Download Keratitis outlook may improve with LDPK

CUTTING-EDGE ADVANCEMENTS
CLINICAL DIAGNOSIS
OphthalmologyTimes.com
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Clinical Diagnosis
EXPLORING PXF
IN IOL SUBLUXATION,
DISLOCATION
SURGERY
September 1, 2015 VOL. 40, NO. 14
DRUG THERAPY
Keratitis outlook may
improve with LDPK
Long-term visual results favorable; procedure should
be considered more often, suggests chart review
Chart Review Take-Aways
70%
SALT L AKE CIT Y :: PSEUDOEXFOLIATION (PXF) is an important risk factor
for late spontaneous IOL subluxation/
dislocation, according to findings from
a histopathologic study. Research also
indicates that because of significant
clinical underdiagnosis, pseudoexfoliation may be responsible for more
of these complications than previously
thought, notes Nick Mamalis, MD.
( See story on page 24 : Risk factor )
85%
of patients had
clear grafts
had structural
integrity
71%
50%
had improvement
in visual acuity
required repeat
transplant
PROGNOSTIC INDICATORS of better
outcomes included better preoperative
visual acuity, infectious etiology
IN VIEW: Patient with a large-diameter transplant
immediately after surgery. (Image courtesy of Danielle Trief, MD)
GRAFT SIZE did not influence final visual
acuity
Surgery
LASIK, PRK BOTH
EFFECTIVE FOR
RESIDUAL ERROR
By Nancy Groves;
SAN DIEGO :: BOTH LASIK AND PRK
are safe and effective procedures to
treat residual refractive error following
refractive lens exchange (RLE), according to a multisite, international study.
The research also suggested a preference to perform LASIK for residual
hyperopia and PRK for myopia, said
senior author Steve Schallhorn, MD.
“This large sample—larger than previous reports—showed that laser vision correction after implantation of
a premium IOL is safe and effective
and can improve unaided vision,” Dr.
Schallhorn said.
keratoplasty (LDPK) is usually considered a “last
resort” procedure for patients with severe infectious keratitis.
However, the procedure can have favorable longterm visual outcomes and should be a more frequently suggested option, indicate results from a
recent retrospective chart review.
“[More than] 70% of our patients ultimately
had clear grafts, 85% had structural integrity, and
71% had improvement in their visual acuity,” said
Danielle Trief, MD, who joined the staff of Columbia University College of Physicians and Surgeons,
New York, this month as an assistant professor of
ophthalmology.
“Those results are encouraging, but physicians
should know that half of the patients required a
( See story on page 10 : Refractive lens )
Reviewed by Danielle Trief, MD
NE W YORK ::
LARGE-DIAMETER PENETRATING
repeat transplant, so it does take a lot of time and
effort—and maybe more surgery—to get to that endpoint,” Dr. Trief added.
Physicians should also be aware that, in this
review, prognostic indicators of better outcomes
included better preoperative visual acuity and infectious etiology.
Investigators at the New York Eye and Ear Infirmary, where Dr. Trief was a cornea fellow, reviewed
records of all eyes with culture-proven infectious
keratitis that underwent LDPK (defined as 10 mm
or greater) at the facility from January 2004 to December 2014.
The analysis included 41 eyes of 41 patients. Outcome measures were visual acuity (converted to
LogMAR), complications, and graft failure rates,
and all patients had at least 3 months of follow up.
The surgical technique for all patients was similar to that of regular penetrating keratoplasties
but with modifications—including a conjunctival peritomy, a hand-held trephine, and excision
( Continues on page 19 : Keratitis )
VISION
LEAVE YOUR LEGACY IN
EACH PATIENT’S LIFESTYLE.
Start with
ME.
It’s my vision, but I trust it to you. Don’t give me
anything less than a full range of vision as sharp
as I am — with enhanced focus where I’ll use it
most. The legacy you leave is the life I live. And
with the TECNIS® Multifocal Family of 1-Piece
IOLs, you can leave me with the sharpest vision,
less dependence on glasses and an IOL not tied
to glistenings.
Don’t wait to leave a legacy of excellent outcomes.
Start now with the TECNIS® Multifocal Family
of IOLs.
TECNISIOL.COM
+4.0
+3.25
See Indications and Important Safety Information on the adjacent page.
TECNIS is a trademark owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates.
© 2015 Abbott Medical Optics Inc. | www.AbbottMedicalOptics.com | PP2015CT0732
+2.75
SEPTEMBER 1, 2015 :: Ophthalmology Times
letters
QUANTIFYING THE VALUE OF OPHTHALMIC CARE
I read the recent “Sight Lines” column by J.C. Noreika, MD, MBA, about
the timeless work and lifelong vision
of Gary and Melissa Brown (http://
bit.ly/1MT6nhn) toward improving
the evaluation of patient quality of
life that we provide our patients by
our medical care. I am well aware of
their work and of the dedication of
these two timely physicians.
The problem I have is with the
chronic dependency of ophthalmology and optometry upon utilizing chart
visual acuity in the measurement of
our outcomes, and it is the basis of
the Browns’ research in evaluating ocular procedures against others in defining their Quality–Adjusted Life–Year
(QALY) methodology. The difficulty is
that while we have measured vision
outcomes using chart acuity for more
than 160 years, this method is a poor
psychophysical threshold and, contrary
to popular belief, has never been validated against visual performance.
To the contrary, studies such as the
Smith-Kettlewell Foundation’s measurement of visual decline in normal
eyes of aging individuals (60 to 90)
demonstrate that it only very poorly
detects the severe decline in vision performance, even in these “normal eyes.”
While ophthalmic surgeons and
optometrists have utilized this measurement as justification for what
we do, it would be similar to the orthopedic surgeon evaluating the outcome of their surgical manipulation
or joint implantation by measuring
the position of the limb before and
after surgery but failing to measure
the range of motion, stability of the
joint, strength of the joint, the pain
associated with operation of the joint,
or the performance of that joint in
a number of desired daily activities
(playing golf, hitting a tennis ball).
I recognize that for FDA trials in
which ophthalmologists participate,
recompensed by pharmaceutical companies, often quality-of-life visual function questionnaires are recorded as
well as measurements of visual acuity.
However, at meetings, patient-reported
outcomes are never reported. Why?
Because “docs don’t want to hear
about this.” I have informally polled
about 200 retina specialists, 100
cataract surgeons, and more than
50 LASIK surgeons, but outside of
such pharmaceutical trials, VFQs are
never performed in the office.
I have read the Browns’ book, “Evidence–Based to Value–Based Medicine,” published in 2005, and applaud
their work in their attempt to prove
to the rest of the medical world “that
the benefit ophthalmology provides
for them (these baby boomers) and
society as a whole is enormous but
won’t be rewarded unless we educate those who determine our compensation and formulate regulations
to ophthalmology’s value.”
In order to define the value that our
surgical procedures and office work
provide to our patients, we must proceed beyond the mere measurement
of chart acuity or chart contrast sensitivity measurements.
Enabling that direction, I have invented an iPad-based application that
allows the patient to easily record answers to standard visual function questionnaires (such as the NEIVFQ-25) in
large print while sitting in the waiting room, waiting to see the doctor.
The results are uploaded to the cloud
where they can be compared against
prior measurements, measurements
of other patients, or others’ results
as well for research.
The app also provides printouts
for patients, providing general recommendations to assist the tasks
for which they have noted difficulties (and acknowledging the physician’s concern and caring). Apps such
as this should be recommended for
physicians to add to their exams in
justifying the office and operating
room procedures for which we ask
reimbursement.
Certainly as David Parke, MD, has
commiserated with me, in the future
we will be relegated to The Wall Street
Journal’s list of overpaid clinicians. In
the zero-sum dollars competition for
medical care-allocated payments we
have to use every method feasible to
demonstrate to the world our value
at a time when the baby boomers
need us the most.
—Stephen Sinclair, MD
Sinclair Retina Associates
Media, PA
INDICATIONS AND IMPORTANT SAFETY
INFORMATION FOR THE TECNIS®
MULTIFOCAL FAMILY OF 1-PIECE IOLs
Rx Only
ATTENTION: Reference the Directions for Use for a complete listing
of Indications and Important Safety Information. INDICATIONS:
The TECNIS® Multifocal 1-Piece Intraocular Lenses are indicated for
primary implantation for the visual correction of aphakia in adult
patients with and without presbyopia in whom a cataractous lens has
been removed by phacoemulsification and who desire near,
intermediate, and distance vision with increased spectacle
independence. The intraocular lenses are intended to be placed in
the capsular bag. WARNINGS: Physicians considering lens
implantation should weigh the potential risk/benefit ratio for any
conditions described in the Directions for Use that could increase
complications or impact patient outcomes. Multifocal IOL implants
may be inadvisable in patients where central visual field reduction
may not be tolerated, such as macular degeneration, retinal pigment
epithelium changes, and glaucoma. The lens should not be placed in
the ciliary sulcus. Inform patients about the possibility that a
decrease in contrast sensitivity and an increase in visual
disturbances may affect their ability to drive a car under certain
environmental conditions, such as driving at night or in poor
visibility conditions. PRECAUTIONS: Prior to surgery, inform
prospective patients of the possible risks and benefits associated
with the use of this device and provide a copy of the patient
information brochure to the patient. The long term effects of
intraocular lens implantation have not been determined. Secondary
glaucoma has been reported occasionally in patients with controlled
glaucoma who received lens implants. Do not reuse, resterilize or
autoclave. ADVERSE EVENTS: The rates of surgical reinterventions, most of which were non-lens related, were statistically
higher than the FDA grid rate for both the ZMB00 (+4.00 D) and
ZLB00 (+3.25 D) lens models. For the ZMB00, the surgical
re-intervention rates were 3.2% for first eyes and 3.3% for second
eyes. The re-intervention rate was 3.3% for both the first and
second eyes in the ZLB00 group.
TECNIS is a trademark owned by or licensed to
Abbott Laboratories, its subsidiaries or affiliates.
www.AbbottMedicalOptics.com
© 2015 Abbott Medical Optics Inc. | PP2015CT0732
SEPTEMBER 1, 2015
contents
Advancing Diversity
in Leadership.
24
12
OWL members
attending the ESCRS
meeting in Barcelona
22
are invited to
gather for a casual
networking event:
OWL Roost
Sunday, Sept 6th
5:30 - 7:00 PM
Surgery
8 LATEST TECHNOLOGY ENHANCES
COMPLEX SURGICAL CASES
Capsular tension rings and intraocular stains
among tools that can ease management
Clinical Diagnosis
24 PXF EXPLORED IN LATE IOL
SUBLUXATION/DISLOCATION
Analysis provides insight on disorder as risk
factor; highlights underdiagnosis
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Drug Therapy
26 TOPICAL DELIVERY VIA MPP AIMS
TO BLOCK VEGF SIGNALING
Video
Animal models explore receptor tyrosine kinase
inhibitor as noninvasive retinal disease therapy
In This Issue
3 LETTERS
6 EDITORIAL
27 MARKETPLACE
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surgical case, go to http://bit.ly/1N1gPVt
(Courtesy of Clara C. Chan, MD/Edward J. Holland, MD)
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SEPTEMBER 1, 2015 :: Ophthalmology Times
editorial
SEPTEMBER 1, 2015 ◾ VOL. 40, NO. 14
CONTENT
Engaging in free speech
On making truthful statements about a drug’s off-label uses
By Peter J. McDonnell, MD
director of the Wilmer Eye Institute,
Johns Hopkins University School of
Medicine, Baltimore, and chief medical
editor of Ophthalmology Times.
