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JANUARY 2016 VOL. 8, NO. 01 PRACTICAL CHAIRSIDE ADVICE SPECIAL SECTION Glaucoma Understanding drainage in surgery Procedures and practices for postoperative care BUBBLES The 1 p a t i e n t s l o v e j u s t g o t e v e n b e t t e r. 7 Figure 1. Insertion of the tube into the anterior chamber to increase aqueous outflow. Image courtesy Ike Ahmed, MD Figure 7. Baerveldt Glaucoma Implant. Image courtesy of Abbott Medical Optics. By Barbara J. Fluder, OD OptometryTimes.com Top financial obstacles facing ODs in 2016 By Colleen E. McCarthy Content Specialist Each year brings its own challenges, and 2016 will be no different. Optometry Times Editorial Advisory Board member John Rumpakis, OD, MBA, and Bryan Rogoff, OD, MBA, CPHM, director Introducing theof doctor strategy for Pearle Vision, share the chalnext level of lens care. lenges they expect optometrists will encoun• Exclusive ter in the coming year. HydraGlyde technology for Last year, we spoke with Dr. Rogoff about long-lasting moisture this same subject. Some of the challenges we • Unsurpassed disinfection predicted for 2015 will continue into 2016— 1 like increasing•deductibles—while Preservative free to be others, more like the ICD-10 transition, will stay a thing like natural tears of the past. Thankfully, the ICD-10 transition wasn’t as traumatic as many predicted at this time last year. While practitioners likely invested in training and preparing for the switch, the actual transition hasn’t caused any major problems, says Dr. Rogoff. ® See 2016 challenges on page 5 ODs battle UPP, CA hiring laws G By Colleen E. McCarthy laucoma drainage devices are increasingly flowing in many glaucoma pracContent Specialist tices. You may be familiar with laser procedures, including The laws governing ODs across the country Introduce glaucoma your patients to new CLEARargon CARE® PLUS formulated with the unsurpassed laser trabeculoplasty, selective laser trabec-® are constantly evolving, so it can be hard to cleaning andand disinfection CLEAR CARE – and exclusive now with be familiar withour these devices and the rauloplasty, micropulseof laser trabeculokeep track of who ® can do what from state CLEAR CARE PLUS ® ® the device chosen. This artiplasty. Trabeculectomy is a commonly per-softtionale to state. New laws in one state can lay the Moisture Matrix to provide lensesbehind with long-lasting moisture. HydraGlyde formulated with cle describes what each device is, how they formed filtering surgery as well. groundwork for similar changes in another. Ask your Alcon rep for more information or learn more at CLEARCARE.com. work, complications, and postoperative care. But, you may not know the differences “Every state initiative can advance our among Baerveldt Glaucoma Implant (Abbott profession and is important to the American Medical Optics), Ahmed Glaucoma Valve Optometric Association (AOA),” says AOA iStent ™ PERFORMANCE DRIVEN BY SCIENCE (New World Medical, Inc), iStent (Glaukos), President Steve Loomis, OD. The iStent trabecular micro-bypass is a and ExPress Glaucoma FiltraSome of the new laws are smaller victomicro invasive glaucoma surgery (MIGS) tion Device (Alcon). It is imries, while others will change the way optool.1 It is essentially a small snorkel com1 Gabriel M, Bartell J, Walters R, et al. Biocidal ef?cacy of a new hydrogen peroxide contact lens care system against bacteria, fungi, and Acanthamoeba species. See Legislative changes on page 6 portant for©optometrists to CCS15069AD-B See Glaucoma drainage on page 22 Optom Vis Sci. 2014; 91: E-abstract 145192. 2015 Novartis 5/15 Q&A | MARY K. MERCADO, OD NAIL POLISH, OPENING A PRACTICE, AND SKYDIVING SEE PAGE 33 JANUARY 2016 VOL. 8, NO. 01 OptometryTimes.com PRACTICAL CHAIRSIDE ADVICE SPECIAL SECTION Glaucoma Understanding drainage in surgery Procedures and practices for postoperative care 1 Figure 1. Insertion of the tube into the anterior chamber to increase aqueous outflow. Image courtesy Ike Ahmed, MD Figure 7. Baerveldt Glaucoma Implant. Content Specialist Each year brings its own challenges, and 2016 will be no different. Optometry Times Editorial Advisory Board member John Rumpakis, OD, MBA, and Bryan Rogoff, OD, MBA, CPHM, director of doctor strategy for Pearle Vision, share the challenges they expect optometrists will encounter in the coming year. Last year, we spoke with Dr. Rogoff about this same subject. Some of the challenges we predicted for 2015 will continue into 2016— like increasing deductibles—while others, like the ICD-10 transition, will stay a thing of the past. Thankfully, the ICD-10 transition wasn’t as traumatic as many predicted at this time last year. While practitioners likely invested in training and preparing for the switch, the actual transition hasn’t caused any major problems, says Dr. Rogoff. ODs battle UPP, CA hiring laws Image courtesy of Abbott Medical Optics. By Barbara J. Fluder, OD G Q&A By Colleen E. McCarthy See 2016 challenges on page 5 7 laucoma drainage devices are increasingly flowing in many glaucoma practices. You may be familiar with laser glaucoma procedures, including argon laser trabeculoplasty, selective laser trabeculoplasty, and micropulse laser trabeculoplasty. Trabeculectomy is a commonly performed filtering surgery as well. But, you may not know the differences among Baerveldt Glaucoma Implant (Abbott Medical Optics), Ahmed Glaucoma Valve (New World Medical, Inc), iStent (Glaukos), and ExPress Glaucoma Filtration Device (Alcon). It is important for optometrists to Top financial obstacles facing ODs in 2016 By Colleen E. McCarthy Content Specialist The iStent trabecular micro-bypass is a micro invasive glaucoma surgery (MIGS) tool.1 It is essentially a small snorkel com- The laws governing ODs across the country are constantly evolving, so it can be hard to keep track of who can do what from state to state. New laws in one state can lay the groundwork for similar changes in another. “Every state initiative can advance our profession and is important to the American Optometric Association (AOA),” says AOA President Steve Loomis, OD. Some of the new laws are smaller victories, while others will change the way op- See Glaucoma drainage on page 22 See Legislative changes on page 6 be familiar with these devices and the rationale behind the device chosen. This article describes what each device is, how they work, complications, and postoperative care. iStent | MARY K. MERCADO, OD NAIL POLISH, OPENING A PRACTICE, AND SKYDIVING SEE PAGE 33 BIOFINITY & BIOFINITY XR SPHERE LENSES Did you know that Biofinity offers the widest range of lens parameters in the monthly sphere silicone hydrogel category? Biofinity® It’s true. CooperVision Biofinity® and our extended range of Biofinity® XR sphere lenses cover powers from +15.00D to -20.00D. You’ll be able to fit a wider range of myopic and hyperopic patients, including patients who have never been able to wear contact lenses before. Want more reasons to believe in Biofinity? How about our exclusive Aquaform® Technology? It creates an unmatched balance between breathability, natural wettability, and flexibility that provides a more comfortable lens-wearing experience for your patients—and a healthier one, too. Biofinity & Biofinity XR Biofinity toric Biofinity multifocal Find out more about Biofinity and the extended range of Biofinity XR at coopervision.com/biofinity ©2014 CooperVision, Inc. | PRACTICAL CHAIRSIDE ADVICE FROM THE Chief Optometric Editor 3 Help, I have been robbed! By Ernie Bowling, OD, FAAO Chief Optometric Editor He is in private practice in Gadsden, AL, and is the Diplomate Exam Chair of the American Academy of Optometry’s Primary Care Section [email protected] 256-295-2632 ost of my travels take me through Atlanta’s airport. The old saying here in Th’ South seems to be true: If you wanna go to hell, you have to fly through Atlanta. Fortunately, my offspring live in Georgia’s capital, so every time I’m passing through Hartsfield-Jackson, I try to spend some time with my children. One Sunday evening after a trip to Chicago, we had dinner at a Mexican restaurant we had frequented at least a dozen times. After a quick meal, returning to the parking lot I found my truck to be the subject of what the very polite Atlanta policeman later described as a classic “smash and grab.” The passenger side windows were destroyed, and my suitcase and computer bag gone. My first thoughts weren’t of the nice suits in my travel bag. Oh no, my first thought M was of my laptop. My life was on that laptop. Business data, photos, videos, you name it—it was on there. I had a great collection of anterior segment ocular photos of which I was truly proud collected over a career. But the greatest loss was my lectures: every PowerPoint presentation I’ve ever given was on that computer. occasion I had placed them…in my suitcase. So, what did I learn from this very painful experience? First, back up early and often. There’s a shiny new one terabyte hard drive sitting on the desk at my home office. And Dropbox is my new best friend. Heck, where before I had one backup copy of my data, I now have three! Second, while I had lost faith in people (I mean, how damn low can someone go?), I have been doubly blessed by the help of our Academy Primary Care Section Diplomates who covered for a missed lecture as I sorted through all the details (again, something you really don’t want to have to do), and the well wishes of colleagues, many who have graciously offered to help replenish my photos and PowerPoints. Thanks, folks. I’ll gladly take whatever you’re willing to share. While my friends commiserated with my loss, many said they also learned from my Gee, Ernie, you dummy, didn’t you have misfortune and immediately backed backups? Of course I did. I’m obsesSee up all their data. So let’s all learn sive; I back everything up. Like I our a lesson. If you haven’t backed up was taught, I kept those backups in glaucoma your data, I highly recommend you a location separate from my comcoverage. Turn do that. Now. More than once! puter bag. Because I had work to to page 14 for do on this trip, on this particular more. My suitcase and computer bag were gone. My first thought was of my laptop. My life was on that laptop. Editorial Advisory Board Ernie Bowling, OD, FAAO Chief Optometric Editor Editorial Advisory Board members are optometric thought leaders. They contribute ideas, offer suggestions, advise the editorial staff, and act as industry ambassadors for the journal. Jeffrey Anshel, OD, FAAO Michael P. Cooper, OD Alan G. Kabat, OD, FAAO Mohammad Rafieetary, OD, FAAO Joseph Sowka, OD, FAAO Ocular Nutrition Society Encinitas, CA Chous Eye Care Associates Tacoma, WA Southern College of Optometry Memphis, TN Charles Retina Institute Memphis, TN Sherry J. Bass, OD, FAAO Douglas K. Devries, OD David L. Kading, OD, FAAO Michael Rothschild, OD Nova Southeastern University College of Optometry Fort Lauderdale, FL SUNY College of Optometry New York, NY Eye Care Associates of Nevada Sparks, NV Specialty Eyecare Group Kirkland, WA West Georgia Eye Care Carrollton, GA Justin Bazan, OD Steven Ferucci, OD, FAAO Danica J. Marrelli, OD, FAAO John Rumpakis, OD, MBA Park Slope Eye Brooklyn, NY Sepulveda VA Ambulatory Care Center and Nursing Home Sepulveda, CA University of Houston College of Optometry Houston, TX Practice Resource Management Lake Oswego, OR Lisa Frye, ABOC, FNAO Katherine M. Mastrota, MS, OD, FAAO Eye Care Associates Birmingham, AL Omni Eye Surgery New York, NY Eyecare Consultants Vision Source Englewood, CO Ben Gaddie, OD, FAAO John J. McSoley, OD Gaddie Eye Centers Louisville, KY University of Miami Medical Group Miami, FL University of Alabama at Birmingham School of Optometry Birmingham, AL David I. Geffen, OD, FAAO Ron Melton, OD, FAAO Peter Shaw-McMinn, OD Gordon Weiss Schanzlin Vision Institute San Diego, CA Educators in Primary Eye Care LLC Charlotte, NC Southern California College of Optometry William D. Townsend, OD, FAAO Sun City Vision Center Advanced Eye Care Sun City, CA Canyon, TX Jeffry D. Gerson, OD, FAAO Highland, CA Diana L. Shechtman, OD, FAAO William J. Tullo, OD, FAAO Patricia A. Modica, OD, FAAO Nova Southeastern University Fort Lauderdale, FL TLC Laser Eye Centers/ Princeton Optometric Physicians Princeton, NJ Marc R. Bloomenstein, OD, FAAO Schwartz Laser Eye Center Scottsdale, AZ Crystal Brimer, OD Crystal Vision Services Wilmington, NC Mile Brujic, OD Premier Vision Group Bowling Green, OH Benjamin P. Casella, OD Casella Eye Center Augusta, GA Michael A. Chaglasian, OD Illinois Eye Institute Chicago, IL WestGlen Eyecare Shawnee, KS Milton M. Hom, OD, FAAO A. Paul Chous, OD, MA Azusa, CA Chous Eye Care Associates Tacoma, WA Renee Jacobs, OD, MA Practice Management Depot Vancouver, BC Pamela J. Miller, OD, FAAO, JD SUNY College of Optometry New York, NY Laurie L. Pierce, LDO, ABOM Hillsborough Community College Tampa, FL John L. Schachet, OD Leo P. Semes, OD Joseph P. Shovlin, OD, FAAO, DPNAP Northeastern Eye Institute Scranton, PA Kirk Smick, OD Clayton Eye Centers Morrow, GA Loretta B. Szczotka-Flynn, OD, MS, FAAO University Hospitals Case Medical Center Cleveland, OH Marc B. Taub, OD, MS, FAAO, FCOVD Southern College of Optometry Memphis, TN Tammy Pifer Than, OD, MS, FAAO University of Alabama at Birmingham School of Optometry Birmingham, AL J. James Thimons, OD, FAAO Ophthalmic Consultants of Fairfield Fairfield, CT Walter O. Whitley, OD, MBA, FAAO Virginia Eye Consultants Norfolk, VA Kathy C. Yang-Williams, OD, FAAO Roosevelt Vision Source PLLC Seattle, WA Digit@l 4 JANUARY 2016 t VOL. 8, NO. 01 Content CONTENT CHANNEL DIRECTOR Gretchyn M. Bailey, NCLC, FAAO [email protected] 215/412-0214 CONTENT SPECIALIST Colleen McCarthy [email protected] 440/891-2602 VP, CONTENT & STRATEGY Sara Michael [email protected] 203/523-7107 GROUP CONTENT DIRECTOR Mark L. Dlugoss [email protected] 440/891-2703 DIRECTOR, DESIGN AND DIGITAL PRODUCTION Nancy Bitteker [email protected] 203/523-7074 ART DIRECTOR Lecia Landis CHECK OUT THE LATEST OPTOMETRY TIMES BLOGS Optometry Times offers weekly blogs from some of the leaders in the optometric profession. Haven’t read them yet? Here’s what you’re missing. 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Ext. 124 LIST ACCOUNT EXECUTIVE Renée Schuster [email protected] 440/891-2613 PERMISSIONS/INTERNATIONAL LICENSING Maureen Cannon [email protected] 440/891-2742 Dr. Melanie Denton received her MBA in May 2015 and shares the ROI of getting an MBA for an OD. Thinking about going back to school? Read this first. Dr. Tracy Schroeder Swartz says the holidays can be hectic for everyone, but that time of year is especially crazy when you’re both an OD and a parent. She shares the best and worst parts of the holidays as an OD mom. The holidays may be over, but her blog is definitely worth a read if you need a good laugh. Dr. Mile Brujic is a pro at meeting new people now, but he says it wasn’t always that way. His latest blog utlines why making connections is such a vital part of developing your career as an optometrist. Dr. David Kading explains why being a good OD also means being a good salesperson, especially when it comes to communicating value to patients. optometrytimes.com/tag/odt-blog what your colleagues are reading. Check out the craziest stories from 2015 Optometry’s 10 biggest stories in 2015 1 2 3 OptometryTimes.com/ODTop10of0215 Affording OCT in your practice OptometryTimes.com/affordingOCT The ROI of an MBA for an OD OptometryTimes.com/MBAforOD Production PHOTO: G-STOCKSTUDIO/SHUTTERSTOCK.COM TOP HEADLINES Take a look at It was a wild year in optometry, and we were there to cover it all. OptometryTimes.com/crazieststories2015 SENIOR PRODUCTION DIRECTOR Karen Lenzen Circulation VICE PRESIDENT, MARKETING & AUDIENCE DEVELOPMENT Joy Puzzo DIRECTOR, AUDIENCE DEVELOPMENT Kristina Bildeaux AUDIENCE DEVELOPMENT MANAGER Molly Tomfohrde UBM Medica: CHIEF EXECUTIVE OFFICER Joe Loggia EXECUTIVE VICE-PRESIDENT, LIFE SCIENCES Tom Ehardt EXECUTIVE VICE-PRESIDENT Georgiann DeCenzo EXECUTIVE VICE-PRESIDENT Chris DeMoulin EXECUTIVE VICE-PRESIDENT, BUSINESS SYSTEMS Rebecca Evangelou EXECUTIVE VICE-PRESIDENT, HUMAN RESOURCES Julie Molleston EXECUTIVE VICE-PRESIDENT, STRATEGY & BUSINESS DEVELOPMENT Mike Alic SR VICE-PRESIDENT Tracy Harris VICE-PRESIDENT, GENERAL MANAGER PHARM/SCIENCE GROUP Dave Esola VICE-PRESIDENT, LEGAL Michael Bernstein VICE-PRESIDENT, MEDIA OPERATIONS Francis Heid VICE-PRESIDENT, TREASURER & CONTROLLER Adele Hartwick UBM Americas: CHIEF EXECUTIVE OFFICER Simon Foster CHIEF OPERATING OFFICER Brian Field CHIEF FINANCIAL OFFICER Margaret Kohler R 2015 12 DECEMBE VOL. 7, NO. 