (PXF) present multiple challenges for cataract complications, and its performance has been surgery as they are at increased risk for a num- very promising.” Dr. Bley said that in eyes with PXF, placeber of complications during and after the procedure. Zonular weakness is a key issue in ment of a capsular tension ring to expand the these cases as it affects both capsular bag intraoperatively is important for intraoperative safety and post- increasing the safety of cataract removal in eyes with frank zonular dehiscence. Leaving operative IOL stability. According to Leonard M. the CTR in the eye can also help maintain capBley, MD, multiple features sule stability, although it does not prevent late of a particular single-piece IOL dislocation. The benefit of using the enVista hydrophobic Dr. Bley IOL in eyes with PXF relates to the acrylic IOL (enfact that the lens is constructed of a Vista, Bausch+Lomb) make it an relatively stiff hydrophobic acrylic excellent choice for implantation material. Consequently, it can act in eyes with PXF. Cataract surgery to keep the capsular bag expanded Dr. Bley is surgical director, NYL- in eyes with and help to resist the forces created ASIK Laser and Microsurgery In- pseudoexfoliation through capsular bag contraction stitute, New York, and sees many syndrome is associated that can lead to zonular dehiscence. patients of Eastern European and with increased “Especially in cases where a CTR Russian heritage among whom PXF intraoperative and is not used, an IOL that is made is common. postoperative risks. After switching to using the en- Strategies for improving of a very stiff material essentially acts like a CTR to help to keep the Vista IOL for eyes with PXF about outcomes include bag open,” Dr. Bley said. 12 months ago, Dr. Bley estimates attention to IOL The aberration-free aspheric optic he has implanted it in about 200 selection, and one of the enVista IOL is another one of cases either alone or with a capsu- surgeon describes why its advantages, according to Dr. Bley. lar tension ring. So far, he is very he is using a particular He explained this feature makes satisfied with the outcomes. IOL. the optical performance of the lens “Longer follow-up is needed bemore forgiving to changes in aligncause eyes with PXF are at risk for late IOL dislocation due to progressive zonu- ment, centration, or axial position that can occur lar weakness and anterior capsule phimosis,” with time in eyes with PXF considering the pohe said. “However, I believe the unique ma- tential for progressive zonular weakness and increased risk of capsular phimosis. The potential for late in-the-bag IOL dislocation in eyes with PXF underlies another reason why Dr. Bley likes to implant the enVista IOL in these cases. He explained that the implant features holes at the junction of the haptic and optic that enable repositioning by iris or scleral suture fixation. Careful preoperative examination is important for identifying PXF if it has not been diagnosed already so that surgeons will be prepared to use techniques and technologies that can reduce the risk of complications. Dr. Bley said it is important to determine preoperatively whether the case can be done with a standard technique or will require placement of a device for capsular support. “Surgeons should look for movement or shimmering of the lens during the examination in the office preoperatively, but also need to look carefully at how the capsule behaves during capsulotomy,” he said. Dr. Bley also recommended approaching nucleus and cortex removal using techniques that will minimize pressure exerted on the capsular bag. “It is important to have good hydrodissection and hydrodelineation, and surgeons might also consider placing an expansion device or lens in the bag prior to cortex removal,” he said. ■ PROS, CONS was essentially the same, Dr. Vasavada said. However, the difference in the rate of posterior synechiae was significant. ■ take-home ( Continued from page 24 ) return for numerous follow-up exams, the office helped support their travel. The study examined glaucoma (defined as an IOP of more than 21 mm Hg), visual obscuration, and inflammation (e.g., synechiae and cell deposits). The rate of glaucoma in the aphakic group was 16.7% and 13.4% in the pseudophakic group. Visual axis obscuration was 6.3% in the aphakic group and 10% in the pseudophakic group. Posterior synechiae occurred in 10% of aphakic patients and 25% of pseudophakic patients. There were also some cell deposits in the pseudophakic group, but they disappeared after 6 months postoperatively. The glaucoma rate between the two groups LEONARD M. BLEY, MD E: [email protected] Dr. Bley has no relevant financial interests to disclose. ABHAY VASAVADA, MS, FRCS E: [email protected] This article was adapted from Dr. Vasavada’s presentation at the 2015 meeting of the American Academy of Ophthalmology. He did not indicate any proprietary interest in the subject matter. MAY 2016 :: Ophthalmology Times 26 Special Report ) STATE-OF-THE-ART INNOVATION IN IOLS Phakic IOLs address challenge of broad range of refractive errors Current, novel technologies provide good predictability, stable results, good safety profiles By Lynda Charters; Reviewed by Allon Barsam, MBBS, FRCOphth LONDON :: PATIENTS WHO UNDERGO implan- of the final best spectacle-corrected visual tation of phakic IOLs to correct high refractive acuity. errors can gain a number of benefits from this Finally, patients who underwent phakic type of surgery. Namely, some preserved accom- IOL implantation had better contrast sensitivmodation and use of surgery that most cataract ity than those who underwent excimer laser and refractive surgeons find surgery for moderate-to-high myopia and the familiar, said Allon Barsam, patient satisfaction levels were higher after MBBS, FRCOphth. phakic IOL procedures compared with excimer In addition, the phakic IOL laser procedures, according to Dr. Barsam. procedure is reversible, there is lower risk of a retinal deTYPES OF tachment compared with that PHAKIC IOLS Dr. Barsam associated with refractive lens Among the types of phakic IOLs available, exchange, the natural corneal shape is pre- the Implantable Collamer Lens (ICL) (Visian served, and patients with ocular surface dis- ICL, STAAR Surgical) is approved by the ease are candidates for the surgery. FDA for the correction of myopia. This is in contrast to PRK and LASIK, which It is indicated for implantation in patients are limited in the degree of refractive errors who are between the ages of 21 and 45 years that are correctable and have lower to correct myopia ranging from predictability and stability levels 3 to 20 D with a maximal level in patients with high myopia, acof 2.5 D of astigmatism, and the cording to Dr. Barsam, a consulanterior chamber aqueous depth tant in cornea, cataract, and remust exceed 2.8 mm. Phakic IOLs are fractive surgery, L&D University viable alternatives In Europe, surgeons can corHospital, UCL Partners, London. for treating high rect from +21.00 D of hyperopia However, as with all good refractive errors. The to -23.0 D of myopia in patients things, complications are possi- technology provides with up to 6 D of cylinder. ble with phakic IOL implantation, good predictability and “The 3-year outcomes with such as development of cataracts, stable results, and has this lens in 526 eyes of 294 paendothelial cell loss, development good safety profiles. tients were excellent, with 60% of glaucoma, iris atrophy associof patients achieving an UCVA of ated with the claw configuration, and trau- 20/20 or better and 95% achieved 20/40 or matic dislocation, he noted. better,” Dr. Barsam said. “The lens has good predictability and low complications rates.” OUTCOMES The Verisyse phakic IOL (manufactured COMPA R ISON by Ophtec and referred to as Verisyse in the Dr. Barsam and colleagues compared the out- United States and Artisan in Europe) is an comes achieved with phakic IOLs with excimer iris claw-fixated phakic IOL that can corlaser procedures in studies that were published rect from -5 to -20 D of myopia with 2.5 D during the past 10 years. of astigmatism and higher degrees of myoHe reported that 12 months postoperatively pia, hyperopia, and astigmatism in Europe. there was no difference between the two sur- A potential concern with this lens is the engeries in the percentages of patients with an dothelial cellular loss over time compared uncorrected distance visual acuity (UNVA) with the ICL. of 20/20 or better. A few improvements in phakic IOL techThe investigators also reported that the nology have been introduced. phakic IOL procedure was safer for correctA newer ICL model is the V4c, which has ing moderate to high myopia with less loss an artificial port in the center of the lens take-home optic that eliminates the need for a preoperative peripheral laser iridotomy and might decrease the risks of glaucoma and cataract development, Dr. Barsam explained. “This lens is very encouraging,” he noted, but pointed out that it has not yet received FDA approval. A toric ICL and the toric Artisan are currently yielding excellent results. Dr. Barsam likes these lenses for patients who have more than 1.5 D of refractive astigmatism. In addition, these lenses can be used to treat keratoconus and astigmatism that develops after a corneal graft procedure. ADDITIONAL TECHNOLOGY Novel posterior chamber phakic technology (IPCL phakic IOL, Care Group India) to correct presbyopia and myopia and astigmatism has also been recently introduced. The lens provides near additions ranging from +1.5 to +3.5 D that can be customized to the patient’s degree of accommodation. “It is an interesting lens because it is a presbyopic ICL that is a reversible solution for presbyopia in patients aged 40 to 55 years who have not yet developed cataracts,” Dr. Barsam said. “There are no long-term results with this lens regarding safety and efficacy.” ■ ALLON BARSAM, MBBS, FRCOPHTH E: [email protected] This article was adapted from Dr. Barsam’s presentation at Refractive Surgery Subspecialty Day during the 2015 meeting of the American Academy of Ophthalmology. Dr. Barsam has no financial interest in the subject matter. 47 ANNUAL TH DOHENY DAYS CONFERENCE — JUNE 11, 2016 The Annual Doheny Days Conference hosts presenters from various specialties disseminating state-of-the-art research findings to improve clinicians’ ability to better diagnose and manage patients with ocular disease. The Doheny Memorial Lecturer The Irvine Memorial Lecturer DAVID W. PARKE, II, MD RICHARD K. PARRISH, II, MD Chief Executive Officer American Academy of Ophthalmology San Francisco, California Professor of Ophthalmology Associate Dean for Graduate Medical Education Bascom Palmer Eye Institute Miami, Florida R ESERVE YOUR S EAT T ODAY ! Registration fee $100 For more information: www.doheny.org/cme or contact Mary Collins-Smith [email protected] | 323-442-6427 MAY 2016 :: Ophthalmology Times 28 Special Report ) STATE-OF-THE-ART INNOVATION IN IOLS Finding ideal mix-match IOL strategy Combination of low-add multifocal, extended-range-of-vision lens may be solution for many By Jeffery J. Machat, MD, FRCSC, and Sondra Black, OD, Special to Ophthalmology Times TORON TO :: FOR SURGEONS WHO may have had a bad experience with earlier multifocal IOLs and vowed not to implant another presbyopia-correcting lens, times have changed. 100.0 The latest presbyopia-correcting 92.7 89.0 lenses are not just incrementally 90.0 None better—they represent a dramatic Mild/Moderate 80.0 improvement in patient satisfacSevere 70.0 tion, night vision quality, and (FIGURE 1) The beads on this near reading card functional vision. It would be a 55.5 60.0 correspond to 33 cm (+4.00 add), 40 cm (+3.25 mistake not to revisit the cateadd), and 50 cm (+2.75 add). (Figures courtesy of 50.0 gory, especially since surgeons Jeffery J. Machat, MD, FRCSC, and Sondra Black, OD) can now mix and match within 40.0 a single lens platform to meet a 30.0 patient’s visual goals. lenses in the past year, this may 20.0 A variety of mix-and-match strategies have be the best combination avail9.8 been used in the past. Surgeons have tried to able for a full range of vision. 6.1 10.0 combine various multifocal lenses to maxiFor surgeons who do not yet 1.2 1.2 0.0 mize functionality, with limited success. A have access to the Symfony lens, Halo Starbursts year ago, we had been using a combination of the combination of a 2.75-add lens the Crystalens (Bausch + Lomb) for the dom- in the dominant eye and 3.25(FIGURE 2) Clinical trial results demonstrate that night-vision inant eye and a Tecnis Multifocal +4.00 add add lens in the non-dominant symptoms are mainly mild to nonexistent. (Abbott Medical Optics) for the non-dominant eye could achieve similar results. eye, to give patients both reading and intermediate vision, as well as their distance. Both of GET TING BACK tasks to guide the decision of what to implant these lenses had significant drawbacks, though. I N T O M I X-A N D - M AT C H in the second eye. If the patient is already satNow, two lenses that have recently been in- A surgeon who may be apprehensive about isfied with near vision, put the same lens in troduced to market—the Tecnis Multifocal low getting back into multifocal IOL implantation the second eye. If he or she wants better near, add and the Tecnis Symfony extended range might want to start with bilateral implanta- choose a higher add (3.25) for the second eye. of vision IOL (Abbott Medical Optics)—seem tion of the Tecnis Multifocal 2.75 add or the There is exponentially less chance of havto provide the ideal combination. ReStor 2.5 add. ing a patient who is unhappy with results if When the Symfony lens was introduced in These low-add lenses are well tolerated, and the surgeon starts with low-add (2.75) or SymCanada, we began implanting it bilaterally, they provide good distance vision and practi- fony lenses and adjusts from there to achieve with great results. It provides about 1.5 D of cal intermediate. the functional range of vision that meets the accommodative amplitude, so patients could Depending on the patient, they may provide patient’s needs. be counseled to expect to use a pair of +1.00 sufficient reading vision, as well. It is a good readers for small print. segue into other combinations. PaNIGHT VISION Then, we began trying to give tients will also experience less halo Another concern with earlier presbyopic lenses patients a “boost” for their near viand glare than with the higher-add was the potential for nighttime dysphotopsias. sion by implanting a Symfony lens multifocal lenses. It is a clinically With a +4.00 add, when the patient focuses on in the dominant eye for intermedisignificant improvement. distance, the reading vision is out of focus. The ate and a +3.25 low-add multifocal The best way to start mixing and difference between the distance and the near Two clinicians explore in the non-dominant eye for near. why an optimal visual matching is to implant a Symfony focal points is so large that there is a large blur Both eyes, together or individually, solution for patients or low-add lens (2.75) in the domi- circle, which is what causes halo and glare. see really well at distance. nant eye first. At the 1-week postWith a low-add lens, the blur circle is smaller. may be using both a A prospective study of outcomes low-add multifocal and operative visit, use the patient’s as- While halos and glare may still be present, they with this combination is under way, an extended-range-ofsessment of how he or she is func- are much less bothersome and patients seem to but after implanting 800 of these vision lens. tioning for near and intermediate tolerate these low-add multifocal IOLs better. Percentage of Subjects Night Vision Symptoms Reported with Tecnis Symfony IOL Harmony EMEA Trial take-home MAY 2016 :: Ophthalmology Times 29 Special Report ) 4 Steps to Mix and Match Questionnaire/good history. Patients’ responses will indicate whether they want to be completely spectacle independent or are willing to wear glasses at some distances; what activities they do regularly; and how much of a perfectionist they are. 1 Astigmatism. Visually significant astigmatism affects options. New low-add and extended rangeof-vision lenses do not come in a toric option yet so it will be necessary to correct the astigmatism with femtosecond arcuate incisions, manual LRIs, or laser vision correction if the patient wants presbyopia correction. 2 Physical size. Take into consideration whether the person is short or tall and has long or average length arms. A tall man with long arms may do best with Symfony in both eyes. 3 Near preference. During the preoperative workup, patients are given a reading card and asked: “In an ideal world, where do you want to read?” The reading card has a string with colored beads at 33 cm (to correspond to a +4.00 add), 40 cm (+3.25 add), and 50 cm (+2.75 add). Present the reading card upside down. When patients flip it right side up, they will naturally adjust it to their reading distance. If a reading distance of 40 cm, the Symfony/+3.25 add combination is likely ideal. No matter what lens is chosen, surgeons do not make a promise for 100% spectacle independence, and still tell patients to expect to need a pair of reading glasses for threading a needle or reading fine print. 4 The Symfony design goes even further toward eliminating night-vision problems. It has an echelette design in which each ring has increasing foci. This provides a continuous curve rather than two distinct focal point peaks. Patients can hold something at intermediate range and bring it in closer while continuing to read with ease, which is a more natural visual experience. Clinical trial results demonstrate that night-vision symptoms are mild to nonexistent. Because of these important improvements in lens quality and functionality, surgeon confidence in and market penetration of presbyopia-correcting IOLs should significantly increase over the next 2 to 3 years. It cannot be stressed enough the difference between low- and high-add multifocal lenses. STATE-OF-THE-ART INNOVATION IN IOLS Anyone who begins implanting low-add multifocal IOLs and talking to patients postoperatively about the experience will realize how much better they are. The add powers can already be mixed and matched to achieve an excellent range of vision and high satisfaction for most patients. Where the Symfony lens is available, the combination of it with a low-add multifocal may be ideal. ■ V is it JEFFERY J. MACHAT, MD, FRCSC Dr. Machat is chief medical officer, Crystal Clear Vision, Toronto. He is a consultant/researcher/investigator for Abbott Medical Optics. SONDRA BLACK, OD Dr. Black is vice president and clinical director, Crystal Clear Vision. She is a consultant for Abbott Medical Optics. us at S ASC1R6 0 2 245 Boot h# FAMOUS FOR SEEING WHAT OTHERS CAN’T. Innovation and craftsmanship that helps you rise above. Haag-Streit vision spans more than 150 years. Our goal is simple: to develop ever more useful tools for the precise understanding of the human eye. At Haag-Streit, you will see the future clearly. Haag-Streit BQ 900 LED Haag-Streit Surgical Hi-R NEO 900 80O.787.5426 haag-streit-usa.com © 2016 Haag-Streit USA. All Rights Reserved. Octopus 600 Reliance FX920 LENSTAR APS MAY 2016 :: Ophthalmology Times 30 Special Report ) STATE-OF-THE-ART INNOVATION IN IOLS Novel optic designs drive presbyopiacorrecting IOL technology Continuous range of vision serves as focus without limitations of bifocal multifocal lenses By Cheryl Guttman Krader; Reviewed by Boris Malyugin, MD, PhD MOSCOW :: THE LIMITATIONS of bifocality for providing a full range of good uncorrected vision have driven the development of novel optic designs in presbyopia-correcting IOL technology, said Boris Malyugin, MD, PhD. Trends in Europe—where a variety of such implants is available—show surgeons are favoring trifocal designs over IOLs producing only two areas of focus, and use of a low-add multifocal IOL is gainDr. Malyugin ing popularity. In addition, when used in a micromonovision approach, extended range of vision and extended depth of field IOLs seem to be providing good functional vision at near, intermediate, and far with reduced risk of dysphotopsias. Results with small-aperture IOLs are promising, but more data are needed, Dr. Malyugin noted. “In the future we will likely see further developments in multifocal optics for pseudophakic IOLs,” said Dr. Malyugin, professor of ophthalmology, and deputy director general (R&D, Edu), S. Fyodorov Eye Microsurgery State Institution, Moscow. “However, these lenses may have almost reached their physical limits because loss of contrast sensitivity and quality of vision continue to be issues.” Meditec) are also available in Europe. Data published in the peer-review literature show that compared with bifocal IOLs, the trifocal design provides better intermediate vision while maintaining good vision at far and near. In addition, results of a study comparing the first two trifocal IOLs showed no significant differences between them, Dr. Malyugin said. However, there is also