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DECEMBER 2016 VOL. 12, NO. 10
A
B
C
D
ISSUE FEATURE
Top ophthalmic
challenges
in 2017
Medical, surgical options
at forefront
RETINA
CATARACT & REFRACTIVE
Managing giant
retinal tear
re-attachment
Case involves incidental
subfoveal perfluorocarbon
heavy liquids
EXCLUSIVE VIDEO
CORNEA
Bowman
layer graft in
keratoconus
AD-IOL mimics
natural lens
movement
Novel concept for accommodating IOLs
captures, transforms zonular movement
into axial shift
PAGE 10
Transplant promising to
stabilise ectasia
CAPTION
A. The foldable implant is positioned into the
capsular bag with a restraining device that keeps
the optic temporarily in a flat position. B, C, and
D. The activated optic mimics movement of the
crystalline lens. (Images courtesy of Dr Paul M Beer)
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December 2016 l Volume 12 Number 10
contents
Glaucoma
32 Seeking evidence-based
answers to lifestyle
modification questions
Exercise, nutrition, acupuncture may
be topics to discuss with patients
Cornea
34 Exploring Bowman layer graft
in eyes with keratoconus
Surgical transplantation showing
potential to reduce, stabilise corneal
ectasia
34
Issue Feature
Retina
5 Top ophthalmic challenges
in 2017
18 Managing challenges in giant
retinal tear re-attachment
Changing healthcare environment,
medical/surgical options at forefront
Cataract & Refractive
10 AD-IOL mimics natural lens
movement
Novel concept for accommodating
IOLs captures, transforms zonular
movement
14 Evolutions in laser
technologies making
cataract surgery safer
Superior outcomes can be achieved
precisely, consistently, predictably
Unique case involves incidental
subfoveal perfluorocarbon heavy
liquids
Plastics
38 Orbital surgery aided
by 3-D printing
Computerised preop planning,
intraop models can increase fracture
repair precision
Regulars
41 Product News
20 SD-OCT enhances
visualisation earlier
in disease process
Detailed imaging facilitates evaluation
of foveal disorders
20
26 Targeting refractory vitreous
seeds in retinoblastoma
Intravitreal topotecan found
impressive for efficacy, safety
29 Exploring effects of anti-VEGF
on retinal diseases
Physicians weigh in on role of
aflibercept in treatment interval
extensions
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editorial advisory board
EDITORIAL ADVISORY BOARD
Jorge L. Alió, MD, PhD
Erik L. Mertens, MD, FEBO
Instituto Oftalmologico de Alicante,
Alicante, Spain
Antwerp Eye Center, Antwerp,
Belgium
Winfried Amoaku
Norbert Pfeiffer, MD
University Hospital, Queen’s Medical
Centre, Nottingham, UK
University of Mainz, Mainz, Germany
Gerd Auffarth, MD
University of Heidelberg, Germany
Istituto Laser Microchirurgia
Oculare, Brescia, Italy
Albert Augustin, MD
Matteo Piovella, MD
Klinikum Karlsruhe, Karlsruhe,
Germany
C.M.A. srl Centro Microchirurgia
Ambulatoriale, Monza, Italy
Rafael Barraquer, MD
Imola Ratkay-Traub, MD
Institut Universitari Barraquer and
Centro de Oftalmología Barraquer,
Barcelona, Spain
Danube Band Medical Centre,
Hungary
Christophe Baudouin, MD
Quinze-Vingts National
Ophthalmology Hospital, Paris,
France
Paracelsus University Salzburg,
SALK
University Eye Clinic, Salzburg,
Austria
Johan Blanckaert, MD
Gisbert Richard, MD
Eye & Refractive Centre, Ieper,
Belgium
University Medical Center,
Hamburg-Eppendorf, Hamburg,
Germany
Burkhard Dick, MD
Center for Vision Science, Ruhr
University Eye Hospital, Bochum,
Germany
Christoph Faschinger, MD
Medical University of Graz, Clinic of
Ophthalmology, Graz, Austria
Paolo Fazio, MD
Roberto Pinelli, MD
Herbert A. Reitsamer, MD
Theo Seiler, MD
Institut für Refraktive & OphthalmoChirurgie (IROC) and University of
Zurich, Zurich, Switzerland
University of Geneva, Geneva,
Switzerland
Sunil Shah, FRCOphth, FRCSEd,
FBCLA
Alessandro Franchini, MD
Birmingham and Midland Eye Centre,
Midland Eye Institute, Solihull, UK
David Spalton, MD
St Thomas’ Hospital & King Edward