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Baileynt Channel Direct By Gretch Conte iary in Chief, subsid Editor and its its fire for aceuticals t Pharm have come under ting gas Valean + Lomb purchasing compe r Paracture Bausch in actions t lens manuf to purchase recent (GP) contac attempts ny has permeable Sciences and The compa and agon Vision GP laboratories. increases price Conindependentcriticism for rt group ). suppo ry (CLMA also faced from indust Association Commis1. awal withdr Figure acturers l Trade Manuf n which Ganglio tact Lens n to a U.S. Federa n deal, x the Parago on ortho-k In additio cell comple probe into monopoly This sh report. a backla sion (FTC) t a de facto is facing indepenscan yields gave Valeanthe company and tion py (ECPs) informa materials, e practitioners who are unhap l the that is from eyecart lens laboratories nt t to contro importa contac the attemp quickly” box.) dent and the ed iin hikes is and with price “Change happeng choice or consol diagnos (See limitin sion has proven market. progres you start history a. “Any time among a few, Ryan McKinnis, of glaucom says power seen it courtesy dating happen,” OH.” We’ve Images things OD, ica and and, that bad Ernie Bowling, in Clevel with Luxott page 3 on OD, FAAO, the retail side FAAO lenses on See GP happen d vices an new de y for it of two pa A review the math to doing 1 OPTOMETRY TIMES APP Get access to all the benefits Optometry Times offers at your fingertips. The Optometry Times app for iPad and iPhone is now free in the iTunes store. l y with dea ODs unhapp and VSP between CVS The techcenter. rthy agement ng: imagn E. McCa MS, FAAO of amazi wn. r at a coman By Collee list g, OD, g short directo in usly unkno s Specia Bowlin stic is nothin ioners Content a fundu diagno ways previo nology e practit ge of new month a retina in see things that those layeyecar CVS’ anndent ing the ns over no shorta every to . All I could Indepe here is it seems And with each with VSP Baltimore— do justice in optometry raised concer Suddenly logy— didn’t le. nd have it would work s at five of the learn techno Maryla is availab to ask I had to there to be seen! that photo really care service retina How new device , we will have e, I’ve nouncement ing vision Washington, actual ly itself? ers of the practic ore and ndent new deviceWill it pay for it? The last were now in private Baltim begin provid indepe be to have school again ons: in the among afford would ent I it once but questi Can its stores raise concerns great Now, same office, of equipm nd. iit cost? ht how our a piece ble in my simply out in Maryla DC, areas, OD, immed 8 with it much doesof us needs is often thoug logy availa providers John Burns, was just and along on page paying value: eyecare like thing any that techno the device ing dust adds to and VSP etrists fact we’re that for CVS collect imnt. the Optom fact See just at elepha sitting the cost Another beyond ring anger for that white the cohersimme of my reach. logy has moved now image optica l 38 h the nose years since uced can 28 throug r SEE PAGE OCT technoretina. OCT on page 20 first introd disOCT bange been t was ing the eye It has aging and bucke See Review raphy (OCT)treatment of Tetons, ated with ence tomog sis and the Grand e infatu a center diagno becam , hiking for the g as ease. 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For uses beyond those listed above, please direct your written request to Permission Dept. fax 440-756-5255 or email: [email protected]. | PRACTICAL CHAIRSIDE ADVICE 2016 challenges Continued from page 1 Increasing deductibles Increasing deductibles means costs are shifting more and more onto the shoulders of patients. “Cost shifting is going to change how we have to communicate with our patients,” says Dr. Rumpakis. “I do think that it’s going to significantly affect our patients’ willingness to comply with what they need to do.” When you’re trying to justify the cost of this diagnostic test or regular imaging to keep that glaucoma in check, but those services are not covered by the patient’s insurance—you’ll likely face some pushback. There’s a good chance some patients aren’t going to be very pleased to drop hundreds of dollars on a service if they don’t see or understand the direct benefit to them. It’s all about communicating the value, a skill that not enough doctors have mastered, says Dr. Rumpakis. “I think optometrists are among the most compassionate and caring healthcare providers out there—that is both our strength and it is our weakness,” says Dr. Rumpakis. “The weakness is that oftentimes we want to be our patients’ best friend instead of being their doctor. We tend to capitulate rather easily to what the patient wants to do rather than really trying to be their doctor and make sure that they understand the clinical needs.” The demands of healthcare reform Dr. Rumpakis says that healthcare reform mandates that doctors perform at a higher quality and volume with a lower price— and it’s not going to be easy. And while all healthcare providers will face this problem, he says that optometrists are especially ill equipped to manage these demands. “I think that is going to be a challenge— not to optometry particularly—but to all healthcare practitioners,” says Dr. Rumpakis. “But the problem in optometry is that we don’t have the ancillary staff that is accessible to us like a general practitioner has.” The costs of adding new members to your staff can add up in terms of salary, but if increasing head count allows you to see more patients and maintain your quality of care, it might be worth the investment. Dr. Rumpakis says that building the right team at your practice is a direct cost, but you have to measure the return on investment over a three- to five-year period to be able to get an appropriate cost analysis. In Focus 5 It’s all about communicating the value, a skill that not enough doctors have mastered, says Dr. Rumpakis. Consolidation, consolidation, consolidation It seems that practically every week of 2015 brought news of yet one company buying up another, and the eyecare industry was no different. “This past year has been a tremendous year for consolidation,” says Dr. Rogoff. “You have some heavy hitters out there who have been gobbling up a lot of stuff. That was the biggest thing that has been on my radar on for 2016: With everyone buying this, everyone buying that—what’s going to happen?” One of the biggest was Essilor’s acquisition of Vision Source. Essilor also acquired Professional Eyecare Resource Co-Operative (PERC) and Infinity Vision Alliance (IVA). “It’s nice to know that a company like Essilor is buying Vision Source and PERC as opposed to a venture capitalist group whose sole purpose is short-term profits,” says Dr. Rogoff, “instead of long-term things that would help out that buying group.” And there are a number of other groups out there buying up practices left and right, so Dr. Rogoff says that independent doctors need to differentiate themselves. He says doctors need to focus on marketing and creating the best customer experience. Increased competition from corporate opticals Another big trend we saw in 2015 was the expansion of corporate opticals through partnerships with other brands. VSP partnered with CVS to bring vision care centers to several of its stores in the Washington, DC, and Baltimore areas, while Luxottica is bringing its LensCrafters brand to 500 Macy’s locations across the country. These deals mean even more competition for your patients. “There has been such a movement—venture capitalists are seeing the value in optical, and obviously this was the year for that,” says Dr. Rogoff. Access to patients We hate to say it, but insurance plans will likely continue to be a major headache in the coming year, just as they were in the last year. Dr. Rumpakis says that access to patients will not only continue to be a problem, but that problem will likely grow over the next year. “I think that we’re going to start to see greater narrowing of networks, meaning more focus on who the patients can see for their care,” says Dr. Rumpakis. Bring on the New Year Although the number of changes that have happened and will continue to happen in eye care can be daunting, Dr. Rumpakis says change doesn’t need to be a bad thing. “As part of my personal philosophy, I think any time there’s disruption,” he says, “for as many negatives as there are, there are just as many opportunities. I think there are plenty of opportunities for people to thrive in this marketplace—but people have to be willing to change their paradigm, not just do things the way they’ve always done it.” IN BRIEF Alcon launches Air Optix Colors iOS app FORT WORTH, TX—Alcon has launched the Air Optix Colors Color Studio app for iOS devices. The app allows users to upload a photo and virtually “try on” any of the nine colors of Air Optix Colors contact lenses. The app is available for free in the App Store. “The cosmetic lens market is a fraction of its potential size, and driving interest means meeting patients where they are already receiving information—on their mobile devices,” says Carla Mack, OD, MBA, FAAO, director of professional and clinical support for US Vision Care at Alcon. Revamped for mobile and tablet, the Color Studio app is equipped with new functionality, including the ability to compare two lens colors and to virtually try on makeup to create a custom look. Says Dr. Mack: “A mobile app creates opportunity for eyecare practitioners to more easily integrate the Color Studio into their practices, offering patients and staff a tool to quickly evaluate how certain colors might look, before trying on the lenses.” 6 In Focus Legislative changes Continued from page 1 tometrists in that state do business. And other victories came in the form of blocking laws that would be threats to optometry. “Of course, state associations determine their own specific priorities for each legislative session, and the AOA works stateby-state to help pass these bills, including for expansion of scope, to fix abusive policies imposed by insurers and vision plans, and to strengthen public health and quality care safeguards,” says Dr. Loomis. “Also, whenever and wherever there is a concern about bill attacking optometry or potentially JANUARY 2016 for business relationships among ODs andopticians, optical companies, and health plans, including the outlawing of employment by opticians of optometrists. As of January 1, a registered dispensing optician, optical company, and health plan will no longer be allowed to newly employ an optometrist. For those that currently employ ODs, there will be a three-year transition period during which they must convert to a landlord-tenant arrangement. “AB 684 is all about safeguarding a doctor of optometry’s independent clinical judgement for the benefit of the patient,” says Barry Weissman, OD, PhD, FAAO, Califor- A registered dispensing optician, optical company, and health plan will no longer be able to newly employ an OD in California. undermining patient care, the AOA helps state associations fight back and defeat it.” The latest on the UPP battle Earlier this year, 1-800 CONTACTS-backed legislation that attempted to block unilateral pricing polices (UPP) was introduced in 14 states around the country. According to Dr. Loomis, over the last few months, anti-UPP legislation was defeated thanks to advocacy responses by state associations in six of the targeted states: Arizona, Florida, Idaho, Louisiana, Mississippi, and Tennessee. But the fight isn’t over. There are still anti-UPP bills pending in California, Illinois, Minnesota, New York, Oregon, Rhode Island, and Washington. And Dr. Loomis says more states may see further action as 2016 grows closer. Despite fending off anti-UPP legislation, Arizona expects to see legislation to be introduced early next year that would eliminate expiration dates and notation of brands on contact lens prescriptions, prevent optometrists from selling products they prescribe, and legitimizing prescriptions generated from online refraction and vision kiosks without the necessity of a health assessment from an eyecare provider. “The AOA stands ready to help affiliates battle harmful legislation,” says Dr. Loomis. Changes in California Three new laws in California will affect optometrists. The first will go into effect on January 1, 2016, and establishes new, enforceable rules nia Optometric Association president. “Importantly for doctors, the measure contains enforceable protections to ensure the doctor will be able to maintain exclusive control over his or her practice. For doctors currently employed in a retail setting, it is anticipated they will be offered a lease or employment from a doctor who has leased space at the establishment over the next three years.” The state also enacted a law that will allow for a therapeutic pharmaceutical agents (TPA) certification for optometrists who have not yet obtained it. Optometrists who graduated before 1996 were left with few pathways to obtain TPA certification because many TPA stand-alone courses were discontinued. After 1996, students graduated optometry school with TPA certification. This new law will clarify the pathway for those ODs who graduated prior to 1996. And finally, California passed a law that requires health plans and insurers to provide updated provider directories and sets standards on how to make this possible. This measure also requires online directories to be updated at least weekly. Further, it requires health plans or insurers to reimburse enrollees for any amount over what they would have paid for in-network services in circumstances where the enrollee reasonably relied upon inaccurate, incomplete, misleading or confusing information in a provider’s directory. “This legislation builds upon the promise of the Affordable Care Act’s goal of increasing access to care,” says Dr. Weissman. | “Consistently accurate provider directories are an integral component to assisting the public in locating doctors accepting their insurance and the resulting timely access to vision and eye health care. It also will help decrease the uncomfortable and costly situations when a patient comes to the practice and learns the doctor is not a provider.” The latest in Pennsylvania In the spirit of keeping students safe, Pennsylvania enacted a law that requires school bus drivers to carry a certificate of physical and vision exam. An optometrist or ophthalmologist must conduct the vision exam. What’s in the works A number of bills are in various stages that could affect optometrists in the coming months should they become laws: – A bill was introduced in Pennsylvania in September that would allow ODs to administer and prescribe all FDA-approved legend (requiring a prescription) and nonlegend drugs necessary for the treatment of diseases and conditions of the eye and adnexa, including removal of foreign bodies, drainage of superficial cysts, injection into the adnexa and for anaphylaxis. – A bill in Florida would prohibit a health insurer, prepaid limited health service organization, or HMO from requiring an OD to join a network solely for the purpose of credentialing the provider for another organization’s vision care plan or restrict a provider to a specific supplier of materials or optical labs. Directories of network providers must be updated monthly to reflect current vision care providers. Violators of this law would constitute an unfair insurance trade practice. – A bill in Kentucky would establish a policy governing the procedures for changing the existing agreement with a provider to include: requiring a face-to-face meeting to discuss proposed changes if requested by a medical provider; requiring certified letter detailing the proposed changes; requiring the provider either agree or not agree to the proposed changes; and requiring that a new agreement be established and agreed upon after three or more material changes are made to the existing agreement. – A bill in Ohio would exempt the first $500 of prescription eyeglasses, contact lenses, and other optical aids sold by licensed dispensers from sales and use tax. – A bill in Illinois would encourage all drivers in the state to get annual eye exams. Looking deeper Exploring innovation Shire’s Vision for Ophthalmics At Shire, we’re a leading biotech with a global track record for our work in rare diseases and specialty conditions. Now we’re expanding our vision and bringing the same commitment to ophthalmics. 