evidence that unwanted visual symptoms, particularly glare, ghosting, halos, and problems with night driving, still occur with trifocal IOLs. “Trifocal IOLs are unlikely to be worse than bifocal IOLs in generating unwanted optical phenomenon,” Dr. Malyugin said. “However, surgeons should still warn patients about the potential for halos and other symptoms after surgery.” Extended depth of focus or extended range of vision IOLs represent another type of presbyopia-correcting technology. Graham Barrett, MD, pioneered the concept for this design and there are now two lenses in this category. The first on the market features an aspheric design that provides a controlled amount of spherical aberration (EDF, Hoya). The other product, an extended range of vision IOL (Tecnis Symfony, Abbott Medical Optics), uses a combination of optics designs for elongating the depth of focus and correcting chromatic aberration and also incorporates spherical aberration correction. UPDATE ON TECHNOLOGY Data published in the peer-review literature Dr. Malyugin said the idea of a trifocal IOL was first introduced in Russia by the local on the first extended depth of focus IOL show hydrophobic IOL manufacturer “Reper-NN.” that it provides visual quality outcomes simiHowever, the design of the diffractive part of lar to those associated with prior multifocal the lens optic, which had square elements, IOL technology and that modest monovision is needed for optimizing near UCVA. was not optimal. Dr. Malyugin said he was not Subsequently, a trifocal implant aware of any papers published in (FineVision, PhysIOL) based on the the peer reviewed literature reportpatented design of a research group ing clinical outcomes achieved with headed by Damien Gatinel, MD, was the extended range of vision IOL. launched in March 2010. Currently, New IOLs based on a Small-aperture IOLs represent two other trifocal IOLs, each with another approach for enhancing different design characteristics, as variety of optic designs depth of focus, and two such imwell as toric versions of trifocal are aiming to provide plants are available. IOLs (FineVision Toric, PhysIOL; presbyopic correction One lens (IC-8TM, AcuFocus), AT Lisa tri toric 939MP, Carl Zeiss for pseudophakia. take-home 1st Trifocal IOL optic design by REPER-NN Material foldable hydrophobic acrylic Refractive index 1.505 Optical diameter 6.0 mm Total Diameter 12.5 mm Central diffractive zone 3.4 mm Diffractive near addition +4.0D (FIGURE 1) The first trifocal IOL introduced in Russia was designed with square elements in the diffractive part of the lens optic. Subsequent lenses have improved in their designs. (Figure courtesy of Boris Malyugin, MD, PhD) developed by the same manufacturer that is marketing the small-aperture corneal inlay (KAMRA, AcuFocus), is a single-piece hydrophobic acrylic lens with an aspheric optic and centrally located opaque annular mask that is implanted in the non-dominant eye. Data from a series of 11 patients show this approach provided a continuous broad range of vision with excellent visual acuity across all distances. A second small-aperture IOL made of hydrophobic acrylic is designed for implantation in the ciliary sulcus and acts via a pinhole mechanism to increase depth of focus (Xtra Focus, Morcher). Reported outcomes with this technology show that it improved vision in eyes with irregular corneal astigmatism after corneal transplantation, but it can also be used to extend the depth of focus in normal pseudophakic eyes, Dr. Malyugin said. MAY 2016 :: Ophthalmology Times 31 Special Report ) M U LT IFOC A L DE SIGNS Other new concepts in presbyopia-correcting IOLs include novel multifocal designs described as zonal refractive, rotationally asymmetric, inferior segmental addition, and sectorial addition. One such lens featuring a refractive section that directs light to another focal point on the retina (Lentis Mplus, Oculentis) is similar to existing multifocal IOL technology for providing STATE-OF-THE-ART INNOVATION IN IOLS good uncorrected visual acuity at near and far. A low near-add IOL with +1.5 D near add power (Lentis comfort, Oculentis) seems to provide good intermediate uncorrected vision and can be used with a micromonovision approach. A supplementary sulcus-fixated multifocal IOL (Sulcoflex Multifocal 653F, Rayner) has been shown to improve near vision and is reversible if the patient is not satisfied with it. ■ BORIS MALYUGIN, MD, PHD E: [email protected] This article was adapted from Dr. Malyugin’s presentation at Refractive Surgery Subspecialty Day during the 2015 meeting of the American Academy of Ophthalmology. Dr. Malyugin does not have any financial interests relevant to the subject matter. He acknowledges consulting services for Alcon Laboratories, Bausch + Lomb, and Carl Zeiss Meditec. Visitec® I-Ring® Pupil Expander A simple, safe and innovative solution for intraoperative small pupil expansion / Gentle on iris and other intraocular tissue / Iris quickly returns to natural shape post surgery / Easy insertion and removal Amar Agarwal MS, FRCS, FRCOphth “The I-Ring eases pupillary woes with good folding — unfolding; engaging — disengaging of the iris in small pupil and IFIS cases.” Call your local sales rep or BVI customer service at 1-866-906-8080. Visit us at www.beaver-visitec.com Beaver-Visitec International, Inc. | 411 Waverley Oaks Road Waltham, MA 02452 USA US patent # 8,900,136. Additional US and international patents pending. BVI, BVI Logo and all other trademarks (unless noted otherwise) are property of a Beaver-Visitec International (“BVI”) company © 2016 BVI MAY 2016 :: Ophthalmology Times 32 Special Report ) STATE-OF-THE-ART INNOVATION IN IOLS Comparing intraoperative aberrometry, toric IOL calculator Intraoperative aberrometry reduces residual astigmatism in patients with high astigmatism By Vanessa Caceres; Reviewed by Robert J. Cionni, MD Postoperative Refractive Astigmatism at 1 Month 100 Toric Calculator 90 Mean (SD) 1-Month Postoperative Astigmatism Intraoperative Aberrometer 1.0 85.4 0.9 80 0.8 p=0.002 0.7 55.5 50 Diopters Percentage of eyes 70 60 ±0.36 44.5 Dr. Cionni 40 ±0.28 0.6 0.52 0.5 0.4 p=0.001 30 0.29 0.3 20 14.6 10 0.2 0.1 0 0 ≤0.5 D Toric Calculator >0.5 D Intraoperative Aberrometer SD, standard deviation (FIGURE 1) Left: The number of subjects falling outside of the 0.5D threshold was 29.9% lower for the cases using the intraoperative aberrometer. Right: The mean residual astigmatism in the intraoperative aberrometry group was 0.28 D, compared with 0.36 D in the toric calculator group. (Figures courtesy of Robert J. Cionni, MD) SALT L AK E CI T Y :: THE USE OF INTRAOPERATIVE results, including best-corrected distance viaberrometry during cataract surgery decreased sual acuity and manifest refraction, and postthe amount of residual astigmatism in a group operative astigmatism at 1 month after cataof patients with high astigmatism, said Robert ract removal and toric IOL implantation (AcrySof, Alcon). This particular study J. Cionni, MD. was part of a larger study that inThe randomized, observercluded T3 to T7 toric IOL models, masked study led by Dr. Cionni but this subset only included T5 included 45 subjects (90 eyes) with to T7 models. high astigmatism. Dr. Cionni is medThe use of There were the standard incluical director, The Eye Institute of intraoperative sion and exclusion criteria. No eyes Utah, Salt Lake City. aberrometry led to with corneal abnormalities, such Investigators randomly assigned better outcomes in a as ectasia, were allowed, Dr. Cieyes to the use of intraoperative group of post-cataract onni said. aberrometry (ORA, Alcon Labo- surgery eyes with high “Results showed a significant ratories) to provide aphakic and astigmatism. difference between the two groups, pseudophakic data and guide the surgeon in IOL selection or a toric IOL calcula- with results that favored intraoperative abertor. Subsequently, the fellow eye was randomly rometry,” Dr. Cionni said. Slightly more than 85% of eyes in the inassigned to the opposite group. Study investigators examined visual acuity traoperative aberrometry group had 0.5 D or take-home less of astigmatism at 1 month compared with 55.5% in eyes in the toric IOL calculator group. The mean residual astigmatism in the intraoperative aberrometry group was 0.28 D, compared with 0.36 D in the toric calculator group. The use of intraoperative aberrometry also changed the recommended toric magnitude in 56% of eyes in that group. Many eyes required a decrease in IOL power magnitude while three eyes had an increase in IOL power magnitude, Dr. Cionni said. Although some of the IOL power differences may seem small, even small differences can affect visual acuity, he said. C A SE ST U DY In one typical case study, a 69-year-old subject received a T5 lens in both eyes. His left eye, which had intraoperative aberrometry performed, was operated on first. Then, a toric MAY 2016 :: Ophthalmology Times 33 Special Report ) IOL calculator was used with the right eye. Investigators measured 1 D less corneal astigmatism than planned in the right eye, and therefore a T3 lens was implanted instead of a T5. The patient’s uncorrected visual acuity in the toric IOL calculator eye was 20/25, compared with 20/20 in the eye in which intraoperative aberrometry was used. STATE-OF-THE-ART INNOVATION IN IOLS The study showed less residual astigmatism in eyes in which intraoperative aberrometry had been used. “For this group of patients with higher astigmatism, intraoperative aberrometry had a higher percentage of eyes with 0.5 D or less of astigmatism and a lower mean postoperative astigmatism,” Dr. Cionni said. ■ ROBERT J. CIONNI, MD E: [email protected] This article was adapted from Dr. Cionni’s presentation at the 2015 meeting of the American Academy of Ophthalmology. Dr. Cionni is a consultant and lecturer for Alcon Laboratories. VISIT JCAHPO AT BOOTH #1412 JCAHPO Certifications for your entire team = RESULTS! Ophthalmic Certifications y Assistant (COA®) y Technician (COT®) y Medical Technologist y Scribe (OSC®) y Diagnostic Sonographer (CDOS®) y Registered Ultrasound (COMT®) y Surgical Assisting (OSA®) Biometrist (ROUB®) Meet with the Certification Experts at the ASCRS ASOA Symposium and Congress Providing Certification and Education for Eye Care Excellence Since 1969 JCAHPO y 2025 Woodlane Drive y St. Paul, MN 55125 y 800-284-3937 y [email protected] y www.jcahpo.org MAY 2016 :: Ophthalmology Times drug therapy Novel dry eye therapy shows efficacy, rapid onset of action Nanomicellar cyclosporine formula may expand options; long-term safety to be studied By Lynda Charters; Reviewed by Joseph Martel, MD EL K GROVE, CA :: newly developed drug for treating dry eye (OTX-101; Seciera, Auven Therapeutics) seems to be a potential beneficial therapy based on the results of a phase IIb/III clinical trial in which the safety and efficacy of the formulation were evaluated. Results showed that the two concentrations of the drug were well tolerated and patients had improved tear production and less inflammation by 12 weeks. The future introduction of a new dry eye formulation would be a welcome addition considering the high frequency with which dry eye occurs, according to Joseph Martel, MD. Up to 40% of all visits to ophthalmologists are scheduled because patients are seeking help for dry eye symptoms, he noted. “Ten to 15 million patients in the United States have dry eye and Sjorgen’s syndrome, the latter of which is associated with dry eye, dry mouth, and inflamed joints, and develops in 1% of the population,” said Dr. Martel, director, Department of Ophthalmology, California Northstate College of Medicine, Elk Grove, CA. “Dry eye is a painful, debilitating disease.” A number of dry eye therapies have become commercially available recently. However, many of the dry eye drops are palliative and do not address the disease. The efficacy with cyclosporine ophthalmic emulsion 0.05% (Restasis, Allergan) helps some, but many patients cannot tolerate it due to burning and irritation upon instillation, which reduces patient compliance. Currently, this suggested there is a large number of a patient without effective treatment. The manufacturer describes OTX-101 as a novel patented nanomicellar formulation of unpreserved cyclosporine that in animal studies of New Zealand rabbits exhibited superior ocular tolerability to that of cyclosporine A. In that study, the tissue distribution of the drug in the cornea and superior bulbar conjunctiva was greater when compared with that of cyclosporine A. A Shirmer's Test — Responder Analysis 20% Propertion of subjects with ≥10 mm improvement 34 p-value versus vehicle C-M-H test, 2-tailed p=0.007 17.9% 15% 13.3% 10% 5% 7.6% 0% Vehicle Seciera 0.05% Seciera 0.09% (FIGURE 1) A higher proportion of patients treated with the 0.09% drug concentration (17.9%) experienced a 10 mm or greater improvement for Schirmer’s test compared with only 7.6% of patients receiving vehicle (p = 0.007). (Source: Auven Therapeutics) rolled, 426 completed the study, in the three PHASE IIB/III FINDINGS The trial had a multicenter, double-masked, groups, 144, 142, and 140, respectively. Investigators reported that both drug conparallel group design with three treatment arms: vehicle (n = 152) and two doses of the centrations were superior to the vehicle at cyclosporine nanomicellar solution, 0.05% all time points when analyzing the changes in conjunctival staining from and 0.09% (n = 151 and n = baseline (0.05% concentration, 152, respectively). p = 0.006; and 0.09% concenAfter a 2-week vehicle run-in The efficacy of tration, p = 0.008, compared period, patients were treated a novel dry eye with the vehicle). for 12 weeks. Patients were therapeutic may Both concentrations also not permitted to use artificial bring a valuable were superior to the vehicle tears during the study, which addition to the dry in total and inferior corneal was conducted at 29 sites in eye armamentarium fluorescein staining at the final the United States. with a rapid onset evaluation. Tear production was Primary efficacy endpoints of action and better superior with both concentrawere conjunctival staining and patient tolerability. tions of the active treatment the SANDE (Symptom Assesscompared with the vehicle. ment iN Dry Eye) score. SecA higher proportion of paondary efficacy endpoints were corneal staining, tear film break-up time, and tients treated with the 0.09% drug concentraSchirmer’s test results. Of the patients en- tion (17.9%) experienced a 10 mm or greater TAKE-HOME MAY 2016 :: Ophthalmology Times drug therapy improvement for Schirmer’s test compared with only 7.6% of patients receiving vehicle (p = 0.007). Regarding the SANDE score, the three study arms showed an approximate 30% improvement in symptoms over the study course. PE R F OR M A N C E A N A LY S I S The agent seemed to perform well in the central cornea, which is the area that the FDA considers to have the greatest clinical relevance, Dr. Martel noted. In contrast, the OPUS-1 study of lifitegrast (Shire Pharmaceuticals) showed that compared with placebo, lifitegrast did not differ significantly from that of placebo in central corneal staining but did differ significantly inferiorly and superiorly. The OPUS-2 and -3 studies of the drug did not show a trend toward significance in inferior corneal staining when the changes from baseline were evaluated. The most commonly reported adverse effect with OTX-101 and cyclosporine is burning upon instillation of the drops, which can affect patient compliance. With cyclosporine, about 17% of patients assigned to the 0.05% and 0.1% concentrations of cyclosporine A reported burning on instillation. In contrast, 1.3% of patients assigned to both OTX-101 concentrations reported severe discomfort. In addition, the increased tear production with OTX-101 was seen at 12 weeks compared with that of cyclosporine, which the FDA approved based on increased tear production after 6 months. “It is gratifying to see that [OTX-101] is so well tolerated and may soon provide our patients with dry eyes another clinically proven effective treatment,” Dr. Martel said. “I have been very impressed with its clinical efficacy.” The FDA directed that one phase III trial be conducted to confirm the significant increase in tear production and the significant decrease in inflammation of the ocular surface compared with placebo resulting from instillation of OTX101 in the phase IIb/III clinical trial. This confirmatory study has begun, according to a March 3 statement issued by Auven Therapeutics. A long-term safety study will be conducted concurrently. The manufacturer anticipates that if these studies are successful, a new drug application will be submitted in 2017. ■ 35 ‘It is gratifying to see that [OTX-101] is so well tolerated and may soon provide our patients with dry eyes another clinically proven effective treatment.’ — Joseph Martel, MD The OCULUS Pentacam® AXL Always an Axial Length Ahead Now Available! The gold standard, now with axial length measurement – versatile, profitable, indispensable! /NCEAGAINTHE0ENTACAMDElNESTHEhMEASUREOFALLTHINGSv4HE!8,VERSION FEATURINGINTEGRATEDOPTICALBIOMETRYMAKESITACOMPREHENSIVEINDISPENSABLE INSTRUMENTFORCATARACTSURGERY!SAFULLSCALESYSTEMTHE0ENTACAM!8,ALSO PROVIDESFORSAFEANDSWIFT)/,CALCULATIONnEVENINDIFlCULTCASES 6ISITWWWPENTACAMAXLCOMTOLEARNMORE JOSEPH MARTEL, MD E: [email protected] Dr. Martel has no financial interest in the subject matter. Tel. 1 888-519-5375 [email protected] www.oculususa.com facebook.com/OCULUSusa 36 MAY 2016 :: Ophthalmology Times technology Retinal exam brings diabetic retinopathy screening to PCPs System aims to enhance low screening rates, improve access of care, increase quality outcomes By Vanessa Caceres; Reviewed by Yvonne I. Chu, MD, MBA, and Sunil Gupta, MD t is no secret that a diabetes epidemic exists in the United States. A 2014 report from the Centers for Disease Control and Prevention states that 29.1 million Americans have diabetes—or a little more than 9% of the total U.S. population. Almost one-third of those with diabetes are undiagnosed, according to the report. With the possible damaging effects on the eyes, not to mention the rest of the body, it has been a challenge for eye-care professionals (ECPs) to reach those with diabetes for a recommended annual exam. Pensacola, FL-based Intelligent Retinal Imaging Systems (IRIS) is changing that by providing access for diabetic patients to complete their annual retinal exams in the primary-care physician (PCP) office. The company’s retinal exam system integrates into the electronic medical record and identifies patients who need the test performed. At the primary-care office, staff uses IRIS to capture images of the patient’s eye, adding about 5 minutes on to an existing appointment. Then, the images are interpreted by an ophthalmologist or retina subspecialist. Sometimes, the eye specialist interpreting an image is already based in the same local area as the PCP and IRIS helps to bring them together virtually using the IRIS Cloud which stores the retina images, said Jason Crawford, IRIS chief executive officer. Other times, a larger health-delivery system may incorporate its own eye specialists already within their system to interpret those images, like at the Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami. Yet, a third scenario is that physicians who are part of the IRIS Reading Center will interpret the images. These readers are contracted by IRIS and provide the interpretation via the IRIS Reading Center. The Harris Health System, the public safety net for Harris County in Houston, uses this model in collaboration with the Department of Ophthalmology at Baylor College of Medicine and University of Texas-Health. I The retinal exam system aims to address low screening rates for diabetic retinopathy. The purpose of the technology is to reach as early as possible the patients with diabetes who would not otherwise go for an annual eye exam, according to Sunil Gupta, MD, chief medical officer of IRIS. (Photo courtesy of Intelligent Retinal Imaging Systems) Patients with suspicious pathology—be it diabetic retinopathy, glaucoma, cataract, or an epiretinal membrane—are guided to follow up with an ophthalmologist or retinal specialist for further care. “Our system reaches those patients who do not currently seek eye care and encourages them to establish care,” Crawford said. The purpose of IRIS is to reach as early as possible the patients with diabetes who would not otherwise go for an annual eye exam, said Sunil Gupta, MD, chief medical officer of IRIS. Dr. Gupta started the company in 2011. “In some parts of the country, only 30% to 40% have that annual exam,” Dr. Gupta said. “For whatever reason, Dr. Gupta it doesn’t happen, maybe because they aren’t symptomatic until they have significant vision loss.” By reaching these patients earlier, eye problems are usually less severe, and patient care costs are lower, Dr. Gupta said. Better visual outcomes also are more likely. This is why the idea of implementing IRIS within a PCP’s office seemed to work most effectively, as those with diabetes