He can be reached at 727 Maumenee Building
600 N. Wolfe St. Baltimore, MD 21287-9278
Phone: 443/287-1511 Fax: 443/287-1514
E-mail: [email protected]
“I disapprove of what you say, but I will
defend to the death your right to say it.”
—Evelyn Beatrice Hall
(although often misattributed to Voltaire)
MY FRIEND (a skilled ophthalmologist)
lives in a country that has been having some
difficulties lately: lack of economic growth, fiscal mismanagement, and governmental corruption. Tomorrow, he plans to attend—along with
a million or so of his fellow citizens—a public
protest calling for a change, via constitutional
means, in the political leadership.
This does not worry me too much because he
lives in a country where people can peacefully
assemble and give speeches denouncing what
they perceive to be corrupt or incompetent government officials without fearing that they will
be tear-gassed, beaten, imprisoned, or worse.
DEFENSE OF RIGHT
TO ‘FREE SPEECH’
My own country is famous for its defense of
“free speech.” We Americans can spout things
from our pie holes that are incredibly ridiculous and inane and get away with it (for proof
of this, simply listen to some of the candidates
aspiring to the presidency of this fair land).
We are not supposed to yell “Fire!” in a
crowded theater, when there is no fire, because
of the physical danger that would pose to innocent moviegoers that could be hurt in a stampede to the exits. But along with some other
mostly reasonable exceptions designed to protect the safety of others, we can pretty much
say what we want.
So, it is with interest that I read news reports
about a dispute within the U.S. government on
the issue of free speech. The dispute is between
the federal courts and the FDA as to whether
employees of pharmaceutical companies may
speak the truth to physicians if that truth might
lead the doctors to use a medicine for an offlabel indication, for which the FDA has not
deemed the drug to have been proven safe and
effective.
The FDA interprets the law as requiring the
agency to make certain that drugs are marketed only for conditions for which they are approved (by the FDA) to treat. The agency has
therefore criminally prosecuted companies and
individual salespersons and other employees of
companies and demanded large fines for sharing information with physicians, even if that
information is obviously truthful, that includes
information about unapproved use of the drug.
Now, federal judges are saying the FDA
has violated the sacred American right to free
speech. In January 2013, the federal appellate court in Brooklyn, NY, rules that Frederick Cordonia, a drug company employee, could
not be denied the ability to provide truthful
information.
The FDA did not appeal the decision, but
subsequently tried to stop a company called
Amarin Pharma from sharing information that
its fish oil-derived drug (Vascepa) could reduce
serum triglycerides is people with elevated levels (the FDA wants the company to only speak
about people with “severely elevated” levels).
In a separate court, U.S. District Judge Paul
A. Engelmayer has recently ruled that the
First Amendment allows Amarin to engage in
“truthful and non-misleading speech” about
what this drug can do.
I take it on faith that my governmental employees, FDA staff, and federal judges are doing
their best to follow the constitution and our
laws as they best interpret them. And I am
grateful that my ophthalmologist friend and I
live and practice in countries where we are free
to speak our minds. Q
P.S. In the interest of full disclosure, the author of this
editorial is a co-founder of a start-up pharmaceutical company and a board member of Allergan plc.
Chief Medical Editor Peter J. McDonnell, MD
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2014 :: Ophthalmology Times
editorial advisory board
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Official publication sponsor of
EDITORIAL ADVISORY BOARD
Chief Medical Editor
Peter J. McDonnell, MD
Wilmer Eye Institute
Johns Hopkins University
Baltimore, MD
Anne L. Coleman, MD
Joan Miller, MD
Jules Stein Eye Institute, UCLA
Los Angeles, CA
Massachusetts Eye & Ear Infirmary
Harvard University
Boston, MA
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Harvard & Tufts Universities
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Los Angeles, CA
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Wilmer Eye Institute, Johns Hopkins University
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How to Contact Ophthalmology Times
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8
SEPTEMBER 1, 2015 :: Ophthalmology Times
surgery
Latest technology may help
in complex surgical cases
Capsular tension rings and intraocular stains among tools that can ease management
By Laird Harrison
SALT L AK E CI T Y ::
ew technology can improve
outcomes of complex cataract
cases in glaucomatous eyes,
said Alan S. Crandall, MD.
“There are a bunch of new
tools that we have that makes it
a lot easier to do these cases,”
said Dr. Crandall, professor and senior vice
chairman of ophthalmology and visual sciences, and director of glaucoma and cataract
at the John A. Moran Eye Center, University
of Utah, Salt Lake City.
For example, the Active Fluidics technology
of the Centurion Vision System (Alcon Laboratories) “makes chamber maintenance much
easier than our old systems,” he said. He referred to the Whitestar Signature (Abbott Medical Optics) as “a beautiful machine as well.”
N
in a variety of complex cases, he said, listing
Marfan’s syndrome, pseudoexfoliation, and
trauma cases.
“There is some indication that high myopes
would benefit from it because it stabilizes the
anterior segment and may decrease the rate of
retinal detachment,” he added.
The timing of placement for CTRs is critical.
“If you put it in prior to phaco, you have
better stability, but it can be difficult to put
it in with a hard nucleus or a large one,” he
said. “It makes rotation and removal difficult.”
CTRs are contraindicated in anterior capsular tear/posterior capsular rent. If surgeons can
convert a posterior capsular rent to a full circular
capsulotomy, they can use the CTR, he noted.
For large subluxations, Dr. Crandall advocates
the new Type 1G Cionni ring (FCI Ophthalmics).
“It’s more flexible and it’s easier to put in,”
he said. He also uses the Malyugin Ring (MicroSurgical Technology), which can be injected.
ON THE LIST
Also in the armamentarium for surgeons who
treat cataracts in glaucoma cases, Dr. Crandall
GETTING STARTED
added capsular tension rings and intraocular stains. “Trypan blue helps visualization To start the capsulorhexis, Dr. Crandall likes
in some of these typical cases,” he said. “You to use the Mackool Hook (FCI Ophthalmics) or
need to have vitreous stain available in case hooks by MicroSurgical Technology. “They’re
very easy to get in and get out, and really
you run into issues.”
A viscoadaptive agent (OVD) is also criti- maintain the bag well,” he said.
Regarding pseudoexfoliation cases, Dr. Crancal, he said. “You can use it to maintain the
dall has made changes in his
chamber and protect the vitreapproach since 2014. He assesses
ous from coming forward.” He
the zonules more carefully, lookmentioned both Healon5 (AbAn array of
ing for chamber asymmetry.
bott) and DisCoVisc (Alcon).
technologic
CTRs may help decrease phiTo manage the capsule coradvancements can
mosis but they do not protect
rectly, Dr. Crandall likes to use
help to improve the
against lens dropping, he said.
Ahmed Capsular Tension Segoutcomes of complex
Dr. Crandall emphasized the
ments (FCI Ophthalmics). “The
surgical cases. Some
importance of expanding punice thing about them is you
examples are given
pils in these cases.
can put them in if you have an
by Alan S. Crandall,
“We used to teach courses
anterior capsular tear, because
MD.
on doing a phaco in a 2-mm
they don’t put stress on the syseye,” he said. “Yes, you can
tem,” he said.
do that. But in pseudoexfoliaDr. Crandall is also a fan of
the capsular anchor, “if you happen to have tion, it’s a big mistake because you leave too
much material. You can’t get all of the cortex
access to European devices.”
Capsular tension rings (CTRs) have value out. You leave lens epithelial cells.”
TAKE-HOME
SURGICAL COMPLEXITIES
VIDEO Alan S. Crandall, MD, discusses
the complexities encountered with cataract surgery
in glaucoma patients.
Go to http://bit.ly/1KnSZ4D
He advocated viscodissection to help rotation.
“Bimanually rotate so that there is no pressure on the zonules while you’re doing that,”
he advised.
Anterior lens epithelial removal and the use
of capsular tension rings when indicated are
important because of the stress caused by rotation even with a small lens. “You’ve got to get
the bag open, so you can remove all the lens
epithelial cells,” he said. “So I use Malyugin
rings or other types of rings because of that.”
Never come out of a pseudoexfoliation eye
without letting the bag come forward, Dr. Crandall advised. “I use an (OVD) after every single
maneuver,” he said. “We’ll see in 10 years if
this makes a difference.”
He recommended tangential rather than
radial aspiration. The best way to decrease
zonular stress, Dr. Crandall said, is to use a
femtosecond laser, followed by UltraChopper
(Alcon), followed by vertical chopping, followed by horizontal chopping. ■
ALAN S. CRANDALL, MD
E: [email protected]
This article was adapted from Dr. Crandall's presentation at the 2015 Glaucoma 360
meeting. Dr. Crandall did not indicate a financial interest in the subject matter.
ADVERTISEMENT
This article is brought to you by
Smoothing the Learning Curve of the CATALYS® Precision Laser System
PAUL KANG, MD
C
ongratulations! You’ve decided to wisely invest in a
CATALYS® Precision Laser System for your surgical
practice. As you wait for it to arrive and be installed, here are
a few things I can suggest to make the transition curve smoother:
Closely examine the footprint of your facility and the physical
space the laser will require. At our practice, we initially
transformed a room in which minor oculoplastic procedures
were being performed and turned it into our
laser room. It is important to note that the
room housing the laser does not need to be
sterile but does need to be a clean procedure
room. Optimally, the laser room will either
adjoin or be located near the sterile operating
DR. KANG
room to minimize the distance patients will
need to travel from point A to point B. In some cases, the laser
may even be placed within the OR itself.
1. Think about the impact a femtosecond laser is
going to have on your overall workflow. Many
surgeons have noted that the addition of a femtosecond
laser increases the amount of time they need to spend with
each patient, and this is sometimes the case. But when you
consider that you are performing, and being compensated,
for 2 separate procedures rather than 1, it is much easier to
justify this additional time.
At our office, we currently work out of a single operating
room (OR). Ideally, we try to have 3 laser cases ongoing
simultaneously with each patient at a different active
“station.” For example, we may begin the day with our first
femtosecond laser patient at 8 a.m. and then begin work on
the second laser patient at 8:10 a.m. while the initial patient
is being prepped for the OR. Once that first patient is ready
for the OR at 8:20 a.m., the second patient should be
through the laser procedure and beginning prep for the OR.
A third patient is then scheduled for the laser procedure.
The rest of the day, we aim to rotate—1 patient under
the laser, 1 patient being prepped for the OR, and 1
patient in the OR—to maximize our efficiency.
Whether your practice has 1 or multiple operating
theaters, it’s important to develop a rhythm among your
staff so that there is minimal downtime wasted in waiting
for patients to progress from 1 station to the next. Initially, it
took us about a month for our practice of about 12 to 15
surgeons to find the right rhythm.
2. Understand that there is going to be a modest
learning curve. I have been using a femtosecond laser
since 2011. My practice initially had a LenSx laser before
switching to a CATALYS® laser in early 2015. Manufacturer
representatives and onsite trainers are extremely thorough
in working with new users and their staff on assimilating the
surgical team to their specific femtosecond laser.
New users should recognize that there is going to be an
adjustment period to a femtosecond laser. The surgical
procedure, patient flow, and even some of the intraocular
components of cortical clean-up and hydrodissection are
going to be a little different. You can plan for some of these
things, while for others you’ll need to adjust as you go.