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 Focus On DIABETES JANUARY 2016 | What’s new in management, prevention 2015 was a year of advances, bringing new tools to the fight against diabetes From new ways of predicting who will and won’t develop diabetes, to new diabetes meds, to new evidence regarding which anti-vascular endothelial growth factor (VEGF) might be better for your specific patient, the last year has given us better tools for helping our patients with diabetes. in the gut microbiome that fosA number of interesting develters insulin resistance, at least opments have arisen in the last some of which is attributable year concerning risk assessment, to both excess consumption of treatment, and management of refined carbohydrates and nonboth diabetes and diabetes-renutritive sweeteners like asparlated eye disease. The stage has tame and sucralose.3,4 Elevated been set by the increasing prevaA. PAUL CHOUS, lence of diabetes, with 29.1 milliver enzymes ALT and AST also MA, OD, FAAO, lion Americans having diabetes, have been shown to be highly has a private and another 86 million having predictive of T2DM, particularly practice specializing pre-diabetes.1 More recently, analin women, and these are comin diabetes eye care and education in monly associated with non-alcoysis published recently in JAMA Tacoma, WA. holic fatty liver disease (NAFLD).5 shows that about 12 percent of U.S. adults have diabetes, with Both of these findings bolmore than half of the adult population ster evidence that avoidance of added having either diabetes or pre-diabetes, indietary sugars (the World Health Orgacluding an astounding 83 percent of U.S. nization now recommends less than 40 adults over the age of 65 years.2 Worldgrams per day, with an ideal target less than 25 grams per day)6 will lower diawide, diabetes rates continue to climb, particularly in Asia. In fact, if we total betes risk at a population level. Lifestyle intervention continues to trump metformin for preventing T2DM over 15 years in high-risk subjects from the Diabetes Prevention Program (DPP), with 27 per- Avoidance of added dietary sugars will lower diabetes risk at a population level the number of people living with diabetes in China (100 million), India (50 million), and the U.S., this amalgam would represent the third most populous country in the world.3 Clearly, we need to do a better job of identifying those at highest risk for development of both diabetes and especially sight-threatening eye disease. The other thing we need is a whole lot of prevention. Risk factors for type 2 diabetes Some interesting and novel risk factors for type 2 diabetes (T2DM) have arisen within the last year, including alterations cent and 18 percent reduced incidence comparing 100 minutes/week walking to metformin vs. no intervention.7 Interestingly, a composite index of microvascular complications did not differ significantly between the treatment groups, though women assigned to the “lifestyle” group were about 22 percent less likely to experience any microvascular complication, including retinopathy. The latest diabetes medications A number of new diabetes medications have become available, including two new glucagon-like peptide 1 (GLP-1) agonists: Trulicity (dulaglutide, Lilly) and Tanzeum (albiglutide, GSK), which improve postmeal insulin production, reduce glucagon secretion, suppress appetite, and assist with weight loss—significant benefits for patients above ideal body weight (additionally, Novo received FDA approval for double-strength Victoza (liraglutide, trade name Saxenda for weight loss). A new sodium glucose transporter -2 (SGLT2) inhibitor was also released in the U.S., Jardiance (empagliflozin, Boehringer). These oral drugs lower blood sugar by reducing resorption of serum glucose in the proximal renal tubule, leading to urinary excretion of glucose, reduced blood pressure, and weight loss. Figure 2. A 62-year-old male recently diagnosed with type 2 diabetes presented to our office with center-involved diabetic macular edema (DME) OS >OD. Best-corrected vision was 20/80 in both eyes. Based on DRCR. net Protocol T, this gentleman may be significantly more likely to benefit from aflibercept (Eylea, Regeneron). | PRACTICAL CHAIRSIDE ADVICE A major finding of the EMPA-REG study is that type 2 diabetes patients with high cardiovascular risk placed on empagliflozin were 38 percent less likely to die from cardiovascular causes compared to patients on other diabetes meds.8 Two other trials with SGLT2 inhibitors are ongoing to see if this cardiovascular protection is a class effect. If so, these drugs are anticipated to become major second-line agents after metformin for treatment of patients with T2DM. The latest in diabetic eye disease In regard to diabetic eye disease, the evidence grows that anti-VEGF drugs are superior to laser therapy for diabetic macular edema (DME). Three-year data with ranizibumab (Lucentis, Genentech) and 100-week data with aflibercept (Eylea, Regeneron) show that visual gains are maintained with these agents and are superior to gird or focal macular laser in isolation.9,10 The long-awaited Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol T results were released last May and showed that ranizibumab, aflibercept, and bevacizumab (Avastin, Genentech) were roughly comparable in efficacy for treatment of center-involved DME.12 Subgroup analysis did show, however, that patients with baseline visual acuities of 20/50 or worse achieved better visual outcomes with aflibercept compared with the other two agents (about one additional line of acuity. Adverse events were slightly elevated but infrequent and about the same DIABETES in all three groups—it must be remembered that patients with diabetic retinopathy (DR) and/or DME have higher CV risk to begin with. Both Lucentis and Eylea were also granted additional FDA indications for treating non-proliferative DR in patients with co-existing DME; of course, both remain far more costly than their off-label counterpart, Avastin. I had the pleasure of attending a special ARVO Diabetic Retinopathy Small Meeting at U.S. National Institutes of Health at the end of August 2015. Attendees heard from a number of esteemed investigators and clinicians about groundbreaking work into the pathophysiology, genetics, and treatment of DR and DME. I look forward to sharing with you a few items that particularly piqued my interest in my next department. REFERENCES 1. CDC National Diabetes Statistics Report 2014. Available at: http://www.cdc.gov/diabetes/data/ statistics/2014statisticsreport.html. accessed 12/08/2015. 2. Menke A, Casagrande S, Geiss L, et al. Prevalence of and Trends in Diabetes Among Adults in the United States, 1988-2012. JAMA. 2015 Sep 8;314(10):1021-9. 3. Guariguata L, Whiting DR, Hmableton I, et al. Global estimates for diabetes prevalence in 2013 and projections for 2035. Diabetes Res Clin Pract. 2014 Feb;103(2):137-49. 4. Barlow GM, Yu A, Mathur R. Role of the Gut Microbiome in Obesity and Diabetes Mellitus. Nutr Clin Pract. 2015 Dec;30(6):787-97. 5. Suez J, Korem T, Zeevi D, et al. Artificial sweeteners induce glucose intolerance by altering the gut microbiota. Nature. 2014 Oct 9;514(7521):181-6. Focus On 6. Ko SH, Baeg MK, Han KD, et al. Increased liver markers are associated with higher risk of type 2 diabetes. World J Gastroenterol. 2015 Jun 28;21(24):7478-87. 7. World Health Organization. WHO calls on countries to reduce sugars intake among adults and children. Available at: http://www.who. int/mediacentre/news/releases/2015/sugarguideline/en/. Accessed: 9/10/2015. 8. Diabetes Prevention Program Research Group. Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year followup: the Diabetes Prevention Program Outcomes Study. Lancet Diabetes Endocrinol. 2015 Nov;3(11):866-75. 9. Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. 10. Boyer DS, Nguyen QD, Brown DM, et al. Outcomes with As-Needed Ranibizumab after Initial Monthly Therapy: Long-Term Outcomes of the Phase III RIDE and RISE Trials. Ophthalmology. 2015 Dec;122(12):2504-2513. 11. Brown DM, Schmidt-Erfurth U, Do DV, et al. Intravitreal Aflibercept for Diabetic Macular Edema: 100-Week Results From the VISTA and VIVID Studies. Ophthalmology. 2015 Oct;122(10):204452. 12. Diabetic Retinopathy Clinical Research Network, Wells JA, Glassman AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015 Mar 26;372(13):1193203. Dr. Paul Chous has a private practice specializing in diabetes eye care and education in Tacoma, WA. He is the author of Diabetic Eye Disease: Lessons From a Diabetic Eye Doctor (Fairwood Press, Seattle, 2003), which was included in the “Top 12 Diabetes Books” by Diabetes Update magazine in 2004. He is a consultant to ZeaVision, Freedom Meditech, Risk Medical Solutions, Regeneron and VSP. IN BRIEF Second annual virtual conference to be held January 16-17 BOCA RATON, FL—Online eyecare professional community ODwire.org will hold its second annual live virtual optometric conference, CEwire2016, January 16-17. CEwire2016 will be held live online on January 16-17, 2016, from 11:00 a.m. to 7:00 p.m. ET on both days. All lectures and exhibit hall will be available on-demand to registrants for an additional 90 days. CEwire2016 features more than 45 COPE-approved CE lecture hours on a variety of topics, including comanagement, scleral lenses, and new technology. The conference will also feature a large virtual exhibit hall where attendees can view materials, access show discounts on products and services, and interact live with participating vendors. Last year, more than 1,500 eyecare professionals from the U.S., Canada, and other countries attended CEwire2015. “The cost and convenience factors of a virtual conference offer advantages for participants, as there are no travel costs and the technology is universally available, enabling registrants to fulfill their mandatory CE requirements at their own convenience,” says ODwire.org cofounder and conference co-organizer Paul Farkas, OD, FAAO. Practitioners may register individually, and group office registration provides a discount and free staff attendance. Optometry students may register for free. Profits from CEwire2016 will be distributed to The American Optometric Foundation and Volunteer Optometric Services to Humanity (VOSH)/International. Last year’s conference raised more than $20,000 for three optometric charities. Visit www.cewire2016.com. 9 10 Focus On PRACTICE MANAGEMENT JANUARY 2016 | Why you need a practice mission You’ll need to know where you’re going to know if you’re getting there “How are you?” Everyone knows that in casual conversation, the answer to this question is, “Fine,”(or “Good,” or “Pretty good”). We ask it, and we answer every day without much thought or consideration. It is really more of a polite greeting than an inquiry into one’s current status. your practice vision or mission. You must clearly articulate what you are working to accomplish with your practice. For instance, if your mission is to provide all the eyecare needs to as many in your community as you can, BY MICHAEL your vision is different from that ROTHSCHILD, OD of a practice who limits its care How’s the practice? Director of What’s to vision therapy. But what about when we ask it Next-Leadership OD. Here are two examples. of each other professionally? It Practice 1 is in a suburban/ may be something like, “How’s rural area next to the local hosthe practice?” pital. The largest employers in the area What is your answer to that question? are a wire manufacturer, an EHR develUsually it is the same type of generic anopment company, and a hospital. As a swer that has minimal meaning; “Good,” primary care eyecare provider, the prac“Pretty good,” “Fine.” tice strives to be the choice for eye care for every member of the family. It provides eye exams, contact lenses, specialty lenses, and surgical comanagement, and – Daily deposits it provides a lot of medical eye care. Its – Number of exams vision is to earn trust by providing the – Income per exam highest quality care and products to pa– Capture rate (optical) tients. It works hard to grow 10 percent – Collection rate (insurance) yearly, be a good member of the com– Percentage full (scheduling) munity, and feed its staff’s passion to – Write-offs care for patients. – Patient wait time Practice 2 has five locations in vari– Net promoter score ous strip malls around a larger metro area. This practice strives to create a consistent experience at all of its locations. But in reality, do you even know how All of its stores carry the same brands things are going in your practice? When I of frames, accept the same insurances, am at my best, I can tell you my capture and are priced identically. As a primary rate, collection rate, cost of goods sold, care provider, it too provide exams, conand expenditures compared to budget. tact lenses, and surgical comanagement. But other times I can judge my practice’s For the most part, medical care and spestatus only by my ability to pay my bills. cialty care will be referred to practices In my consulting work with practices, I that are more equipped. Growth is parhave found that most of us don’t know if amount with clear goals of adding two our practice is doing well or not. locations per year for the next decade. When we really want to know how someone is doing, we ask it differently. We may say, “I saw on Facebook that you lost your goldfish. Are you doing OK?” or, “How have you been dealing with your new situation?” Metrics to watch It depends So, how do you know how your practice is doing? The answer is, “It depends.” To have any understanding of how your practice is doing, you must clearly define have identified your mission and made it clear to the rest of the team, your practice will just be “fine.” Once you have identified where you are going, you can monitor your progress. Then you can truthfully answer, “We are performing much better than we thought we would be at this point.” There are too many metrics that can be measured in our practices to remain effective. If I wanted, I could calculate the amount of electricity being used per box of contact lenses sold. I am not sure of the value of that, so I do not measure it. Other metrics may be relevant twice a year, while others need to be monitored daily. I recommend finding five metrics that help you determine how you are progressing toward your goals, and I recommend you look at those metrics a lot. Determine what is “good,” what is “not so good,” and what is “reaction worthy.” For almost every eyecare practice, the amount of money being deposited into the bank needs to be monitored daily. Find how much needs to be deposited daily to keep the cash flow going. If you have several days in a row below that amount, do something. Other big metrics to watch ones include: – Number of exams – Income per exam – Capture rate (optical) – Collection rate (insurance) – Percentage full (scheduling) – Write-offs – Patient wait time – Net promoter score Don’t compare Be cautious about comparing these metrics with your colleagues because the practice vision can dramatically affect these numbers. Practice 1 is likely to have higher staff costs than Practice 2 simply because of the variety of testing. Practice 2 is more likely to garner a higher capture rate because optical is more of a focus. The point is to continuing nudging your benchmarks in the direction you want. Find out where you’re going This is just two examples. There is really an unlimited number of ways that eyecare practices can be operated. Until you Dr. Rothschild is also a consultant for Alcon, Optos, and Vision Source; a member of the speakers’ bureau for VSP; and a clinical researcher for CIBA Vision. When treating your patients with bacterial conjunctivitis – Unleash power against pathogens of concern. 1 2 1,3: – S. aureus, S. epidermidis, S. pneumoniae, H. influenzae – Pseudomonas aeruginosa Indication BESIVANCE® (besifloxacin ophthalmic suspension) 0.6% is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: Aerococcus viridans*, CDC coryneform group G, Corynebacterium pseudodiphtheriticum*, Corynebacterium striatum*, Haemophilus influenzae, Moraxella catarrhalis*, Moraxella lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis*, Staphylococcus lugdunensis*, Staphylococcus warneri*, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus salivarius* * Efficacy for this organism was studied in fewer than 10 infections. Important Safety Information about BESIVANCE® BESIVANCE® is for topical ophthalmic use only, and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. As with other anti-infectives, prolonged use of BESIVANCE® may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy. Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with BESIVANCE®. The most common adverse event reported in 2% of patients treated with BESIVANCE® was conjunctival redness. Other adverse events reported in patients receiving BESIVANCE® occurring in approximately 1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache. BESIVANCE® is not intended to be administered systemically. Quinolones administered systemically have been associated with hypersensitivity reactions, even following a single dose. Patients should be advised to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction. Safety and effectiveness in infants below one year of age have not been established. Please see brief summary of Prescribing Information on adjacent page. To learn more about BESIVANCE® call your Bausch + Lomb sales representative today. References: 1. BESIVANCE® Prescribing Information, September 2012. 2. At 12 hours, the concentration of besifloxacin in tears was >10 μg/mL. Proksch JW, Granvil CP, Siou-Mermet R, Comstock TL, Paterno MR, Ward KW. Ocular pharmacokinetics of besifloxacin following topical administration to rabbits, monkeys, and humans. J Ocul Pharm Ther. 2009;25(4):335-344. 3. Comstock TL, Paterno MR, Usner DW, Pichichero ME. Efficacy and safety of besifloxacin ophthalmic suspension 0.6% in children and adolescents with bacterial conjunctivitis: a post hoc, subgroup analysis of three randomized, double-masked, parallel-group, multicenter clinical trials. Paediatr Drugs. 2010;12(2):105-112. Besivance is a trademark of Bausch & Lomb Incorporated or its affiliates. © 2015 Bausch & Lomb Incorporated. All rights reserved. US/BES/15/0010 BRIEF SUMMARY OF PRESCRIBING INFORMATION This Brief Summary does not include all the information needed to use Besivance safely and effectively. See full prescribing information for Besivance. Besivance (besifloxacin ophthalmic suspension) 0.6% Sterile topical ophthalmic drops Initial U.S. Approval: 2009 1 INDICATIONS AND USAGE Besivance® (besifloxacin ophthalmic suspension) 0.6%, is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: Aerococcus viridans*, CDC coryneform group G, Corynebacterium pseudodiphtheriticum*, Corynebacterium striatum*, Haemophilus influenzae, Moraxella catarrhalis*, Moraxella lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis*, Staphylococcus lugdunensis*, Staphylococcus warneri*, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus salivarius* *Efficacy for this organism was studied in fewer than 10 infections. 2 DOSAGE AND ADMINISTRATION Invert closed bottle and shake once before use. Instill one drop in the affected eye(s) 3 times a day, four to twelve hours apart for 7 days. 4 CONTRAINDICATIONS None 5 WARNINGS AND PRECAUTIONS 5.1 Topical Ophthalmic Use Only NOT FOR INJECTION INTO THE EYE. Besivance is for topical ophthalmic use only, and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. 5.2 Growth of Resistant Organisms with Prolonged Use As with other anti-infectives, prolonged use of Besivance (besifloxacin ophthalmic suspension) 0.6% may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining. 5.3 Avoidance of Contact Lenses Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with Besivance. 