will make more of an effort to see their primary-care office, Dr. Gupta said. OPHTHALMOLOGIST’S ROLE One point that both Dr. Gupta and Crawford want to make clear is that IRIS is not a system that will take patients away from ophthalmologists. In fact, they say the system actually provides additional patients for eye-care specialists—and it gets the patients to them who have the most acute pathology. One in eight of the patients with diabetes who are examined have sight-threatening disease. IRIS works with primary-care providers to set up a system for referral to local ECPs. At systems like Harris Health, there’s already a connection with physicians from Baylor College of Medicine and University of Texas. “Their ophthalmologists and optometrists have been able to take these patients and manage them,” Dr. Gupta said. Yvonne I. Chu, MD, MBA, chief of Ophthalmology Service, Ben Taub Hospital, Harris Health System, and associate professor at Baylor College of Medicine, said Harris Health decided to invest in IRIS in 2013 because leaders at the system wanted to do a better job of managing care for those with diabetes. MAY 2016 :: Ophthalmology Times technology They purchased eight systems and ments the patients risk complications. “After the patient, the insurance strategically placed them at different Harris Health Community Clinic loca- payers have the most economic intions in the Houston area. They trained centives as we are successfully imtechnicians, many of whom had zero proving access for their members to eye-care experience before, on how to complete the diabetic retinal exam,” use them system. As the only things Crawford said. “As our largest payer, needed were Internet access and a the Centers for Medicare and Medicaid small room with dim lights, Dr. Chu Services insures the largest number said the upfront start-up costs were of patients with diabetes.” When a practice decides to work with manageable. Since purchasing the systems in the IRIS system, someone on practice 2013, more than 58,000 scans have staff, often a medical assistant or even been performed at Harris Health, Dr. front-desk person, is given a half day of training on how to use the system. Chu said. “We have developed a customized- Dr. Gupta describes the training and care plan based on the interpretation support as high touch. “We don’t just sell them a box,” results performed in the IRIS Reading he said. Center,” she said. Incorporating use “Patients with susof the imaging syspected pathology are tem along with everyreferred to optometrists A retinal exam thing else a primaryfor further screening, system improves care practice does may and those patients with access for patients take some getting used proliferative disease with diabetes to to at first. It takes some can come directly to detect eye disease thoughtful workflow our retina specialists early and refers among nurses, schedfor timely care,” Dr. them to an eye-care uling staff, and within Chu said. “In a system specialist for further the electronic medical where we have greater evaluation and record systems, Dr. demand than resources, treatment. Gupta said. we’ve been able to filter Primary-care pracout patients who don’t tices that follow the have pathology to create more capacity for those who need company’s recommended best practices do well with IRIS, Crawford said—the timely intervention.” The percentage of patients with ones that struggle are those that do diabetes who are getting the initial not have buy-in. “It’s the primary-care practices that screenings since they have implemented IRIS has dramatically increased, and say ‘We’ll try to this out’ that get marthe system is now starting to look at ginal improvement,” Crawford said. “We work hard to ensure that the practheir outcomes. Some primary-care offices are now tice is invested and have adopted a setting up systems where the test is system-wide approach to improving administered at their office, but a local outcomes.” ■ ophthalmologist’s office will call with the results and set up the follow-up eye exam, Crawford said. The PCP also receives a copy of the results. 37 ‘We have developed a customized-care plan based on the interpretation results.’ — Yvonne I. Chu, MD, MBA TAKE-HOME BUSINESS SIDE AND LOGISTICS The IRIS system is now in 25 states. There were 80,000 patients screened with IRIS last year, said Dr. Gupta, and that’s a number that may at least double this year, he believes. Insurance coverage has been favorable as this approach saves cost, improves quality outcomes, and docu- Comfort in the blink of an eye. For computer users, the average blink rate drops from 12 to only 3 times per minute. With the average American spending up to 8 hours per day in front of a computer, it’s no wonder so many suffer from dry eye. The VeraPlug™—the clinically proven choice for comfort—offers your patients simple, effective relief. Expand your practice with the VeraPlug™ today. YVONNE I. CHU, MD, MBA E: [email protected] Dr. Chu did not indicate any financial interest in the subject matter. SUNIL GUPTA, MD E: [email protected] Dr. Gupta is founder and chief medical officer of Intelligent Retinal Imaging Systems. Visit us at ASCRS booth #1334 A FRESH PERSPECTIVE™ lacrivera.com (855) 857-0518 © 2016 Lacrivera, a division of Stephens Instruments. All rights reserved. 38 MAY 2016 :: Ophthalmology Times technology Mobile refractive screening system yields real-world applications Added benefit of portable diagnostics could bring autorefraction to underserved populace By Tal Raviv, MD, FACS, Special to Ophthalmology Times NE W YORK :: WITH A SMALL, mobile platform, autorefractive technology (SVOne Pro, Smart Vision Labs) allows virtually anyone capable of operating a mobile device to conduct an autorefraction, potentially opening the door to providing refractive screening virtually anywhere in the world, or just outside office walls. The 1-pound, hand-held, smartphone-based autorefractor utilizes Hartman-Shack wavefront aberrometry. This update to the first version of the unit adds expanded measurement parameters and enhanced usability. The SVOne Pro allows the operator to see the patient’s eye when aligning the pupil, and once a good Shack-Hartmann grid is present, the software automatically records three autorefraction measurements. All of this is accomplished within 3 seconds per eye. The SVOne Pro has a spherical range of -14 to +14 D and cylindrical range of -7 to +7 D. The SVOne Enterprise includes all the features of the SVOne Pro, but is a patient-directed vision testing station. In other words, patients can autorefract themselves using onscreen and voice prompts. ministered refraction tests were compared with the in-office legacy autorefractor and subjective exams. The results matched well for young healthy eyes, with occasional outliers. Accommodation must be controlled for with all autorefractors, and the device’s open-field design allows the patient to look in to the distance during the test. A recently published clinical study on the SVOne reported refractive measurements (in visually normal, young individuals) that were not significantly different from four other subjective and objective procedures.1 R E A L-WOR LD IMPLIC AT IONS The potential of these low-cost, portable diagnostic instruments is large, and is just the tip of the iceberg of what is possible. There are already smartphone attachments in development for lensometry, subjective visual acuity, and indirect ophthalmoscopy/fundus photography. The platform may eventually measure higherorder aberrations, and perhaps even perform topography. Its portability increases access and can help bring refractive eye care to underserved populations around the globe and here in the United CLINICAL USE States. Domestically, future versions of this deThe device sits atop on a tripod/stand. First vice may be of value for school vision screenthe device takes a photo of the patient and ings, mobile medical services, pediatric mediasks a series of patient history questions, then cal practices, or nursing homes to name a few. guides the patient through each Future versions of the selfeye’s measurement, and finally guided, vision-testing station it displays the result—which can could become integral to the The advent be printed or sent to a HIPAAburgeoning realm of telemedof portable secured cloud account. icine. Imagine a refractive viautorefractor Most millennial patients eassion-screening kiosk next to the technology may ily performed their own refracblood pressure testing kiosk in deliver autorefraction tions without any assistance; pharmacy retail locations. Sigto populations that basically, anyone who can take nificant refractive errors can might not otherwise a “selfie” can operate the unit. be evaluated by eye-care prohave any access to Once they completed the exam, fessionals from any location, eye care. and saw their refraction, most and follow-up service can be patients had a “wow” response provided or recommended as and described the experience needed. as “cool.” A few older patients who were able Theoretically, the device will become small to operate it did so with mixed reactions and and inexpensive enough to ship to consumers results. who could perform their own refraction and Exam findings generated from the self-ad- send the device back (or purchase it). TAKE-HOME SELF-GUIDED TEST VIDEO Watch as a patient participates in a vision exam through the self-guided refraction system.Go to http://bit.ly/1T0sQrY (Video courtesy of Tal Raviv, MD, FACS) POSSIBILITIES LARGE, LIMITATIONS EXIST Subjective manifest refinement of autorefraction data is the standard of care in the United States, as is a comprehensive eye examination for pathology. This technology is not going to replace autorefractors that are currently in physician’s practices, or comprehensive exams that all patients should undergo. In the near term, this technology may bring autorefraction to populations who might not otherwise have access to eye care. Though in its infancy, this technology is promising in that it has real-world applications, and will only get better. ■ References 1. Ciuffreda KJ, Rosenfield M. Evaluation of the SVOne: A handheld, smartphone-based autorefractor. Optometry and Vision Science. 2015;92:1113-1139. TAL RAVIV, MD, FACS P: 212/889-3550 Dr. Raviv is founder and medical director, Eye Center of New York. He dxid not indicate a proprietary interest in the subject matter MAY 2016 :: Ophthalmology Times practice management 39 For whose convenience: The practice or the patient? View systems from perspective of patients for areas that actually inconvenience them Putting It In View By Dianna E. Graves, COMT, BS Ed The 15th Annual BOS TON :: do a fair amount of travelOn a mission now, I began to ing, so I have become a frewatch all of the times inconvequent customer of the local nient “things” were done for my transport facility that houses convenience—the number was my truck offsite and shuttles astounding. me to the airport. About a year ago, they STOP TO THINK ABOUT IT started taking online reservations It’s pouring rain, you need gas; you to expedite the process, as well as pump in the amount you need (which to reserve a space for your vehiis like taking your daily SAT tests all cle. You estimate the length of time over again by the time you push ten butyou need to park and pre-pay the tons regarding your zip code, whether amount. you want a car wash, and whether Recently, my you want a receipt) and flight departure time begin to pump. returning to MinneAt the end, waitGiving pause to soapolis was pushed ing for the receipt, a called conveniences up two hours, so my prompt pops up that that are offered arrival time to the says: “See attendant for the sake of the parking ramp ended for receipt.” patient may reveal up being 2.5 hours I don’t want to just the opposite. early. see the attendant As I was settling because someone the final bill, I nodidn’t put in new ticed I pre-paid $62.00 but the final paper—that’s why I did everything bill totaled $57.00. I asked the attenat the pump. Now, I have to walk in dant if my card would be refunded the rain to get the receipt—for my the difference. convenience. She smiled and stated: “No, we I was in a restaurant that autodon’t do that. Your original resermatically added in a 15% tip for me vation is what we base the total on, so I wouldn’t have to do the math. including a $3.00 fee for the ability The service was marginal, food to pre-book. Pre-booking is a conve- overcooked and over-spiced, and nience to ensure a space!” the wait time after ordering was riSo I smiled back and said: “So diculous. Yet the automatic recomI’m being overcharged because the mendation was 15%. Not this time! airline made a change for my conI was surrounded by the frustravenience and my truck had a place tion of people being good to me for to be even if it was for a shorter my convenience. than planned trip?!”. So you can imagine my shock She returned my receipt, smiled, when I had a patient call to comand said: “That’s right.” plain that during their exam they I want stock in that company! had requested to have their glasses How many people a day were and refraction checked so they overcharged ten cents, a quarter, or could buy a new pair of glasses dollars because of no refunds? Continues on page 40 : Convenience I Downeast Ophthalmology Symposium SEPTEMBER 23-25, 2016 Bar Harbor, Maine TAKE-HOME For further information, contact: Shirley Goggin Maine Society of Eye Physicians and Surgeons P.O. Box 190, Manchester, ME 04351 Tel: 207-445-*%#[email protected] www.maineeyemds.com 40 MAY 2016 :: Ophthalmology Times practice management CONVENIENCE ( Continued from page 39 ) (total would have been $895.00 profit to our business) and the technician told them they would do the exam as the doctor had ordered and then bring them back—wait for it—at their convenience, for the refraction at later date. The patient went on a rant for 10 minutes how she had taken a PTO day for this appointment and would need to take another day out of her vacation time for the refraction. She had requested the refraction two weeks ago and no one told her she couldn't have it. She ended that she would be going to one of the box stores for the exam and glasses on the weekend versus returning to us because they truly were convenient to her. A N D, SH E WA S R IGH T ! Another area you see this in your office is when the doctor schedules a patient for a routine exam, and then they request a visual field, OCT and even A-SCAN at the same time. Patients think they are coming for an hour and a half and are there much longer. Even if you prepare them for an expanded time, they are not happy. Their work is not happy and their kids are waiting on the curb to be picked up! Last but not least, they ran out of money on the parking meter or in the parking ramp and they now want help with the parking fee due to the inconvenience. Yes, the inconvenience. Guess which patient isn’t going to keep the follow-up appointment? What I have painfully begun to see is that many things that are done for the customer's convenience are not done for the customer at all. They are done for your convenience and the business you are running. Unfortunately, customer service “buzzwords” such as “for your convenience” become easy go-to answers when patients are angrily contesting your true motives. When a patient finally realizes it is more about your convenience, they will get angry and vocal. I challenge you to look at your systems and see if you have these areas that actually inconvenience your patients: 1. Physicians who cancel clinics on short notice and rebook at times, or clinic sites that the patient didn’t choose. 2. The physician is out, or called into surgery, and the patient is seeing a physician they don’t know. Patients have trust in their doctor, and while their partner is willing to see the patient so they don’t have to be rescheduled, and therefore inconvenienced, please make sure to advise the patient of the substitution before they get to the office. A past personal physician’s office of mine did that twice to me—and I now go to another office, and a new provider. 3. Give options please! Patient requests: “I’ve already been here two hours, can I please reschedule for another time?” Explain that there will be another office fee, or change of location, and let me make the decision. The patient is thinking: “If this change of location or even physician, is for my con- venience, then why am I irritated? Just because the office has a plan for me, doesn’t mean I agree with it. Please involve me in discussions regarding me and my treatment.” Once you start looking for the “for your convenience” moments examples in your office, you will soon become inundated, and ‘I challenge you to look at your systems and see if you have these areas that actually inconvenience your patients.’ shocked, with what you find. These need to be rectified and corrected in your practice. They also need to be seen as they really are—more of a convenience for your group versus the patient. So the next time I’m at the airport parking area and I hear how waiting for the pick-up van to be totally full (sometimes 35 minutes) before we are allowed to go to the ramp—while needing to ride around exiting customers for another 15 minutes— is for my benefit because it keeps costs down, I am going to give the woman a big smile and say: “Excuse me—I disagree.” ■ DIANNA E. GRAVES, COMT, BS ED E: [email protected] Dianna Graves is clinical services manager at St. Paul Eye Clinic PA, in Woodbury, MN. Graves is a graduate of the School of Ophthalmic Medical Technology, St. Paul, MN, and has been a member of its teaching faculty since 1983. Advertiser Index Advertiser Abbott Medical Optics www.amo-inc.com Page CVTIP, 5 Advertiser Haag-Streit Page 29 Page OCuSOFT CV3 P: 513/658-0574 Rhein Medical www.haag-streit-usa.com Alcon Laboratories Inc. Advertiser 15-16, 19-20, 23-24, 46, CV4 3 P: 800/637-4346 JCAHPO 33 www.rheinmedical.com Lacrivera 37 Shire Ophthalmic P: 800/862-5266 www.alcon.com Bausch + Lomb 7 P: 415/971-4650 10-13 P: 800/227-1427 www.bausch.com Maine Society of Eye Physicians and Surgeons Beaver Visitec International 31 Modernizing Medicine www.modmed.com/ophthEMR Doheny Eye Institute 27 Oculus Inc. 39 CV2 35 Sun Pharmaceutical Industries 17 This index is provided as an additional service. The publisher does not assume any liability for errors or omissions. IN DISPENSABLE 41 ( In Brief ) Consumer survey results Getty Images/Eyecandy Images (top); Graphic courtesy of Transitions Optical (right) TRANSITIONS SHEDS LIGHT ON UV, BLUE LIGHT HARM Managing dispensary complaints Five simple steps to resolving customer concerns begin by turning ‘A LEAF’ Dispensing Solutions By Arthur De Gennaro n old adage says: “The customer is always right.” I used to work for an optical company that leased optical shops inside J.C. Penney. Our human resources manager modified that rule to say: “The customer is not always right, but he/she is still the customer.” As a guide for customer service, we were asked to follow the Golden Rule, which everyone knows as: “Do unto others as you would have others do unto you.” To keep that idea top of mind, employees wore a small golden ruler on their lapel or collar. Continues on page 42 : Complaints A NE W YORK :: THOUGH EXPOSURE to ultraviolet (UV) rays and harmful blue light are both on the minds of Americans, many do not know these types of light share a source, according to a Transitions Optical consumer survey, conducted by Wakefield Research. When asked which types of light are harmful to the eyes long term, most people identify sunlight (76% agree) as well as light from digital screens like computers or smartphones (61% believe this). Only 4% of respondents, however, can correctly identify all common sources of blue light (digital devices and screens, fluorescent lights, incandescent light bulbs, and the sun). More specifically, less than one in five (17%) know that the sun is a source of harmful blue light, when it is actually the largest singular source, emitting over 100 times the intensity of electronic devices and screens. “Even though discussions around the dangers of harmful blue light are at the public forefront, we are finding that many people are misinformed about the sources of harmful blue light,” said Patience Cook, director, North America marketing, Transitions Optical. “Eyecare professionals should be ready to discuss this topic of concern and recommend products that offer blue-light-filtering benefits that appeal to today’s modern lifestyle.” To that end, Transitions has also developed new educational materials (http://bit.ly/1YQqEIh) to equip ECPs with the knowledge they need to patients about harmful blue light. ■ 42 MAY 2016 :: Ophthalmology Times indispensable COMPLAINTS ( Continued from page 41 ) Customers and customer service, however, have evolved. Today’s consumers are far more demanding and knowledgeable. They expect more value for their money and extremely good service. Consequently, contemporary retail workers are asked to use what I call the “new” Golden Rule: “Do unto others as they would like you to do unto them.” The new rule takes into consideration that not everyone will want what you or I might want. It is therefore imperative that you determine what each customer views as valuable and try to provide it. Since everyone is different there is no one formula for success. Here’s a process that should help to resolve dispensary complaints more effectively. Use the acronym “A LEAF” to remember the individual steps: LISTEN connect, the more likely it is they will see Listening is the most important customervalue in your plan and accept it. Any plan service tool in anyone’s armament. Learning that exceeds customers’ expectations will be to listen with an empathetic heart will enviewed extremely positively. The reverse is able you not only to understand what cusalso true tomers are looking to accomplish, but also what assurances they will need in order FOLLOW THROUGH to trust you to handle the problem to their Keep in mind that customers have already satisfaction. experienced dissatisfaction and have lost After asking customers what the probtrust in the dispensary. The only way to relem is, simply listen. Listen establish that trust is to demintently. Don’t rush this proonstrate the event was an cess. Customers need to vent. unusual occurrence and that Just allowing customers to your dispensary’s service is Having a clear vent can often make a situabetter than that. understanding of tion much easier to resolve. Consequently, whatever expectations from The goal is to determine what the plan, follow through diloptical dispensary customers are looking to acigently on every aspect of consumers is key to complish and what it will it. This means engineering being able to resolve take to satisfy them. processes that allow you to complaints. monitor the progress of your plan on at least a daily basis. EMPAT H Y Communicate with customPutting yourself in another’s shoes, so to ers promptly at those times when you said speak, was the intent of the old Golden Rule. you would. In that respect, it still has validity. Customers’ concerns are not over until Something as customers have obtained the agreed-upon simple as, “I unservice they were looking for and acknowlderstand how you edge having received it. This assumes you feel. I’m sorry you will follow through by personally speaking have experienced with them and getting them to express their (this problem). It satisfaction. must be very frusIf you have done a good job, they will trating” is a good thank you for providing such a high level way to begin to reof service and, more importantly, for carbuild rapport. This ing about them. This type of individual car— Arthur De Gennaro technique works ing is what often turns customers with combecause it allows plaints into advocates for your business. customers to feel Wouldn’t that be a nice outcome? ■ that you are on their side. TAKE-HOME ‘The goal is to determine what customers are looking to accomplish and what it will take to satisfy them.’ A N T ICIPAT E The first step in being a good customer service representative is to anticipate what customers are thinking and, more importantly, feeling. Anticipate that returning customers may be angry, frustrated, annoyed, stressed, inconvenienced, disappointed, disillusioned, skeptical, and a host of other negative emotions. All of this equates to a loss of trust in you and your practice. To turn the situation around, it will be necessary to re-establish trust. OPHTHALMOLOGY TIMES (Print ISSN 0193-032X, Digital ISSN 2150-7333) is published semimonthly except for one issue in Jan, May, Aug and Dec (20 issues yearly) by UBM Medica, 131 W First Street, Duluth, MN 55802-2065. Subscription rates: $200 for one year in the United States & Possessions, Canada and Mexico; all other countries $263 for one year. Pricing includes air-expedited service. Single copies (prepaid only): $13 in the United States & Possessions, Canada and Mexico; $20 all other countries. Back issues, if available are $25 in the U.S. $ Possessions; $30 in Canada and Mexico; $35 in all other countries. Include $6.50 per order plus $2 per additional copy for U.S. postage and handling. If ASSIST While listening, formulate a plan of action. This is a list of what you will propose specifically to satisfy customers or make things right. Now is the time to share your plan with customers. If you have listened carefully, your plan should suit their needs. As you make your proposal, be sure to “connect the dots” between what you are proposing and what customers expressed they wanted/needed. The more dots you ARTHUR DE GENNARO is president of Arthur De Gennaro & Associates LLC, an ophthalmic practice management firm that specializes in optical dispensary issues. De Gennaro is the author of the book The Dispensing Ophthalmologist. He can be reached at 803/359-7887, [email protected], or through the company’s Web site, www. adegennaro.com. He maintains a blog at www.adgablog.wordpress.com. shipping outside the U.S., include an additional $10 per order plus $5 per additional copy. Periodicals postage paid at Duluth, MN 55806 and additional mailing offices. POSTMASTER: Please send address changes to OPHTHALMOLOGY TIMES, P.O. Box 6009, Duluth, MN 55806-6009. Canadian G.S.T. number: R-124213133RT001, Publications Mail Agreement Number 40612608. Return undeliverable Canadian addresses to: IMEX Global Solutions, PO Box 25542 London, ON N6C 6B2 CANADA. Printed in the U.S.A. recording, or information storage and retrieval without permission in writing from the © 2016 UBM. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, uses beyond those listed above, please direct your written request to Permission Dept. fax publisher. Authorization to photocopy items for internal/educational or personal use, or the internal/educational or personal use of specific clients is granted by UBM for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 fax 978-646-8700 or visit http://www.copyright.com online. For 440-756-5255 or email: [email protected]. Content published by Branded vs. Generics: You Make the Call Videos, whitepapers — top ophthalmologists weigh in. ophthalmologytimes.com/makethecall 44 MAY 1, 2016 :: Ophthalmology Times marketplace For Products & Services advertising information, contact: Tamara Phillips BUFYUt'BYt&NBJMUQIJMMJQT!BEWBOTUBSDPN For Recruitment advertising information, contact: Joanna Shippoli BUFYUt'BYt&NBJMKTIJQQPMJ!BEWBOTUBSDPN PRODUCTS & SERVICES BILLING SERVICES BILLING SERVICES EQUIPMENT We’re open for business! Exclusive Ophthalmology Billers Expert Ophthalmology Billers Excellent Ophthalmology Billers Triple E = Everything gets Paid Concentrating on one Specialty makes the difference. We are a Nationwide Ophthalmology Billing Service. We have been in business over twenty years. Our staff consists of billers who are certified Ophthalmic Techs, Ophthalmic assistants, and fundus photographers who are dual certified ophthalmic coders and billers. 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GENERAL OPHTHALMOLOGIST—FLORIDA 7QEPPWXEFPITVEGXMGIMR8LI:MPPEKIW*PSVMHE EVIXMVIQIRXGSQQYRMX]QMPIWRSVXL SJ3VPERHS[MXLX[SPSGEXMSRWWIIOMRK IRIVKIXMG3TLXLEPQSPSKMWXJSVIZIRXYEP TEVXRIVWLMTSTTSVXYRMX],IEZ]WYVKIV] WGLIHYPII\TIGXIH7IIOMRK+IRIVEPMWX 7TIGMEPM^EXMSRWGSRWMHIVIHSREGEWIF]GEWI FEWMW&)&'VIUYMVIH'SQTIXMXMZIWEPEV] ERHFIRI½XWTEGOEKIMRGPYHMRKTVEGXMGI FY]MRSTXMSRW'PSWIXS3VPERHSERH8EQTE ERHETTVS\MQEXIP]SRILSYVXSFIEGLIWSR FSXLGSEWXW2SWXEXIMRGSQIXE\ %PPMRUYMVMIW[MPPVIQEMRGSR½HIRXMEP 46-2'-4%07320=236)'69-8)67 ;I[MPPFIGSRHYGXMRK MRXIVZMI[WEX%7'67 Please send Cover Letter and Resume to [email protected] VERMONT '3146),)27-:)34,8,%01303+-78¯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ecruitment Advertising Can Work For You! Reach highly-targeted, market-specific business professionals, industry experts and prospects by placing your ad here! after-hours 46 by Jolie Higazi Vitreoretinal surgeon fnds purpose in community service F practicing at The Eye Associates, Sarasota, FL, and still looks for opportunities to get involved in service. In 2009, Dr. Mali volunteered as a camp counselor at Georgia LIONS Camp for the Blind, a summer camp in Waycross, GA for 6- to 10-year-old visually impaired campers. At camp, Dr. Mali was responsible for Stevie, a 9-year-old with a history of aniridia and glaucoma. “I showed him how to fish for the first time and he even Joshua Mali, MD, has volunteered at multiple caught his first fish!” he explained. camps and mission trips to help children and “He was so happy and to me it was adults who are visually impaired. so inspirational because I was able to help him overcome his visual impairthings I cherish. I reflect on those ment and together we succeeded with courage fun experiences and being able to and conviction,” he said. “This was such a rehelp all those people.” warding experience and serves as a constant reIn November 2015, Dr. Mali served in his own community in minder of why I became and love Florida with Remote Area Medibeing an ophthalmologist and in individuals with the AcrySof® Natural cal, an organization aimed at proretinal specialist.” IOL and normal color vision. The effect viding medical care to those with Later that same year, Dr. Mali on vision of the AcrySof® Natural IOL in subjects with hereditary color vision limited medical access. served again with Camp Abilidefects and acquired color vision defects “It touched home for me beties at LIONS Camp in Maryland, secondary to ocular disease (e.g., cause this is where I live, these where he worked with campers glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve in a sports-centered environment. are local people in the community diseases) has not been studied. Do not who need healthcare,” he said. “I love sports,” he explained. resterilize; do not store over 45° C. Dr. Mali’s continued service “So it was cool to be able to help ATTENTION: Reference the Directions for Use for Model AU00T0 for a complete work is a constant reminder of campers who are visually imlisting of indications, warnings and why he got into ophthalmology. paired play sports and have some precautions. “[It provides] a sense of purgood old camp fun. They don’t pose and a sense of peace,” Dr. let [being visually impaired] stop Mali said. them. I am definitely trying to Dr. Mali anticipates participatmake an effort to continue that ing in more projects and incorpothroughout my career. That’s the rating them into family trips with reason I got into this, and I don’t his wife, who is completing her want to forget it.” residency in ophthalmology, and During a Medical Ministry Intheir future children. ternational Project in 2012, he “Whether it’s family, religion, served as a volunteer ophthalmic service work—whatever brings surgeon in Tulipan, Mexico, where you peace and a sense of purpose he performed cataract surgery for in your life, make sure to make the indigenous population. time for it,” he said. “We work a One of his favorite memories from the trip was walking around lot, but always in life it’s about prioritizing and making time for the village and joining a soccer those things that are important game with the local children. to you. For me, it’s been easy to “We kind of just jumped in merge those things and make it a and played with them spontane© 2015 Novartis 1/15 US-ULS-15-E-0442-A hybrid.” ■ ously,” he said. “Those are the CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: The AcrySof® IQ aspheric intraocular lens (“AcrySof IQ”) is intended for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. This lens is intended for placement in the capsular bag. WARNING/PRECAUTION: Use the UltraSert™ Pre-loaded Delivery System (“UltraSert”) at temperatures between 18° C (64° F) and 23°C (73° F). Use only Alcon viscoelastic qualified for this device. Do not use the UltraSert if the nozzle appears damaged or deformed. Follow the Directions for Use for correct order and sequence of steps to avoid damage to the IOL or the UltraSert. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use. Caution should be used prior to lens encapsulation to avoid lens decentrations or dislocations. Studies have shown that color vision discrimination is not adversely affected magenta cyan yellow black Photos courtesy of Joshua Mali, MD or Joshua Mali, MD, the road to becoming an ophthalmologist started when he was just a teenager. When Dr. Mali was about 14 years old, his family took a trip to Nicaragua with Health for Humanity, a Baha’i-inspired volunteer organization that provides medical services to those in poverty. He remembered how inspired he felt that even at such a young age, he could help others by volunteering. This was the beginning of what would be a decades-long service-oriented passion for Dr. Mali. “Doing service work kind of inspired me,” he said. Having the opportunity to spend time with his family at the same time as providing service to these people who really needed it was a merger of the things he most enjoyed in life. “I really liked that feeling,” he said. Today, Dr. Mali is a vitreoretinal surgeon ES773709_OT050116_046.pgs 04.26.2016 03:02 ADV Ask Yourself This Question... “Why Prescribe?” Kills Bacteria on Contact -“0” Eye y Irritation Stable 18 Months Opened or Unopened www.whyprescribe.com For more information and to order, call (800) 233-5469 or visit www.ocusoft.com © 2016 OCuSOFT, Inc., Rosenberg, TX 77471 NEW! UltraSert ™ Pre-loaded Delivery System Exceptional control for \RXU$FU\6RI® IQ IOL implantations.1-3 Combining the control of a manual delivery system with the benefits of a pre-loaded injector, the UltraSert™ System provides: • Smooth Injection. The TensionGlide™ plunger provides smooth, one-handed plunger *,1,2 advancement. • Preserved Incisions. The depth guard nozzle is designed to minimize wound stretch. 2,3 • Consistent Delivery. The plunger tip is designed Please see adjacent page for important product information. to ensure correct haptic configuration and precise 2,3 IOL placement. UltraSert PRE-LOADED DELIVERY SYSTEM ™ Advancing CATARACT SURGERY ©2015 Novartis 9/15 US-ULS-15-E-0442-A *Results of prototype testing of Pre-loaded IOL Delivery System (UltraSert) in artificial setting by 42 Ophthalmologists and 20 nurse/technicians (US). (Alcon Market Research, Feb. 2015) 1. UltraSert™ Delivery System Prototype Human Factor Testing, February, 2015. 2. AcrySof® IQ Aspheric IOL with the UltraSert™ Pre-loaded Delivery System Directions for Use. 3. Comparative Assessment of IOL Delivery Systems. Alcon internal technical report: TDOC-0018957. Effective Date 19 May 2015. CME MONOGRAPH Instant CME Certificate Available With Online Testing and Course Evaluation at http://bit.ly/pressure16 EYE Proceedings From a CME Symposium Held During AAO 2015 ORIGINAL RELEASE DATE: MAY 1, 2016 MOST RECENT REVIEW DATE: APRIL 15, 2016 EXPIRATION DATE: MAY 1, 2017 FACULTY Robert N. Weinreb, MD (Chair) This continuing medical education activity is jointly provided by The University of Louisville Office of Continuing Medical Education and MedEdicus LLC. Robert M. Feldman, MD Neeru Gupta, MD, PhD, MBA Tony Realini, MD, MPH Rohit Varma, MD, MPH This continuing medical education activity is supported through an unrestricted educational grant from Bausch & Lomb Incorporated. Distributed with CHAIR Robert N. Weinreb, MD Chairman and Distinguished Professor of Ophthalmology Director, Shiley Eye Institute Director, Hamilton Glaucoma Center University of California, San Diego San Diego, California FACULTY Robert M. Feldman, MD Clinical Professor and Chair, Department of Ophthalmology & Visual Science Richard S. Ruiz Distinguished University Chair Robert Cizik Eye Clinic University of Texas Health Science Center at Houston UTHealth Medical School Houston, Texas Neeru Gupta, MD, PhD, MBA Professor and Dorothy Pitts Chair Ophthalmology & Vision Sciences Laboratory Medicine & Pathobiology Chief of Glaucoma University of Toronto Toronto, Canada Tony Realini, MD, MPH Associate Professor of Ophthalmology West Virginia University Eye Institute Morgantown, West Virginia Rohit Varma, MD, MPH Grace and Emery Beardsley Professor and Chair Department of Ophthalmology University of Southern California (USC) Director, USC Eye Institute Associate Dean for Strategic Planning and Network Development Keck School of Medicine of USC Los Angeles, California Purpose and Target Audience The armamentarium of intraocular pressure (IOP)lowering pharmacologic and surgical treatments for glaucoma continues to grow. Nonetheless, patients with glaucoma are still at risk for vision loss and blindness due to their disease. Unfortunately, treatments to protect retinal ganglion cells from degeneration — the ultimate cause of vision loss — are lacking. New drugs, new fixed combinations of existing drugs, and new procedures constantly challenge the traditional treatment paradigm and are showing promise in lowering IOP and slowing disease progression by multiple mechanisms of action. Ophthalmologists who treat glaucoma must stay abreast of new treatments and understand their role in the context of the pathophysiology and cell biology of glaucoma to optimize patient outcomes. The purpose of this activity is to review recent advances in the understanding of the pathophysiology and treatment of glaucoma that are challenging traditional treatment paradigms. This educational activity is intended for ophthalmologists. Learning Objectives Upon completing this educational activity, participants should be able to: • Discuss the etiology of glaucoma • Select and document IOP-lowering treatment plans for patients with glaucoma based on efficacy, safety, guidelines, and patient preferences • Describe the potential role of emerging therapeutics in the management of glaucoma Joint Provider Statement This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the University of Louisville and MedEdicus LLC. The University of Louisville is accredited by the ACCME to provide continuing education for physicians. AMA Credit Designation Statement The University of Louisville Office of Continuing Medical Education designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Grantor Statement This continuing medical education activity is supported through an unrestricted educational grant from Bausch & Lomb Incorporated. Joern B. Soltau, MD Disclosure of Unlabeled Use This educational activity might contain discussion of evidence-based and/or investigational uses of agents that are not indicated by the FDA. For additional information about approved uses, including approved indications, contraindications, and warnings, please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings. Associate Professor Director, Glaucoma Service Director, Ophthalmology Residency Training Program University of Louisville School of Medicine Louisville, Kentucky Instructions & Registration This course takes approximately 1.0 hour. Please read the monograph, consult any additional references if needed. Once the materials have been reviewed, you will go to http://XXX to take a post test followed by course evaluations, after which you will be able to generate your CME certificate. Reviewed by: 2 Hardware & Software Requirements • High speed Internet connection (Broadband, Cable or DSL) • Windows 2000 or higher • 256 MBs or more of RAM • Internet Explorer 6.0 or higher • Windows Media Player 10.0 or higher • Adobe Acrobat 7.0 or higher • Course content compatible with Mac OS Disclaimer The views and opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of the University of Louisville, MedEdicus LLC, or Bausch & Lomb Incorporated. Disclosures As a provider accredited by the ACCME, the Office of CME & PD, School of Medicine, University of Louisville, must ensure balance, independence, objectivity, and scientific rigor in all its sponsored educational activities. All planners, faculty, reviewers, and other persons that affected the content of this CME activity were required to submit a financial disclosure form from which relevant conflicts of interest were determined. The persons below disclosed the following: CME Reviewer: Dr Joern B. Soltau: No relevant financial relationships with any commercial interests. Faculty: Dr Robert M. Feldman: Alcon (Consultant); InnFocus Inc; XOMA (Contracted Research). Dr Neeru Gupta: Bausch & Lomb Incorporated (Consultant). Dr Tony Realini: Alcon; Alimera Sciences; Bausch & Lomb Incorporated; Inotek Pharmaceuticals Corporation; Reichert, Inc (Consultant); Alcon (Contracted Research); Lumenis (Speaker’s Bureau). Dr Rohit Varma: Bausch & Lomb Incorporated (Consultant). Dr Robert N. Weinreb: Alcon; Allergan; Bausch & Lomb Incorporated; Valeant (Consultant); Aerie Pharmaceuticals, Inc; Genentech, Inc; Quark (Contracted Research). MedEdicus: Cynthia Tornallyay, RD, MBA, CHCP; Diane McArdle, PhD; and Michelle Ong have no relevant financial relationships with any commercial interests. University of Louisville CME & PD: The CME & PD staff and Advisory Board have nothing to disclose. Medium or Combination of Media Used: Online Enduring Material Activity Method of Physician Participation: Printed and Online/Digital Monograph Estimated Time to Complete the Educational Activity: 1.0 hour Provider