3. Pick appropriate patients for your initial cases.
There is no prize awarded for the most challenging initial
case with a femtosecond laser. In your first week with the
laser, try not to choose patients who present with complex
pathology. For instance, your first cases should not be on
poorly dilating patients or patients with pseudoexfoliation.
In addition, try to avoid patients who cannot easily lay flat or
stay still, or a patient who seems extremely nervous about
the cataract procedure. Save those types of patients for
when you have more experience. Leave a bit of extra wiggle
room in your surgical schedule unless things take longer
initially than you expect. You don’t want to be rushing these
procedures as you familiarize yourself with the technology.
Surgeons who anticipate an initial adjustment period to the
use of a femtosecond laser and are prepared for the learning
process are the ones that are more satisfied during the
transition period. It is a technology that takes some adjustment,
but many of the processes are intuitive and quickly become
second nature.
Finally, one of the nicest things about the CATALYS® laser,
especially for newcomers to the technology, is that surgeons can
almost design their own learning curve. Let’s say, for instance,
that you feel like your patient has dilated enough and you’re not
sure about the centration of capsulorrhexis. This can be a patient
in whom you only put in the arcuate incisions without any
intraocular components to the procedure. Or you may want to
focus initially simply on performing the capsulorrhexis but not the
lens softening. Or you could do the arcuate incisions, capsulorrhexis, and lens softening, but omit the corneal incisions. The
CATALYS® system is not an “all or nothing” technology, which
works to the advantage of surgeons who want to ease into the
platform. You can do the procedures with which you are
comfortable and then build your personal skill portfolio as you go.
Dr Kang is a partner and cornea, cataract, and refractive
surgeon at Eye Doctors of Washington, Washington, DC. He also
serves as an assistant clinical professor at the Department of
Ophthalmology at Georgetown University and the Washington
Hospital Center.
INDICATIONS AND IMPORTANT SAFETY INFORMATION Rx Only CAUTION: Should be used only by qualified physicians who have extensive knowledge of the use of this device and have been trained and certified by Abbott Medical Optics/OptiMedica. ATTENTION:
Reference the labeling for a complete listing of Important Indications and Safety Information. INDICATIONS: The OptiMedica® Catalys® Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract
surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. CONTRAINDICATIONS: Should not be used in
patients with corneal ring and/or inlay implants, severe corneal opacities, corneal abnormalities, significant corneal edema or diminished aqueous clarity that obscures OCT imaging of the anterior lens capsule, patients younger than 22 years of age, descemetocele with impending corneal
rupture, and any contraindications to cataract surgery. PRECAUTIONS: The CATALYS® System has not been adequately evaluated in patients with a cataract greater than Grade 4 (via LOCS III); therefore no conclusions regarding either the safety or effectiveness are presently
available. ADVERSE EFFECTS: Complications include mild Petechiae and subconjunctival hemorrhage due to vacuum pressure of the LIQUID OPTICS Interface suction ring. Potential complications and adverse events include those generally associated with the performance of
capsulotomy and lens fragmentation, or creation of a partial-thickness or full-thickness cut or incision of the cornea.
OptiMedica, Catalys, and Liquid Optics are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. © 2015 Abbott Medical Optics Inc.
PP2015CT0815
10
SEPTEMBER 1, 2015 :: Ophthalmology Times
surgery
LASIK, PRK both effective
for refractive error after RLE
Myopic corrections, wavefront-guided LASIK more likely to result in 20/20 UCDA
By Fred Gebhart; Reviewed by Steve Schallhorn, MD
SAN DIEGO ::
hen it comes to treating residual refractive
error following refractive lens exchange (RLE),
both LASIK and PRK are
safe and effective procedures, according to a multisite, international study.
The research also suggested a preference
to perform LASIK for residual hyperopia and PRK
for myopia, said senior author Steve Schallhorn, MD.
“This large sample—
larger than previous reports—showed that laser
Dr. Schallhorn
vision correction after implantation of a premium IOL is safe and
effective and can improve unaided vision,”
said Dr. Schallhorn, clinical professor of
ophthalmology, University of California,
San Diego School of Medicine and chief
medical director for Optical Express.
LASIK is the preferred procedure for
faster visual recovery, as more patients
attained 20/20 vision in the early postoperative time period, he noted.
However, PRK has multiple advantages,
including not needing pressure-raising suction for the flap creation. PRK is also a
simpler procedure to perform, according
to Dr. Schallhorn.
Both LASIK and PRK have similar longterm outcomes and both carry the possibility of dry eye side-effect symptoms,
he added.
W
TARGETING GOAL
OF EMMETROPIA
Patients who receive a premium IOL tend
to have higher expectations than patients
receiving a standard monofocal IOL following cataract surgery, Dr. Schallhorn said.
Presuming that emmetropia is the target, the closer the postoperative refractive error is to zero, the higher the patient
LASIK and PRK Postoperative MRSE
60%
50%
LASIK; ± 0.5D: 96%
PRK; ± 0.5D: 94%
40%
30%
20%
10%
0%
–2.0
–1.5
–1.0
–0.5
0.0
0.5
1.0
1.5
2.0
(FIGURE 1) A total of 96% of LASIK patients were within 0.5 D of goal at final refraction compared
with 94% of PRK patients.
LASIK and PRK UCDVA
100%
80%
60%
Preop
Postop LASIK
Postop PRK
40%
20%
0%
20/16
20/20
20/25
20/32
20/40
(FIGURE 2) Both LASIK and PRK were found to be effective in terms of uncorrected vision at distance,
according to a multisite, international study. (Figures courtesy of Steve Schallhorn, MD)
11
SEPTEMBER 1, 2015 :: Ophthalmology Times
surgery
satisfaction, and the fewer and less intrusive and June 2014 using Optical Express’ electhe patient’s visual symptoms are likely to be. tronic medical records.
The study cohort included 661 patients
“Getting to that goal of emmetropia is important and well recognized,” Dr. Schallhorn and 893 eyes that underwent LASIK after
RLE and 602 patients and
said. “The real question is how
724 eyes that underwent PRK
best to achieve it.”
after RLE. The two cohorts
For patients who have reResearchers
were well matched—a mean
sidual refractive error, several
explore the efficacy
age of 54 in both groups, and
options have potential. If the
and reliability of laser
52% male in the LASIK group
refractive error is significant,
vision correction
versus 53% male in the PRK
the IOL can be repositioned or
for the treatment of
group. The LASIK group had
exchanged or a piggyback lens
residual refractive
49% of left eyes and 51% of
can be implanted.
error after refractive
right eyes treated compared
Astigmatic keratotomy may
lens exchange.
with 44% left and 56% right
be appropriate if the spherical
in the PRK group.
equivalent is on-target, but
The preoperative refraction
there is visually significant
showed a mean sphere of 0.28 ± 1.06 D with
astigmatism.
For patients with a relatively modest refractive a minimum of –3.75 and a maximum of +3.75
error—typically within a few diopters—laser D. This improved to +0.03 ± 0.52 D for LASIK
and +0.08 ± 0.57 D for PRK (p < 0.001 for
vision correction may be more appropriate.
Prior studies have used both PRK and LASIK both LASIK and PRK). The average time from
procedures in smaller populations. Regardless laser vision correction to last postoperative
of the procedure selected, patients must meet refraction was 5.4 months.
The mean preoperative cylinder was –1.00
four basic criteria for laser vision correction
± 0.67 D with a maximum of –4.5 D. This
following RLE:
improved to –0.36 ± 0.37 D for LASIK and
> The patient must have a visually significant
–0.43 ± 0.46 D for PRK, Dr. Schallhorn noted.
A total of 96% of LASIK patients were within
refractive error.
> The error cannot be large enough to warrant
0.5 D of goal at final refraction compared
with 94% of PRK patients.
IOL repositioning or exchange.
> The patient must desire improved vision.
Patients who had a myopic correction after
> The patient must meet other indications for
RLE were more likely to have 20/20 uncorrected distance acuity (UCDA) compared with
laser vision correction.
patients who had a hyperopic correction, 70.8%
versus 60.4% (p < 0.001).
ST U DY R E V I E W
Treatments that were wavefront guided were
Researchers conducted a retrospective review
of patients who underwent laser vision cor- more likely to produce 20/20 UCDA, as were
rection following RLE between January 2008 LASIK treatments, Dr. Schallhorn said.
Attaining 20/20 UCVA
by Procedure
TAKE-HOME
LASIK
PRK
Preoperative Myopia
70.8%
50.3%
Preoperative Hyperopia
60.4%
51.4%
Source: Steve Schallhorn, MD
“We showed that both LASIK and PRK are
safe and effective,” he said.
PRK has some advantages in that the procedure is relatively easy to perform, particularly for surgeons who do not have extensive refractive surgery experience, he noted.
“You would need appropriate training and
access to an excimer laser, but this should
not be particularly onerous to achieve,” Dr.
Schallhorn said. “Being simple and straightforward to perform are important advantages
for PRK to enhance the final outcome of a
premium IOL.”
At the same time, faster visual recovery and
less perioperative discomfort are significant
advantages of LASIK. However, long-term outcomes for the two procedures are similar. ■
STEVE SCHALLHORN, MD
E: [email protected]
This article was adapted from Dr. Schallhorn’s presentation at the 2015 meeting of the
American Society of Cataract and Refractive Surgery. Dr. Schallhorn is chief medical
director for Optical Express.
Bausch + Lomb announces 23-gauge fragmentation needle availability
RETINA SPECIALISTS have a new
tool in their armamentarium with the availability of a 23-gauge fragmentation needle for
a proprietary surgical platform (Stellaris PC
Vision Enhancement System, Bausch + Lomb).
This new ultrasonic needle design is used
during vitreoretinal procedures to effectively
remove the lens material from the posterior
chamber of the eye with balanced irrigation
and aspiration through 23-gauge incisions providing enhanced intraoperative control and efficiency, according to the company.
Prior to its introduction, surgeons were re-
quired to use larger fragmentation needles (20gauge) in order to remove lens fragments during surgery—thus necessitating the need for
increased incision size, suturing of the wounds
and lengthened recovery time, the company
noted. Surgeons are now able to utilize the 23gauge fragmentation needle to help balance the
inflow and outflow in the eye and achieve a
sutureless wound closure.
When combined with the Stellaris PC with
23-gauge valve entry site alignment system,
the company said, this advancement will provide surgeons:
> Use of the existing cannula wound architecture to insert the 23-gauge fragmentation needle into the eye.
> Fluidic and IOP stability during lens nucleus
removal, due to the consistency in gauge sizes
for in-flow and outflow of fluid.
> Easy replacement of the original valved cannula in the same wound for completion of the
procedure. ■
12
TOP-NOTCH ASSESSMENTS IN THE TREATMENT OF
Special Report )
CORNEAL DISEASE
AN UPDATE ON THE LATEST APPROACHES FOR THE DIAGNOSIS AND MANAGEMENT OF DISORDERS OF THE CORNEA
(FIGURE 1) Descemet membrane endothelial
keratoplasty at 1-week postoperatively from a
75-year-old diabetic donor stored for 8 days
preoperatively. (Image courtesy of Mark A. Terry, MD)
DMEK AND RISK
OF RE-BUBBLING:
INFLUENCE OF DONOR
CHARACTERISTICS
Graft adherence rate found similar in comparison
of diabetic and non-diabetic donors
By Cheryl Guttman Krader; Reviewed by Mark A. Terry, MD
D
POR T L AND, OR ::
take-home
In an analysis
of 340 cases
of Descemet
membrane endothelial
keratoplasty with a
standardized technique
by both experienced
and novice surgeons,
the re-bubbling rate
was 10.6%.
onor tissue characteristics—
including diabetic status—
do not appear to affect Descemet membrane endothelial keratoplasty (DMEK)
graft adherence when using
eye bank-provided donor material, according to results of a study conducted by Mark A. Terry, MD.