6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with the rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice. The data described below reflect exposure to Besivance in approximately 1,000 patients between 1 and 98 years old with clinical signs and symptoms of bacterial conjunctivitis. The most frequently reported ocular adverse reaction was conjunctival redness, reported in approximately 2% of patients. Other adverse reactions reported in patients receiving Besivance occuring in approximately 1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C. Oral doses of besifloxacin up to 1000 mg/kg/day were not associated with visceral or skeletal malformations in rat pups in a study of embryo-fetal development, although this dose was associated with maternal toxicity (reduced body weight gain and food consumption) and maternal mortality. Increased post-implantation loss, decreased fetal body weights, and decreased fetal ossification were also observed. At this dose, the mean Cmax in the rat dams was approximately 20 mcg/mL, >45,000 times the mean plasma concentrations measured in humans. The No Observed Adverse Effect Level (NOAEL) for this embryo-fetal development study was 100 mg/kg/day (Cmax, 5 mcg/mL, >11,000 times the mean plasma concentrations measured in humans). In a prenatal and postnatal development study in rats, the NOAELs for both fetal and maternal toxicity were also 100 mg/kg/day. At 1000 mg/kg/day, the pups weighed significantly less than controls and had a reduced neonatal survival rate. Attainment of developmental landmarks and sexual maturation were delayed, although surviving pups from this dose group that were reared to maturity did not demonstrate deficits in behavior, including activity, learning and memory, and their reproductive capacity appeared normal. Since there are no adequate and well-controlled studies in pregnant women, Besivance should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 8.3 Nursing Mothers Besifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Besivance is administered to a nursing mother. 8.4 Pediatric Use The safety and effectiveness of Besivance® in infants below one year of age have not been established. The efficacy of Besivance in treating bacterial conjunctivitis in pediatric patients one year or older has been demonstrated in controlled clinical trials [see CLINICAL STUDIES (14)]. There is no evidence that the ophthalmic administration of quinolones has any effect on weight bearing joints, even though systemic administration of some quinolones has been shown to cause arthropathy in immature animals. 8.5 Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Besifloxacin is a fluoroquinolone antibacterial [see CLINICAL PHARMACOLOGY (12.4)]. 12.3 Pharmacokinetics Plasma concentrations of besifloxacin were measured in adult patients with suspected bacterial conjunctivitis who received Besivance bilaterally three times a day (16 doses total). Following the first and last dose, the maximum plasma besifloxacin concentration in each patient was less than 1.3 ng/mL. The mean besifloxacin Cmax was 0.37 ng/mL on day 1 and 0.43 ng/mL on day 6. The average elimination half-life of besifloxacin in plasma following multiple dosing was estimated to be 7 hours. 12. Microbiology Besifloxacin is an 8-chloro fluoroquinolone with a N-1 cyclopropyl group. The compound has activity against Gram-positive and Gram-negative bacteria due to the inhibition of both bacterial DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme required for replication, transcription and repair of bacterial DNA. Topoisomerase IV is an essential enzyme required for partitioning of the chromosomal DNA during bacterial cell division. Besifloxacin is bactericidal with minimum bactericidal concentrations (MBCs) generally within one dilution of the minimum inhibitory concentrations (MICs). The mechanism of action of fluoroquinolones, including besifloxacin, is different from that of aminoglycoside, macrolide, and β-lactam antibiotics. Therefore, besifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to besifloxacin. In vitro studies demonstrated cross-resistance between besifloxacin and some fluoroquinolones. In vitro resistance to besifloxacin develops via multiple-step mutations and occurs at a general frequency of < 3.3 x 10-10 for Staphylococcus aureus and < 7 x 10-10 for Streptococcus pneumoniae. Besifloxacin has been shown to be active against most isolates of the following bacteria both in vitro and in conjunctival infections treated in clinical trials as described in the INDICATIONS AND USAGE section: Aerococcus viridans*, CDC coryneform group G, Corynebacterium pseudodiphtheriticum*, C. striatum*, Haemophilus influenzae, Moraxella catarrhalis*, M. lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, S. epidermidis, S. hominis*, S. lugdunensis*, S. warneri*, Streptococcus mitis group, S. oralis, S. pneumoniae, S. salivarius* *Efficacy for this organism was studied in fewer than 10 infections. 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to determine the carcinogenic potential of besifloxacin have not been performed. No in vitro mutagenic activity of besifloxacin was observed in an Ames test (up to 3.33 mcg/ plate) on bacterial tester strains Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2uvrA. However, it was mutagenic in S. typhimurium strain TA102 and E. coli strain WP2(pKM101). Positive responses in these strains have been observed with other quinolones and are likely related to topoisomerase inhibition. Besifloxacin induced chromosomal aberrations in CHO cells in vitro and it was positive in an in vivo mouse micronucleus assay at oral doses × 1500 mg/kg. Besifloxacin did not induce unscheduled DNA synthesis in hepatocytes cultured from rats given the test compound up to 2,000 mg/kg by the oral route. In a fertility and early embryonic development study in rats, besifloxacin did not impair the fertility of male or female rats at oral doses of up to 500 mg/kg/day. This is over 10,000 times higher than the recommended total daily human ophthalmic dose. 14 CLINICAL STUDIES In a randomized, double-masked, vehicle controlled, multicenter clinical trial, in which patients 1-98 years of age were dosed 3 times a day for 5 days, Besivance was superior to its vehicle in patients with bacterial conjunctivitis. Clinical resolution was achieved in 45% (90/198) for the Besivance treated group versus 33% (63/191) for the vehicle treated group (difference 12%, 95% CI 3% - 22%). Microbiological outcomes demonstrated a statistically significant eradication rate for causative pathogens of 91% (181/198) for the Besivance treated group versus 60% (114/191) for the vehicle treated group (difference 31%, 95% CI 23% - 40%). Microbiologic eradication does not always correlate with clinical outcome in anti-infective trials. 17 PATIENT COUNSELING INFORMATION Patients should be advised to avoid contaminating the applicator tip with material from the eye, fingers or other source. Although Besivance is not intended to be administered systemically, quinolones administered systemically have been associated with hypersensitivity reactions, even following a single dose. Patients should be advised to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction. Patients should be told that although it is common to feel better early in the course of the therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Besivance or other antibacterial drugs in the future. Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with Besivance. Patients should be advised to thoroughly wash hands prior to using Besivance. Patients should be instructed to invert closed bottle (upside down) and shake once before each use. Remove cap with bottle still in the inverted position. Tilt head back, and with bottle inverted, gently squeeze bottle to instill one drop into the affected eye(s). Manufactured by: Bausch & Lomb Incorporated Tampa, Florida 33637 Besivance® is a registered trademark of Bausch & Lomb Incorporated. ©Bausch & Lomb Incorporated U.S. Patent Nos. 6,685,958; 6,699,492; 5,447,926 †DuraSite is a trademark of InSite Vision Incorporated US/BES/15/0019 Based on 9142605(flat)-9142705(folded) | PRACTICAL CHAIRSIDE ADVICE DRY EYE Focus On Why you’re missing dry eye in front of you The risk factors are endless, but we’re still not catching most dry eye patients As we head into 2016, perhaps you are considering providing specialty services in dry eye or ocular surface disease (OSD). A common barrier to many practitioners is concern that the practice does not have the patient foundation to make investment profitable. I assure you that OSD management will profit the patient in clearer, more comfortable vision, enhancing productivity and wellbeing. Patients at risk for dry eye hormone therapy Patients with arthritis or other autoimmune disease Who are the current patients in your practice that can benefit Patients who see another from your new OSD specialty? specialty provider for any How can you identify them? chronic disease Where can you find them? The Patients with blepharitis, BY KATHERINE M. following is my stream-of-conMGD, BMD MASTROTA, MS, sciousness brainstorm to help Patients with any corneal OD, FAAO Center you recognize patients with or disease director of Omni Eye at-risk for ocular surface disease. Patients with recurrent “conSurgery in New York City. These patients include, but junctivitis” or patients who are not limited to all: have had true conjunctivitis of any etiology Diabetic patients Glaucoma patients on topical or oral Patients whose school or job demands therapy include excessive computer or digital device use Post-surgical patients (cataract, especially femto- assisted, glaucoma, Patients who wear makeup ptergium, retina, plastics) Patients who wear contact lenses Patients with sleep apnea or continuPatients who work for airlines, hospious positive airway pressure (CPAP) tals, hotels, or in any environmentallydevice users controlled buildings (any building with dry heat or air conditioning), or in any old building with older heating, air conditioning or ventilation; have homes or offices with carpeting; or in the top 20 states for high allergen count Patients who cut grass, work around or use chemicals on a daily basis, or travel a good part of the time Patients with Parkinson’s disease Incomplete blinkers I hope you are starting to think that practically every patient you encounter Patients with allergy, asthma, or is at risk for OSD. I am a firm believer atopic skin disease or dermatologic that we all have some level of dry eye disease (especially rosacea) disease—we are only on different places Patients who receive in-office inin the path to symptomatic and life-altraocular injections (anti-vascular tering disease. endothelial growth factor [VEGF]) Patients with pseudoexfoliation Female patients in menopausal/periTapping into this population menopausal age range and those on How do you tap into your patient popu- I hope you are starting to think that practically every patient you encounter is at risk for OSD. lation to help yourself and your patients? Here are ideas to get started: Detailed education of your staff Detailed educational brochure for your patients Detailed educational brochure for referring primary/specialty care doctors (especially endocrinologists, allergists, pediatricians) Questionnaire designed with specific questions about occupation, medication, health, and allergy available on your practice website and at check in with either Ocular Surface Disease Index (OSDI) or Standard Patient Evaluation of Eye Dryness (SPEED) or other verified dry eye screening tool Manual keratometry on all patients to observe the tear film/mire quality and topography to identify other irregularity Tear osmolarity testing on every patient as a baseline or screening If possible, digital ocular redness assessment, tear meniscus height, tear stability, lipid layer thickness, and meibography on every patient as a baseline/diagnostic test Eyelash rotation on every patient to identify and quantify demodex Eyelash photography as baseline documentation (Can you improve the health of the eyelashes? I believe you can) I recommend office-based lid and lid margin microblepharoexfoliation to every patient after photo documentation and explanation of blepharitis and its sequelae In addition to the aforementioned benefits of attention and treatment of OSD, you and your patients’ efforts will help ensure successful ocular surgery (including injections) with better pre-operative data and infection risk reduction. Aesthetics will be improved. Contact lenses will be worn longer. And you will have happier patients. Offer lid hygiene products, omega supplements, and occlusion products (such as eye masks, specialty eyewear, and CPAP eye protection) in your office. Go forth, educate, and treat. [email protected] 13 14 Focus On GLAUCOMA JANUARY 2016 | How patients perceive glaucoma matters What I learned when a patient asked when she’d go blind from glaucoma The other day, I had the pleasure of seeing one of my favorite glaucoma patients for an intraocular pressure (IOP) check and visual field study. She is an 86-year-old white female from rural Nebraska who found her way to Georgia many years ago with her late husband in an attempt to find carpentry work. serious question. We both sat She has no family here and is down, and she asked me how essentially independent, living long she had before she went alone, and still driving. Her mediblind because her mother went cal history is remarkable for arteblind from glaucoma before seekrial hypertension and high choing ophthalmic care. My mind lesterol, and her systemic mediimmediately went back to my cations are Lipitor (atorvastatin BY BENJAMIN fourth year at University of Alacalcium, Pfizer) and Tribenzor P. CASELLA, OD, bama at Birmingham School of (olmesartan medoxomil/amloFAAO Practices Optometry in the ocular disease dipine/hydrochlorothiazide, Daiin Augusta, GA , clinic when a patient asked me ichi Sankyo). with his father in his grandfather’s the very same thing. I froze up I have been successfully treatpractice. at the time because I didn’t reing her IOP with prostaglandin ally know how to handle such a analog monotherapy for two blunt and potentially life-altering question. years. She first presented with IOPs of My attending, Dr. Nowakowski, who 28 mm Hg in the right eye and 29 mm was in the room, sensed the feeling of tenHg in the left eye. After a diagnosis of sion in the air and immediately jumped early primary open-angle glaucoma, I set in by emphatically saying, “No. We’re her target pressures to 18-21 mm Hg for not going to let that happen.” He then both eyes, corresponding to about a 30 went on to briefly say that the patient was doing everything she needed to do with her drops and to simply continue being compliant. I could literally see the relief appear on the patient’s face. I felt relieved, as well, and I never forgot about that short 10-second conversation. Never pass up an opportunity to give a patient good news, so long as it is rational percent IOP reduction. She has consistently been at or below target since the initiation of therapy. The big question She had just started the Tribenzor and asked me if I thought it could affect her glaucoma. I told her that amlodipine, being a calcium channel blocker, was actually helping by opening up the blood vessels feeding her optic nerves. At the completion of the examination, I was getting ready to walk her up to the front when she stopped me and said she had a very Lessons learned I took two lessons away from that day in clinic. The first lesson I learned was the fact that patients tend to perceive information in a much different way than doctors. Further, in the age of the Internet and its seemingly unending ether of information, it’s not difficult to search long enough to convince oneself that a particular symptom or diagnosis carries with it an impending sense of doom. The second lesson I learned on that day was the fact that many patients tend to look to their doctors for a sense of comfort. As fiduciaries, doctors have an obligation to explain what is going on with their patients’ health, and glaucoma can and often does lead to blindness with no treatment (or treatment that is ineffective). Moreover, the “I feel fine, so this must not be a big deal” mantra is still very much alive and well in glaucoma, and some patients truly need to be rattled about the seriousness of their condition. However, passing up an opportunity to give reassurance in the face of paranoia means passing up an opportunity to potentially make a big difference in one’s mindset, noting that appropriate levels of concern and understanding of one’s condition can lead to better compliance (and, thus, better overall health). In short, never pass up an opportunity to give a patient good news, so long as it is rational. I’m not going to let that happen Turning back to my present glaucoma patient’s sinister question, I simply said, “You’re not going blind from glaucoma because I’m not going to let that happen. At this point, you and I are doing everything we need to do to prevent that from happening. So, let’s just keep up the good work.” She smiled and thanked me, and I walked her up to the front desk to schedule an IOP check for three months down the road. Taking care of patients’ eyes, adnexa, and visual systems can be challenging enough. However, the science of what we do is often one of the easiest parts of our days. It is the art of conveying information to our patients in an appropriate manner (and dealing with subsequent reactions) that can be delicate to handle. I learned much regarding this concept (among many other things) from Dr. Nowakowski, and I have come to realize that people tend to get more bad news than good news from doctor visits. This notion could be framed to especially reign true in the arena of glaucoma, when the goal of therapy, to this date, really isn’t to improve function, but to just keep things from getting worse. Again, never pass up an opportunity to give a patient good news (keeping in mind the fact that news of blindness not being imminent may be just good enough). [email protected] Add Avenova® with NeutroxTM (Pure Hypochlorous Acid 0.01% as a preservative), the only Rx lid hygiene product with pure hypochlorous acid, to the lid & lash hygiene regimen for all your patients. AV E N O VA . C O M Daily lid and lash hygiene. | | R X O N LY SPECIAL SECTION 16 JANUARY 2016 | Glaucoma Glaucoma in women Gender, hormones may play a bigger role than previously thought t has been estimated that by the Secondary glaucomas year 2020, there will be an inWhen looking at the less common crease in the number of Ameriforms, women are more likely to cans living with glaucoma from be susceptible to narrow-angle glaucoma. There has been a long60 to 80 million. Given that women outnumber and outlive men, this standing theory that shorter axial will result in a vast number of palength was the physical difference; BY LOUISE tients who will require optometric however, new evidence from Wang SCLAFANI, OD, care. As we review risk factors for using anterior segment tomography FAAO this disease, perhaps gender and reveals that it may also be related is clinical associate hormonal factors should be factored to iris thickening and curvature of ophthalmology in to the decision-making process.1 variations.6,7 Many studies in the and visual science and director of U.S. and Scandinavia agree that As glaucoma is a disease of the optometric services women are more at risk for pseuaged optic nerve, it makes sense The University of doexfoliation syndrome8 and less that those who live longer will have Chicago Medicine an increased risk. With glaucoma at risk for pigmentary dispersion being a disease of progression, it is more glaucoma.2,8 essential to diagnose and treat earlier, espeHowever, because these forms can be more cially those who may have silent risk factors, aggressive, so should their management. Of such as exposure to endogenous estrogen.1 greatest concern is low tension glaucoma because it is the most underdiagnosed form— There have been a number of epidemioyet according to the Collaborative Normal logic studies conducted to determine if there Tension Glaucoma Study (CNTGS), women is a gender difference in the incidence of have a higher risk. This is likely due to the multifactorial causes for glaucoma, such as vasospasm disorders that women develop which include low blood pressure, migraine headaches, and reduced circulation to hands and feet which may contribute to loss of blood flow to the optic nerve.8-10 I As women delay pregnancy to their late 30s and 40s and glaucoma has a known propensity to affect us as we age, the initial glaucoma diagnosis may occur during pregnancy glaucoma. Due to variances in study designs and populations, there are no conclusive findings for primary open-angle glaucoma. The Baltimore and Beaver Dam Studies showed no difference, the Blue Mountain Study showed an increased incidence for women, and the Framingham, Barbados, and Rotterdam Studies showed an increased incidence for men.2-5 Effects of pregnancy It is imperative to look at the pregnant state both as a factor in glaucoma diagnosis and treatment. As women delay pregnancy to their late 30s and 40s and glaucoma has a known propensity to affect us as we age, the initial glaucoma diagnosis may occur during pregnancy. However, studies have shown that during the second trimester, normal patients have a 10 to 20 percent reduction in IOP. Ocular hypertensive patients have an even higher reduction, 25 percent during Weeks 24 to 30. There are several theories as to why this may occur. Perhaps hormonal changes increase uveo-scleral flow. We know that other ligaments soften as women prepare to deliver, and perhaps this mechanism applies to aqueous outflow.11,12 TAKE-HOME MESSAGE As the number of women with glaucoma is likely to increase, gender and hormonal factors should be part of the optometrist’s glaucoma diagnosis and treatment considerations. Women are more susceptible to narrow-angle glaucoma, and pregnancy may be a factor during diagnosis and treatment. In addition, estrogen may offer a protective benefit. Dementia plays a role with incidence, vision loss, and high intraocular pressure. Ask more questions of your glaucoma or glaucoma suspect patients, especially women. Treatment during pregnancy This finding offers the patient some protection during pregnancy and may be a safeguard to delay management. If it is decided that the patient needs to start or continue treatment, the potential teratogenic effects need to be considered. As most glaucoma treatment is topical, recall that 80 percent of the drop drains into the nasolacrimal duct and leads to systemic absorption. All steps should be taken to reduce this, such as punctual occlusion, wiping excess, and closing eyes for a few minutes after instillation. The only true Category B glaucoma agent is brimonidine; however, many glaucoma specialists concur that the risk-benefit ratio would allow other medications, such as timo- 43 years women who had hysterectomies prior to this age had increased risk to develop glaucoma lol, to be used during pregnancy. Many will discontinue a few weeks prior to delivery to reduce any potential effects to the baby. Topical carbonic anhydrase inhibitors may be indicated, but orals should be avoided. Theoretically, the prostaglandin category is contraindicated due to the potential to induce premature labor, yet these drugs are safe during lactation. Remember that all drops will end up in breast milk, so it is best to See Women and glaucoma on page 18 New! Corneal Hysteresis (CH) CPT® Code 92145 CORNEAL HYSTERESIS. You shouldn’t have to be a fortune teller to predict glaucoma progression. Only Ocular Response Analyzer® measures Corneal Hysteresis, a superior predictor of glaucoma progression, providing you with ŘʁƬƋǞƞƬǜǚŘˁƋŘʁǔʊǘŘʊʊƬʊʊƬǜƖ Introducing the all-new Ocular Response Analyzer® G3. Learn more about Corneal Hysteresis and CPT Code 92145 at www.reichert.com/ora. Advancing Eye Care. American Innovation. © 2015 AMETEK, Inc. & Reichert, Inc. (9-2015) · All rights reserved · www.reichert.com Ocular Response Analyzer® is made in the USAƊ,ñďǔʊʁƬǔʊǜƬʁƬƞǜʁŘƞƬŘʁǘnjǜǒƬÄƬʁǔƋŘÀƬƞǔƋŘǚÄʊʊƋǔŘǜǔƖ SPECIAL SECTI O N 18 JANUARY 2016 Glaucoma Women and glaucoma protection, but even within the gender, the source of estrogen plays a role. In summary, Continued from page 16 women who have early menses and late onset of menopause will have longer exposure to administer single daily-dose medications endogenous estrogen, and this is shown to just before the longest sleep interval for the be protective against glaucoma.15-18 infant. If multiple doses are needed, recommend the patient breast feed immediately The results of the Rotterdam Study in the before instillation. Finally, many women Netherlands, n=3078, showed that if natural suffer from severe dry eye, so the use of menopause occurs before the age of 45 years, there was a 2.3 times higher risk to develop open-angle glaucoma even the number of Ameriwith hormone replacement therapy.19 cans living with glauThe Blue Mountain Study in Australia coma by the year 2020 showed that late menarche of onset >13 years old, or early menopause beta-blockers may be prohibited, making it <45 years old, increases risk.20 The Nurses more difficult to get adequate IOP control Health Study in the U.S., n=66.417, was a and needing more surgical intervention for prospective study that concluded that later the disease.13,14 menopause, onset >54 years, showed a reduced risk.21 And finally, studies from the Of concern is the patient at risk for acute angle closure because labor can precipiMayo Clinic indicate that women who had tate an angle closure. A laser peripheral irihysterectomies before the age of 43 years dotomy (LPI) can be safely performed durhad an increased risk to develop glaucoma.22 ing pregnancy with topical anesthesia and Another consideration is the role of iron, an upright position during the procedure. which causes oxidative stress. Women are For those who have a pre-existing condition often iron deficient during menses, and this of glaucoma prior to pregnancy, this may may have a protective effect. be a more severe form due to earlier age of When we look at exogenous estrogen, such onset. IOP is slightly elevated during natuas in hormone replacement therapy (HRT) ral childbirth, therefore a Cesarean section or oral contraceptives (OC), the findings delivery should be discussed if control is vary. For those post-menopausal women on questionable.13,14 HRT, the Heart and Estrogen Replacement Study (HERS) and Women’s Health Initiative (WHI) studies, published in 1998 and The role of estrogen 2002, respectively, indicated a 0.40 percent Numerous studies have looked at the role of risk reduction for POAG for every month of estrogen in the development of glaucoma.15-18 therapy.21 Today, in the U.S., HRT is very tarEstrogen has been known to offer neuro- 60-80M | geted for those symptomatic women (symptoms include hot flashes, urogenital atrophy, osteoporosis) and therefore the benefit is limited due its reduced use. Contrary are pre-menopausal women on OC. The Nurses Health Study, n=80,000, was a retrospective study looking at patients from 1980-2006.21 It revealed that the use of OC for five years or longer increased the risk for primary openangle glaucoma by 25 percent. The difference in these exogenous sources is likely the formula, but also the physiologic outcome. Oral contraceptives contain progestin which suppresses ovulation, thereby altering the natural hormonal patterns. The role of estrogen in the central ner- There seems to be a correlation between ED and the diagnosis of glaucoma, not its treatment vous system has been well studied, and it is thought that some of these findings may be applicable to retinal and optic nerve health. Retinal ganglion cells express estrogen receptors, and this may contribute to neuroprotection. Estrogen increases extra-cellular matrix production that may protect the optic nerve head from axonal damage. And See Women and glaucoma on page 20 IN BRIEF Dry eye is linked to chronic pain syndromes, says study MIAMI—Researchers with Bascom Palmer Eye Institute have found a link between dry eye and chronic pain syndromes—a finding that suggests that a new paradigm is needed for diagnosis and treatment to improve patient outcomes. Results were published in Journal of Pain. “Our study indicates that some patients with dry eye have corneal somatosensory pathway dysfunction and would be better described as having neuropathic ocular pain,” says lead author Anat Galor, MD, MSPH, a cornea and uveitis specialist and associate professor of clinical ophthalmology at Bascom Palmer Eye Institute at the University of Miami Miller School of Medicine. Corresponding author Roy C. Levitt, MD, a neuroanesthesiologist, pain specialist, and geneticist at the Miller School, says, “A multidisciplinary approach used for chronic pain treatment may also benefit these dry eye patients.” Their research team evaluated 154 dry eye patients from the Miami Veterans Affairs Hospital. “Dry eye patients in our study reported higher levels of ocular and non-ocular pain associated with multiple chronic pain syndromes and had lower scores on depression and quality-of-life indices consistent with a central sensitivity disorder,” says Levitt. “We also suspect that neuropathic ocular pain may share causal genetic factors with other overlapping chronic pain conditions.” “Traditionally, eye specialists have treated dry eye with artificial tears or topical medications for the surface of the cornea,” said Galor. “However, even if these treatments improve some dry eye symptoms, many patients continue to report underlying ocular and non-ocular pain.” Reflecting on the implications of the study, Galor said, “Our highest priority is educating physicians that dry eye represents an overlapping chronic pain condition. Consequently, a multidisciplinary approach should be considered in the diagnosis and pain management of dry eye patients.” ModernMedicine Topic-Based Resource Centers Resource Center modernmedicine.com/resource-center/contact-lenses-and-lens-care iPad Video | Related Articles | Continuing Education | Clinical Tools & Tips This is your go-to place for the latest information on JVU[HJ[SLUZÄ[[PUNSLUZJHYLHUKV[OLYJVUKP[PVUZ [OH[HLJ[Z\JJLZZM\SJVU[HJ[SLUZ^LHY SPECIAL SECTI O N 20 JANUARY 2016 Glaucoma Women and glaucoma Continued from page 18 because estrogen regulates smooth muscle control, this may enhance blood flow to the optic nerve. Another concern is that some cancer agents are anti-estrogen—careful monitoring is needed.15-18 similarities between AD and elevation in intraocular pressure including decreased cerebrospinal fluid and amyloid plaques that aggravate in both the brain and retinal ganglion cells.25-27 Lifestyle We have all heard that 50 is the new 40. In fact, 70 is the new 60! People of this age have more active lifestyles than before and Women as caregivers strive to stay healthy. This may include acWomen are often the caregivers or mantivities such as yoga, golf, and yes, sex. age the family health care, so indirectly Depending on the level of activity, inverthe use of oral contraceptives for this time frame (or longer) increased the sions in yoga and latrisk for primary open-angle glaucoma eral extension in golf by 25 percent have been shown to elevate intraocular pressure. On a positive note, sleeping with they may affect the incidence and detection the head slightly elevated 30 degrees on of glaucoma. A recent study in India pubtwo pillows has been shown to decrease lished in British Journal of Ophthalmology IOP up to 20 percent. This is a very comrevealed that in 1,259 pediatric glaucoma mon position for women in the age group cases, five percent were steroid induced due because they are likely to make a weekly to the overuse of steroids for severe GPC or visit to their salon for an up-do hairstyle, vernal conjunctivitis. Children are affected and they like to maintain their style until by steroids at lower dosing and duration the next visit.28-30 than adults, so it is important to monitor IOP and discontinue treatment in a timely Age does not discriminate for those who manner. Because mothers might be instilllike to maintain beauty and sex appeal. Erecing the medications and treating recurrent tile dysfunction (ED) is more commonly conditions, it is important they know the discussed as treatment has become more potential risks.23 effective. More and more seniors are sexually active. It was long thought that erectile dysfunction was a side effect of the use of Glaucoma in mature populations beta blockers systemically or topically for As our gender thrives into more advanced glaucoma. On the contrary, there seems to years, dementia becomes another health concern. Treatment success for glaucoma is based on compliance, and the ability for patients to self-administer their medications is reduced with memory loss. As cognitive impairment and glaucoma share a common vascular risk factor, the relationship between Alzheimer’s disease (AD) and glaucoma has been reviewed. Previous studies in Europe and the U.S. have not shown a relationship; however, a be a correlation between ED and the diagnorecently published population-based study in sis of glaucoma, not its treatment. Because Taiwan has. The study looked at ICD codes women often take care of their spouse’s and co-morbidity factors of over 15,000 pahealth needs, this is a discussion they should tients. Of interest is that in this population, be having.31 when compared to the controls, women (not men) with dementia were more likely have Ask questions a prior diagnosis of open-angle glaucoma. In the past, the pertinent history for glauOther studies have shown that women with coma included family history, age, race, and glaucoma have more severe vision loss. This trauma. Today we need to query further. may be due to longevity, financial burdens, As we can see, age of menses, use of OC/ or simply late diagnosis.1,24 This sensory imHRT, and hysterectomy play a key role. A discussion regarding childbearing may have pairment and lack of visual stimulation can been just in passing, but this information easily contribute to the progression of cogmay now be significant because the choice nitive loss. This study also discussed other 5 years | is delayed and our optic nerves age. Six percent of women enter menopause before the age of 45,32,33 and although we don’t typically ask this question of our patients, perhaps we should. Many men don’t always disclose all of their medications or their diagnosis of ED because they don’t think it affects their eyes. Perhaps we need to specifically ask them and their partners about this information. Lifestyle choices that may be more focused to our gender should be discussed. Given some of the findings, future treatment may be more targeted toward hormonal control. Globally women live longer and 90 percent of centenarians are women.34 It is important to keep that in mind when determining target IOP and when to treat. REFERENCES 1. Vajaranant TS, Nayak S, Wilensky JT, Joslin CE. Gender and glaucoma: what we know and what we need to know. Curr Opin Ophthalmol. 2010 Mar;21(2):91-9. 2. Takusagawa H, Mansberger S. Do Ethnicity and Gender Influence Glaucoma Prevalence? Ophthalmology Management. Available at: http:// www.ophthalmologymanagement.com/articleviewer. aspx?articleID=106702. Accessed 12/28/15. 3. The Eye Diseases Prevalence Research Group Prevalence of open-angle glaucoma among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4): 532–538. 4. Leske MC, Connell AM, Schachat AP, Hyman L. The Barbados Eye Study. Prevalence of open angle glaucoma. Arch Ophthalmol. 1994 Jun;112(6):821-9. 5. Leske MC, Connell AM, Wu SY, Nemesure B, Li X, Schachat A, Hennis A. Incidence of openangle glaucoma: the Barbados Eye Studies. The Treatment success for glaucoma is based on compliance, and the ability for patients to self-administer their medications is reduced with memory loss Barbados Eye Studies Group. Arch Ophthalmol. 2001 Jan;119(1):89-95. 