Contact Information For questions about the CME activity content, please contact University of Louisville at [email protected]. Privacy Policy All information provided by course participants is confidential and will not be shared with any other parties for any reason without permission. Copyright ©2016 MedEdicus LLC. INTRODUCTION EYE Primary open-angle glaucoma (POAG) is a leading cause of vision loss in the United States and the world, and represents one of the most common ocular conditions for which patients visit their eye care provider. Although the tools used to treat glaucoma have evolved over time, the approach to glaucoma management, that is, reduction of intraocular pressure (IOP), has remained constant for more than 150 years. In this review, our expert faculty will review new information on glaucoma pathophysiology, including the role of ocular perfusion pressure (OPP) and cerebrospinal fluid (CSF) pressure in the development of glaucomatous optic neuropathy. In addition, promising treatments in the clinical trial pipeline will be reviewed. Finally, a case discussion will highlight the process by which the selection of glaucoma therapies can be tailored to treat individual patients. —Robert N. Weinreb, MD, for the faculty PATHOPHYSIOLOGY OF GLAUCOMA —Robert N. Weinreb, MD Primary open-angle glaucoma presents numerous challenges in terms of both diagnosis and management. In the absence of a definitive test for the disease, the diagnosis of glaucoma remains a clinical impression based on the synthesis of physical findings and both structural and functional testing. A fairly nebulous definition of POAG, the language of which underscores the imprecision of the diagnostic features of the disease, further complicates the process. According to the American Academy of Ophthalmology: Primary open-angle glaucoma (POAG) is a chronic, progressive optic neuropathy in adults in which there is a characteristic acquired atrophy of the optic nerve and loss of retinal ganglion cells and their axons. This condition is associated with an open anterior chamber angle by gonioscopy. At the most basic level, POAG is an optic neuropathy; however, definitive causal factors have remained elusive. The role of elevated IOP in glaucoma, once thought to be the primary cause of POAG, has become more complex over time. Epidemiologic and longitudinal studies have demonstrated that elevated IOP is neither necessary nor sufficient to explain the development of POAG.2 Instead, IOP is considered a risk factor for both the development and progression of glaucoma. Interventional clinical trials support this relationship; the reduction of IOP reduces the risk of developing glaucoma and its progression across the full range of IOPs.3-5 In these studies and others, however, one consistent observation remains clear: some eyes with glaucoma continue to progress despite significant IOP reduction. One explanation may be that these eyes required even greater IOP reductions to achieve disease stability. Another explanation is that other factors beyond IOP also play a role in the pathophysiology of glaucoma. Pathophysiologic Mechanisms Many candidate contributors to glaucoma pathogenesis have been postulated (Figure 1).6 These all share 1 key feature: they have the potential to damage retinal ganglion cells (RGCs). The health of both the RGCs and the cells of the lateral geniculate nucleus depends on anterograde and retrograde axoplasmic flow to deliver crucial nutrients and prosurvival factors. Intraocular pressure is believed to lead to RGC loss by deforming the lamina cribrosa in the optic nerve head and blocking axoplasmic flow. Microcirculation Intraocular pressure Lateral geniculate nucleus and other target Ischaemia—hypoxia Retinal ganglion cell Lamina cribrosa Aberrant immunity Inflammatory cytokines Blockade of neurotrophins and other target derived factors Astrocytes Excessive glutamate stimulation Glial cells Figure 1. Key contributors to POAG pathophysiology6 Reprinted from The Lancet, 363, Weinreb RN, Khaw PT, Primary open-angle glaucoma, 1711-1720, Copyright 2004, with permission from Elsevier. The optic nerve head’s microcirculation may also be impaired in some eyes, leading to hypoxia and ischemia. Clinical evidence in support of this theory includes the frequent observation of disc hemorrhages in eyes with glaucoma as well as the common finding of migraine and vasospastic comorbidities, such as Raynaud phenomenon, in patients with glaucoma, which may be related to progression in these patients.7 Other putative factors include circulating autoantibodies to RGCs and proinflammatory cytokines that may also contribute to RGC death.6 3 Established Risk Factors for Glaucoma Clinically, many risk factors for the development of POAG have been identified in clinical trials. These include elevated IOP, increasing age, thin central corneas, as well as both optic nerve and visual field parameters.8 Other risk factors exist as well. Corneal hysteresis is a biomechanical property that reflects the viscoelastic nature of the cornea, that is, how easily it can be deformed and how easily it returns to its normal configuration after deformation. Like corneal thickness, corneal hysteresis may alter the accuracy of applanation tonometry. However, corneal hysteresis is a significant risk factor for glaucoma independent of corneal thickness, suggesting that it may provide additional information on glaucoma risk, such as a possible measure of the eye’s biomechanical susceptibility to glaucomatous optic nerve damage.9 Additionally, family history remains a relevant risk factor for glaucoma. First-degree relatives of patients with glaucoma have higher than expected rates of glaucoma,10 although identification of genes that explain more than a tiny proportion of glaucoma cases remains elusive. It is likely that the genetics of glaucoma is a highly complex relationship involving epigenetics mechanisms, such as gene-gene or gene-environment interactions, among others.11 Emerging Risk Factors Cerebrospinal fluid pressure. The optic nerve head is the site of injury in glaucoma, and within the optic nerve head, the lamina cribrosa, in particular, is relevant. The lamina cribrosa provides structural support for the nerve head, and the axons of the RGCs pass through the lamina en route to their synaptic junction in the lateral geniculate nucleus. The lamina cribrosa separates the spaces under the influence of IOP anteriorly and intracranial pressure posteriorly. Any force that alters the anatomic configuration of the lamina can threaten the health of RGC axons. On the anterior side of the lamina cribrosa is IOP, which, when elevated, can cause backbowing of the lamina cribrosa. This deformation of the lamina may create shearing forces that can impinge on the axons and interrupt axoplasmic flow, to the detriment of RGC health. On the posterior side of the lamina cribrosa is intracranial pressure. The space within the optic nerve that lies between the nerve tissue and the dura mater is filled with CSF and is contiguous with the intracranial space. Like aqueous humor, CSF is not stagnant but is continually produced by the choroid plexi of the lateral ventricles; bathes the brain, spinal cord, and cranial nerves (including the optic nerve); and is absorbed by the cranial and spinal arachnoid villi. Also, like aqueous humor, the CSF is under constant positive pressure, CSF pressure, which is determined by the balance between CSF production and resorption. Because both aqueous humor and CSF generate positive pressures, under homeostasis, a laminar configuration that reflects the balance between these 2 opposing forces exists. But because the relative magnitudes of IOP and CSF pressure vary, laminar deformation can occur. The role of CSF pressure in the pathophysiology of glaucoma has received significant attention. In 2008, a retrospective study from the Mayo Clinic was the first to demonstrate a statistically significant difference in mean CSF pressure among subjects with and without primary POAG.12 In this study, the medical records of patients referred to the Mayo Clinic for lumbar puncture for a variety of indications were reviewed. The CSF opening pressure of 28 patients with POAG and 49 nonglaucomatous control subjects was recorded. The mean opening pressure of the POAG group was significantly lower than that of the control group (9.2 ± 2.9 mm Hg vs 13.0 ± 4.2 mm Hg; P < .00005). Subsequently, a prospective study conducted in China confirmed this finding, in which the 4 mean CSF opening pressure of subjects with normal-tension glaucoma, those with high-tension POAG, and healthy subjects was 9.5 ± 2.2 mm Hg, 11.7 ± 2.7 mm Hg, and 12.9 ± 1.9 mm Hg, respectively.13 The CSF pressure of the normal-tension group was significantly lower than that of the other 2 groups (P < .001). The relationship of CSF pressure measured by lumbar puncture in these studies with intracranial pressure is unclear. The observation that CSF pressure is low in eyes with glaucoma might help explain some paradoxes surrounding the relationship between glaucoma and IOP. For instance, why do some eyes with high IOP never develop glaucoma, whereas many eyes with normal IOP develop glaucoma? These 2 studies demonstrate that CSF pressure is lower in eyes with normal-tension glaucoma, suggesting that even low IOP is adequate to deform the lamina in the presence of low CSF pressure on the posterior side of the lamina. Further evidence for this hypothesis comes from a recent case report, in which a patient with normal-tension glaucoma demonstrated sudden progression upon undergoing ventriculoperitoneal shunting to lower CSF pressure in the setting of normal-pressure hydrocephalus.14 Conversely, perhaps some individuals with elevated IOP also have elevated CSF pressure, which might neutralize the pressure gradient across the lamina cribrosa and prevent deformation of axons. A third study, in which 17 patients with ocular hypertension and 71 nonglaucomatous control subjects underwent lumbar puncture, with measurement of CSF opening pressure, supports this hypothesis. The mean opening pressure in the ocular hypertensive group was significantly higher than that of the control group (16.0 ± 2.5 mm Hg vs 12.9 ± 1.9 mm Hg; P < .001).15 These studies and observations suggest that the relative magnitudes of IOP and CSF pressure, also called the translaminar pressure difference, may be important when considering the relationship between IOP and glaucoma. Additional research is necessary to add strength to this intriguing hypothesis. Further elucidation of the role of CSF pressure in IOP and glaucoma could lead to a novel therapeutic strategy for glaucoma, given that CSF pressure is modifiable. However, the invasive nature of current methods for CSF pressure assessment and modification might limit such a strategy. Ocular perfusion pressure. In simplest terms, OPP can be thought of as the arithmetic difference between blood pressure and IOP. In more specific terms, OPP represents the relative intraluminal blood pressure within the ocular circulation. Table 1 gives the formulas for calculating mean, systolic, and diastolic OPP.16 Table 1. Formal Definitions of OPP: Mean, Systolic, and Diastolic16 Mean OPP 2/3 [diastolic BP + 1/3 (systolic BP – diasylic BP)] – IOP Systolic OPP Systolic BP – IOP Diastolic OPP Diastolic BP – IOP When OPP is high, ocular tissues are well perfused, and when OPP is low, ocular tissues are less well perfused. Just as the interplay between CSF pressure and glaucoma may represent a pathophysiologic theoretical basis for mechanical glaucomatous optic nerve damage, variations in OPP may provide a basis for the ischemic theory of glaucoma damage. Numerous epidemiologic studies have demonstrated that low OPP and, more specifically, low diastolic OPP, increases the risk for developing glaucoma 2- to 6-fold (Table 2).17-22 Like CSF pressure, OPP is modifiable, and OPP assessment is less invasive. Spot estimates of OPP can be easily obtained in the assessment is a synthesis of all known and suspected risk Odds Ratio factors for the development Study Design Participants (95% Confidence Interval) and/or progression of glaucoma. Validated calculators Non-Hispanic Whites and 17 Baltimore Eye Survey Cross-sectional 6.22 (2.15-17.94)* African Americans exist to aid in the synthesis of data and provide quantitative 18 † Egna-Neumarkt Study Cross-sectional Non-Hispanic Whites 0.39 (0.22-0.69) estimates of the risk of developing glaucoma or its Proyecto VER19 Cross-sectional Hispanics 0.96 (0.94-0.99)* progression. These instruments Los Angeles Latino Eye Study20 Cross-sectional Hispanics 1.9 (1.1-3.0)* are limited by our lack of knowledge of risk factors, Barbados Eye Study21,22 Longitudinal Afro-Caribbeans 3.2 (1.6-6.6)*‡ which are gleaned primarily * Glaucoma risk from low diastolic OPP vs normal diastolic OPP. from relatively small studies † Glaucoma risk from high diastolic OPP vs low diastolic OPP. compared with those of other ‡ At 4 years. disease states. Also, they do not incorporate all known risk factors, each of which must be considered separately and in addition to the calculator’s estimates of risk. Importantly, risk office by measuring both IOP and blood pressure and applying profiles change over time, so risk assessment should be the formulas from Figure 1. A more comprehensive assessment considered an ongoing process rather than a one-time event. of OPP, however, can be made by assessing both blood pressure and IOP over a 24-hour period. Risk calculators for the development of POAG in eyes with ocular hypertension have been developed.29,30 One of these, developed from The 24-hour assessment of blood pressure can be easily data collected in both the Ocular Hypertension Treatment Study and accomplished using continuous ambulatory blood pressure the European Glaucoma Prevention Study,29 can be accessed, at no monitoring. This may be best accomplished in coordination with cost, at http://ohts.wustl.edu/risk/calculator.html. After entering a the patient’s primary care provider. The assessment is generally small amount of patient-specific data, the calculator determines the well tolerated and provides data from both daytime and critical patient’s 5-year risk of developing POAG. This risk estimate can be nighttime periods. useful in determining the value of prophylactic therapy. Likewise, the Triggerfish contact lens–based continuous IOP monitor (Sensimed AG, Lausanne, Switzerland), which was THERAPEUTIC OPTIONS FOR IOP recently approved for use in the United States,23 can be used to estimate IOP throughout the 24-hour period. This minimally REDUCTION: TODAY AND TOMORROW invasive system consists of a contact lens sensor with an –Robert M. Feldman, MD embedded strain gauge. It does not directly measure IOP. Rather, it detects changes in corneal curvature that result from changes Glaucoma therapy has 3 major goals. First, we must apply in IOP and uses these measurements as a surrogate for IOP. An adequate therapy to achieve our target IOP. Second, we should antenna positioned around the orbital rim receives telemetric prevent, or at least slow, the progression of glaucoma to prevent data from the sensor. Data are transmitted to a portable storage blindness. Third, and often overlooked, we should strive to device. The system makes 300 measurements over 30 seconds, optimize the quality of life for our patients with glaucoma with every 5 minutes, for a full 24-hour cycle. The device is well every clinical decision, considering the effect of both the disease tolerated by most patients,24,25 and the output provides a and our treatment choices on quality of life. validated qualitative representation of IOP curve shape over time and in response to IOP-lowering interventions.26,27 Selecting Initial Therapy Table 2. Summary of Key Epidemiologic Studies Linking Glaucoma and OPP The combined data from 24-hour assessment of both blood pressure and IOP can present challenges for interpretation. An automated way to combine the digital output of these devices for a continuous calculation of OPP does not currently exist. One key period worthy of close attention is the nocturnal period. At night, in the supine position, IOP tends to be highest and blood pressure often drops compared with daytime measurements, thus producing nadir OPP in this period for many patients.28 Once identified, low nocturnal OPP can be addressed in several ways and should be approached in consultation with the patient’s primary care provider. Some patients may be overmedicated for systemic hypertension and can discontinue 1 or more antihypertensive medications. In other patients, changing nighttime dosing to morning dosing may help prevent nocturnal dips. When these options are either not available or not effective, nighttime salt loading in some patients may have value; patients can often achieve this by simply consuming a salty snack, such as a small bag of potato chips, before bedtime. Global Risk Assessment in Glaucoma When facing the decision to treat or not to treat a glaucoma suspect, or to treat more aggressively in established glaucoma, a global risk assessment can inform decision making. A global risk The selection of initial therapy should be tailored to the needs of individual patients. Considerations should include the magnitude of IOP reduction needed, comorbidities that might make some therapies contraindications, lifestyle issues that might make some therapies undesirable, and any physical or cognitive impairment that might affect the ability to reliably self-dose. For most patients, prostaglandin analogues are the optimal first-line therapy. These drugs are highly effective, exceedingly safe, well tolerated, conveniently dosed once daily, and, with the availability of generic latanoprost, also affordable. Several recent studies suggest that selective laser trabeculoplasty is a reasonable alternative to medications for first-line therapy.31,32 Primary surgical intervention is typically reserved for patients with extremely high IOP, those with end-stage disease, monocular patients at high risk for blindness, and those with difficult-to-manage secondary glaucoma. Emerging Glaucoma Therapeutics In large part, the unparalleled efficacy and safety of prostaglandins have set the bar high for future drug development. A novel glaucoma drug has not been introduced to the marketplace since the launch of latanoprost in the 1990s. This may soon change. Several new molecules are in late-stage clinical development and may reach the US marketplace in the near future. 5 Latanoprostene bunod. This modification of the latanoprost molecule adds a nitric oxide (NO)-donating moiety to the compound. The result is a dual-action therapeutic, in which the latanoprost component increases aqueous outflow through the uveoscleral pathway and the NO component activates the cyclic guanosine monophosphate pathway, leading to trabecular relaxation and increased conventional outflow.33 In a phase 2 study, latanoprostene bunod provided an approximately 1 to 1.5 mm Hg greater IOP reduction than did latanoprost (P ≤ .009).34 A phase 3 evaluation revealed that, compared with timolol, 0.5%, dosed twice daily, once-daily dosing of latanoprostene bunod, 0.024%, produced a lower mean IOP at each of the 9 time points: 8 AM, 12 PM, and 4 PM at weeks 2, 6, and 12.35 Further, more patients treated with latanoprostene bunod than with timolol achieved IOP ≤ 18 mm Hg and IOP reduction ≥ 25%, with comparable adverse events between the 2 groups. Rho kinase inhibitors. Like latanoprostene bunod, the Rho kinase inhibitor netarsudil mesylate (AR-13324) has multiple mechanisms of action. The molecule inhibits the enzyme Rho kinase and also inhibits the norepinephrine transporter, which increases adrenergic activity. The net effect is a reduction of IOP via increased trabecular outflow and reduced episcleral venous pressure, which are both mediated by Rho kinase inhibition, and reduced aqueous production mediated by norepinephrine transporter inhibition.36,37 Two phase 3 trials have been completed but not yet published. Future development for this drug includes a fixed combination with latanoprost. Advances in drug delivery. One important limitation shared by all topical glaucoma medications is the need for daily administration by the patient. Adherence with glaucoma medications has been shown in numerous studies to be consistently poor.38 Several products under development seek to reduce the frequency of dosing by using sustained-release technology. Among these is a sustained-release formulation of bimatoprost, which is packaged in a biodegradable implant injected into the anterior chamber in the clinic setting and expected to provide IOP reduction for 4 to 6 months.39 A phase 3 trial vs timolol is under way.40 Both a punctal plug delivery system41 and an intraocular implant for travoprost42 and bimatoprost43 are also in development. Other novel delivery systems, including the use of nanoparticles, are also being developed.44 CASE STUDY –Neeru Gupta, MD, PhD, MBA This patient was a 48-year-old woman with a complex medical history that included fibromyalgia, depression, headache, and sleep disorder. Her medications included fluoxetine and amitriptyline. She had a sulfonamide allergy. Her father had glaucoma. On examination, her visual acuity was 20/30 in the right eye and 20/25 in the left eye. Anterior segments and angles were unremarkable. Her IOP was 14 mm Hg in both eyes, with a corneal thickness of 545 μm in both eyes. Figure 2 shows her optic nerves, and Figure 3 shows her visual fields. Her target IOP was set at 10 mm Hg, and she was started on a prostaglandin analogue, but did not tolerate it. Dr Weinreb: Dr Feldman, is there any other history or evaluation that might be relevant? Dr Feldman: Given the advanced stage of disease with such a low untreated IOP, a diurnal IOP curve might be useful. Dr Gupta: We considered that as well. Her diurnal IOP range was 8 to 14 mm Hg on no treatment. Dr Feldman: In that pressure range, I start thinking beyond IOP. Does she have any vascular risk factors? What is her blood pressure? 