“Our previous studies have shown that donor characteristics
in tissue approved by the eye bank do not influence a variety of
early and longer-term outcome measures in Descemet stripping
automated endothelial keratoplasty (DSAEK),”
said Dr. Terry, director, Corneal Services, Devers Eye Institute, Portland, OR. “However,
the influence of donor characteristics in the
outcomes of DMEK has not been analyzed in
detail in a large series.
“Our analyses found no statistically significant
differences between grafts that
needed re-bubbling and those
that did not in terms of traditional graft characteristics,
including donor age, preoperative endothelial cell density
(ECD), death-to-preservation
Dr. Terry
time, death-to-use time, and
pre-stripping-to-use time,” he said.
In addition, the adherence rate was found
similar when comparing grafts from diabetic
and non-diabetic donors, he noted.
“Therefore, special requests by surgeons with
high cell counts, younger or ‘fresher’ donors
simply are not warranted,” Dr. Terry said. “We
believe that corneal surgeons should feel comfortable accepting any tissue for DMEK that
the eye bank has passed according to today’s
standards.”
DONOR CH A R ACTER ISTICS
To investigate if donor characteristics influenced the adherence of DMEK grafts, Dr. Terry
and colleagues undertook a retrospective review that included 340 consecutive eyes with
a diagnosis of Fuchs’ corneal dystrophy undergoing DMEK performed with a standardized surgical technique.
“The cases also included those done by novice surgeons (cornea fellows) who were still
in their DMEK learning curve but who used
our standardized technique,” Dr. Terry said.
Eyes with glaucoma tubes, an anterior chamber IOL, aphakia, a history of trabeculectomy,
vitrectomy, or failed penetrating keratoplasty
were excluded from analysis.
WHEN TO PERFORM
R E-BUBBLING?
The decision to perform re-bubbling was based
on optical coherence tomography (OCT)-defined
criteria or subjective findings. Specifically, rebubbling was done if on OCT, more than 33%
of the graft was separated at 1 week postopContinues on page 14 : Re-bubble
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©2015 Akorn, Inc. All rights reserved. P435 Rev 06/15
SEPTEMBER 1, 2015 :: Ophthalmology Times
14
Special Report )
TOP-NOTCH ASSESSMENTS IN THE TREATMENT OF CORNEAL
RE-BUBBLE
( Continued from page 12 )
eratively; if there was progressive graft separation over 2 consecutive visits; or if central
graft separation was present over the visual
axis and persistent at the next visit.
In addition, re-bubbling was performed if
there was any evidence of graft separation associated with reduced vision and the patient
was asking for intervention rather than being
willing to wait for spontaneous clearing.
cases with and without re-bubbling showed
the mean donor age was about 66 years in both
groups. Mean preoperative ECD in the non-rebubbling and re-bubbled grafts was 2,690 and
2,625 cells/mm 2, respectively.
Other comparisons between the non-rebubbling and re-bubbled grafts showed that
mean death-to-preservation time, death-to-use
time, and pre-stripping-to-use time were all
slightly longer in the group that was not rebubbled, but none of the differences was statistically significant, he noted.
Dr. Terry and colleagues also undertook
an analysis of whether diabetic status of the
donor influenced
graf t adherence.
That issue was investigated based on
a paper by Greiner
et al. that reported
an increased risk of
tissue tearing while
preparing DMEK
grafts from diabetic
donors [Cor nea.
2014;33:1129-1133].
“When the
Greiner paper was published, we had 17 rebubble cases in our DMEK series, and almost
half were from diabetic donors,” Dr. Terry said.
“Since diabetic donors seemed to be over-represented in the re-bubble group relative to their
prevalence in the general population, we decided to reduce at that time our use of diabetic donors.”
In the final analysis of the total cohort of 340
DMEKs, however, diabetic donors accounted
‘We believe the level of trauma
at the time of surgery and
interface obstacles are more
important factors for adherence.’
— Mark A. Terry, MD
Of the 340 eyes, 36 (10.6%) underwent
re-bubbling.
“This rate is lower than that reported in
other large DMEK series with multiple surgeons,” Dr. Terry said. “It is higher than the
6% rate we initially reported, however, and
that is due to the relaxation of our re-bubbling
criteria, which now include a patient’s request
for faster visual rehabilitation.”
The analyses comparing the grafts from
DISEASE
for only 22% of the re-bubbled grafts. The rate
of re-bubbling among the 272 grafts from nondiabetic donors was 9.5% and the rate of rebubbling of the 68 diabetic donors was 12%.
The difference between groups was not statistically significant.
“We believe the level of trauma at the time
of surgery and interface obstacles are more
important factors for adherence than diabetic
status, donor endothelial cell count, age, and
preservation time,” Dr. Terry said.
STANDARDIZED
DMEK TECHNIQUE
Dr. Terry and colleagues described their DMEK
surgical technique in a recently published article [Cornea. 2015;34:845-852]. They use donor
tissue pre-stripped by an eye bank technician
that is also marked by the eye bank with an “S”
stamp on the Descemet’s side of the tissue to
guide intraoperative orientation and eliminate
the possibility of upside-down grafts.
Other novel elements include use of a Straiko
glass injector (Gunther-Weiss) attached to a syringe; a modified Yoeruek tap technique with
a shallow anterior chamber; and injection of
20% SF6 gas to achieve 70% to 90% fill at the
end of the case, which, they have found, encourages prolonged graft support. ■
MARK A. TERRY, MD
E: [email protected]
This article is adapted from Dr. Terry’s presentation at the World Cornea Congress VII
during the 2015 meeting of the American Society of Cataract and Refractive Surgery.
Dr. Terry and colleagues have no financial interests in any aspect of DMEK surgery
or this study.
Allergan completes Oculeve acquisition; expands dry eye portfolio
ALLERGAN announced it has completed
the acquisition of Oculeve, a development-stage
medical device company focused on developing novel treatments for dry eye disease.
Under the terms of the agreement, Allergan
acquired Oculeve for a $125 million upfront
payment and commercialization milestone payments related to Oculeve’s lead development
program, OD-01.
The agreement also includes the acquisition
of an additional earlier-stage dry eye device
development program.
“The acquisition of Oculeve further enhances
Allergan’s world-class position in eye care and
underscores our commitment to continuing
to develop a broad range of treatment options
for patients with eye conditions,” said Brent
Saunders, chief executive officer and president of Allergan.
“Dry eye is currently an underserved condition, with many patients not receiving adequate treatment from over-the-counter options,”
Saunders added. “Allergan is committed to expanding our product offerings in this category,
and the development of OD-01, an intranasal
neurostimulation device, is complementary
to our market-leading dry eye treatment, [cyclosporine ophthalmic emulsion] Restasis, as
well as other dry eye products in development
within our pipeline.”
The acquisition of Oculeve adds novel, complementary dry eye development programs to
Allergan’s current eye care research and development programs, including OD-01, a noninvasive nasal neurostimulation device that
increases tear production in patients with dry
eye disease, according to a prepared statement.
Oculeve has completed four clinical studies
of OD-01 to date in more than 200 patients,
showing positive safety and efficacy of the device, according to the statement.
Allergan added it plans to conduct two additional pivotal trials prior to FDA submission,
which is expected in 2016 with potential commercial launch in 2017. ■
SEPTEMBER 1, 2015 :: Ophthalmology Times
Special Report )
15
TOP-NOTCH ASSESSMENTS IN THE TREATMENT OF CORNEAL
DISEASE
Artificial cornea may be alternative
to repeat PK in certain patients
Prospective comparison study could help to determine which cases more likely to benefit
By Nancy Groves; Reviewed by Esen K. Akpek, MD
BALT IMORE ::
PATIENTS WHO underwent implantation with an artificial cornea (Boston Type 1
keratoprosthesis [KPro]), Massachusetts Eye
and Ear) had greater visual improvement—and
were more likely to retain this improvement
for at least 2 years—than patients who had
undergone repeat full-thickness penetrating
keratoplasty (PK).
In this single-center, retrospective case series, rates of complications were similar for
the two procedures.
One conclusion that could be drawn from
these findings is that, pending further studies—particularly prospective
clinical trials rather than retrospective reviews—the use
of KPros could be expanded,
said Esen K. Akpek, MD, the
Bendann Family Professor of
Ophthalmology and RheumaDr. Akpek
tology, Wilmer Eye Institute,
Johns Hopkins University School of Medicine,
Baltimore. She and her colleagues conducted
the study and have submitted a manuscript
for publication.
“Perhaps KPro is being underutilized,” Dr.
Akpek said, suggesting that many physicians
may be unfamiliar with several recent studies
that have reported favorable outcomes with
implantation, or that they may associate the
prosthetic with earlier designs and surgical
techniques that were less successful.
“Maybe we should do a head-to-head comparison of repeat donor keratoplasty versus
KPro in patients who have already failed a
donor transplantation,” Dr. Akpek said. “It’s
not known how many transplants you can
possibly do with reasonable expectation of
visual recovery. After how many should you
stop because the risk of complications goes up
significantly? That’s not known. How many
failed transplants should you have before you
switch to KPro?”
COMPA R I NG T H E BE N EF I T S
Though numerous studies have examined
the outcomes of repeat donor corneal transplantation or, separately, implantation of the
device, there is little information comparing
“The patients in the KPro group started
the relative merits of the two.
with much worse visual acuity and more coDr. Akpek and colleagues took an initial step morbidities, but at the end of the study they
toward obtaining such evidence by conduct- seemed to do fine,” Dr. Akpek said.
ing their review, hypothesizing that the visual
Most patients in both groups had at least
outcomes of the device would be
one postoperative complication,
superior to repeat PK over an inmost commonly glaucoma. Rates
termediate follow-up period.
of postoperative complications—
They reviewed the medical resuch as endophthalmitis, glaucords of patients who had undercoma, and retinal detachment—
Findings of a
gone any corneal transplantation retrospective case
were similar in each group (p =
procedure at the Wilmer Eye In- review show that
0.60 for all).
stitute from January 2008 to De- eyes that underwent
However, the incidence of retcember 2010.
roprosthetic
membrane formation
implantation of
Primary donor corneal trans- the Boston Type 1
in the artificial cornea group was
plantations and primary KPro im- keratoprosthesis had
26%, while the rate of retrocorplantations were excluded from greater improvement
neal membranes in the PK group
the analysis.
was much lower (4%).
in visual acuity than
Eighty eyes of 80 patients who those undergoing
had at least one previously failed repeat donor corneal
NEED FOR
full-thickness donor corneal trans- transplantation.
F U R T H E R ST U DY
plant and underwent either PK (n
Though these results may sug= 53) or KPro implantation (n = 27) were gest that the device could be an alternative
included in the analysis.
to repeat PK in selected patients, more needs
The chart review was completed in No- to be learned about the preoperative patient
vember 2012.
profile most likely to produce good outcomes,
according to Dr. Akpek.