6. Kang JH, Loomis S, Wiggs JL, Stein JD, Pasquale LR. Demographic and geographic features of exfoliation glaucoma in 2 United States-based prospective cohorts. Ophthalmology. 2012 Jan;119(1):27-35. 7. Wang B, Sakata LM, Friedman DS, Cahn YH He M, Lavanya R, Wong TY, Aung T. Quantitative iris parameters and association with narrow angles. Ophthalmology. 2010 Jan;117(1):11-17. 8. Kang JH, Lookis S, Wiggs JL, Stein JD, Pasquale LR. Demographic and geographic features of exfoliation glaucoma in 2 United States-based prospective cohorts. Ophthalmology. 2012 Jan;119(1); 27-35. 9. Wang D, He M, Wu L, Yaplee S, Singh K, Lin S. Differences in iris structural measurements among SPECIAL SECTI O N | PRACTICAL CHAIRSIDE ADVICE American Caucasians, American Chinese and mainland Chinese. Clin Experimental Ophthalmol. 2012 Mar;40(2): 162-9. 10. Kamal D, Hitchings R. Normal tension glaucoma--a practical approach. Br J Ophthalmol. 1998 Jul;82(7):835-40. 11. Tehrani S. Gender difference in the pathophysiology and treatment of glaucoma. Curr Eye Res. 2015 Feb;40(2):191-200. 12. Razeghinejad MR1, Tania Tai TY, Fudemberg SJ, Katz LJ. Pregnancy and glaucoma. Surv Ophthalmol. 2011 Jul-Aug;56(4):324-35. 13. American Academy of Ophthalmology. Drugs and Pregnancy. Focal Points: Clinical Modules for Ophthalmologists. September 2007 Glaucoma Of concern is the patient at risk for acute angle closure because labor can precipitate an angle closure PT. Is open-angle glaucoma associated with early menopause? The Rotterdam Study. Am J Epidemiol. 2011 July 15:154(2): 138-144. 14. Johnson SM, Martinez M, Freedman S. Management of glaucoma in pregnancy and lactation. Surv Ophthalmol. 2001 Mar-Apr;45(5):449-54. 20. Lee AJ, Mitchell P, Rochtchina E, Healey PR; Blue Mountain Eye Study. Female reproductive factors and open angle glaucoma: the Blue Mountain Eye Study. Br J Ophthalmol. 2003 Nov;87(11): 1324-8. 15. Pasquale LR, Rosner BA, Hankinson SE, Kang JH. Attributes of female reproductive aging and their relation to primary open-angle glaucoma: a prospective study. J Glaucoma. 2007 Oct-Nov;16(7): 598-605 21. Pasquale LR, Kang JH. Female reproductive factors and primary open-angle glaucoma in the Nurse’s Health Study. Eye (Lond). 2011 May;25(5): 633-41. 16. Altintaş O, Caglar Y, Yüksel N, Demirci A, Karabaş L. The effects of menopause and hormone replacement therapy on quality and quantity of tear, intraocular pressure and ocular blood flow. Ophthalmologica. 2004 Mar-Apr;218(2): 120-129. 17. Zhou X, Li F, Ge J, Sarkisian SR Jr, Tomita H, Zaharia A, Chodosh J, Cao W. Retinal ganglion cell protection by 17-beta-estradiol in a mouse model of inherited glaucoma. Dev Neurobiology. 2007 Apr;67(5): 603-616. 18. Vajarant TS, Pasquale LR. Estrogen deficiency accelerates aging of optic nerve. Menopause. 2012 Aug 19(8): 942-7. 19. Hulsman CA, Westendorp IC, Ramrattan RS, Wolfs RC, Witteman JC, Vingerling JR, Hofman A, de Jong 22. Vajaranant TS, Grossardt BR, Maki PM, Pasquale LR, Sit AJ, Shuster LT, Rocca WA. The risk of glaucoma after early bilateral oophorectomy. Menopause. 2014 Apr; 21(4): 391–398. 23. Gupta S, Shah P, Grewal S, Chaurasia AK, Gupta V. Steroid-induced glaucoma and childhood blindness. Br J Ophthalmol. 2015 Nov;99(11):1454-6. 24. Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3);262-7. 25. Chung SD, Ho JD, Chen CH, Lin HC, Tsai MC, Sheu JJ. Dementia is associated with open-angle glaucoma: a population-based study. Eye (Lond). 2015 Oct;29(10):1340-6. 26. McCKinnon SJ. Glaucoma: ocular Alzheimer’s 21 Disease? Front Biosci. 2003 Sep 1;8:s1140-56. 27. Berdahl JP, Allingham RR, Johnson DH. Cerebrospinal fluid pressure is decreased in primary open-angle glaucoma. Ophthalmology. 2008 May;115(5):763-8. 28. Weinreb RN, Cook J, Friberg TR. Effect of inverted body position on intraocular pressure. Am J Ophthalmol. 1984 Dec 15;98(6):784-7. 29. Buys YM, Alasbali T, Jin YP, Smith M, Gouws P, Geffen N, Flanagan JG, Shapiro CM, Trope GE. Effect of sleeping in a head-up position on intraocular pressure in patients with glaucoma. Ophthalmology. 2010 Jul;117(7):1348-51. 30. Seo H, Yoo C, Lee TE, Lin S, Kim YY. Head position and intraocular pressure in the lateral decubitus position. Optom Vis Sci. 2015 Jan;92(1):95-101. 31. Nathoo NA, Etminan M, PharmD, Mikelberg FS. Association between glaucoma, glaucoma therapies, and erectile dysfunction. J Glaucoma. 2015 Feb;24(2):135-7. 32. McKinley SM, Brambilla DJ, Posner JG. The normal menopause transition. Maturitas. 2008 SepOct;61(1-2):4-16. 33. Miro F, Parker SE, Apsinall LJ, Coley J, Perry PW, Ellis JE. Sequential classification of endocrine stages during reproductive aging in women; the FREEDOM study. Menopause. 2005 May-Jun;12(3); 281-90. 34. Austad SN. Why women live longer than men: sex differences in longevity. Gend Med. 2006 Jun;3(2): 79-92. Dr. Sclafani is president of Women of Vision, past president of the Illinois Optometric Association, past chair of the AOA Contact Lens and Cornea Section, and has served as a consultant for the Chicago Blackhawks. [email protected] IN BRIEF Portable tool being developed to diagnose sideline concussions BLOOMINGTON—Two Indiana University scientists continue their work toward a portable sideline device that will be able to quickly detect signs of mild brain trauma. Since 2010, Nicholas Port and Steven A. Hitzeman, researchers at the IU School of Optometry, have gathered baseline data on the eye movements and balance of IU athletes and have since expanded their work to high schools and local club and youth sports. To measure concussion symptoms, Port devised a system that consists of eye-tracking goggles within a shoebox-sized device and a balance platform based on technology in Nintendo’s Wii gaming system. By comparing an athlete’s baseline numbers with similar tests after a high-impact blow, the tester can quickly determine whether the athlete suffered a concussion and should be withheld from competition. So far, data on more than 1,000 athletes—as well as 69 concussions—has been collected, about two-thirds of which came from football. There is not yet enough information to produce statistically valid conclusions. Says Port, “Ocular and motor performance can be severely impaired during the acute phase of a concussion, which is the first 10 minutes to an hour after a concussion occurs. We like to test the affected athlete within 10 minutes of the event.” Once fully developed, such technology could help eliminate scenarios such as what occurred in the Nov. 22 NFL game between the St. Louis Rams and the Baltimore Ravens when Rams quarterback Case Keenum hit his head on the turf. Despite the Rams sending its head trainer on the field to talk with Keenum and the presence of an NFL injury spotter, Keenum remained in the game. Only after the game was it found that Keenum had suffered a concussion. “The research being conducted will add an objective approach to this problem by developing a device that not only measures symptoms on-site but eliminates athletes’ ability to fool trainers, physicians, and coaches into thinking they are fit to play,” Port says. In some cases, athletes may not be aware they sustained a concussion until days later, says Orlin Watson, head athletic trainer for Bloomington North High School, which has had about 15 students take part in the study. “We explain to our student-athletes why it is important to report symptoms,” Watson says. “But you’re still dealing with subjective information. A device that can provide objective information would serve as a valuable tool for athletic trainers in treating and diagnosing concussions.” SPECIAL SECTI O N 22 JANUARY 2016 Glaucoma Glaucoma drainage ditional glaucoma surgery. It is the smallest FDA-approved device for mild to moderate Continued from page 1 glaucoma. The iStent Inject is being developed with multiple iStents in prised of Heparin (heparin sodium, a preloaded injector system if the Hospitra)-coated titanium. The iSsurgeon deems it necessary to use tent is usually implanted nasally more than one.2 into Schlemm’s canal during cataract surgery and is designed to Contraindications for iStent use improve the aqueous outflow and include primary- or secondary-anBARBARA J. decrease intraocular pressure (IOP) gle closure glaucoma, neovascuFLUDER, OD by creating a permanent opening lar glaucoma, thyroid eye disease, has been in practice in the trabecular meshwork. Sturge-Weber syndrome, or any other for 22 years and The procedure involves insertcondition that may cause elevated currently practice ing the iStent through the phacoepiscleral venous pressure. Goniat Williams Eye Institute in emulsification incision site past oscopy should be performed beMerrillville, IN. the pupillary margin. The angle fore surgery to rule out peripheral is viewed with a gonioscopy lens, anterior synechiae, rubeosis, and and an approach is made to the upper one any angle abnormalities or conditions that third of the trabecular meshwork at an angle would occlude sufficient visualization of the of 15 degrees. The trabecular meshwork is angle that could lead to improper placement engaged, and the iStent is gently inserted of the stent.1 Complications can include corinto Schlemm’s canal. The bottom of the neal edema, posterior capsular haze, stent inserter is pushed to release the iStent. The obstruction, early postoperative cells in the button is released, and the side of the snoranterior chamber (AC), and early postop- Selection of the device depends on numerous factors, such as patient’s age, glaucoma subtype, and treatment goals. kel is gently tapped to ensure the device is properly seated. The inserter and viscoelastic are then removed.1 Because the procedure is minimally invasive, it spares tissue damage caused by tra- 1 erative corneal abrasion.1 Postoperative care generally includes the usual cataract recovery drop schedule as well as the patient’s currently prescribed glaucoma medications. Commonly used postop- | TAKE-HOME MESSAGE Optometrists comanaging glaucoma surgery or even seeing glaucoma patients should know their way around drainage devices. Baerveldt Glaucoma Implant, Ahmed Glaucoma Valve, iStent, and ExPress Glaucoma Filtration Device share commonalities in usage, complications, and postop care; however, there are differences in these devices. erative drops include Besivance (besifloxacin, Bausch + Lomb) tid for one week; prednisolone tid for one week, then bid for one week, then qd for two weeks, and Ilevro (nepafenac ophthalmic suspension, Alcon) qd for four weeks. If the IOP remains the same as it was preoperatively, then usually the patient will continue with his glaucoma drop regimen. A trial discontinuation of the glaucoma drops may be used to see how well the IOP is maintained.3 Baerveldt Glaucoma Implant Baerveldt Glaucoma Implant is designed for patients with medically uncontrolled glaucoma or patients who have failed conventional surgery. It is available in three models: 250 mm, 350 mm, and 350 mm pars plana.4 The 250 mm is the most commonly used size. Its features include a large surface area plate, single quadrant insertion, a drainage tube, recessed knot capability, decreased bleb height, low edge height, and four fenestrations to promote fibrous adhe- Figure 1. Insertion of the tube into the anterior chamber to increase aqueous outflow. Image courtesy Ike Ahmed, MD SPECIAL SECTI O N | PRACTICAL CHAIRSIDE ADVICE 2 Glaucoma Figures 2, 3, 4. Postop after Baerveldt insertion. Images courtesy Brad Sutton, OD. 23 Complications can include a choroidal hemorrhage, hyphema, choroidal effusion, hypotony, flat AC, phthisis bulbi, retinal detachment, endophthalmitis, tube erosion, tube touch to cornea, tube block by iris or vitreous, bullous keratopathy, uveitis, and diplopia.5 Corneal patch grafts are used to prevent tube erosion. The tube is initially restricted with a suture to prevent early hypotony. Some surgeons make fenestrations in the tube to control pressure early in the poSee Glaucoma drainage on page 24 3 Digital Photography Solutions for Slit Lamp Imaging Digital SLR Camera 4 sions to the sclera, which may reduce bleb height. A fenestrated Baerveldt may reduce bleb height by 50 percent. These advantages allow for long-term IOP control, easier implantation, decreased surgery time, less trauma, and faster healing.4 A Vicryl suture is used to tie off the tube before implantation and is tested with balanced salt solution (BSS) to ensure it is occluded. Some surgeons also insert a ripcord into the tube to be released later if further IOP reduction is necessary. The superior temporal conjunctiva is dissected, creating a conjunctival flap between the superior and lateral rectus muscles. The plate is placed behind the muscles and is secured to the sclera. If superior temporal placement is not possible, it may be placed inferonasally. An incision is made parallel to the iris through the sclera for entry of the tube into the anterior chamber. The tube is cut to size before being inserted into the AC. The tube should be close to the surface of the iris without indenting it. The tube is then covered with a patch graft. Two to three fenestrations may be made into the tube as well. If a ripcord is used, it is placed in the inferior conjunctival space and the conjunctival flap is closed. Universal Smart Phone Adaptor for Slit Lamp Imaging Made in USA TTI Medical Transamerican Technologies International Toll free: 800-322-7373 email: [email protected] www.ttimedical.com SPECIAL SECTI O N 24 JANUARY 2016 Glaucoma Glaucoma drainage Continued from page 23 stop period. Tube touch to cornea can be avoided by placing the tube in the sulcus in pseudophakic patients.3 Regarding postoperative care, if an elevation in the IOP occurs early in the postop period and the suture has not broken, breaking the suture is an option. Using a ripcord suture gives the surgeon an addi- 10 days. Routinely, patients are seen at one day, one week, three weeks, and five weeks until IOP is stabilized.3 5 6 Ahmed Glaucoma Valve Although there are several models of this device, the original S2 is commonly used. The body plate is made of polypropylene, and the valve is made of polypropylene with a silicone elastomer membrane to control IOP. The Ahmed features immediate reduction Baerveldt Glaucoma Implant is designed for patients with medically uncontrolled glaucoma or patients who have failed conventional surgery tional choice. Glaucoma drops are continued during the initial postop period until the suture dissolves or is broken. Prednisolone drops are prescribed qid for approximately two weeks then tapered and Polytrim (trimethoprim/polymyxin B, Allergan) qid for | of IOP and a valve system to prevent excessive drainage and AC collapse. There is no need for drainage tube ligature sutures, ripcord sutures, and occluding sutures. Other models include a pediatric or small globe S3, FP7, pediatric F8, PC7, pediatric PC8, Figure 6. Ex-Press Glaucoma Filtration Device. Image courtesy Alcon. and FX1 (with a bi-plate design). The latest model is M4 It is comprised of a porous polyethylene which allows soft tissue growth into the pores, promoting integration with surrounding tissue and vascularization.2 The procedure is performed almost the same as the Baerveldt Implant; however, no ripcord or tube occlusion is needed because it is a valved device. The valve needs to be primed with BSS. A patch graft is also used to prevent erosion in this procedure. Figure 5. Ex-Press Glaucoma Filtration Device diverting aqueous humor to a bleb in the subconjunctival space. Image courtesy Alcon. SPECIAL SECTI O N | PRACTICAL CHAIRSIDE ADVICE Patch grafts can be corneal, pericardial or scleral. Our glaucoma specialist, Tyler Kirk, MD, prefers a corneal patch graft.3 Complications with an Ahmed Valve are similar to those of the Baerveldt and can include hypotony. However, it is usually transient and often spontaneously resolves. Postop care includes discontinuation of all glaucoma drops, prednisolone qid for two weeks, and Polytrim qid for 10 days. Patients are seen at one day, one week, and three and five weeks until IOP stabilizes and the eye has healed.3 Glaucoma 25 7 ExPress Glaucoma Filtration Device ExPress Glaucoma Filtration Device is a 3-mm long non-valved device that, like a trabeculectomy, diverts aqueous humor flow from the AC to a bleb in the subconjunctival space. The initial procedure is similar to that of a trabeculectomy as well. ExPress is preloaded in an injector with a metal rod fitted through the lumen, which is attached to the end of the injector. The Figure 7. Baerveldt Glaucoma Implant. Image courtesy of Abbott Medical Optics. See Glaucoma drainage on page 26 We have the handle on Chronic Dry Eye We accept: Visa, MasterCard, American Express, Discover, Bank Wire-Transfer, and Business Checks SPECIAL SECTI O N 26 JANUARY 2016 Glaucoma Glaucoma drainage Continued from page 25 shunt is then placed under a scleral flap into the AC through the incision made with a 25-gauge needle. The shunt is inserted all the way into the wound so the plate is flush with the scleral bed. Like a punctal plug, the shaft of the injector is depressed, retracting the metal rod and releasing the shunt. The scleral flap and the conjunctiva are sutured. The flow is tested by inflating the AC with BSS through the temporal paracentesis. A fluorescein strip is used to check for wound leak. Complications with ExPress Glaucoma Filtration Device include hypotony, although a study by Maris et al6 show a 32 percent hypotony rate with trabeculectomy and a four percent rate with the ExPress device. It is thought that this lower rate of hypotony is attributed to the resistance to flow due to the 50 μm lumen of the shunt.7 Postoperative care consists of discontinuation of all glaucoma drops, prednisolone four to six times per day for approximately four weeks, and Polytrim qid for 10 days. If the device is combined with cataract extraction, it is common to add Ilevro qd. Patients are seen