6 A B Figure 2. Right (A) and left (B) optic nerves of the patient. Note the loss of inferior rim in the right eye. Images courtesy of Neeru Gupta, MD, PhD, MBA A B Figure 3. Visual fields from the patient. Note the superior visual field loss in the right eye (A). Images courtesy of Neeru Gupta, MD, PhD, MBA Dr Gupta: When we asked, she reported cold fingers and Raynaud phenomenon. We measured her blood pressure in the clinic at 108/70 mm Hg. Dr Weinreb: Dr Varma, you have studied the relationship between OPP and glaucoma in the Los Angeles Latino Eye Study. What is the significance of this low blood pressure reading in this patient? Dr Varma: In our study and others, as you pointed out earlier, low diastolic perfusion pressure is a strong risk factor for developing glaucoma. It is also a strong predictor of glaucoma progression. In patients with hypertension, we have the opportunity to reduce systemic antihypertensive therapy or shift dosing from nighttime to morning to prevent nocturnal dips in blood pressure. But in this patient, the hypotension is intrinsic and not iatrogenic. That is more difficult to address. Dr Gupta: This patient was sent for 24-hour blood pressure monitoring and found to have nocturnal hypotension. In an effort to address low diastolic perfusion pressure at night, salty bedtime snacks, such as pretzels, olives, tomato juice, or nuts, were suggested. She does this each night before bed, and, fortunately, she has remained stable, with no further progression. SUMMARY Glaucoma is a complex and incompletely understood multifactorial disease, with many known and likely many unknown risk factors. New risk factors are emerging and may shed light on the pathogenesis of glaucoma. Reduction of IOP remains the only established treatment, but novel therapeutic targets may be on the horizon. A wider selection of available and emerging therapies may give clinicians more options to individualize glaucoma therapy on the basis of each patient’s unique needs and desires. Sustained-release drug delivery options may improve the patient experience by reducing the need for daily dosing. The role of sustained-release formulations of products available as topical medications in routine clinical practice remains to be clarified, and insurance coverage issues will also likely play a role in the clinical utility of these products. REFERENCES 1. American Academy of Ophthalmology Glaucoma Panel. Preferred Practice Pattern® Guidelines. Primary Open-Angle Glaucoma. San Francisco, CA: American Academy of Ophthalmology; 2015. 2. Bahrami H. Causal inference in primary open angle glaucoma: specific discussion on intraocular pressure. Ophthalmic Epidemiol. 2006;13(4): 283-289. 3. Kass MA, Heuer DK, Higginbotham EJ, et al. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary openangle glaucoma. Arch Ophthalmol. 2002;120(6):701-713. 4. Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002;120(10):1268-1279. 5. Collaborative Normal-Tension Glaucoma Study Group. Comparison of glaucomatous progression between untreated patients with normaltension glaucoma and patients with therapeutically reduced intraocular pressures. Am J Ophthalmol. 1998;126(4):487-497. 6. Weinreb RN, Khaw PT. Primary open-angle glaucoma. Lancet. 2004; 363(9422):1711-1720. 7. Drance S, Anderson DR, Schulzer M; Collaborative Normal-Tension Glaucoma Study Group. Risk factors for progression of visual field abnormalities in normal-tension glaucoma. Am J Ophthalmol. 2001;131(6):699-708. 8. Gordon MO, Beiser JA, Brandt JD, et al. The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary openangle glaucoma. Arch Ophthalmol. 2002;120(6):714-720. 9. Medeiros FA, Meira-Freitas D, Lisboa R, Kuang TM, Zangwill LM, Weinreb RN. Corneal hysteresis as a risk factor for glaucoma progression: a prospective longitudinal study. Ophthalmology. 2013;120(8):1533-1540. 10. Sung VC, Koppens JM, Vernon SA, et al. Longitudinal glaucoma screening for siblings of patients with primary open angle glaucoma: the Nottingham Family Glaucoma Screening Study. Br J Ophthalmol. 2006;90(1):59-63. 11. Doucette LP, Rasnitsyn A, Seifi M, Walter MA. The interactions of genes, age, and environment in glaucoma pathogenesis. Surv Ophthalmol. 2015; 60(4):310-326. 12. Berdahl JP, Allingham RR, Johnson DH. Cerebrospinal fluid pressure is decreased in primary open-angle glaucoma. Ophthalmology. 2008; 115(5):763-768. 13. Ren R, Jonas JB, Tian G, et al. Cerebrospinal fluid pressure in glaucoma: a prospective study. Ophthalmology. 2010;117(2):259-266. 14. Chen BH, Drucker MD, Louis KM, Richards DW. Progression of normaltension glaucoma after ventriculoperitoneal shunt to decrease cerebrospinal fluid pressure. J Glaucoma. 2016;25(1):e50-e52. 15. Ren R, Zhang X, Wang N, Li B, Tian G, Jonas JB. Cerebrospinal fluid pressure in ocular hypertension. Acta Ophthalmol. 2011;89(2):e142-e148. 16. Costa VP, Harris A, Anderson D, et al. Ocular perfusion pressure in glaucoma. Acta Ophthalmol. 2014;92(4):e252-e266. 17. Tielsch JM, Katz J, Sommer A, Quigley HA, Javitt JC. Hypertension, perfusion pressure, and primary open-angle glaucoma. A populationbased assessment. Arch Ophthalmol. 1995;113(2):216-221. 18. Bonomi L, Marchini G, Marraffa M, Bernardi P, Morbio R, Varotto A. Vascular risk factors for primary open angle glaucoma: the EgnaNeumarkt Study. Ophthalmology. 2000;107(7):1287-1293. 19. Quigley HA, West SK, Rodriguez J, Munoz B, Klein R, Snyder R. The prevalence of glaucoma in a population-based study of Hispanic subjects: Proyecto VER. Arch Ophthalmol. 2001;119(12):1819-1826. 20. Memarzadeh F, Ying-Lai M, Chung J, Azen SP, Varma R; Los Angeles Latino Eye Study Group. Blood pressure, perfusion pressure, and open-angle glaucoma: the Los Angeles Latino Eye Study. Invest Ophthalmol Vis Sci. 2010;51(6):2872-2877. 21. Leske MC, Wu SY, Nemesure B, Hennis A. Incident open-angle glaucoma and blood pressure. Arch Ophthalmol. 2002;120(7):954-959. 22. Leske MC, Wu SY, Hennis A, Honkanen R, Nemesure B; BESs Study Group. Risk factors for incident open-angle glaucoma: the Barbados Eye Studies. Ophthalmology. 2008;115(1):85-93. 23. FDA permits marketing of device that senses optimal time to check patient’s eye pressure. U.S. Food and Drug Administration Web site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm489308.htm. Published March 4, 2016. Accessed April 6, 2016. 24. Lorenz K, Korb C, Herzog N, et al. Tolerability of 24-hour intraocular pressure monitoring of a pressure-sensitive contact lens. J Glaucoma. 2013;22(4):311-316. 25. Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. Continuous 24-hour monitoring of intraocular pressure patterns with a contact lens sensor: safety, tolerability, and reproducibility in patients with glaucoma. Arch Ophthalmol. 2012;130(12):1534-1539. 26. Holló G, Kóthy P, Vargha P. Evaluation of continuous 24-hour intraocular pressure monitoring for assessment of prostaglandin-induced pressure reduction in glaucoma. J Glaucoma. 2014;23(1):e6-e12. 27. Tojo N, Oka M, Miyakoshi A, Ozaki H, Hayashi A. Comparison of fluctuations of intraocular pressure before and after selective laser trabeculoplasty in normal-tension glaucoma patients. J Glaucoma. 2014;23(8):e138-e143. 28. Costa VP, Jimenez-Roman J, Carrasco FG, Lupinacci A, Harris A. Twentyfour-hour ocular perfusion pressure in primary open-angle glaucoma. Br J Ophthalmol. 2010;94(10):1291-1294. 29. Gordon MO, Torri V, Miglior S, et al; Ocular Hypertension Treatment Study Group; European Glaucoma Prevention Study Group. Validated prediction model for the development of primary open-angle glaucoma in individuals with ocular hypertension. Ophthalmology. 2007;114(1):10-19. 30. Medeiros FA, Weinreb RN, Sample PA, et al. Validation of a predictive model to estimate the risk of conversion from ocular hypertension to glaucoma. Arch Ophthalmol. 2005;123(10):1351-1360. 31. Katz LJ, Steinmann WC, Kabir A, Molineaux J, Wizov SS, Marcellino G; SLT/Med Study Group. Selective laser trabeculoplasty versus medical therapy as initial treatment of glaucoma: a prospective, randomized trial. J Glaucoma. 2012;21(7):460-468. 32. Realini T. Selective laser trabeculoplasty for the management of openangle glaucoma in St. Lucia. JAMA Ophthalmol. 2013;131(3):321-327. 33. Cavet ME, Vittitow JL, Impagnatiello F, Ongini E, Bastia E. Nitric oxide (NO): an emerging target for the treatment of glaucoma. Invest Ophthalmol Vis Sci. 2014;55(8):5005-5015. 34. Weinreb RN, Ong T, Scassellati Sforzolini B, Vittitow JL, Singh K, Kaufman PL; VOYAGER Study Group. A randomised, controlled comparison of latanoprostene bunod and latanoprost 0.005% in the treatment of ocular hypertension and open angle glaucoma: the VOYAGER study. Br J Ophthalmol. 2015;99(6):738-745. 35. Weinreb RN, Scassellati Sforzolini B, Vittitow J, Liebmann J. Latanoprostene bunod 0.024% versus timolol maleate 0.5% in subjects with open-angle glaucoma or ocular hypertension: the APOLLO Study. Ophthalmology [published online ahead of print February 11, 2016]. doi:10.1016/j.ophtha.2016.01.019. 36. Wang SK, Chang RT. An emerging treatment option for glaucoma: Rho kinase inhibitors. Clin Ophthalmol. 2014;8:883-890. 37. Wang RF, Williamson JE, Kopczynski C, Serle JB. Effect of 0.04% AR-13324, a ROCK, and norepinephrine transporter inhibitor, on aqueous humor dynamics in normotensive monkey eyes. J Glaucoma. 2015;24(1):51-54. 38. Budenz DL. A clinician’s guide to the assessment and management of nonadherence in glaucoma. Ophthalmology. 2009;116(11)(suppl):S43-S47. 39. Dalton M. Sustained-release bimatoprost implant addresses challenge of adherence. Ophthalmol Times. http://ophthalmologytimes. modernmedicine.com/ophthalmologytimes/news/sustained-releasebimatoprost-implant-addresses-challenges-adherence. Published January 1, 2016. Accessed March 30, 2016. 40. Allergan. Efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension. ClinicalTrials.gov Web site. https://clinicaltrials.gov/ct2/show/NCT02247804. Updated January 12, 2016. Accessed March 30, 2016. 41. Molla D, O’Connor M, Blizzard CD, et al. One-year stability of a sustained release travoprost biodegradable hydrogel punctum plug for the treatment of glaucoma. Invest Ophthalmol Vis Sci. 2015;56(7):5707. 42. Envisia Therapeutics. A parallel-arm, randomized, dose-ranging study of ENV515 travoprost extended-release (XR) in subjects with bilateral ocular hypertension or early primary open-angle glaucoma. ClinicalTrials.gov Web site. https://clinicaltrials.gov/ct2/show/NCT02371746. Accessed March 30, 2016. 43. Lewis R, Christie WC, Day DG, et al. Bimatoprost sustained-release implants for glaucoma therapy: interim results from a 24-month phase 1/2 clinical trial. Paper presented at: American Academy of Ophthalmology 2015 Annual Meeting; November 14-17, 2015; Las Vegas, NV. Scientific Poster 93. 44. Foldvari M. Noninvasive ocular drug delivery: potential transcorneal and other alternative delivery routes for therapeutic molecules in glaucoma. J Glaucoma. 2014;23(8)(suppl 1):S80-S82. 7 POST TEST CME Monograph To obtain AMA PRA Category 1 Credit™ for this activity, complete the CME Post Test and course evaluation online at http://bit.ly/pressure16. Upon successful completion of the post test and evaluation, you will be able to generate an instant certificate of credit. Instant CME Certificate Available With Online Testing and Course Evaluation at http://bit.ly/pressure16 Following are the questions that will be asked. 1. Which of the following is not a component of the definition of POAG? a. Optic nerve degeneration b. Elevated IOP c. Loss of RGCs d. Open anterior chamber angle 2. All potential contributors to the pathophysiology of POAG share which of the following mechanisms? a. Raised IOP b. Damage to the visual cortex c. Damage to the trabecular meshwork d. Damage to RGCs 3. Evidence in support of impaired microcirculation of the optic nerve head as part of the pathophysiology of glaucoma includes: a. Optic nerve cupping b. Optic atrophy c. Disc hemorrhages d. Elevated OPP 4. Established risk factors for POAG include: a. Elevated IOP and thick central corneas b. Increasing age and thick central corneas c. Positive family history of glaucoma and elevated IOP d. Young age and thin central corneas 5. Which of the following best describes the relationship between OPP and the risk of developing POAG? a. Elevated systolic OPP decreases the risk of POAG b. Low diastolic OPP increases the risk of POAG c. Low mean OPP decreases the risk of POAG d. Low systolic OPP decreases the risk of POAG 7. For a patient with early POAG who also has benign essential tremor and lives alone with no caregiver, which of the following is a reasonable first-line therapy for IOP reduction? a. Prostaglandin analogue b. Beta-blocker c. Laser trabeculoplasty d. Trabeculectomy 8. For a patient with newly diagnosed end-stage POAG who has IOP in the range of 35 mm Hg and has already lost central visual acuity in 1 eye because of the disease, which of the following is the best intervention for preventing blindness in the remaining eye? a. Prostaglandin analogue b. Beta-blocker c. Laser trabeculoplasty d. Trabeculectomy 9. In clinical trials, latanoprostene bunod is thought to reduce IOP by: a. Decreasing aqueous humor production and increasing trabecular (conventional) outflow b. Increasing both uveoscleral and trabecular outflow c. Decreasing aqueous humor production and increasing uveoscleral outflow d. Increasing aqueous humor production and decreasing uveoscleral outflow 10. A significant advantage of sustained-delivery devices for glaucoma medication is: a. Cheaper cost b. Less invasive than drops c. Better adherence d. Neuroprotection 6. What is the preferred method for determining target IOP for glaucoma therapy? a. Use a validated formula based on risk factor analysis b. An educated estimate based on the risk profile of the individual patient c. Seek to lower IOP by 15% from untreated baseline for most patients d. Start a medication and see how effective it is 83 Published as a promotional supplement to FUNDING AND CONTENT ASSISTANCE PROVIDED BY MAY 2016 Choosing and Using the AcrySof® IQ ReSTOR® IOL Family CUSTOMIZING OPTIONS FOR INDIVIDUAL PATIENTS CONTRIBUTORS Stephen S. Lane, MD* Associated Eye Care, Stillwater, Minnesota; University of Minnesota, Minneapolis, Minnesota, USA Mehmet Söyler, MD Batıgöz Eye Center, Izmir, Turkey Enrique Suárez, MD Centro Medico Docente La Trinidad, Caracas, Venezuela Francesco Carones, MD* Carones Ophthalmology Center, Milan, Italy Abhay Vasavada, MD† Raghudeep Eye Clinic, Ahmedabad, India Lisa Cibik, MD* AIO Ltd, Pittsburgh, Pennsylvania, USA Richard Potvin, OD* Science in Vision, Burleson, Texas, USA *Receives consulting fees from Alcon Laboratories † Receives grant support from Alcon Laboratories Introduction The AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL with ACTIVEFOCUS™ (“ReSTOR +2.5”; Model SV25T0) is the newest addition to the AcrySof IQ family of IOLs from Alcon Laboratories, Inc.. Launched in Europe in October 2012 and approved by the FDA in the United States in April 2015, the ReSTOR +2.5 expands the AcrySof IOL family and augments clinicians’ ability to meet patients’ specific needs based on their lifestyle and preferred vision goals. In a program moderated by Stephen S. Lane, MD, in April 2013, leading European cataract surgeons discussed the ReSTOR IOLs, patient selection, surgical considerations, and early outcomes. This supplement presents the highlights from that meeting, along with case studies, results of the ReSTOR +2.5 US FDA clinical trial, and the thoughts of Lisa Cibik, MD, a US FDA clinical trial investigator and rapid adopter of the ReSTOR +2.5. Trademarks are the property of Alcon Laboratories, Inc. 2 Choosing and Using the AcrySof® IQ ReSTOR® IOL Family: Customized Options for Individual Patients The ReSTOR family: Lens profiles more intermediate distance (from about 40 cm to about 50 cm) and is designed to provide better intermediate vision.1,3,4 In addition, the ReSTOR +2.5 was designed to deliver sharper distance visual acuity The ReSTOR +2.5 is built on the same established hydrophobic than the ReSTOR +3.0 because of modifications in its center zone AcrySof platform as the ReSTOR +3.0. Unique design features of the that make it behave more like a monofocal IOL than a multifocal ReSTOR +2.5, however, give rise to some performance differences when it comes to distance vision (Figure 2).1,2 The modifications in- that allow surgeons to meet a broader range of patient needs. clude a change from a diffractive to a refractive design; an increase in diameter (from 0.86 to 0.94 mm); increased light distribution (from The ReSTOR +2.5 IOL is designed for patients with active lifestyles who desire more range of vision than a monofocal IOL offers, 40% to 100%); and an increase in negative asphericity (from –0.1 but whose primary visual needs are for distance and intermediate to –0.2 μm).2 The increased negative asphericity also leads to excel- vision and who are not willing to compromise the quality of their lent mesopic contrast sensitivity with the ReSTOR +2.5 (Figure 3).1 distance visual acuity. The ReSTOR +2.5 meets these goals and with The increased light distribution through the center zone com- a low rate of visual disturbances based on its novel optical design bined with the reduced number of rings in the apodized diffractive (ACTIVEFOCUS™) that reflects several modifications compared multifocal zone (from 9 to 7) results in less light scattering with with the ReSTOR +3.0 (Figure 1; Table 1).1,2 the ReSTOR +2.5 compared with the ReSTOR +3.0, reducing the With its lower add power compared to the ReSTOR +3.0, the potential for halos and glare.2 Bench headlight image simulations ReSTOR +2.5 moves the patient’s preferred reading distance to a show the reduced potential for these photic phenomena with the Figure 1. Optic design differences: ReSTOR® +2.5 vs. ReSTOR® +3.02 ReSTOR® +2.5 Center DISTANCE ZONE ReSTOR® +3.0 !PODIZED DIFFRACTIVE multifocal ZONE Outer DISTANCE ZONE Reduced the add power from 3.0 D to 2.5 D by: Center INTERMEDIATE ZONE Outer DISTANCE ZONE s2EDUCINGDIFFRACTIVESTEPSFROMTOAND INCREASINGSPACING Altered the light distribution by: s)NCREASINGTHEDISTANCEENERGYOFTHECENTERZONE from 40% to 100% s2EDUCINGAPODIZEDDIFFRACTIVEAREABY s)NCREASINGTHEOUTERDISTANCEAREABY Table 1. Design features of the AcrySof IQ ReSTOR +2.5 and +3.0 IOLs2 +2.5 D ReSTOR +2.5 D1 Parameter ReSTOR +3.0 D SV25T0 Model number SN6AD1 +2.5 D ADD power at IOL plane +3.0 D +2.0 D ADD power at spectacle plane +2.5 D 0.94 mm Central ring diameter 0.86 mm 100% Distance function of the center zone 40% 7 Number of steps 9 8.4 mm2 Apodized diffractive area 10.2 mm2 Distance 69% Near 18.0% Energy distribution (3 mm IOL plane) Distance 59% Near 25.5% –0.2 μm Asphericity –0.1 μm +3.0 D Published as a promotional supplement to Ophthalmology Times® 3 Figure 2. Simulated retinal images using a Badal optometer (3-mm pupil)2 Distance 80 cm (31 in) 70 cm (28 in) 60 cm (24 in) 40 cm (16 in) ReSTOR +3.0 ReSTOR +2.5 AcrySof IQ Figure 5. Post-op mean binocular defocus curves*,**,‡,1,4,5 Figure 3. Binocular mesopic contrast sensitivity with glare 4–6 months postop2 67 cm 50 cm 40 cm 33 cm (26 in) (20 in) (16 in) (13 in) 20/20 0.0 2.00 20/25 0.1 20/32 0.2 20/40 0.3 Snellen 2.25 1.75 1.50 1.25 0.4 20/50 +0.00 1.00 –0.50 –1.00 –1.50 –2.00 –2.50 –3.00 –3.50 –4.00 Refraction (D) 0.75 0.50 0.25 0.00 1.5 cpd 3 cpd 6 cpd (n=127/130) (n=129/132) (n=116/128) 12 cpd (n=103/117) Spatial Frequency (cycles per degree) AcrySof® IQ ReSTOR® +2.5 D IOL AcrySof® IQ Monofocal IOL Standard deviation AcrySof® IQ ReSTOR® +2.5 D IOL (n=130) (1-month postop data) AcrySof® IQ Monofocal IOL (n=149) (1-month post-op data) AcrySof® IQ ReSTOR® +3.0 D IOL (n=116) (6 months post-op; control not shown) AcrySof® IQ ReSTOR® +4.0 D IOL (n=114) (6 months post-op; control not shown) *AcrySof® IQ IOLs have not been compared in a head-to-head study. **Data for AcrySof® IQ ReSTOR® +2.5 D IOL, +3.0 D IOL, and +4.0 D IOL mean defocus curves are from the Directions for Use for each respective IOL. ‡ The methodology used to derive all defocus curve data was the same test methodology for each IOL. No direct clinical comparison is implied. Figure 4. Simulated headlight images in Alcon Mode Eye (5-mm pupil measured on the Optikos MTF System) 2 AcrySof IQ ReSTOR +2.5 ReSTOR +3.0 MTF = modulation transfer function *Trademarks are the property of their respective owners. 