VII’s Hospital, London, UK
Günther Grabner, MD
Einar Stéfansson, MD, PhD
University Eye Clinic Salzburg,
Salzburg, Austria
University of Iceland, National
University Hospital, Reykjavik,
Iceland
Moorfields Eye Hospital, London, UK
John Thygesen, MD
Gábor Holló ,MD, PhD, DSc
Copenhagen University Hospital
Glostrup, Glostrup, Denmark
Baha Toygar, MD
Vikentia Katsanevaki, MD
Dünya Eye Hospital, Istanbul, Turkey
Vardinogiannion Eye Institute,
University of Crete, Greece
Petja Vassileva, MD
Omid Kermani, MD
National Eye Institute, Sofia,
Bulgaria
Augenklinik am Neumarkt,
Augenlaserzentrum Köln, Germany
Jan Venter, MD
Hans-Reinhard Koch, MD
Carlos Vergés, MD, PhD
Hochkreuz Augenklinik, Bonn,
Germany
C.I.M.A. Universidad Politécnica de
Cataluña, Barcelona, Spain
Anastasios G.P. Konstas, MD, PhD
Paolo Vinciguerra, MD
1st University Department of
Ophthalmology, AHEPA Hospital,
Thessaloniki, Greece
Istituto Clinico Humanitas, Rozzano,
Milan, Italy
Pavel Kuchynka, MD
University Hospital, Leuven, Leuven,
Belgium
Charles University, Prague, Czech
Republic
Optimax UK & Croydon Clinics, UK
Thierry Zeyen, MD
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DECEMBER 2016 :: Ophthalmology Times Europe
IS SU E F E AT U R E
2017 outlook for ophthalmology
Top ophthalmic challenges in 2017:
What to watch in the year ahead
Changing healthcare environment, medical/surgical options at forefront
OTE Staff Reports
As the year 2016 winds to a close, thoughts begin to turn to the next challenges for ophthalmology in the new year.
Top of mind for many are concerns over the diagnosis and management of retinal disease, glaucoma, and
cornea/anterior segment disease, along with a watchful eye on a new administration in the United States.
Five members of the Ophthalmology Times Europe Editorial Advisory Board share their perspectives on the
top challenges that ophthalmologists likely will face in 2017.
Dr Jorge L Alió
Dr Gábor Holló
Dr Einar Stefánsson
Professor and chairman
Miguel Hernández University
Alicante, Spain
Director, Glaucoma and Perimetry Unit
Department of Ophthalmology
Semmelweis University, Budapest,
Hungary
Professor and chairman of
ophthalmology
University of Iceland, National
University Hospital
Reykjavík, Iceland
Dr Albert J Augustin
Professor and chairman
Department of Ophthalmology
Klinikum Karlsruhe
Karlsruhe, Germany
IN SHORT
In this Q&A with
members of the
Ophthalmology
Times Europe
Editorial Advisory
Board, participants
take a look at
some of the top
challenges and
opportunities
facing
ophthalmologists
in Europe today.
www.oteurope.com
Dr med Omid Kermani
CEO and surgical consultant
Cataract and Refractive Surgery
Augenklinik am Neumarkt
Köln, Germany
THOUGHTS ON Retina
Dr Stefánsson: The global pandemic in diabetes
produces an epidemic of diabetic eye disease
that strains ophthalmology resources.
There were 150 million diabetic patients in
the world in the year 2000 and now there are
430 million. Two-thirds of type 2 diabetics
develop retinopathy and one-third reach sightthreatening retinopathy in their lifetime.
Screening and preventive treatment is the
way to go, but global resources cannot deal with
annual screening of this enormous group of
patients. Also, the ophthalmology resources to
provide lifelong intravitreal injections for tens
of million of patients with diabetic macular
oedema are not available.
Eye clinics around the world are already
strained by the treatment load of intravitreal
anti-vascular endothelial growth factor
(VEGF) injections for wet age-related macular
degeneration (AMD). Aging populations will
increase the number of patients over the coming
decades. At the same time, this treatment should
be made available to more wet AMD patients and
at optimal frequency. Various treat-and-extend
protocols are a compromise between healthcare
resources and patient needs. Many elderly patients
are receiving fewer injections than what would
give them best vision outcome.