at one day and every week after for several weeks. Suture lysis may occur at three weeks as needed. Prednisolone drops are generally tapered at four weeks. Choosing a device Selection of the device depends on numerous factors, such as patient’s age, glaucoma subtype, and treatment goals.8 There can be The Centers for Medicare and Medicaid (CMS) announced in September 2015 that it will bundle and revalue tube shunt and patch graft surgeries. | considerable pressure volatility in the early postoperative period with the Baerveldt Implant. However, lower long-term pressure control is often achieved. The Baerveldt tube is occluded during the first four to six weeks after surgery while the bleb forms around the plate. Flow begins when tube occlusion dissolves or is removed. This often causes a quick pressure drop and may cause hypotony-related complications. The Ahmed device has a built-in valve that allows for immediate flow postoperatively and thus prevents hypotony. However, glaucoma medications may be required long term. There are many other tube shunt devices such as the Molteno 3 and the Krupin.8 Other postoperative aids may include fibrin glue. Fibrin glue is a biological tissue adhesive that mimics the final stages of the coagulation cascade. Fibrin glue incorporates a fibrinogen and a thrombin component, both prepared by processing plasma. Fibrin glue forms a smooth seal along the wound and helps reduce hypotony and increase patient comfort. The glue is used in conjunction with sutures.9 If IOP is extremely low early in the postoperative pe- IN BRIEF Transitions Optical names finalists of first innovation awards PINELLAS PARK, FL—Transitions Optical, Inc. has named the finalists for its new Transitions Innovation Awards program, which recognizes both individuals and companies from the U.S. and Canada for their innovative efforts to support the Transitions brand over the past year. The finalists will be honored during Transitions Academy 2016, where the winners will be announced. “Innovation exists within all business functions and teams; sometimes it’s the company culture that supports and sustains this creativity and at times it’s an individual that inspires a change or idea,” says Jose Alves, general manager, Americas, Transitions Optical. “All of our finalists have applied smart, innovative thinking to achieve their professional and personal goals. We are grateful for their partnership and for all they do to promote the Transitions brand.” Transitions Brand Ambassador This award celebrates an individual who best showcases their dedication to being an influential advocate of the Transitions brand. The 2015 finalists include: – Eric White, OD, Complete Family Vision Care,San Diego – George Thomas, Territory Director – Visionworks, Chicago region – Rachel Hill, Personal Optical (St. Catherines, Ontario) Best in Growth Achievement The Best in Growth Achievement title is awarded to an individual or company that has demonstrated a strong commitment to Transitions Optical and photochromic growth. The 2015 finalists include: – Henry Ford OptimEyes, Detroit – Insightful Visions, Sechelt, BC – Vision Arts Eyecare Center, Fulton, MO and Ontario – U.S. Optical, Syracuse, NY – Visionworks Best in Marketing This award honors an individual or company for creative and strategic marketing tactics to effectively promote the Transitions brand or Transitions family of products among customers or within their communities. The 2015 finalists include: – Lunetterie New Look Eyewear, Québec and Ontario – Opto-Réseau, Québec – Visionworks Best in Patient Experience Best in Training This award celebrates an individual, company, or educator that has shown creativity in developing or offering training and education opportunities that include dispensing photochromic lenses, the Transitions brand or Transitions family of products. The 2015 finalists include: – Lunetterie New Look Eyewear, Québec This award is presented to an individual or company for developing a forward-thinking approach to consistently dispense Transitions lens products to meet individual patient needs. The 2015 finalists include: – Advanced Vision & Achievement Center, Phoenix – Vision Arts Eyecare Center, Fulton, MO – Vision Source Olmos Park, San Antonio, TX SPECIAL SECTI O N | PRACTICAL CHAIRSIDE ADVICE Glaucoma 27 Figure 8. 8 Baerveldt Glaucoma Implant. Image courtesy of Abbott Medical Optics. riod, atropine can be administered bid to deepen the AC and raise IOP. Additionally, a large diameter contact lens can be applied to tamponade the flow.3 The Centers for Medicare and Medicaid Services (CMS) announced in September 2015 that it will bundle and revalue tube shunt and patch graft surgeries.10 Surgeons have been placing patch grafts over tubes for years to reduce the incidence of tube erosion through the underlying conjunctiva. Therefore, a patchless technique is now appearing. Dr. Rafael Bohorquez recorded a video to demonstrate a 6-mm scleral tunnel used in lieu of a patch graft to cover the tube on its way into the AC.11 He recommends inserting a 22-gauge needle parallel to the iris to create the tunnel. He closes the back of the tunnel with a Vicryl suture to reduce the chance of filtration around the tube.12 Looking ahead There are continually new procedures and devices on the horizon. InnFocus Micro Shunt is currently in Phase I FDA trials at 11 U.S. centers and is being implanted either alone or in combination with cataract surgery in clinical trials outside the U.S. The company reports that patients are experiencing a “stable reduction in mean IOP to below 14 mm Hg.” The report states that 70 to 80 percent of patients are requiring few medications or no medications at all.13 Other procedures include endocyclophotocoagulation, which reduces aqueous inflow by selective ablation of the ciliary body. This procedure can be done in conjunction with outflow procedures as well.13 Canaloplasty decreases IOP by creating a Descemet window and dilation and tensioning of the trabecular meshwork. This is performed using an iTrack micro catheter, developed by iScience Interventional, and a suture placement in Schlemm’s canal.13 Trabectome by NeoMedix uses bipolar cautery on a disposable handpiece to ablate a certain number of clock hours of the trabecular meshwork in an effort to increase outflow. It is approved for mild to moderate glaucoma and can be combined with cataract surgery.13 CyPass Micro-Stent by Transcend Medical is inserted via a clear corneal incision and placed in the supraciliary space. Its design is to increase uveoscleral outflow and it can be combined with cataract surgery.13 The ability of these many options allows the glaucoma specialist to customize procedures based on the physiological needs of each diseased eye and meet each patient’s individualized needs. REFERENCES 1. Glaukos Corporation website. Available at: http:// www.glaukos.com/istent. Accessed 12/22/15. 2. New World Medical, Inc. website. Available at: http:// www.ahmedvalve.com. Accessed 12/22/15. 5. Sarkisian SR. Going with the flow: Managing tube shunts. Rev Ophthalmology. Available at: http://www. reviewofophthalmology.com/content/d/glaucoma_ management/i/1210/c/22807/. Accessed 12/28/15. 6. Maris PJ Jr, Ishida K, Netland PA. Comparison of trabeculectomy with Ex-PRESS miniature glaucoma device implanted under scleral flap. J Glaucoma. 2007 Jan;16:14-9 7. Sarkisian SR. The ExPress mini glaucoma shunt: technique and experience. Middle East Afr J Ophthalmol. 2009 Jul-Sep;16(3): 134-137. 8. Ahmed IK, Christakis PG. Ahmed, Baerveldt, or something else? Rev Ophthalmology. Available at: http://www.reviewofophthalmology.com/content/t/ glaucoma/c/41000/. Accessed 12/28/15. 9. Panda A, Kumar S, Kumar A, Bansal R, Bhartiya S. Fibrin glue in ophthalmology. Indian J Ophthalmol. 2009 Sep-Oct; 57(5): 371–379. 10. Corcoran S. Glaucoma coding: 2015 brings changes. Ophthalmol Management. Available at: http:// www.ophthalmologymanagement.com/articleviewer. aspx?articleID=112312 11. Eyetube.net: Available at: www.eyetube.net/ video/non-extrusion-b-drainage-device-technique/. Accessed 12/28/15. 12. Myers JS. Tube coverage: Another approach. Glaucoma Today. Available at: http://glaucomatoday. com/2014/12/tube-coverage-another-approach/. Accessed 12/28/15. 13. Noecker RJ. Update on new glaucoma surgical devices. EyetubeOD. Available at: http://eyetubeod. com/2011/12/update-on-new-glaucoma-surgicaldevices. Accessed 12/28/15. 3. Kirk, Tyler. Personal interview. 16 Jan 2015. 4. Abbott Medical Optics website. Available at: http:// www.abbottmedicaloptics.com/products/cataract/ glaucoma-implants/baerveldt-bg-101-350-glaucomaimplant. Accessed 12/22/15. Dr. Fluder is a member of the American Optometric Association and the Indiana Optometric Association. She has no financial interest in any of the devices discussed. [email protected] Practice Management 28 JANUARY 2016 | 5 tips to prepare yourself for private practice purchase So you want to be a practice owner. Do these things first practice, I suggest conducting demographic research and obtaining information about the school systems to nail down your deurchasing a private practice is a sired area. big decision and requires thorYou’ll need to weigh the pros and ough preparation. The cons of the area for both personal practice that you purchase and business reasons. Be sure that can determine where you live and the city is a good fit for you, and where your children go to school, determine the need for your serand it ultimately shapes the lifevices in your desired area. Durstyle you’ve been dreaming about ing your search, it is important your entire life. to remain flexible—there can be When the practice purchase is limited opportunities for a given conducted properly, it will provide DIRK MASSIE, OD, has two practice city depending on the size and the a great income throughout your calocations in the St. number of private practice ownreer. Typically, owners of a private Louis metro area. ers who could potentially be repractice can earn considerably more tiring soon. than employed practitioners. One of the best features of owning a private practice is that you build equity in the practice Determine the type of (and sometimes also the building in which practice you want to you practice). Another big advantage with purchase Do you want to purchase a smaller practice for a low price and work hard to turn it into a full-time practice? There are several smaller practices coming onto the market as baby boomers are starting to retire. Several of these practices have annual revenue of only about $400,000 and can usually be purchased for under $250,000. With hard By Dirk Massie, OD P 2 Be sure that the city is a good fit for you, and determine the need for your services in your desired area owning your practice is total freedom—freedom to care for your patients in the manner that is in line with your philosophy, and freedom to make your own schedule. Careful planning is necessary when making such a big investment decision. Here are five tips you should know before you take the plunge into practice ownership. 1 Study the area where you want to practice (and live) Ideally, practice owners live in the same city where their practice is located. While it is not a must, being involved in the community where you practice has long been a driver of growth in private practice. As you are searching for the perfect area to 1M. Like smaller practices, larger ones grossing this can be purchased outright work and dedication, a young practice owner can grow the practice rapidly. In fact, I did that myself. I bought a practice grossing $375,000 a year, and within five years our annual sales were over $1,000,000. If you prefer to not work so hard to turn around a smaller practice, consider buying a larger practice. While a large practice comes at a higher price, there is usually not much additional investments needed; a smaller, older practice often needs an office remodel and updated equipment. A large practice purchase is often structured as a junior partnership in which the younger partner slowly learns about practice own- TAKE-HOME MESSAGE From carefully examining the area in which you are hoping to purchase, to deciding what kind of practice you wish to buy, to buttoning up your finances, these tips can help ease your way into practice ownership. Private practice ownership is big emotional and financial decision. Make sure you’re ready before you make the leap. ership from the senior partner. However, large practices grossing over $1,000,000 can also be purchased outright just as a smaller practice. Ultimately, it comes down to the exit strategy for the seller and if he wants to remain working in the practice. Unfortunately, many young prospective buyers have been promised an opportunity to “buy into a practice” when they are hired on as an associate only to be led along for years with the practice purchase never coming to fruition. This happens for various reasons but mostly because the selling doctor overvalues her practice. The best way to avoid this situation is to have the practice appraised prior to ever seeing your first patient. The terms of the employment contract should include details of a possible practice purchase if/when it happens. In my experience, private practices are as unique as the owner. Each practice has its own personality, and the buyer (and his agent) should do his due diligence to dig deep and find out what the practice is truly like. 3 Decide if you should you hire an agent to help you Do you have spare time to search for potential practices for sale? Are you comfortable knowing if the terms of the sale are fair and reasonable? If you answered “no” to either of those questions, then you should seek out the help of a practice broker. A practice broker can be a huge help with buying a practice. Some of their serSee Practice purchase on page 30 Practice Management 30 Practice purchase Continued from page 28 vices include: Determine the type of practice that is suitable for the buyer Confidentially search for the practice, freeing up the buyer to continue working full time Perform a fair market valuation of the practice Negot iate t he terms of the transaction and assist the buyer through closing Help the buyer obtain financing for the purchase “You make your money when you purchase” is a longstanding phrase used by real estate investors and accountants. It is crucial not to overpay for your new practice, and a practice broker can help you avoid making that mistake. Each practice has its own personality. Do your due diligence first. 4 Get your finances in order Despite having significant student loan debt, practice buyers are typically suitable for financing, sometimes for 100 percent of the sale price, for purchasing a private practice. TIPS FOR BUYING A PRACTICE 1 Study the area where you want to practice (and live) 2 Determine the type of practice you want to purchase 3 Decide if you should hire an agent to help you 4 Get your finances in order 5 Protect your investment Banks want to see good credit scores, minimal credit card debt, and personal tax returns showing high levels of income in recent years. If the prospective buyer has a spouse who works, that is very appealing to banks who finance private practices. One variable banks examine is your debt-to income ratio. If you are serious about buying a practice soon, I recommend saving your money and limiting your debt. Hold off on buying that new car or home until after you’ve settled into your new practice. After all, the car expenses can be paid by your future practice! 5 Protect your investment The goodwill of the selling doctor can be the largest portion of your investment when purchasing a practice. See Practice purchase on page 34 JANUARY 2016 / OptometryTimes.com Marketplace PRODUCTS & SERVICES Advertisers Index Advertiser DIGITAL IMAGING Alcon Laboratories Inc Tel: 800-862-5266 Web: www.alcon.com Page CVTIP, 34, CV3, CV4 Allergan Inc Tel: 714-246-4500 Fax: 714-246-4971 Customer Service: 800-433-8871 Web: www.allergan.com 29, 30 Bausch + Lomb Tel: 800-227-1427 Customer Service: 800-323-0000 Web: www.bausch.com 11, 12 Cooper vision Web: www.coopervision.com Mibo Medical Group Tel: 214-507-8091 25 Nova Bay Pharmaceuticals Web: [email protected] 15 REICHERT Tel: 716-686-4500 17 Shire ophthalmic Tel: 415-971-4650 7 TTI Medical Tel: 800-322-7373 Web: www.ttimedical.com CONFERENCES & EVENTS CAREERS American Academy of Optometry New Jersey Chapter NEW HAMPSHIRE CV2 23 This index is provided as an additional service. The publisher does not assume any liability for errors or omissions. 14 t h A n n u a l E d u c a t i o n a l C o n f e r e n c e April 13-17, 2016 Myrtle Beach, South Carolina Hilton Embassy Suites at Kingston Plantation Dr. Joseph Sowka, O.D., F.A.A.O. Dr. Mile Brujic, O.D., F.A.A.O. 16 HOURS COPE CE Registration: $475.00 One, Two or Three Bedroom Suites Accommodations Include a Daily Breakfast Buffet and Evening Cocktail Reception PACK YOUR CLUBS! Golf details to follow. For Accommodation and Additional Information, contact: Dennis H. Lyons, OD, F.A.A.O. Phone: (732) 920-0110 E-Mail: [email protected] Concord Eye Center is currently interviewing for an Optometrist to join our busy practice of 14 providers, in a multispecialty practice. We are located in the heart of NH, with only an hour to the coast, Boston and the mountains. GmjimYdaÚ]\[Yf\a\Yl]oadd]f`Yf[]l`]aj overall experience with performing complete eye exams, with a special interest in contact lens patients. We offer a competitive salary and compensation package. @gmjkYj]Û]paZd]ZYk]\gf^mddlae]klYlmk& Repeating an ad ENSURES it will be seen and remembered! Please inquire within to Pat Bourgault VP of Operations by email: [email protected] or call 603 224-2020 ext 2117 ADVERTISE NOW! Call Joanna Shippoli to place your Recruitment ad at 800-225-4569 ext. 2615 [email protected] ADVERTISE TODAY! 