FINDINGS FROM THE
The pool of prospective patients for a direct
CHART REVIEW
comparison between PK and the device would
The analysis showed that patients undergo- be relatively small—perhaps only 10,000 paing implantation with the device had greater tients a year in the United States, she added.
mean improvement in visual acuity compared
However, these patients are usually younger
with baseline at each postoperative time point. than those who undergo treatment for other
In the PK group, 35% of eyes achieved best- eye diseases, such as macular degeneration,
ever vision of 20/70 compared with 45% of and are otherwise relatively healthy and in
KPro eyes.
their most productive stage of life.
Further, 21 of 27 patients (78%) in the KPro
Prospective comparison studies could help
group had better postoperative than preop- demonstrate whether it would be more effecerative vision compared with 5 of 49 patients tive to recommend the device rather than a
(10%) in the PK group. More patients in the series of donor corneal transplants with inKPro group than in the PK group were able to creasing likelihood of failure. ■
retain better vision than baseline through 2
years of follow-up (66% versus 42%).
Since the artificial corneas are mainly imESEN K. AKPEK, MD
planted in patients ineligible for donor keratoE: [email protected]
plasty, the baseline characteristics of patients
This article is adapted from Dr. Akpek’s presentation at the World Cornea Congress
in the device and keratoplasty groups had large
VII preceding the 2015 meeting of the American Society of Cataract and Refractive
discrepancies.
Surgery. Dr. Akpek has no financial interest relevant to the subject matter.
take-home
SEPTEMBER 1, 2015 :: Ophthalmology Times
16
Special Report )
TOP-NOTCH ASSESSMENTS IN THE TREATMENT OF CORNEAL
DISEASE
IOL power calculation for keratoconus:
One-size strategy does not fit all
Analysis takes into account several lens formulas, tactics for enhanced predictability
By Cheryl Guttman Krader; Reviewed by Wayne Bowman, MD, and David T. Truong, MD
DAL L AS ::
THE CHALLENGES OF IOL power
calculation in eyes with keratoconus were reinforced by the results of a retrospective analysis
of refractive outcomes after cataract surgery in
this population. The findings also provide possible insights on approaches
for optimizing accuracy.
The research was undertaken by David T. Truong,
MD, and Wayne Bowman,
MD, Department of Ophthalmology, University of Texas
Dr. Truong
Southwestern Medical School,
Dallas. The review included 22 eyes of 16 patients operated on from 2010 to 2014, and the
mean MRSE obtained using surgeon-specific
algorithms was impressive at –0.21 D. However, the range was –6.5 D to 0.65 D.
Formula Results
HOLLADAY II
HOLLADAY II KCN HOLLADAY I
HOFFER-Q
SRK-T
K < 47 D (n = 12)
Prediction Error
–0.091
–0.021
–0.298
–0.103
–0.394
Absolute Error
0.741
0.534
0.612
0.584
0.674
Prediction Error
0.787
1.476
0.901
1.279
0.059
Absolute Error
1.196
1.716
1.313
1.547
0.956
K ≥ 47 D (n = 7)
Source: David T. Truong, MD
For eyes with a corneal power between 47
and 50 D, surgeons might consider using the
SRK-T with a target of –1.5 D. For eyes with
a higher corneal power, none of the formulas
FINDING THE RIGHT
evaluated seemed to have reasonable accuFORMULA
Using clinical data to calculate predicted refrac- racy, and “the only recommendation we can
tion and prediction errors using five modern make is that surgeons should probably not use
lens power formulas, the investigators found the actual corneal power,” Dr. Truong noted.
The 22 eyes in the study had a mean MRSE
the best-performing option varied depending
of –3.59 D, mean axial length of 24.21 mm,
on the preoperative corneal power.
and mean corneal power (K) of
However, none of the formulas
47.81 D. Applying the various foroffered good predictability in eyes
mulas for all eyes pooled, the SRK-T
with a corneal power ≥50 D.
performed the best with a mean
“IOL calculation is difficult in
absolute error of 0.797 D. The reeyes with keratoconus due to the
Analyses of predicted
sults with the other formulas ranged
abnormal corneal curvature, be- refractive outcomes
from 0.903 D with the Holladay I
cause the visual axis may not pass using different IOL
to 1.027 D using the Holladay II
through the steepest part of the cor- calculation formulas
with double-K adjustment.
nea, and since assumptions made suggest possible
When the eyes were stratified
during calculations to determine strategies for increasby preoperative corneal power, the
the correct IOL power are not valid ing predictability in
double-K adjustment of the Hollain eyes with keratoconus,” said Dr. eyes with mild or
day II was associated with the lowTruong, a resident in the ophthal- moderate keratoconus.
est mean absolute error (0.534 D)
mology department. “Our review
in the subgroup of 12 eyes with a
of the literature shows remarkably
corneal power <47 D. The next best results
little guidance on this topic.
“The findings from our analyses suggest that were achieved using the Hoffer-Q (mean abfor eyes with a corneal power <47 D, surgeons solute error 0.584 D).
There were 7 eyes with a corneal power ≥47
might consider using the Holladay II formula
with the double-K adjustment or the Hoffer- D to 49.95 D, and in that subgroup, the lowest
Q if that is not available and with a target of mean absolute error resulted using the SRK-T
formula (0.956 D). For the other 4 formulas,
–1.0 D,” Dr. Truong said.
take-home
the mean absolute error ranged from 1.196 D
(Holladay II) to 1.716 D (Holladay II with double-K adjustment).
The remaining 3 eyes had a corneal power
≥55 D, and for those eyes, all formulas resulted
in a larger hyperopic error (mean ≥11.5 D).
“Comparing eyes with a corneal power <47
D and >47 D, we found no significant differences between them preoperatively in patient
age, BCVA, MRSE, or biometric characteristics
other than corneal power—although there was
a trend for the anterior chamber depth to be
more smaller in eyes with the lower corneal
power,” Dr. Truong said.
PRIOR R ESEARCH
Discussing published research on different
methods of IOL power calculation in eyes
with keratoconus, Dr. Truong cited a study
by Thebpatiphat et al. that included 12 eyes
[Eye Contact Lens. 2007;33:244-246]. Comparing the SRK, SRK-II, SRK-T formulas for IOL
calculation, the researchers found the most accurate results were achieved using the SRK-II.
Another paper by Watson et al. evaluated
results in a series of 92 eyes with mild to severe keratoconus [Br J Ophthalmol. 2014;98:361364]. They found they had good outcomes by
targeting low myopia and using the SRK-T formula with actual K values in eyes with mild
or moderate keratoconus.
Continues on page 19 : IOL power
Richard Lindstrom, MD
Ophthalmologist and
noted refractive and
cataract surgeon.
Minnesota Eye Consultants
“Good lid and lash hygiene is not a sometime event.
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^S\hQMWZhZWQVhUWR]RaRUW\R]2]Q;aRP^\\R]Q
Avenova to my patients.”
Daily lid and lash hygiene.
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OPHTHALMOLOGIST AND OPTOMETRIST TESTED
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SEPTEMBER 1, 2015 :: Ophthalmology Times
18
Special Report )
TOP-NOTCH ASSESSMENTS IN THE TREATMENT OF CORNEAL
DISEASE
En-bloc PK with KLAL a novel approach
for severe limbal stem cell deficiency
Combined procedure affords patients possibility of faster visual recovery, less risk for rejection
By Cheryl Guttman Krader; Reviewed by Farid Karimian, MD
of eyes and with longer follow-up is needed.”
To date, Dr. Karimian has performed enplasty (PK) with annular keratolimbal al- bloc PK with annular KLAL in 14 eyes that had
lograft (KLAL) transplantation is a promis- total limbal stem cell deficiency. The underlying technique for the management of eyes ing causes for the ocular surface damage were
with total limbal stem cell severe chemical burns in 10 eyes and mustard
deficiency needing corneal gas exposure in 4 eyes.
Preoperative best-corrected visual acuity
transplantation, said Farid
(BCVA) in the 14 eyes ranged from light perKarimian, MD.
ception to hand motion. All pa“Compa red
w it h a s t a ge d
tients had clinical evidence of limbal stem cell deficiency based on
approach where
Dr. Karimian
presence of corneal opacification,
360° KLAL is perand the diagnosis was confirmed
formed as a first step followed
Simultaneous en-bloc
3 to 6 months later by central central penetrating
by impression cytology in 10 eyes.
No significant intraoperative
PK, en-bloc PK combined with keratoplasty and
complications were encountered
KLAL offers patients the oppor- peripheral lamellar
in the series. After surgery, patients
tunity for faster visual recovery keratoplasty with
and should have less risk for re- annular keratolimbal
were started on treatment with tacrolimus 2 mg/day and mycophejection since it does not require allograft transplantanolate mofetil 1 gm/day, and the
three donors,” said Dr. Karimian, tion provides patients
immunosuppressive medications
professor of ophthalmology, Sha- with severe limbal stem
hid Beheshti University of Medi- cell deficiency the
are tapered over a period of 18 to
24 months.
cal Sciences, and director, cornea benefit of rapid visual
Available follow-up for the 14
and anterior segment surgery ser- recovery.
patients was between 6 and 32
vice, Labbafinejad Medical Cenmonths. At last visit, BCVA ranged from count
ter, Tehran, Iran.
In addition, because corneal-KLAL ring su- fingers to 20/40, and 11 eyes had BCVA betturing is not needed, the procedure time is ter than 20/200.
“The vision improves immediately after the
shorter than simultaneous 360° KLAL with
central PK, and risks of interface leakage operation, but it may take a few months to be
stabilized,” Dr. Karimian said.
There have been 3
cases of limbal stem cell
rejection, but all could
be controlled medically.
Endothelial graft rejection occurred in 4 eyes.
— Farid Karimian, MD
Other postoperative complications included corand wound apposition problems are reduced, neal epithelial defect, hyphema, and hyptony
that occurred in 2 eyes.
he noted.
“So far in these challenging eyes, the comSURGERY DETAILS
bined procedure has been associated with acceptable safety and functional outcomes after The surgery—which is performed under genshort- and medium-term follow-up,” Dr. Karim- eral anesthesia and takes an average of 2 to 3
ian said. “More experience in a larger number hours—begins with 360° of limbal peritomy
T EHR AN, IR AN ::
EN-BLOC PENETRATING kerato-
take-home
‘More experience in a larger
number of eyes and with longer
follow-up is needed.’
OCULAR SURFACE BURN
VIDEO Watch an en-bloc KLAL technique
combined with central PKP for the management
of a patient case with severe ocular surface burn.
(Video courtesy of Farid Karimian, MD)
Go to http://bit.ly/1hIHtG3
and release and resection of fibrotic tissues.
After hemostasis of episcleral vessels, a circumferential scleral flap (one-third thickness)
is formed 2 mm from the limbus using a crescent knife. The dissection is extended over
the patient’s cornea, resecting all scarred and
opacified anterior lamellae. To reduce the risk
of future rejection, the central cornea (which
will be full-thickness), is trephined with a 7.5mm trephine.
Donor limbal stem cells are harvested with
underlying partial thickness sclera, and central
full-thickness cornea from the whole globe is
provided by the Central Eye Bank of Iran. The
donor cornea trephination is performed from
the endothelial side and made 0.5 mm smaller
than the recipient cornea ring.
Finally, a scleral flap (wing) is sutured to the
recipient scleral bed and donor limbal conjunctiva to the recipient surrounding conjunctiva. ■
FARID KARIMIAN, MD
E: [email protected]
This article was adapted from Dr. Karimian’s presentation during the 2015 meeting of
the American Society of Cataract and Refractive Surgery. Dr. Karimian has no financial
or proprietary interests to disclose.