While anti-VEGF injections have been a godsend
for patients with wet AMD, diabetic macular
oedema, and other retinal diseases, the fact
remains that many patients have a modest or
5
ISSUE FE ATURE
2017 outlook for ophthalmology
even no-treatment response. More
pathophysiologic mechanisms
must be targeted. This may include
inflammation and also other
cytokines
Combination therapy must
be considered for those patients
with wet AMD, diabetic
macular oedema, etc. who have
insufficient response to anti-VEGF
monotherapy.
Dr Kermani: The number of
patients receiving intravitreal
operative medication (IVOM) for
wet AMD is increasing every year.
In my clinic, I do see cases with
therapy refractory to wet AMD
more often. What are we going
to do with them? Continue with
IVOM after 15 to 20 injections?
What kind of life quality is this?
And at what costs? A life before
and after the next injection.
Brachytherapy in combination
with vitrectomy was an
alternative, but the company failed
to perform proper studies and
busted. Oraya? It has become quiet
‘Besides those diseases which can be already
treated with evidence-based strategies, another
challenge is dry AMD.’
— Dr Albert J Augustin
around this radiologic approach.
Not a good sign.
There are rumors of a new
brachytherapy approach. This time
vitrectomy is not necessary. The
approach is ab externo. Let us see
what they are coming up with, and
hopefully, this time the company
takes care that the studies are
performed with quality and care.
Dr. Augustin: We have alternatives
for several diseases, such as
diabetic macular oedema, macular
oedema due to retinal vein
occlusion, and wet AMD. This
means that we must evaluate the
outcome early in the treatment
course and decide to switch to
other approaches if appropriate.
In addition, combination
treatments are under
consideration. Those strategies
should be evaluated further.
Besides those diseases which
can be already treated with
evidence-based strategies, another
challenge is dry AMD. We are
expecting results from several
studies for the treatment of this
disease entity.
Hopefully, we can also expect
alternatives.
Furthermore, we still need
clear measures for a better
evaluation of such a treatment.
Several measures, such as
autofluorescence, did not prove to
be a reliable measure because of
many uncertainties.
THOUGHTS ON Imaging and OCT angiography
Dr Augustin: Ocular imaging
tools to better evaluate both
therapeutic strategies and
the pathophysiology of many
diseases are rapidly expanding
and improving. Especially,
improvements in optical
coherence tomography (OCT)
imaging of the posterior and
anterior segment need further
critical evaluation.
This is not only true for OCT
angiography (OCTA), which
may add additional knowledge
on perfusion characteristics of
different layers of the posterior
segment, but also for higher
resolutions and imaging
6
modalities. Those are sweptsource OCT and the “en face”
presentation.
Dr Holló: OCTA for glaucoma (and
retina) has been gaining increasing
interest and importance.
Of the different OCTA systems
currently available, the AngioVue
OCTA provides the most
developed, quantitative evaluation
on disc and peripapillary
angioflow density, and provides
data for various sectors of the
peripapillary as well for different
layers, separately.
It was recently shown that the
measurement is reproducible, able
to separate glaucoma eyes from
normal eyes, correlates with the
corresponding retinal nerve fibre
layer thickness (RNFLT), visual
function ad visual field damage,
and shows improvement after
significant reduction of IOP.
The value of OCTA vessel
density change in early detection
of glaucomatous progression (in
comparison to that of RNFLT
change) is a particularly important
question, to which follow-up
studies need to be done in the next
years.
DECEMBER 2016 :: Ophthalmology Times Europe
ISSUE FE ATURE
2017 outlook for ophthalmology
THOUGHTS ON Glaucoma
Dr Holló: Although their role is
now established in the treatment
of glaucoma, more extensive and
early use of fixed-combination
drugs is expected for the next
years. All glaucoma patients
need long-term medication, may
potentially undergo filtration
surgery, and will develop agerelated dry eye, etc.
Thus, wider use of
preservative-free, fixedcombination glaucoma drugs is
definitely expected.
‘Wider use of
preservative-free,
fixed-combination
glaucoma drugs is
definitely expected.’