31 32 JANUARY 2016 / Optometry Times Marketplace Content Licensing for Every Marketing Strategy Marketing solutions fit for: t Outdoor t Direct Mail t Print Advertising t Tradeshow/POP Displays t Social Media t Radio & Television Logo Licensing | Reprints | Eprints | Plaques Leverage branded content from Optometry Times to create a more powerful and sophisticated statement about your product, service, or company in your next marketing campaign. Contact Wright’s Media to find out more about how we can customize your acknowledgements and recognitions to enhance your marketing strategies. For more information, call Wright’s Media at 877.652.5295 or visit our website at www.wrightsmedia.com Q&A | PRACTICAL CHAIRSIDE ADVICE Mary K. Mercado, OD 33 Digital marketing manager for CooperVision, Inc. Nail polish, opening a practice, and skydiving As a chemist, what interested you in the contact lens field? Actually, it wasn’t contact lenses, it was polymer chemistry. My organic chemistry teacher told me that there’s a whole science about just making plastics. It could be from making Tupperware to nail polish to contact lenses. I thought, maybe I want to work for OPI, that’s a famous nail polish. I was an impressionable kid who loved fashion and beauty. There’s a lot of polymer chemistry in cosmetics, so I thought that was something I should go into. But CooperVision was in my backdoor. I was initially hired for polymer chemistry. It wasn’t like I wanted to be a contact lens polymerchemist genius. Every girl wants to work for something she uses, like makeup. That was kind of me, and then I grew up really fast working at CooperVision. Photo courtesy Mary Mercado, OD What pulled you into marketing instead of optometry? I got accepted to UC Berkeley. I was super excited. I went to orientation, then I just thought, “I don’t think I’m cut out to do this.” I couldn’t sit in a room for eight hours a day. There’s a lot of responsibility. I didn’t think I was worthy and that I wouldn’t be the right type of doctor for someone’s health. That’s how hard I am on myself. I was devastated. I took about a month or two to figure out what I wanted to do. I thought doing my MBA would be really good. I took my first marketing class, and I thought, “Yes, this is what I want to do.” Why digital marketing? How has the Internet changed how products are sold? Q It’s changed significantly because as we’re seeing millennials becoming doctors—and with people like Alan Glazier— there’s a whole community online, and it’s increasing. We can’t ignore that. If it were decreasing, I would have to rethink my career again. We have to learn where the trend is. It enables sales— it almost enables us to be right there in front of ODs, whether they’re at a conference or in their practice, we can serve them content and the consumption is at their leisure. We’re busy people— you’re busy, I’m busy. So, if we’re at a restaurant and waiting for our spouse or date, of course I’m going to be scrolling through Facebook just seeing what’s on Huffington Post —that trend cannot be denied. So, it’s a fascinating world where we can create content for people to consume when they want it. It’s obvious we live in a very digital world. If I was going to go into marketing, it was going to be at the cutting edge. Print and traditional marketing will always be there. What opened my eyes was the reach frequency with digital vs. print. Give me $10,000 for print and $10,000 for digital—I can measure an ROI more successfully with digital, and I can increase my digital footprint by rate-frequency significantly more. We have Facebook on our phones, Twitter ads, push notifications—we have to embrace it. What’s the craziest thing you’ve ever done? For me, it’s skydiving. I told my parents, “Do you want to go skydiving?” They’re like, “No, you should never do that. Why would you do that to your family? You could die.” OK, well, I’m going to go do it. [Laughs] That was better than getting a tattoo. I did it with a group of friends, videotaped it, and bought the DVD. I shouldn’t have bought it because that was evidence to my parents. How old was I? About 20, still living at home. [Laughs] —Vernon Trollingerr Your husband is an optometrist, and you’re opening a new practice. How’s that going? It’s super exciting. It’s kind of hard to find a job unless you’re going to be an OD in a practice. He just said, “Why not? Let’s just open practice.” [Laughs] It just makes perfect sense. A great OD with clinical and research skills, and we also have me who can market and know how we want to position ourselves. Hopefully we can be successful and give back to the community. To hear the full interview with Mary Mercado, listen online: optometrytimes.com/ MaryMercado 34 Practice Management Practice purchase Continued from page 30 If the selling optometrist will no longer be working in the practice, it is important to have her sign a non-compete agreement so she doesn’t suddenly become your competitor and take all the patients with her. In fact, patient retention should be your primary focus when purchasing an existing practice. The seller should agree to pose for a photo with you that you can mail out in a letter announcing you as the new owner. The goodwill of the selling doctor can be the largest portion of your investment when purchasing a practice JANUARY 2016 will result in a successful practice that patients will appreciate and will provide you with a great lifestyle. Best of luck with your quest to find your dream practice. Dr. Dirk Massie is the primary consultant at Premier Doctor Consultants. [email protected] @dirkmassie Drance hemorrhages and quarterly optic disc evaluation OptometryTimes.com/drance Not knowing IOPs can make you a better clinician OptometryTimes.com/notknowingIOPs Is glaucoma a neurological disease? OptometryTimes.com/neurologicaldisease Your pet may increase your glaucoma risk OptometryTimes.com/glaucomapets Like something we published?, hate something we published?, have a suggestion? Send your comments to [email protected]. Letters may be edited for length or clarity. In the offspring of female rats that received travoprost subcutaneously from Day 7 of pregnancy to lactation Day 21 at doses of ≥ 0.12 mcg/kg/day (3 times the MRHOD), the incidence of postnatal mortality was increased, and neonatal body weight gain was decreased. Neonatal development was also affected, evidenced by delayed eye opening, pinna detachment and preputial separation, and by decreased motor activity t. BRIEF SUMMARY OF PRESCRIBING INFORMATION A ® DOSAGE AND ADMINISTRATION A The recommended dosage is one drop in the affected eye(s) once daily in the evening. TRAV AVATTAN Z (travoprost ophthalmic solution) should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect. ® TRAV AVATTAN Z Solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. CONTRAINDICATIONS A None WARNINGS AND PRECAUTIONS W Pigmentation T avoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most Tr frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as travoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typicall T y, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with TRAV AVATAN Z (travoprost ophthalmic solution) 0.004% can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. ® Eyelash Changes TRAV AVATTAN Z Solution may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment. ® Intraocular Inflammation TRAV AVATTAN Z Solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated. ® Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with travoprost ophthalmic solution. TRA RAVATTAN Z Solution should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. ® Angle-closure, Inflammatory orr Neovascular Glaucoma TRA RAVATTAN Z Solution has not been evaluated for the treatment of angle-closure, inflammatory or neovascular glaucoma. ® Bacterial Keratitis There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. Use with Contact Lenses Contact lenses should be removed prior to instillation of TRAV AVATTAN Z Solution and may be reinserted 15 minutes following its administration. ® ADVERSE REACTIONS Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The most common adverse reaction observed in controlled clinical studies with TRA RAVATTAN (travoprost ophthalmic solution) 0.004% and TRA RAVATTAN Z (tr ( avoprost ophthalmic solution) 0.004% was ocular hyperemia which was reported in 30 to 50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse reactions reported at an incidence of 5 to 10% in these clinical studies included decreased visual acuity, eye discomfort, foreign body sensation, pain and pruritus. Ocular adverse reactions reported at an incidence of 1 to 4% in clinical studies with TRA RAVATTAN or TRA RAVATTAN Z Solutions included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage and tearing. ® ® ® ( avoprost ophthalmic solution) 0.004% There are no adequate and well-controlled studies of TRA RAVATTAN Z (tr administration in pregnant women. Because animal reproductive studies are not always predictive of human response, TRAV AVATTAN Z Solution should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. ® INDICATIONS A AND USAGE TRAV AVATTAN Z (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ® SEE MORE CONTENT ON GLAUCOMA WE WANT TO HEAR FROM YOU! USE IN SPECIFIC POPULATIONS A Pregnancy Pregnancy Category C T atogenic effects: Tr Ter T avoprost was teratogenic in rats, at an intravenous (IV) dose up to 10 mcg/kg/day (250 times the maximal recommended human ocular dose (MRHOD), evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, such as fused sternebrae, domed head and hydrocephaly. Tr T avoprost was not teratogenic in rats at IV doses up to 3 mcg/kg/day (75 times the MRHOD), or in mice at subcutaneous doses up to 1 mcg/kg/day (25 times the MRHOD). Tr T avoprost produced an increase in post-implantation losses and a decrease in fetal viability in rats at IV doses > 3 mcg/kg/day (75 times the MRHOD) and in mice at subcutaneous doses > 0.3 mcg/kg/day (7.5 times the MRHOD). Reduction of the intraocular pressure starts approximately 2 hours after the first administration with maximum effect reached after 12 hours. Ideally, the seller stays on for one to two years to help with the transition so she can verbally tell all the patients how great you are. Even if the seller works only one or two days per week for a period of time, it makes for a very smooth transition and a higher percentage of patients will stay with the practice. Congratulations if you’re considering owning your own private practice! In recent years, we’ve seen negativity surrounding private practice ownership due to the Affordable Care Act (ACA), ICD-10 implementation, and meeting meaningful use guidelines. However, despite some of those challenges, private practices provides a wonderful opportunity to provide a high standard of care and excellent customer service that | ® Nursing Mothers A study in lactating rats demonstrated that radiolabeled travoprost and/or its metabolites were excreted in milk. It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TRAV AVATAN Z Solution is administered to a nursing woman. ® Pediatric Use Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. Geriatric Use No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. Hepatic and Renal Impairment T avoprost ophthalmic solution 0.004% has been studied in patients with hepatic impairment and also in Tr patients with renal impairment. No clinically relevant changes in hematology, blood chemistry, or urinalysis laboratory data were observed in these patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility T o-year carcinogenicity studies in mice and rats at subcutaneous doses of 10, 30, or 100 mcg/kg/day Tw did not show any evidence of carcinogenic potential. However,r at 100 mcg/kg/day, male rats were only treated for 82 weeks, and the maximum tolerated dose (MTD) was not reached in the mouse study. The high dose (100 mcg/kg) corresponds to exposure levels over 400 times the human exposure at the maximum recommended human ocular dose (MRHOD) of 0.04 mcg/kg, based on plasma active drug levels. Tr T avoprost was not mutagenic in the Ames test, mouse micronucleus test or rat chromosome aberration assay. A slight increase in the mutant frequency was observed in one of two mouse lymphoma assays in the presence of rat S-9 activation enzymes. TTravoprost did not affect mating or fertility indices in male or female rats at subcutaneous doses up to 10 mcg/kg/day [250 times the maximum recommended human ocular dose of 0.04 mcg/kg/day on a mcg/kg basis (MRHOD)]. At A 10 mcg/kg/day, the mean number of corpora lutea was reduced, and the post-implantation losses were increased. These effects were not observed at 3 mcg/kg/day (75 times the MRHOD). PATIENT A COUNSELING INFORMATION A Potential for Pigmentation Patients should be advised about the potential for increased brown pigmentation of the iris, which may be permanent. Patients should also be informed about the possibility of eyelid skin darkening, which may be reversible after discontinuation of TRAV AVATTAN Z (travoprost ophthalmic solution) 0.004%. ® Potential for Eyelash Changes Patients should also be informed of the possibility of eyelash and vellus hair changes in the treated eye during treatment with TRAV AVATTAN Z Solution. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment. ® Handling the Container Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. When to Seek Physician Advice Patients should also be advised that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician’s advice concerning the continued use of TRAV AVATTAN Z Solution. ® Use with Contact Lenses Contact lenses should be removed prior to instillation of TRAV AVATTAN Z Solution and may be reinserted 15 minutes following its administration. ® Use with Other Ophthalmic Drugs If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications. Rx Only U.S. Patent Nos. 5,631,287; 5,889,052, 6,011,062; 6,235,781; 6,503,497; and 6,849,253 ® Nonocular adverse reactions reported at an incidence of 1 to 5% in these clinical studies were allergy, angina pectoris, anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold/flu syndrome, depression, dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence and urinary tract infections. In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed. ALCON LABORATORIES A , INC. Fort Worth, TTexas 76134 USA © 2006, 2010, 2011, 2012 Novartis 10/15 US-TRZ-15-E-0278 CHOOSE TRAVATAN Z® Solution: A POWERFUL START Sustained % 30 IOP lowering at 12, 14, and 20 hours post-dose in a 3-month study1,2* Not actual patient TRAVATAN Z® Solution has no FDA-approved therapeutic equivalent available Help patients start strong and stay on track with INDICATIONS AND USAGE TRAVATAN Z® (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Dosage and Administration The recommended dosage is 1 drop in the affected eye(s) once daily in the evening. TRAVATAN Z® Solution should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the IOP-lowering effect. TRAVATAN Z® Solution may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than 1 topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart. IMPORTANT SAFETY INFORMATION Warnings and Precautions Pigmentation—Travoprost ophthalmic solution has been reported to increase the pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as travoprost is administered. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. The long-term effects of increased *Study Design: Double-masked, randomized, parallel-group, multicenter non-inferiority comparison of the efficacy and safety of travoprost 0.004% preserved with benzalkonium chloride (BAK) to TRAVATAN Z® Solution after 3 months of treatment in patients with open-angle glaucoma or ocular hypertension. Baseline IOPs were 27.0 mm Hg (n=322), 25.5 mm Hg (n=322), and 24.8 mm Hg (n=322) at 8 AM, 10 AM, and 4 PM for TRAVATAN Z® Solution. At the end of Month 3, the TRAVATAN Z® Solution group had mean IOPs (95% CI) of 18.7 mm Hg (-0.4, 0.5), 17.7 mm Hg (-0.4, 0.6), and 17.4 mm Hg (-0.2, 0.8) at 8 AM, 10 AM, and 4 PM, respectively. Statistical equivalent reductions in IOP (95% confidence interval about the treatment differences were entirely within ±1.5 mm Hg) were demonstrated between the treatments at all study visits during the 3 months of treatment. References: 1. Data on file, 2013. 2. Lewis RA, Katz GJ, Weiss MJ, et al. Travoprost 0.004% with and without benzalkonium chloride: a comparison of safety and efficacy. J Glaucoma. 2007;16(1):98-103. © 2015 Novartis 10/15 US-TRZ-15-E-0278 pigmentation are not known. While treatment with TRAVATAN Z® Solution can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. Eyelash Changes—TRAVATAN Z® Solution may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment. Use With Contact Lenses—Contact lenses should be removed prior to instillation of TRAVATAN Z® Solution and may be reinserted 15 minutes following its administration. Adverse Reactions The most common adverse reaction observed in controlled clinical studies with TRAVATAN Z® Solution was ocular hyperemia, which was reported in 30 to 50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse reactions reported at an incidence of 5 to 10% in these clinical studies included decreased visual acuity, eye discomfort, foreign body sensation, pain, and pruritus. In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed. Use in Specific Populations Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. For additional information about TRAVATAN Z® Solution, please see the brief summary of Prescribing Information on the adjacent page. NOW AVAILABLE: PLUS POWERS! DAILIES TOTAL1® CONTACT LENSES -10.00D TO -0.50D NOW IN PLUS POWERS PERFORMANCE DRIVEN BY SCIENCE™ See product instructions for complete wear, care and safety information. © 2015 Novartis 08/15 DAL15097JAD +0.50D TO +6.00D