SEPTEMBER 1, 2015 :: Ophthalmology Times
Special Report )
19
TOP-NOTCH ASSESSMENTS IN THE TREATMENT OF CORNEAL
KERATITIS
( Continued from page 1 )
0.5 to 1 mm outside of the infected tissue.
At least 16 interrupted sutures using 9-0
or 10-0 nylon were used to strengthen the
wound integrity.
If a cataract was present, it was not removed
at the time of surgery unless the capsule was
violated.
Statistical analysis showed that graft size
ranged from 10 to 16 mm (median 11 mm).
Follow-up times were from 3 to 105 months
(median 27 months).
Structural integrity was maintained in 35
eyes, Dr. Trief noted.
However, 21 of the total 41 patients required
a repeat transplant or implantation of an artificial cornea (Boston Keratoprosthesis [KPro],
Massachusetts Eye and Ear). Ultimately, 30 patients had a clear graft or stable KPro.
Seventy-one percent of eyes had improved
final best-corrected visual acuity (BCVA) compared with their presenting acuity, and final
BCVA was 20/50 or better in 34%.
DISEASE
lead to less postoperative astigmatism and
cylinder, a factor that could have been in
play with these patients.
However, the eyes with larger
INFECTIOUS
graft size had higher rates of
ETIOLOGY
development or progression of
Acanthamoeba was the most
Large-diameter
glaucoma (p = 0.025). This is
commonly found organism,
penetrating
likely because the larger grafts
present in 12 of the 41 eyes.
keratoplasty for
affect the angle of the eye, alFurther, the visual acuity outinfectious keratitis
tering the dynamics of draincomes varied by etiology. The
may warrant a more
age and IOP, she noted.
eyes infected by Acanthamprominent place
Half of the patients in this
oeba had the best results, posin the treatment
review developed glaucoma or
sibly because the wide exciparadigm, suggest
experienced progression of dission helped eradicate the orresults of a
ease postoperatively. Because of
ganisms, Dr. Trief said.
retrospective chart
this risk, LDKP patients should
The two patients whose inreview.
be followed closely on a longfections were caused by herpes
term basis. ■
simplex virus had the worst
outcomes. Overall, the initial infection was
eradicated in 85% of patients following LDPK.
“Initial vision was predictive of the final vision (p = 0.002),” Dr. Trief said.
TAKE-HOME
EFFECT OF GR AFT SIZE
Another interesting finding was that graft
size did not influence final visual acuity, according to Dr. Trief.
“It didn’t seem to matter if your graft was
10 mm or 16 mm,” she said, adding that some
studies have shown that larger graft sizes
IOL POWER
( Continued from page 16 )
Consistent with the study by Drs. Truong and
Bowman, use of the actual K values resulted in a
larger hyperopic error in eyes with severe keratoconus (mean K >55D). Much better results were
achieved in eyes where a standard K value of 43.25
D was used with a mean target refraction of –1.8 D.
However, while the mean prediction error was just
+0.6 D, there was still a wide range in the outcomes.
While the double-K adjustment of the Holladay
II formula has been advocated by some as a means
for better sizing the keratoconic eye, there is a lack
of published data pertaining to that strategy, Dr.
Truong noted.
Use of the SRK-T is sometimes considered since
it is reputed to achieve better results than the SRKII in myopic eyes and keratoconus is frequently associated with myopia. ■
DAVID T. TRUONG, MD
E: [email protected]
This article was adapted from Dr. Truong’s presentation during Refractive Subspecialty Day at the
2014 meeting of the American Academy of Ophthalmology. Dr. Truong and Dr. Bowman have no
relevant financial interests to disclose.
DANIELLE TRIEF, MD
E: [email protected]
This article is based on Dr. Trief’s presentation at the 2015 meeting of the American
Society of Cataract and Refractive Surgery. A manuscript is being prepared for publication. Dr. Trief did not report any relevant disclosures.
ARVO Foundation announces
David L. Epstein Award for glaucoma
HONORING THE memory of a long-
the treatment of glaucoma, leading to 10
time leader in glaucoma treatment and re- patents that involve all aspects of ophsearch, the Association for Research and thalmic patient care and treatment, acVision in Ophthalmology (ARVO) Foun- cording to a prepared statement released
dation for Eye Research will present the by ARVO.
“David Epstein was a giant
Dr. David L. Epstein Award.
in the field of glaucoma reThe $100,000-prize award
The $100,000-prize
search, as well as being an
was established by the late
award was established
inspiring mentor to young
Dr. Epstein’s family and will
by the late Dr. Epstein’s
researchers and a valuable
be presented annually to
family and will be
leader within ARVO,” said
a senior-level glaucoma
presented annually to a
Mark Petrash, PhD, FARVO
researcher at the ARVO
senior-level glaucoma
researcher at the ARVO
and chairman of the ARVO
annual meeting. The first
annual meeting.
Foundation. “The ARVO
award will be given at ARVO
Foundation is grateful to the
2016 in Seattle.
Epstein family for allowing us to
Prior to his passing in March
2014, David L. Epstein, MD, was the Jo- help carry on his legacy through this
seph A.C. Wadsworth Clinical Profes- award. It demonstrates how enduring
sor of Ophthalmology. He was chairman a leader’s influence can be.”
Applications for the Epstein Aware will
of the Department of Ophthalmology at
Duke University School of Medicine for be accepted through Oct. 30. Go to www.
arvo.org/Foundation/Epstein for more in22 years.
Dr. Epstein developed novel drugs for formation. ■
SEPTEMBER 1, 2015 :: Ophthalmology Times
20
Special Report )
TOP-NOTCH ASSESSMENTS IN THE TREATMENT OF CORNEAL
DISEASE
Bioengineered cornea may address
unmet need for human donor corneas
Option could receive CE Mark this year for superficial, deep anterior lamellar keratoplasty
By Adrianne Resek, MA
MORE THAN 45 million people worldwide
who are blind or severely visually impaired—
with at least 10 million of those unilaterally
or bilaterally blind from corneal disease or injury—could benefit from a corneal transplant,
estimates the World Health Organization.1
With less than 150,000 corneal transplants
performed each year worldwide, however, due
to a shortage of transplantable corneas, bioengineered corneas may be a potential solution to address a large part of this global need.
Penetrating and lamellar keratoplasty are
used to treat a large number of diseases from
corneal opacity, corneal thinning, corneal scars,
trauma, and corneal dystrophies.
Percent of Blindness Caused by Corneal Diseases
Established Market countries: 0
China:
17.6%
Latin America
and Caribbean:
6.8%
SU PPLY A N D DE M A N D
Africa:
R ELATION
19.4%
Lack of healthcare funding and infrastructure
for eye banking in many countries are major
reasons for the shortage of donor eye tissue.
In such areas as the United States and Europe,
there is a network of eye banks that generally
Source: Data on Global Blindness, World Health Organization 1995
meet or exceed local need.2,3
For instance, data from the Eye Bank Association of America indicate 128,600 whole eyes and Latin America—with the need exceeding
and corneas were donated in 2014 and a total corneal donations.5,6
of 76,341 were found to be suitable for corneal
Human corneas have a success rate of begrafts. There were 46,253 corneal transplants tween 69% and 97% at 2 years, depending on
performed in the United States in
the geographic location and pro2014, with the difference shared
cedure. The tissue-processing fee
with other countries.
also varies widely from $125 in
European eye banks recover
developing countries to a $3,000
about 35,000 corneas annually, with
base fee in the United States.7,8,9
The development of a
25,000 used for keratoplasty. Wait- bioengineered cornea
ing for corneal transplantation in may serve to provide
A LT ER NAT I V E S
the United States is not a signifi- corneas to the millions
TO HUMAN CORNEA
cant issue, since the supply sup- of people worldwide
Up until now, it has been difficult
ports demand. In Europe, supply unable to obtain a
to find a substitute for a human
and demand are not equal across human donor cornea.
cornea, with the few artificial opcountries.
tions relegated to severe cases that
The situation worsens in underdeveloped did not succeed with human corneas.
parts of the world. India has the largest popImplantation with a certain artificial cornea
ulation of blind individuals in the world, and (Boston Keratoprosthesis [KPro], Massachuneeds minimally 100,000 corneas per year.4 setts Eye and Ear) is primarily performed in
About 25,000 corneal transplants are performed severe cases with prior corneal surgery. The
largest study to date shows a retention rate of
annually in India.
The situation is similar across Africa, Asia, 95% at 8.5 months.10
take-home
Other Asia and
Islands: 23.6%
India:
9.7%
Middle Eastern
Crescent: 25.7%
Complications include retroprosthetic membrane in 25% of patients, high IOP in 15%, and
sterile vitritis in 5% of eyes. The 2010 cost of
the device was $5,000, although it is available
on a sliding scale to poorer nations.
The bioengineered cornea (LinCor Biosciences) is the first pending option that is a true
alternative to human donor corneas, according
to the company. The cornea is manufactured
from type III recombinant human collagen and
cross-linked with biopolymers that form a scaffold structure similar to the interpenetrating
network of the human cornea. The result is
a biologic material that integrates with the
host cornea as compared with artificial keratoprosthesis. The bioengineered cornea also
may have a 6-month shelf life—significantly
longer than human cadaver corneas.
The bioengineered cornea has been studied for more than 10 years with excellent outcomes. In a comparison of 10 patients with the
bioengineered cornea implanted and a similar
group of patients with human donor corneas
SEPTEMBER 1, 2015 :: Ophthalmology Times
Special Report )
21
TOP-NOTCH ASSESSMENTS IN THE TREATMENT OF CORNEAL
The bioengineered
cornea may have a
6-month shelf life—
significantly longer
than human cadaver
corneas.
a large series of corneal transplants in India. Br J
Ophthalmol. 1997;81:726e31.
9. Thompson RW Jr, Price MO, Bowers PJ, Price
FW Jr. Long-term graft survival after penetrating
keratoplasty. Ophthalmology. 2003;110:1396-1402.
10. Zerbe BL, Belin MW, and Ciolino JB. Results from the
multicenter Boston Type 1 Keratoprosthesis Study.
Ophthalmology. 2006;113:1779 e1-7.
11. Fagerholm P, Lagali N, Ong J, et al. Stable corneal
DISEASE
regeneration four years after implantation of a
cell-free recombinant human collagen scaffold.
Biomaterials. 2014;35:2420-2427.
Holland
DALK SCISSORS
implanted, patients who received the biosynthetic cornea had a faster healing time, required
less postoperative steroids, and improved regrowth of corneal nerves.11
The biosynthetic cornea shape, thickness,
and graft borders also remained constant out to
4 years. In the safety study, the human donor
cornea recipients gained 9.9 lines of visual
acuity, while the biosynthetic cohort had a
5.6-line gain.
The developer of the bioengineered cornea
has also established the independent Corneal
Transplant Foundation, whose mission is to
provide information on corneal transplantation and support research on the topic, as well
as assist patients in need economically to obtain transplants.
It is anticipated the bioengineered cornea
will receive CE Mark in late 2015 for superficial and deep anterior lamellar keratoplasty,
according to the company. ■
to safely excise stromal tissue
K4-5075
This Vannas-style scissors
has straight “micro blades”
that are steeply angled
to facilitate the dissection
of stromal tissue out to the
periphery. The distal tips
of each blade are rounded
and blunt to help protect
underlying tissue while
cutting.
References
1.
2.
3.
4.
5.
6.
7.
8.