— Dr Gábor Holló
I expect further intensive
discussions on the various
minimally invasive glaucoma
surgery (MIGS) devices since
new implants are in the pipeline.
But at the same time, I am sure
that MMC trabeculectomy and
glaucoma drainage devices will
preserve their leading role in the
surgical treatment of glaucoma
for several years.
Patients’ adherence to
topical glaucoma medication
is suboptimal and needs to be
improved. To this, new methods
are needed, and the role of
compliance trainings need to
be better evaluated. Influence
of cultural background on
the effectivity of compliance
trainings needs also to be
analysed.
This is essential since many
ophthalmologists are not fully
familiar with the instrument
(software) provided options,
and the understanding of the
background mathematical basics
also remains suboptimally
understood.
Haag-Streit published its new
Visual Field Digest (a completely
renewed 6th edition) which is
available as a book and is feely
downloadable from its website
(www.haag-streit.com/haagstreit-diagnostics/campaigns/
visual-field-digest). This book is
very didactic and comprehensive,
and guides the reader stepwise
across the different stages of
understanding visual field
analysis, progression analysis,
and automated kinetic perimetry,
and presents several typical cases
to improve readers’ skills on
using modern visual field testing
technologies.
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THOUGHTS ON Laser
cataract surgery
cost-effectiveness
Dr Alio: Femtosecond laserassisted cataract surgery (FLACS)
has become one of the hot topics
in the last years in cataract
surgery. However, its lack of
cost effectiveness, the time that
it requires, and the space in the
operating room have become serious
issues against its global adoption.
The only issue in which it seems
to be offering a real advantage is in
capsulorhexis. Devices, such as the
Zepto or Capsulaser, are challenging
the performance of capsulorhexis
with a far lower cost for ocular
surgeons, which would avoid FLACS
to be adopted.
It is time to offer real evidence
about the effectivity of FLACS or
to reduce its excessive cost, or
otherwise its progression will be
challenged.
Dr Augustin: During the American
Academy of Ophthalmology annual
meeting, the question of whether
FLACS is worth the considerable
cost was the subject of a debate.
One major issue is the longer
procedure time and the high cost
which must be covered by the
patient. The potential advantages,
such as a precise capsulotomy and
reduced endothelial loss, are not
unequivocally accepted.
Overall, the evidence for other
advantages seems also to be very
weak. Even a meta-analysis on the
comparison of FLACS with manual
surgery suggests that the advantages
and disadvantages of FLACS may
cancel each other out.
One final conclusion of this debate
was that FLACS may find its place
for severe cases as a niche product.
Next year, surgeons need to
further evaluate this procedure.
7
ISSUE FE ATURE
2017 outlook for ophthalmology
THOUGHTS ON Presbyopia
Dr Kermani: In my opinion, it
is the presbyopic patient who
is emmetropic. Kamra failed to
convince. Raindrop? “I do not
like plastic in the cornea,” Prof
Kanellopoulos from Athens says,
and I agree. I would rather wait a
few years to see what will come up
with this new method, regardless
if it is approved by the FDA.
So what is the alternative?
Prof. Waring is paving the
way. Is it only presbyopia or is
it lens deficiency syndrome?
Prof. Waring’s concept of lens
deficiency syndrome is more than
a euphemism. It makes sense and
patients understand it.
If presbyopia is the earliest onset
sign of cataract development, then
it is not a matter if we propose lens
exchange, the matter is when we
are proposing lens exchange. Why
would we want to let our patients
suffer, until vision has decreased
below 20/40? With modern laser
technology and IOL design,
refractive lens exchange might
also become the method of choice
for the emetropic presbyope.
It is my opinion that trifocals
and varifocals are superior to
extended-depth-of-focus lenses.
In this year, I expect that
evidence will support one or
the other in a way that surgeons
can have independent and wellsupported information on what to
use.
Among the many techniques
suggested for the compensation of
presbyopia, intracorneal inlays have
always been on the stage due to
their minimally invasive character,
their reversibility (in part), and the
accessibility of the technique as it
does not require high technology or
sophisticated surgery.
However, in spite of all these
theoretical advantages, the lack
Dr Alio: Presbyopia IOLs have been
of reproducibility, the frequent
intolerances happening in
patients, and the explantation
rate which is definitely higher
than that reported by companysponsored studies have made
this topic not to be progressing
adequately.