4 Choosing and Using the AcrySof® IQ ReSTOR® IOL Family: Customized Options for Individual Patients Crystalens® HD500* Tecnis® ZMA00* LogMAR VA Mean Contrast Sensitivity (Log Units) 2.50 ReSTOR +2.5 compared with some other multifocal IOLs (Figure 4).2 Binocular defocus curves show the ReSTOR +2.5 provides the same distance vision as the AcrySof IQ monofocal IOL, but with superior vision—almost 2 lines better—at intermediate distances (Figure 5).1 In addition to an increased range of vision, the ReSTOR +2.5 maintains contrast sensitivity comparable to the AcrySof IQ Monofocal (Figure 3). 2 All of the above highlight that while the ReSTOR +2.5 and the for me a few years ago, but this is not good enough for patients anymore. I think we need to understand how important it is to people these days to have a good range of vision.” Dr. Vasavada went on to explain that for the majority of patients he treats, multifocality is the logical choice. “It is of course important to customize the lens to the patient, but actually the good news is that the ReSTOR lenses are built on a really great, proven platform and are very versatile,” he noted. ReSTOR +3.0 are built on the same proven hydrophobic AcrySof platform, they are not simply the same lens with different amounts The ideal ReSTOR +4.0 patient of add power. Rather they are different lenses providing different The ReSTOR +4.0 provides good uncorrected vision at distance outcomes that together provide surgeons the opportunity to satisfy and near. It may be a good choice for patients who spend the the varying needs of a broad spectrum of patients. majority of their time doing activities at less than arms length, such as sewing, knitting, or reading, and prioritize reducing their European surgeons’ perspectives need for spectacles when doing those activities, but are not as concerned about spectacle use for some intermediate and distance activities, like driving. Choose The ideal ReSTOR +3.0 patient Determination of the patient’s existing and long-term visual require- The ReSTOR +3.0 is configured for distance and near vision: ments will guide the decision on what lens is most suitable and designed for the patient who participates in a wide variety of most likely to result in patient satisfaction with vision after cataract activities over a broad range of distances. The versatile ReSTOR surgery. There are a number of different methods available for +3.0 offers good quality vision for most lifestyle needs and is gathering the information, including using a third party to counsel flexible for most distances. the patient, face-to-face discussions between the patient and the clinician, and questionnaires. Also available from Alcon Laboratories, Inc., are a patient edu- “The ReSTOR +3.0 is my first choice for patients who seek true performance at all distances from multifocal capabilities: those who desire a broad range of vision and want decreased spectacle- cation video that discusses cataract surgery and the various lens dependence for near, intermediate, and distance activities,” options and a downloadable IOL Vision Simulator application that commented Dr. Vasavada. “In general, I would recommend this lens illustrates to patients and their caretakers the effects of different for patients who are easy-going and cosmetically driven, because lens options, as well as the impact of correcting any astigmatism. there are trade-offs with this lens, and those that are relevant, such The video can be obtained through an Alcon Laboratories, Inc., as the possibility of halos, should be discussed with the patient.” sales representative. The IOL Vision Simulator is available for In the opinion of Dr. Francesco Carones, the best candidate for download onto a PC for physicians in the United States (https:// the ReSTOR +3.0 lens is an older patient who is less likely to drive www.myalcon.com/products/ surgical/acrysof-iol-vision-simulator a lot at night and is more likely to take part in activities that require .shtml) and as an app through the Apple Store to clinicians in other greater near vision, like reading or playing cards. “These are selected markets. patients who are not detail-oriented, because we know that the In their discussion, the European surgeons agreed that face- only downside with the ReSTOR +3.0 implanted bilaterally is that to-face discussions between a patient and clinician are invaluable there’s slightly more chance that the patient will experience halos for establishing what aspects of vision are most important to the and night vision problems,” he added. individual, particularly in light of evolving patient needs. “Another important thing to bear in mind is the height of the “It’s amazing how lifestyles are changing all across the globe, patient,” emphasized Dr. Mehmet Söyler. “Shorter patients have and that people are now wanting convenience in all areas of their shorter arms, and so their reading distance will be, for instance, lives. In terms of their vision, it is the flexibility to perform different around 40 cm instead of 50 cm. At this distance, with the ReSTOR activities that patients are demanding and expecting,” said Dr. +2.5, the patient would likely need an additional reading aid, and Abhay Vasavada. “Providing 6/6 or 20/20 vision used to be a target so I would tend to use the ReSTOR +3.0 in my shorter patients.” Published as a promotional supplement to Ophthalmology Times® 5 The ideal ReSTOR +2.5 patient The opportunities of “blended vision” The ReSTOR +2.5 was designed to maintain the quality of distance “For patients desiring the best range of vision, especially with vision offered by the IQ lens with the advantage of better inter- regard to near, when using Alcon IOLs we can implant the ReSTOR mediate vision. According to Dr. Carones, the ideal candidate +3.0 bilaterally; for patients in whom we want to target the quality for a bilateral ReSTOR +2.5 is a younger man or woman interested of vision and enhance the intermediate, we’d implant the ReSTOR in spectacle independence for distance but also for intermediate +2.5 bilaterally,” commented Dr. Carones. “Alternatively, as another tasks like computer usage, video editing; anything that has to be option for customizing vision, we can implant the ReSTOR +2.5 done at 50 to 60 cm. in the dominant eye and the ReSTOR +3.0 in the nondominant “The strength of the ReSTOR +2.5 is the crispness of distance vision it offers, with improved intermediate vision compared with the eye, in a blended fashion.” Most of the European surgeons had some experience in blending ReSTOR +3.0,” agreed Dr. Vasavada. “I also don’t have many patients the two ReSTOR technologies in a certain subset of patients. They who have reported glare or halos after implantation with the ReSTOR reported that in their experience, the range of comfort was the +2.5. Therefore, it’s good for people who drive a lot at night, as well best in these contralaterally implanted patients, who also have as for active professionals, golfers, and others, who don’t mind not reported the level of visual disturbances (such as halos) one possibly using reading aids or increased light for near vision.” could expect with the ReSTOR +3.0. Dr. Vasavada said he would recommend the ReSTOR +2.5 to patients who are already accustomed to using spectacles because A growing population of multifocal candidates these patients would not consider selective use of additional Having the ReSTOR +2.5 has broadened clinicians’ options and visual aids after implantation to be a negative outcome. increased the number of multifocal candidates. Patients who Alternatively, patients could use an extra light source in place who do not want to compromise quality of distance vision would could recommend patients install a flashlight app on their smart- previously have been offered a monofocal lens, but are now phones to decrease their dependence on spectacles. Then, as eligible for the ReSTOR +2.5. long as they had their mobile phone, the patient would always “Historically, we did not have a multifocal option for patients have an extra light source available and would, therefore, have who desired a range of vision and less dependence on spectacles, no need for additional visual aids. but who required monofocal quality distance vision. Patients we Patients who have residual refractive error of around –1.0 D would once have implanted with the IQ are now happy to be using for distance after a previous monofocal lens implantation are good the ReSTOR +2.5 instead, because they don’t mind having to use candidates for the ReSTOR +2.5 in the fellow eye, noted Dr. Lajja a little additional reading aid, and their intermediate vision is much Shastri, a colleague of Dr. Vasavada’s. This is because these patients better,” Dr. Vasavada commented. “This additional option is allowing are already accustomed to using visual aids and are unlikely to be us to expand our practice.” satisfied with the distance vision add needed. “As I look at it, it makes a lot more sense to implant a ReSTOR +2.5 than to use an IQ and ‘over-minus’ the patient, because I think Dr. Vasavada’s fellow panelists reported unanimously that the number of multifocal candidates in their practices had increased by more than 20% since the introduction of the ReSTOR +2.5. in that way you’d lose too much distance vision,” Dr. Lane advised. “I think a reason for this increase is not just because of the “The real beauty of the ReSTOR +2.5 is the crispness and the clarity performance of this lens but also because of the increased con- of the distance vision, and to lose that for a little bit of improve- fidence surgeons have in being able to provide more individually ment in the near using the ReSTOR +3.0 hasn’t been something, tailored results for patients,” commented Dr. Lane. in my experience, that patients are very happy about.” “With the ReSTOR +2.5, we can dare to offer optimal vision to almost anybody who is deemed a multifocal candidate medically— even precision-oriented or visually demanding personality types,” 6 desire a range of vision and less dependence on spectacles of reading aids, said Dr. Stephen Lane. He suggested that clinicians This desire to provide tailored results for patients was illustrated by the lack of preference for the ReSTOR +2.5 versus ReSTOR +3.0 among users. “We are really considering the ReSTOR platform as a family Dr. Vasavada agreed. “This means we can now move to an era and not as standalone products; there is nobody saying ‘I will only not just of meeting patient expectations about refractive outcomes implant the ReSTOR +3.0,’ and nobody saying, ‘I’m done with the but actually upgrading them, in a way that wasn’t possible with ReSTOR +3.0, I want to have the ReSTOR +2.5 only,’” commented only the previous models of IOL that were available.” Dr. Carones. “I think it’s reasonable that the two IOLs will be Choosing and Using the AcrySof® IQ ReSTOR® IOL Family: Customized Options for Individual Patients implanted equally frequently because the two technologies as well as upgrading surgical techniques and instrumentation perform differently and offer different advantages to the patient, for the highest degree of precision. and so they will each be needed in different scenarios. However, since we started implanting the ReSTOR +2.5 routinely in my clin- Preoperative considerations ical practice, the percentage of multifocal lenses we’ve implanted An important aspect of the perioperative assessment when has increased and is continuing to grow. This is a reversal of the selecting an appropriate IOL is the macular optical coherence trend of the previous year, when we had a decrease in the per- tomography, which is essential in patients considering multifocals. centage of multifocal lenses we were implanting.” This is because light scattering, which is associated with multifocal “Personally, I don’t have a preferred lens — I have my preferred lenses, is worse in eyes with drusen than in eyes without, and approach, which is trying to fit a patient’s needs and expectations, therefore multifocals should be avoided in such eyes. Another and this brings me to implant almost the same percentage of important consideration for multifocal lens implantation is pre- ReSTOR +2.5 and ReSTOR +3.0 IOLs. But the reasons my per- existing ocular surface conditions, such as meibomian gland centage of ReSTOR implants expanded when the +2.5 became dysfunction or anterior basement membrane dystrophy. available are that I have much more confidence in terms of “Probably the greatest issue I see in my multifocal IOL patients maintaining quality of vision because of the sharpness, and who are unhappy with their postoperative clinical result relates because now I have many more options for customizing the to ocular surface problems. So I would avoid implanting multifocal results according to the patients’ needs,” Dr. Carones concluded. lenses in eyes in which the ocular surface cannot be optimized,” Dr. Carones said that when assessing the eye dominance is difficult (especially for previously myopic patients) or if a patient cautioned Dr. Lane. Dr. Vasavada noted that he considered preoperative (and ideally is seeking spectacle-free performance at near, he chooses bilateral intraoperative) aberrometry to be essential for patient selection ReSTOR +3.0 implantation. He bilaterally implants the ReSTOR +2.5 and IOL implantation with any lens. At his practice, aberrometry in patients who are really concerned about their postoperative is performed in the mesopic undilated pupil, and multifocal IOLs quality of vision but are still seeking some spectacle independence, are avoided in eyes with high aberrations and wide mesopic pupils patients with significant activities at intermediate distances, (Note: In India, a mesopic pupil >5 mm is rare, and so patients in younger patients, and patients with monocular cataract who are his clinic are rarely excluded on this basis). The aberrometer also not willing or are not able to undergo implantation in the fellow reports angle alpha and angle kappa values, and Dr. Vasavada’s eye. ”However, for patients who qualify, I find myself implanting team would also avoid multifocal IOLs in eyes with greater than about 40% of my cases in a blended fashion,” Dr. Carones said. 0.4-mm angle alpha, for fear of decentration. Use when assessing a patient’s suitability for a ReSTOR lens is total “An ideal IOL should have good intraocular behavior and a good astigmatism, which consists of both pre-existing corneal astigma- refractive performance,” noted Dr. Vasavada. “From a surgical tism and surgically induced astigmatism. He recommended that perspective, the most desirable qualities of an IOL are: compatibility the ReSTOR +2.5 or ReSTOR +3.0 could be considered for eyes with small incisions; ease of insertion and handling; slow, controlled with up to 0.5 D of total astigmatism. However, according to Dr. Vasavada, the principal consideration unfolding; and, reliable stability. A lot of lenses would fit that descrip- “Eyes implanted with a variety of multifocal lenses that have tion, but not many would meet clinicians’ criteria, namely, excellent even as little as 0.75 D of astigmatism might experience significant biocompatibility; favorable anterior capsule opacification rate; favor- enough visual challenges to require postoperative correction,” able posterior chamber opacification rate; and, a time-tested per- added Dr. Vasavada. “I measured reading speed in high resolution formance. So the lens platform that we offer really does not change and low- contrast sensitivity settings and both were better if even the management we’re offering to patients. But it is the refractive 0.5 D of astigmatism was corrected versus not corrected. So it performance that the patients’ expectations rest on, and so the makes sense to me to correct this astigmatism wherever possible.” way we are moving forward in this area is what we’re interested in.” Once patients have been stratified according to their desired There are a number of ways to achieve optimal refractive out- visual outcomes, an appropriate lens has been selected, and the comes and to increase ease of implantation with the ReSTOR +2.5. physical assessments are complete, the final essential aspect These include preoperative consideration of potential complica- of the preoperative preparation should be to manage patients’ tions (including elimination of patients with contraindications) expectations for the anticipated postoperative outcomes. Published as a promotional supplement to Ophthalmology Times® 7 “I tell the patients undergoing ReSTOR +2.5 bilateral implantation that they will very likely experience reduced spectacle dependence according to the needs that they explained, but they still may need Scheimpflug imaging so he can assess posterior corneal curvature and its effect on final astigmatism. Dr. Richard Potvin said that he had analyzed different topography to use glasses for some specific tasks—reading at close distance and keratometry devices for a number of clinicians to determine and maybe when the light is not really bright,” said Dr. Carones. which produced the most reliable results. In general, the surgeons “But I tell them that their vision will be uncompromised in terms were amalgamating the outputs and including their own best of quality.” judg- ment, and this method was found to be more reliable than “When I blend the two technologies, I tell the patients something different. Based on my practice experience, I tell them that they will any individual device. The surgeons agreed that minor decentration of the ReSTOR notice a difference between the two IOLs, with the dominant eye lens does not have a significant impact on the patient’s visual more focused at distance and the nondominant eye more focused outcomes, but that it was wise to avoid decentration as much at near but potentially more prone to visual disturbances. It’s worth as possible. To achieve the greatest degree of centration, the telling the patients that this difference is intentional and is not an participants agreed that the lens should be centered on the unintended side effect of the lenses Purkinje image. or the surgery itself.” “Centering on the Purkinje image is certainly the most common way and that’s the way you can probably stay out of trouble,” Surgical planning and execution stated Dr. Lane. “The material used in the ReSTOR +2.5 has a long Accurate preoperative biometry is essential to achieving a good enough track record that we know the lens will stay pretty much refractive outcome and reducing the amount of visual disturbance where you leave it, although it might move depending on the a patient may experience, which will influence the patient’s size of the bag.” satisfaction with the procedure. As the ReSTOR +2.5 is built on the Dr. Vasavada added that, if he was not satisfied with the proven hydrophobic ReSTOR platform, surgeons familiar with the Purkinje image on the table, he would rotate the lens and use AcrySof technology can continue to use the surgical techniques vertical, rather than horizontal, placement. With hydrophobic they have refined to achieve optimal outcomes, in terms of, for lenses it is also important to ensure that both haptics are within example, performing the rhexis and positioning the lens. the bag and fully opened; using capsular tension rings also To get as close as possible to achieving emmetropia, it is crucial helps to maintain centration and avoid posterior capsule folds. to customize the A-constant by lens. Consider using publicly available sources of personalized A-constants, such as consensus Early outcomes A-constants available from external sources. Alternatively, for their Dr. Söyler reported that, in his early experience, around 60% to first few cases, surgeons can consider targeting a slight degree of 70% of his patients implanted with the ReSTOR +2.5 required residual myopia, to avoid over-correcting and leaving the patient an additional +1.00 D of correction for reading. Dr. Suárez noted slightly hyperopic. that, after bilateral ReSTOR +2.5 implantation, his patients had For example, while the manufacturer’s A-constant is 119.1, Dr. Carones shared, “In my experience, the manufacturer’s A-constant (119.1) does not lead to my estimated outcome and my first cases vision and had no complaints about visual disturbances. Dr. Söyler also reported that his patients who were implanted were slightly hyperopic. My actual A-constant for optical coherence contralaterally with the ReSTOR +2.5 and ReSTOR +3.0 had the biometry with the ReSTOR +2.5 is 119.37. I suggest all surgeons greatest distance comfort for reading from 40 cm to 75 to 80 cm should personalize the A-constant.” under well-lit conditions. The surgeons noted that in their experi- The panel discussed whether it was possible to rely on one ence using this blended vision approach, patients noticed a differ- specific machine for