World Health Organization. Prevention
of blindness and visual impairment:
priority eye diseases.
http://www.who.int/blindness/causes/en/
Eye Bank Association of America.
http://www.restoresight.org
European Eye Bank Association.
http://www.europeaneyebanks.org
Rahmathullah R, Srinivasan M, Rajkumar A.
Eye banking for developing countries in the new
millennium. Vision 2020 e-resource.
http://www.v2020eresource.org
Association of Eye Banks of Asia.
http://eyebankingasia.org
Pan American Association of Eye Banks.
http://www.apaboeyebanks.org
Claesson M, Armitage WJ, Fagerholm P, Stenevi
U. Visual outcome in corneal grafts: a preliminary
analysis of the Swedish Corneal Transplant Register.
Br J Ophthalmol. 2002;86:174e80.
Dandona L, Naduvilath TJ, Janarthanan M, Ragu
K, Rao GN. Survival analysis and visual outcome in
K4-2018 right
K4-2019 left
These sharply curved scissors (right and left) feature miniature blades that
closely match the radius of the previously dissected peripheral rim. The
inner blade has a blunt, horizontally-oriented, spatulated tip which keeps the
scissors in the proper plane, minimizing inadvertent perforation. The delicate,
shortened, outer blade allows the surgeon to trim the tissue near the wall in a
precise fashion.
Watch it!
®
Designed by
Edward Holland, MD
Cincinnati, Ohio
973-989-1600r800-225-1195 r www.katena.com
SEPTEMBER 1, 2015 :: Ophthalmology Times
22
Special Report )
TOP-NOTCH ASSESSMENTS IN THE TREATMENT OF CORNEAL
DISEASE
Modified Anduze technique enhances
outcomes with pterygium excision
Approach maintains low complication, low recurrence rates with change in MMC application
By Lynda Charters; Reviewed by William B. Trattler, MD
MIAMI ::
A SCLERAL MELT IS AMONG the
procedure, Dr. Anduze—who developed the Anmajor risks when using mitomycin C (MMC) duze bare scleral approach in the 1990s—reported
in pterygium surgery. Most surgeons may rec- that of 870 cases who underwent scleral conjuncognize the risk associated with placement of a tival flap excision with one application of 0.1 cc
sponge soaked in MMC directly on the scleral of 0.4 mg/mL of MMC to the subconjunctival
bed, and avoid it by placing sponges soaked with space, only 3 pterygia recurred (Anduze AL. PteMMC under the subconjunctival tissue for 1 to rygium surgery with mitomycin-C: ten-year re4 minutes to keep the scleral bed free of MMC. sults. Ophthalmic Surg Lasers. 2001;32:341-345).
Alfred Anduze, MD, developed a modification to this method of MMC application in
MODIFIED TECHNIQUE
which he placed a small injec- Dr. Trattler begins the procedure with a subtion of MMC directly into the conjunctival injection of 2% lidocaine with
subconjunctival tissue. The use epinephrine into the lesion. He creates a linof this technique appears to ear incision to isolate the head of the pterygprovide excellent safety, with ium and elevate it. The head is removed and
a low recurrence rate.
the cornea is polished with a diamond burr.
Though numerous tech- The subconjunctival fibrovascular tissue is reDr. Trattler
niques for pterygium removal moved, which is important to preventing reexist, some are associated with high rates of re- currences, before MMC is injected.
currence or an increased rate of complications,
MMC 0.02% (0.1 cc) is injected into the subsaid William B. Trattler, MD, in priconjunctival tissue using a 30-gauge
vate practice, Miami, and volunteer
needle with care taken to protect
assistant professor of ophthalmolthe bare sclera. MMC remains in
ogy, Florida International Univerthe tissue at the end of surgery.
sity Wertheim College of Medicine.
The area is rinsed with balanced
Avoiding use of
Current management includes mitomycin C on the
saline solution. At the conclusion
various types of grafts using su- scleral bed during
of the surgery, no cautery is pertures or tissue glue and adjunctive pterygium extraction is
formed or glue applied.
therapies that include application of a modification of the
MMC. Previous recommendations Anduze bare scleral
C A SE ST U DY
for application of MMC were found approach.
Dr. Trattler and colleagues conto be incorrect, and they specifically
ducted a retrospective case study
instructed that a sponge saturated with MMC to evaluate the effectiveness of the subconjuncbe placed on the bare sclera for 1 to 3 minutes tival injection of MMC after pterygium removal.
after pterygia are removed, Dr. Trattler offered.
Patients were included who had either priThough MMC is used by surgeons to maintain mary or recurrent pterygia and underwent
a low recurrence rate, it is critical that MMC bare sclera excision with injection of 0.1 cc
be used properly to avoid complications, such of 0.02% MMC into the subconjunctival tisas scleral melts. Based on work published by sue. No cautery was applied; MMC was not
Dr. Anduze, Dr. Trattler noted he injects the applied to the bare sclera; and no suture or
drug into the subconjunctival tissue to avoid tissue glue was used.
the bare sclera completely.
On postoperative day 1, all patients received
Inflammation also plays a key role in the a silicone punctal plug in the lower punctum to
pathogenesis and recurrence of pterygia.
avoid dry eye. All patients were on an 8-week
“Therefore, limiting the use of pro-inflamma- tapering dose of a strong topical steroid, during
tory sutures or glues also can be advantageous which time IOP was measured 3 and 6 weeks
in preventing pterygium recurrence,” he said. postoperatively.
Underscoring the importance of MMC to the
Follow-up visits included evaluation of the
take-home
SURGICAL TECHNIQUE
VIDEO Watch a short ptergyium excision
(no graft) technique with the use of MMC 0.02%
injected into the subconjunctival tissue.
Go to http://bit.ly/1hJDl8D
Go to http://bit.ly/1LA8PYA
(Videos courtesy of William B. Trattler, MD)
cosmetic appearance of the eye, development
of any complications, and signs of pterygium
recurrence.
A total of 112 eyes were studied. The average patient age was 53 years (range, 19 to 78
years). Most (62.5%) patients were men. Patients were followed for an average of 171.4
days (range, 1 to 1,026 days).
Dr. Trattler reported pterygium recurrences
in 2 (1.8%) eyes. Complications occurred in 4
(3.6%) eyes, with pyogenic granuloma the only
problem. The granulomas were excised under
slit lamp observation. No vision-threatening
complications developed. There were no cases
of scleral melt. The 2 eyes with early recurrences were treated with topical anti-inflammatory medications.
“The results of this clinical review demonstrated that the Anduze bare scleral approach
is an effective surgical technique for pterygium
excision,” Dr. Trattler said. “Injection of 0.1
mL of MMC directly into the subconjunctival
space provides excellent results with minimal
risk to the patient.” ■
WILLIAM B. TRATTLER, MD
E: [email protected]
Dr. Trattler and colleagues have no financial interest in any aspect of this report.
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24
SEPTEMBER 1, 2015 :: Ophthalmology Times
clinical diagnosis
PXF role explored in late IOL
subluxation/dislocation
Histopathologic analysis provides insight on disorder as risk factor; highlights underdiagnosis
By Cheryl Guttman Krader; Reviewed by Nick Mamalis, MD
SALT L AK E CI T Y ::
seudoexfoliation (PXF) is a key
A
risk factor for late spontaneous IOL
subluxation/dislocation, reinforce
findings from a histopathologic
study. The research also indicates
that because of significant clinical underdiagnosis, PXF may be
responsible for more of these complications than
previously thought, said Nick Mamalis, MD.
The study was conducted at the Intermountain Ocular Research Center, John A. Moran
Eye Center, University of Utah,
Salt Lake City, where 53 consecutively explanted specimens
from 53 patients were examined. The explantations were
provided by two surgeons from
Goethe-University, Frankfurt,
Dr. Mamalis
The first step is to recognize PXF. Careful
Germany, and occurred from
preoperative evaluation is critical because PXF
December 2011 to February 2014.
A variety of IOL materials and designs were may be subtle and difficult to diagnose, Dr.
represented, and in three specimens, there was Mamalis noted. He added that his lab often
receives IOLs removed due to dislocation, but
an IOL and capsular tension ring (CTR).
Based on complete histopathological analy- sometimes they do not receive the capsular bag.
Dr. Mamalis and colleagues
sis, 33 (62%) of the 53 explanted
reported finding a clinical hiscapsular bags had evidence of
tory of PXF in 50% of 86 late
PXF. Review of corresponding
Histopathologic
dislocated IOLs they analyzed
charts from the latter cases
analysis of 53
[Davis D, et al. Ophthalmology.
showed evidence of PXF for
consecutive IOL2009;116:664-670]. None of those
only 16 (48.5%) of the 33 eyes.
capsular bag
cases had a CTR, but in a followspecimens explanted
up study including only specRECOGNIZING PXF
after late in-the-bag
imens with a CTR, 74% were
“Our findings indicate that all
IOL subluxation/
from patients with a history of
types of IOLs are susceptible to
dislocation identified
PXF [Werner L, et al. Ophthallate spontaneous dislocation and
pseudoexfoliation
mology. 2012;119:266-271].
that a CTR is not protective,”
in 33 (62%) of
In contrast, the intact capsaid Dr. Mamalis, professor of
cases—less than
sular bag was available for all
ophthalmology, John A. Moran
half of which had a
specimens in the current study,
Eye Center, and co-director, Inclinical diagnosis of
allowing evaluation for signs of
termountain Ocular Research
pseudoexfoliation.
PXF on the capsular bag.
Center. “However, when PXF
“We suspected that the inis recognized preoperatively,
cidence of PXF among cases of
surgeons can implement measures intraoperatively and postoperatively that late spontaneous IOL dislocation/subluxation
may reduce the risk of late IOL dislocation/ was higher than what we were finding before,”
Dr. Mamalis said. “Access to the capsular bag
subluxation.”
P
TAKE-HOME
B
A. A low-powered photomicrograph of a capsular bag
with the classic “iron-filing” pattern of deposition of
pseudoexfoliative material on the anterior capsule
(trichrome stain). B. A higher-powered photomicrograph of the anterior capsule with deposition of
exfoliative material anteriorly and proliferative lens
cortical material posteriorly.
(Images courtesy of Nick Mamalis, MD)
for all cases in the current series allowed us to
get a better idea of the true incidence.”
Patients from whom the specimens were obtained had a mean age of 77 years. The majority
was from women. Mean time to explantation
for the 53 specimens was 12.2 years. IOLs included 1- and 3-piece hydrophobic acrylic and
hydrophilic acrylic lenses, as well as 3-piece
silicone IOLs and 1-piece PMMA IOLs.
Histologic evidence of PXF material in the
current study was based on identification by
an observer masked to diagnosis of an amorphous substance on the outer surface of the
anterior lens capsule in an “iron-filing” pattern.
Measures to reduce the risk of late in-thebag IOL dislocation in eyes diagnosed preoperatively with PXF include creation of a generously sized capsulotomy and careful surgical
technique to minimize zonular stress. In addition, careful follow-up is indicated. ■
NICK MAMALIS, MD
E: [email protected]
This article is adapted from Dr. Mamalis’ presentation at the 2015 meeting of the American Society of Cataract and Refractive Surgery, which was an update to a published
report based on 40 specimens [Liu E, et al. J Cataract Refract Surg. 2015;41:929935]. Dr. Mamalis is a consultant/advisor for companies that market IOLs.
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26
SEPTEMBER 1, 2015 :: Ophthalmology Times
drug therapy
Topical delivery via MPP
aims to block VEGF signaling
Animal models explore receptor tyrosine kinase inhibitor as noninvasive retinal disease therapy
By Lynda Charters; Reviewed by Lisa Schopf, PhD
WALT HAM, MA ::
topical receptor tyrosine kinase
inhibitor candidate (K106, Kala
Pharmaceuticals) is designed to
potently and selectively block
vascular endothelial growth factor (VEGF) signaling.
When applied topically in animals as mucus-penetrating particles (MPPs),
the drug reached the back of the eye—implying
potential relevance in retinal disease therapy,
according to Lisa Schopf, PhD.
Mucus is an innate defense mechanism comprising a heterogeneous mesh
of mucin that defends against
pathogens and other particles
by excluding particles larger
than its pore sizes. In this situation, glycosylated macromolecules bind to foreign particles
Dr. Schopf
to facilitate clearance.
MPPs should be able to overcome both steric exclusion and binding to allow for more
efficient delivery of drugs in mucus-protected
tissues.
“The MPPs rapidly and uniformly coat and
penetrate mucosal barriers, and have the potential to increase drug exposure to underlying tissues and improve topical ocular drug
delivery,” said Dr. Schopf, senior director of
preclinical development, Kala Pharmaceuticals.
The goals of Dr. Schopf and colleagues in
A
this research were to design a small molecu- the back of the eye that were well above the
lar inhibitor of the VEGF signaling pathway IC50 level.
In the rabbit model of vascular leakage, K106that was highly potent against VEGF receptors
and against the platelet-derived growth factor MPP gave significantly decreased vascular leakage compared with the vehicle
receptor with good selectivity
control, which suggested that
against particular growth factopical instillation delivered biotor, cell cycle, and other detriA topical receptor
logically active concentrations
mental receptors. The K106 aftyrosine kinase
of this novel drug formulation
finity for KDR over the other
inhibitor may be a
to the back of the eye, accordtargets—i.e., EGFR, FGFR1, and
potential noninvasive
ing to Dr. Schopf.
RET—were 680, 188, and 28inhibitor of vascular
In the larger mini-pigs, the
fold, respectively.
endothelial growth
results confirmed the drug levels
Ocular and systemic pharmafactor signaling.
at the back of the eye with chocokinetics of K106-MPP were
roidal and retinal tissue levels
evaluated after topical instillawere well above the IC50 levels.
tion in rabbits and mini-pigs.
“We demonstrated that K106 is a potent and
selective VEGF signaling inhibitor,” Dr. Schopf
DOS AGE COMPA R ISON
After one topical 0.5% dose to rabbits, the drug summarized. “When applied topically as a MPP,
concentrations—which were expressed as the the drug reaches the back of the eye in rabbits
area under the curve calculated over 0 to 12 and mini-pigs. The ability to reach the back
hours—were 4,270 in the choroid, 474 in the of the eye may be a major breakthrough in
providing a noninvasive means to treat retiretina, and 9 nM*hr in the plasma.
Multiple doses given twice daily for 5 days nal disease.” ■
were also studied in rabbits and compared
with single doses. The multidose drug levels
in the choroid were 8-fold higher and in the
LISA SCHOPF, PHD
retina 2-fold higher compared with the single
E: [email protected]
dose, Dr. Schopf noted.
This article was adapted from a poster presentation at the 2015 meeting of the
Little or no change was seen in the plasma
Association for Research in Vision and Ophthalmology. Dr. Schopf is an employee of
levels. The MPP delivered concentrations to
Kala Pharmaceuticals.
TAKE-HOME
Avalanche, Avellino Labs recognized as 2015 technology pioneers
TWO COMPANIES in the ophthalmic
space—Avalanche Biotechnologies and Avellino
Labs—have been recognized as 2015 Technology Pioneers by the World Economic Forum.
Avalanche, a biopharmaceutical company
committed to improving or preserving the sight
of people suffering from blinding eye diseases
with an unmet medical need, was selected
in recognition of its achievements in adenoassociated virus-based gene therapy technology,
while Avellino Labs, a leader in genetic testing
for eye care, was honored for its DNA test that
is able to positively identify with high accuracy
a patient’s granular corneal dystrophy status.
Both firms were among 49 companies selected based on their potential to transform and
impact global health, and will be invited to the
World Economic Forum’s “Summer Davos” in
Dalian, China, this month, or the annual meeting in Davos, Switzerland, in January 2016. ■
27
SEPTEMBER 1, 2015 :: Ophthalmology Times
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SEPTEMBER 1, 2015 :: Ophthalmology Times
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SEPTEMBER 1, 2015 :: Ophthalmology Times
practice management
Asking for staff opinions
can be double-edged sword
When feedback comes out of the blue, listen for what may or may not have value
Putting It In View By Dianna E. Graves, COMT, BS Ed
“When we have our all-staff meetings, I
n the middle of a bad day—nestled in
want to hear what the staff says because
the heart of an extremely poor week—
they are key to my practice,” she comthe only solace I had from the insanity
mented. “Without them, I can’t do any of
of the clinic one afternoon was to keep
this. It seems that with some practices,
my dentist appointment. What more
management and doctors alcould the dentist do to me
ways ask their staff what
that had not already been
they think but they don’t
done to me this week?
want to listen to what they
I had already been drilled
Everyone has an
have to say!”
by a physician who, in one
opinion, but are clinic
The light flashed in front
morning shift, had figured
managers prepared
of
my eyes and the sound
out a major problem in the
to listen to staff
of
the ocean filled my head.
largest clinic we have. Unfeedback? ponders
This
was exactly it in a
fortunately, while the anDianna Graves.
nutshell.
swer was an excellent soluAs managers, we are contion for him, his fellow parttinually given advice, direcners would blow the roof off
tives, mandates, and opinif the technicians were to follow his idea in
ions. I have learned so
their clinic.
many lessons through the
I had also had a raw nerve tweaked reyears about opinions and
garding staffing. One of my longest-tenured
the giving and receiving of
technicians—more than 30 years—gave her
those opinions.
2-week notice.
In most cases, I have
My fellow manager said: “Did you think
been able to weed out the
she was going to work until she was 100?!
good and the bad opinions
You knew it was going to happen sooner
when they are freely ofthan later.”
fered. I listen to each one,
No, I did not think she would work until
though I have to admit I
she was 100. However, I had also been notihave had to bite my tongue
fied the same morning that two technicians
while doing so.
are going to need surgery and then be out
Here are some of the valuable lessons I
at least 3 weeks apiece. I would have been
have learned:
thankful to barter for another month or so.
Yes, I was thankful to be sitting in the
dentist chair. Unlike some people, I honestly
“R EMEMBER W HEN I ASK ED
like my dentist. She has always been kind
YOU YOUR OPINION? Y E A H,
and patient. When I told her no way was I
NEITHER DO I.” (AUTHOR
letting her get me ready for an upcoming
UNK NOW N; T-SHIRT AT THE
crown on a grumpy tooth, she simply smiled BE ACH)
at me and advised she couldn’t wait to use
People usually feel free to voice their opingas on me to help me relax.
ions. Since they are theirs, they often feel
that they can offer their opinions without reGETTING TO THE
percussions. They are often meant with the
ROOT OF THE ISSUE
best of intentions, but often come out of the
After my uneventful check-up and cleanblue. If you try to refute this, the response
ing, we were talking about our offices and
usually is: “It was just my opinion, doesn’t
staffing.
mean it was right or wrong.”
I
TAKE-HOME
“CH A NGE YOUR OPINIONS ,
K EEP TO YOUR PR INCIPLES;
CH A NGE YOUR LE AV ES , K EEP
IN TACT YOUR ROOTS .” (V ICTOR
HUGO)
2
On the other hand, opinions can be the
key to a locked door. Keeping an open
mind to others’ opinions can be enlightening when you cannot find a solution to
an issue. Even with adversaries, you often
can find their experiences have some
value as to what may occur in your own
world.
Often, while attending ophthalmic
meetings each year, some of the most
valuable lessons for me as a manager are
the one-on-one sessions that occur be-
‘Your opinion is no more
valuable than anyone else’s,
and can even be harmful in
the wrong venue or delivery
approach.’ — Dianna E. Graves, COMT, BS Ed
1
tween classes. These curbside discussions
could be about what is occurring in clinics with Meaningful Use or with ICD-10,
for example.
While you may agree or disagree with
the other person speaking and his or her
managerial style, he or she might have experience in the area that you are trying to
navigate.
If you are willing to keep to your beliefs, “keep intact your roots” that define
you and your world, but also be willing
to “change the leaves” and bend a little to
shed some of the old thought processes,
you may find the answers you seek.
Continues on page 30 : Opinions
29
30
SEPTEMBER 1, 2015 :: Ophthalmology Times
practice management
your opinion is no more valuable than anyone else’s, and can even be harmful in the
wrong venue or delivery approach.
As a manager, your opinion can help open
employees’ eyes, instill faith in the job they
are doing, or it can devastate them with a
misplaced sentence on what you believe.
OPINIONS
( Continued from page 29 )
“THER E A R E T WO K INDS OF
FOOLS: THOSE W HO C A N'T
CH A NGE THEIR OPINIONS
A ND THOSE W HO WON'T.”
( JOSH BILLINGS)
3
TOMOR ROW IS A NOTHER DAY
As I sit here, way past everyone has left the
building, my quiet revelry is disturbed by
the cleaning service readying the office for
the next business day. I pause one last time
to realize that this dreaded trip to the dentist has allowed me to reflect on all these
thoughts, and to realize that while everyone
has an opinion, it doesn’t mean that I need
to heed them, or even take them to heart.
No matter the volume of the words, this
tree still stands, and tomorrow will be another day. Bring it on! ■
Stick to your beliefs, but know when it is
time to throw in the towel and head in a different direction. Living by the sword and
being willing to march into hell for those
opinions can turn you into a martyr for a
cause no one will remember in 6 months.
It does no one any good if you are so
ridged that you cannot flex with new
changes or new ideas. It only causes you to
be labeled as an obstructionist, and eventually, a person who must go.
“JUDGING A PERSON DOES
NOT DEFINE W HO THEY A R E .
IT DEFINES W HO YOU A R E .”
(AUTHOR UNK NOW N)
DIANNA E. GRAVES, COMT, BS ED
E: [email protected]
Dianna Graves is clinical services manager at St. Paul Eye Clinic PA,
in Woodbury, MN. Graves is a graduate of the School of Ophthalmic
Medical Technology, St. Paul, MN, and has been a member of its teaching faculty
since 1983.
4
Opinions can open doors to growth and development in other people. Be aware that
Study: Most MDs still work in small practices
MOST PHYSICIANS continue to provide
care to patients in small practices, show new
data released by the American Medical Association. Though the majority of physicians
(56.8%) still worked in practices that were
wholly owned by physicians, reform efforts
and market consolidation has led to a decrease
in physician practice ownership and the percentage of physicians working in solo practice,
which is down to 17.1% from 18.4% in 2012.
As a result, the percent of physicians working directly for hospitals or working in practices with at least some hospital ownership
increased to 32.8% from 29% in 2012. ■
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This index is provided as an additional service.
The publisher does not assume any liability for errors
or omissions.
Distribution of Physicians by Practice Size
Number of Physicians in Practice, 1983 and 2014
1983
2014
43.8%
1
25.4%
2 to 4
10.4%
4%
5%
80%
in small practice
11.5%
Source: American Medical Association
5 to 10
11 to 24
25+
Not asked
18.6%
22.3%
19.8%
12.1%
19.8%
7.5%
61%
in small practice
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