the measurements, particularly in cases ence in vision between eyes, but generally did not complain about where machines differed. Dr. Lane commented that he relied it (particularly in cases when patients were briefed preoperatively more upon intraoperative aberrometry and found that it generally to expect a difference). produced a reliable result. Dr. Carones said he prefers using the ® 8 commented that they were happy with the quality of distance Dr. Carones said he gave his patients subjective questionnaires, LenStar LS 900 (Haag-Streit) for determining the amount of and results from ratings of spectacle independence, light depend- astigmatism, topography for axis, and the IOLMaster® (Carl ence for reading, quality of vision, visual disturbances, and overall Zeiss Meditec, Inc.) for axial length measurement. He also uses satisfaction showed patients were satisfied with their outcomes. Choosing and Using the AcrySof® IQ ReSTOR® IOL Family: Customized Options for Individual Patients “When I started implanting ReSTOR lenses in 2003, I had enhancement rates of around 10%, whereas now my enhancement Figure 6. Monocular mean distance-corrected visual acuity measured at 4–6 months postop2 rate is around 0.5%,” he said. “This is in part because the ReSTOR At 53 cm (intermediate) +3.0 and +2.5 lenses are much more tolerant to residual refractive error than the ReSTOR +4.0 was. I’ve learned the importance of results to refine my surgical constants and surgically induced astigmatism, and that has also helped me to consistently achieve greater accuracy in my outcomes.” Conclusions “Although we have had a variety of lenses available to us for a long time, the lens options we have had in the past have not 0.70 Mean Visual Acuity (logMAR) maintaining a spreadsheet that I can easily update. Then I use the covered all the needs that patients have,” said Dr. Suárez. “On 0.60 0.50 0.40 * 0.30 0.20 0.10 0.00 First Eye one hand, we had the AcrySof IQ aspheric monofocal lens, which gives excellent distance vision, but patients may complain about *P<0.0001 vs. monofocal Second Eye Multifocal (n=155) needing glasses for near and intermediate. On the other hand, Monofocal (n=165) At 40 cm (near) we had the ReSTOR +3.0 that gives a broader range of vision for 0.70 independence. Yet some patients complain of visual disturbances. Having a portfolio of different IOLs and solutions may enable us to customize the IOL experience and fit the desired refractive outcome to the expectations that the patients have.” “Essentially, the ReSTOR +2.5 is not a ‘one size fits all’ kind of concept,” summarized Dr. Lane. “And, the ReSTOR +2.5 will not solve all problems for all patients. Instead, the exciting thing about the ReSTOR +2.5 is that it gives us another tool in our chest that we can use to try and make our patients as happy as possible.” “To my understanding, the ReSTOR +2.5 is a really different lens Mean Visual Acuity (logMAR) near, intermediate, and distance with a high degree of spectacle 0.60 0.50 * 0.40 0.30 0.20 0.10 0.00 First Eye *P<0.0001 vs. monofocal Second Eye Multifocal (n=155) Monofocal (n=165) from the ReSTOR +3.0, and is not just a different add power,” added Dr. Carones in conclusion.“ The ReSTOR +2.5 allows the number of patients that will benefit from multifocality to be expanded. The with 155 subjects receiving the SV25T0 (AcrySof IQ ReSTOR +2.5 D) ReSTOR family, therefore, represents a very powerful and complete and 165 subjects receiving the SN60WF (AcrySof IQ Monofocal).1 platform for customizing the surgical experience for our patients according to their individual needs and expectations.” Compared to the controls at 4 to 6 months after the second eye surgery, the ReSTOR +2.5 group showed: sSUPERIORITYP<0.0001) in mean photopic monocular ReSTOR +2.5 clinical study data logMAR CDVA at 53 cm (Figure 6)1 sSUPERIORITYP<0.0001) in mean photopic monocular logMAR distance-corrected near VA at 40 cm (Figure 6)1 The effectiveness and safety of the ReSTOR +2.5 was investigated sNONINFERIORITYFORMONOCULAR#$6!ATM1 in a randomized, patient- and observer-masked, parallel group sNOCLINICALLYRELEVANTDIFFERENCESINBINOCULARCONTRAST 1,2 study conducted at 15 sites in the United States. Patients were assigned to bilateral implantation of the ReSTOR +2.5 or a monofocal IOL built on the same platform—the AcrySof IQ (SN60WF, Alcon Laboratories, Inc.).1 A total of 320 subjects were implanted in this clinical study, sensitivity under photopic or mesopic conditions, with or without glare (Figure 3; see page 4)1 The mean binocular defocus curve showed the ReSTOR +2.5 delivered 20/40 or better binocular vision from approximately 40 cm to distant vision.1 Published as a promotional supplement to Ophthalmology Times® 9 Compared with the monofocal IOL, the ReSTOR +2.5 was approximately 2 lines better at –2.50 D (40 cm), approximately practice. Within the first 5 months after its commercial launch, she had already implanted the ReSTOR +2.5 in 132 eyes. 2 lines better at –2.00 D (53 cm), and more than 1 line better Patient selection at –3.00 D (33 cm).1 There was a low and similar incidence of severe glare in Dr. Cibik says there is an expanded gamut of patients who can the ReSTOR +2.5 and monofocal IOL groups (3.3% and 3.8%, be offered the ReSTOR +2.5 because the results are so good. 1 respectively). Therefore, potential candidates represent a diverse spectrum with respect to vision priorities and needs. Insights of a US surgeon First and foremost, she considers the ReSTOR +2.5 a great option for active patients who prioritize distance and intermediate vision and might not mind wearing readers for near tasks. Participating as an investigator in the ReSTOR +2.5 US FDA clinical Activities enjoyed by patients she implanted with the ReSTOR trial, Lisa Cibik, MD, FACS, enrolled 22 patients, of which 10 were +2.5 IOL include indoor exercise on an elliptical machine, tread- bilaterally implanted with the ReSTOR +2.5. The outcomes from mill, or with free weights; going to casinos; playing cards or her center, consistent with the entire study population, showed board games; attending movies and theater performances; that when compared with controls implanted with the monofocal as well as golf, tennis, and watersports. AcrySof IQ IOL, the ReSTOR +2.5 patients achieved superior vision In addition, because in her experience, the ReSTOR +2.5 provides at intermediate and near distances while maintaining the same good contrast and has a fairly low incidence of severe glare and quality distance vision and contrast sensitivity. In addition, Dr. Cibik halos, Dr. Cibik includes patients with occupations that require stated that severe glare and halo were rarely reported by her good vision at night as potential candidates. Whereas in the past patients who received the ReSTOR +2.5. she would not have considered a multifocal IOL to anyone who Based on the positive experience of her clinical trial patients, Dr. Cibik quickly adopted the ReSTOR +2.5 into her surgical complained of halo and glare preoperatively, she also feels comfortable recommending the ReSTOR +2.5 D to some individuals Case Studies CASE STUDY 1 The patient: A 52-year-old female with bilateral cataract, BCVA of 20/60– OD and 20/25– OS, and sphere of –2.50 D OD and –2.75 D OS. She currently requires +1.00 D of additional correction for reading. Visual priorities: Good distance and intermediate vision—the patient is an avid cross-stitcher who is disabled and relies heavily on her hobbies to find fulfillment and enjoyment in life. IOL strategy: Bilateral ReSTOR +2.5 Discussion: A monofocal IOL would have satisfied some of the patient’s requirements, and the ReSTOR +3.0 and |2.5 scored equally high for each of the anticipated outcomes. The ReSTOR +2.5 was selected, however, because it offered better prospects in terms of intermediate vision and being better suited for patients that desire spectacle independence. 10 Patient outcomes: At 3 months, results in both eyes were: plano refraction, 20/20 distance UCVA, and J2 at 35 cm. The patient has no complaints of vision disturbances. She says she is very satisfied with her vision and wears reading spectacles every now and then only for extensive computer work. CASE STUDY 2 The patient: A 56-year-old male with bilateral cataract, BCVA of 20/50– OD and 20/30– OS, and sphere of –4.25 D OD and –1.25 D OS. He currently requires +1.75 D of additional correction. Visual priorities: The patient is an engineer and spends a great deal of time working on the computer. Although near vision is important to him, he states that he spends more time on the computer than he does reading. He desires good quality vision and is enticed by spectacle independence for both his work and home life. Choosing and Using the AcrySof® IQ ReSTOR® IOL Family: Customized Options for Individual Patients IOL strategy: Bilateral ReSTOR +2.5 Discussion: Good distance and intermediate vision were crucial for the patient, and the ReSTOR +2.5 was selected because it offered better prospects for meeting those needs and his desire for spectacle independence. Prior to coming in for his exam, the patient was favoring the ReSTOR +2.5 based on research he had done. Patient outcomes: At 2 months, the patient was plano in both eyes with bilateral UCVA of 20/20, J3 at 35 cm and 20/25 at 65 cm. While he reported seeing “concentric rings” around lights initially after surgery, this symptom had greatly diminished. The patient said he rarely needs assistance from a weak pair of readers when he uses a certain laptop for work that has a very small screen, but he had no need for glasses otherwise. The patient is thankful he achieved the vision he was hoping for with the ReSTOR +2.5. Table 2. Patient profiling for ReSTOR IOLs Who is this lens for? ReSTOR +2.5 Patients with an active lifestyle that demands more intermediate (21 in) and distance (4 m/13 ft) vision* s$ESIRESMOREOPPORTUNITYFORARANGEOFVISIONVERSUSMONOFOCAL s$ESIRESINCREASEDSPECTACLEINDEPENDENCEATINANDBEYOND s5NDERSTANDSTHATREADERMAYBENEEDEDFORnIN ReSTOR +3.0 0ATIENTSWANTINGABROADRANGEOFVISION s"ALANCEOFACTIVITIESATNEARINTERMEDIATEANDDISTANTFOCALPOINTS sSeeks true performance at all distances from multifocal capabilities: DESIRESFULLRANGEOFVISIONFROMINCMTODISTANCEWITH GREATESTOPPORTUNITYOFSPECTACLEINDEPENDENCEATALLDISTANCES !CTIVELIFESTYLEPATIENTSPARTICIPATEINACTIVITIESTHATREQUIREINTERMEDIATEANDDISTANCEVISIONSUCHASGOLFTENNISTHEATERANDDRIVING with that history after undertaking an in-depth evaluation of their priorities and providing thorough counseling about outcomes. Older, less active patients are another group of excellent can- “Particularly good candidates are patients who were in monovision prior to cataract surgery,” she said. To aid in the IOL selection decision, Dr. Cibik’s patients complete didates for the ReSTOR +2.5 if they have needs for good quality questionnaires that are designed to elicit their current visual distance and intermediate vision. In addition, Dr. Cibik said that difficulties; information about their personality, hobbies, computer she has implanted the ReSTOR +2.5 in patients with a history of usage, and other daily activities; their desire for spectacle inde- corneal refractive surgery, including postLASIK and postRK patients. pendence; and their perceived ideal outcomes. “While I was leery previously about using a multifocal IOL in Counseling for patients who are deemed good candidates for patients who had keratorefractive surgery and my experience in the ReSTOR +2.5 informs them they should have very good quality these individuals is limited, I think the ReSTOR +2.5 is a reasonable dis- tance and intermediate vision while making sure they under- option as long as the patient is very well counseled,” Dr. Cibik said. stand the potential need for readers, similar to what they would Considering its performance and advantages, Dr. Cibik said she have used as an early presbyope. is now using the ReSTOR +2.5 instead of an accommodative lens in any patient who wants good quality distance and intermediate Surgical approach and pearls vision, does not mind wearing reading glasses for near tasks, Knowing that achieving optimal outcomes after cataract surgery and is not a candidate for a toric IOL. depends on a comprehensive preoperative evaluation and “In my opinion, the ReSTOR +2.5 provides near vision that accurate biometry, Dr. Cibik performs refraction and glare testing, is at least as good if not better than some other lenses. In fact, spectral domain optical coherence tomography imaging of the some of my ReSTOR +2.5 patients can read J1 or J2 with good retina, and corneal topography. She also uses the LenStar LS 900 lighting. In addition, I find the implantation is easy with the and VERION™ Reference Unit (Alcon Laboratories, Inc.) to obtain ReSTOR +2.5,” she said. key measurements. The ReSTOR +2.5, however, has not replaced the ReSTOR +3.0. All patients are also evaluated thoroughly for ocular surface Dr. Cibik said that with its higher add power, the ReSTOR +3.0 disease, including measurement of tear osmolarity, and anyone meets the needs of patients who for whatever reason want to be diagnosed with meibomian gland dysfunction/dry eye is started less spectacle dependent for close vision and/or who have less on an individually tailored regimen, which might include artificial dependency on good nighttime driving vision (Table 2). tears, punctal plugs, topical cyclosporine, and/or oral vitamin In some cases, Dr. Cibik reports using a blended vision approach, supplements for ocular surface support. using the ReStor +3.0 in the nondominant eye and the ReStor +2.5 “It is extremely important to be very aggressive treating dry in the dominant eye when patients need a broad and more custom- eye to optimize the ocular surface before implanting a multifocal ized range of vision and desire as limited spectacle use as possible. IOL because these patients have high outcomes expectations,” Dr. Cibik said she has used blended vision in patients who previously underwent unilateral cataract surgery with implantation Dr. Cibik said. Using data from the eyes implanted during the FDA clinical trial of the ReSTOR +3.0. In addition, she is using it as a planned pro- and shortly after product commercialization, Dr. Cibik optimized cedure for select patients who need bilateral cataract surgery. her A-constant from the nominal value of 119.1 to 119.294. Published as a promotional supplement to Ophthalmology Times® 11 “By doing so, I improved the predictability of my refractive outcomes, which typically target between plano and –0.25 D,” she said. “Surgeons just getting started with the ReSTOR +2.5 should refer ReSTOR +2.5: The surgeon- and patient-friendly option Dr. Cibik concluded that the ReSTOR +2.5 broadens opportunities to the A-constant found on the User Group for Laser Interference to meet the vision needs of cataract surgery patients. With its ease Biometry (ULIB) website [ocusoft.de/ulib/] until they have collected of use and excellent outcomes, surgeons can feel completely enough data for personalization.” comfortable adopting it into their practice, she said. Dr. Cibik uses the ASCRS (American Society of Cataract and “The features of the ReSTOR +2.5 make it a particularly great Refractive Surgery) calculator to help guide IOL power selection option for surgeons wanting to begin offering presbyopia-cor- in patients with a history of corneal refractive surgery, and intra- recting IOLs, especially anyone who is already using other AcrySof operative manual retinoscopy is used for validation in those cases. lenses. All surgeons, however, can be confident about achieving Intraoperatively she uses the image from the VERION™ Digital success with the ReSTOR +2.5 as long as they are thorough in Marker in the operating microscope to guide placement of the their preoperative evaluation, planning, and counseling so that ReSTOR IOL, nudging the lens so that the center is slightly toward patients are properly selected and have appropriate expectations the nasal side of the pupil center. for their outcomes.” Astigmatism is evaluated preoperatively by looking at the refraction, topography, and biometry. Dr. Cibik considers patients candidates for the ReSTOR +2.5 D if they have up to 1.0 D of corneal astigmatism, and she addresses astigmatism at the time of surgery as needed. Second eye surgery is typically done within 1 week using the measured refraction in the first eye to determine if any adjustment is needed in the suggested IOL power. REFERENCES 1. AcrySof® IQ ReSTOR +2.5 D Multifocal IOL Directions for Use. Alcon Laboratories, Inc.; Fort Worth, TX. 2. Alcon Laboratories, Inc., data on file. 3. Pedrotti E, Mastropasqua R, Passilongo M, et al. Comparison of two multifocal intraocular lens designs that differ only in near add. J Refract Surg. 2014;30(11):754–760. 4. AcrySof® IQ ReSTOR +3.0 D Multifocal IOL Directions for Use. Alcon Laboratories, Inc.; Fort Worth, TX. 5. AcrySof® IQ ReSTOR +4.0 D Multifocal IOL Directions for Use. Alcon Laboratories, Inc.; Fort Worth, TX. AcrySof® IQ ReSTOR® Family of IOLs – Important Product Information CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: The AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag. WARNINGS/PRECAUTIONS: Careful preoperative evaluation and sound clinical judg- ment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Physicians should target emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery. Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. As with other multifocal IOLs, visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. Spectacle independence rates vary with all multifocal IOLs; as such, some patients may need glasses when reading small print or looking at small objects. Clinical studies with the AcrySof® ReSTOR® lens indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof® IQ ReSTOR® IOLs. Studies have shown that color vision discrimination is not adversely affected in indi- viduals with the AcrySof® Natural IOL and normal color vision. The effect on vision of the AcrySof® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. VERION™ Image Guided System – Important Product Information VERION™ Reference Unit and VERION™ Digital Marker CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician. INTENDED USES: The VERION™ Reference Unit is a preoperative measurement device that captures and utilizes a high-resolution reference image of a patient’s eye. In addition, the VERION™ Reference Unit provides pre-operative surgical planning functions to assist the surgeon with planning cataract surgical procedures. The VERION™ Reference Unit also supports the export of the reference image, preoperative measurement data, and surgical plans for use with the VERION™ Digital Marker and other compatible devices through the use of a USB 12 memory stick. The VERION™ Digital Marker links to compatible surgical microscopes to display concurrently the reference and microscope images, allowing the surgeon to account for lateral and rotational eye movements. In addition, details from the VERION™ Reference Unit surgical plan can be overlaid on a computer screen or the physician’s microscope view. proper functioning of the VERION™ Digital Marker: changes in a patient’s eye between pre-operative measurement and surgery, an irregular elliptic limbus (e.g., due to eye fixation during surgery, and bleeding or bloated conjunctiva due to anesthesia). In addition, the use of eye drops that constrict sclera vessels before or during surgery should be avoided. CONTRAINDICATIONS: The following conditions may affect the accuracy of surgical plans prepared with the VERION™ Reference Unit: a pseudophakic eye, eye fixation problems, a non-intact cornea, or an irregular cornea. In addition, patients should refrain from wearing contact lenses during the reference measurement as this may interfere with the accuracy of the measurements. The following conditions may affect the WARNINGS: Only properly trained personnel should operate the VERION™ Reference Unit and VERION™ Digital Marker. Use only the provided medical power supplies and data communication cable. Power supplies for the VERION™ Reference Unit and the VERION™ Digital Marker must be uninterruptible. Do not use these devices in combination with an extension cord. Do not cover any of the component devices while turned Choosing and Using the AcrySof® IQ ReSTOR® IOL Family: Customized Options for Individual Patients on. The VERION™ Reference Unit uses infrared light. Unless necessary, medical personnel and patients should avoid direct eye exposure to the emitted or reflected beam. PRECAUTIONS: To ensure the accuracy of VERION™ Reference Unit measurements, device calibration and the reference measurement should be conducted in dimmed ambient light conditions. Only use the VERION™ Digital Marker in conjunction with compatible surgical microscopes. ATTENTION: Refer to the user manuals for the VERION™ Reference Unit and the VERION™ Digital Marker for a complete description of proper use and maintenance of these devices, as well as a complete list of contraindications, warnings and precautions. © 2016 Novartis 5/16 US-RES-15-E-1066