During 2017, I hope real
evidence will arise in favor of
intracorneal inlays—particularly
the Kamra, the Raindrop, and
Flexivue, which are those most
progressing with sophisticated
multifocality optics, such as the
varifocal (Oculentis), extended
depth of focus, and trifocals.
These three technologies
provide advantages and
disadvantages, with a clear
progressive increase in their
adoption by surgeons and
patients. The outcomes have been
increasing and the particular role
of each technology is unclear.
extensively used. Lack of evidence
will limit adequate expansion into
the market and what is true is that
previous evidence provided by the
companies has not been backed
by real results. This is the time to
prove this.
Among the new emerging
topics, and still not in practice, is
the pharmacological therapy of
presbyopia. Some companies are
developing at this moment some
topical treatments to increase the
accommodation by reactivating
the ciliary body (FOV presbydrops)
or soften the lens (Encore Vision
study), while others are simply
using myotics.
These drugs should be used
binocularly as pharmacological
‘If presbyopia is the earliest onset sign
of cataract development, then it is not a matter
if we propose lens exchange, the matter is
when we are proposing lens exchange.’
— Dr med Omid Kermani
monovision is not, in my opinion,
attractive for refractive surgeons.
If this is really on a practical
basis helping patients with early
and intermediate presbyopia,
this can become a huge issue
and indeed studies supporting
or providing evidence on this
alternative treatment of presbyopia
will be most welcome and of huge
interest.
How did ophthalmology evolve in 2016? In a view from across the ocean, Editorial Advisory Board
members from sister publication Ophthalmology Times shared thoughts on what advances they were
anticipating, and what hurdles they would face in 2016. OphthalmologyTimes.com/2016Evolve
8
DECEMBER 2016 :: Ophthalmology Times Europe
ISSUE FE ATURE
2017 outlook for ophthalmology
THOUGHTS ON Consolidation versus
expansion
Dr Kermani: I am an ophthalmic
CEO—a doctor who is a manager
at the same time. The LASIK
market in 2016 was extremely good
compared with the years before
and we all know that LASIK is
consumer-behaviour depending.
Our initial plan for 2017 was
expansion: Investing in new
technologies, new lasers, new
therapies, hiring more doctors, and
developing new offices.
With the election result of
the United States in 2016 and
the inauguration of the new
US goverment in 2017 there is
uncertainty coming up. It might
be good for the US; it can be very
bad for Europe. As a CEO, I have
the responsibility to analyse the
situation and foresee what might
come up.
My conclusion is to wait and
see. I will postpone all investments
for at least 6 months and see
what is going to happen. So this
is the business challenge in 2017.
Consolidation has priority over
expansion and growth.
THOUGHTS ON Cornea and dry eye
Dr Kermani: Tear film deficiency
again was in focus in 2016 at our
clinic. We invested in TearLab
and learned a lot about tear
film deficiency and osmolarity.
The challenge will be advanced
treatment of tear film deficiency.
There are many new options
from steaming goggles to light
pulses. Which is the best?
Do we need a combination of
therapies as Prof. McDonald
proposes? Nutritional additives,
local pharmaceutic and physical
therapy, as well as systemic
treatments with hormones? It
seems to develop a subspecialty in
our field.
In my city, the university
hospital has inaugurated a dry
eye outpatient department. Last
week, I tried to get an appointment
for a patient suffering from
severe refractory dry eye. She
was ready to pay private. Next
open appointment was in April
2017. This tells you what is going
on with dry eye. Challenges and
opportunities.
www.oteurope.com
Ectasia-angst! What a beautiful
word creation. I read this in an
article from Prof. McDonald.
Prof. Brad Randleman added
the 40% rule to his risk score
table, noting that the sum of flap
thickness and ablation depth
should not exceed 40% of total
corneal thickness.
Very helpful for risk assessment;
yet, can we prevent ectasia? Onethird of ectasia cases had normal
corneas prior to surgery. Ectasia
has prevalence also with SMILE.
No big difference.
What is needed is ectasia
prevention in order to overcome
ectasia-angst. LASIK Xtra could
be the way to go. The company,
however, fails to deliver studies to
bring science into the discussion.
So this would be a challenge for
2017. Who is coming up with
scientific proof that LASIK Xtra
works?
THOUGHTS ON
SMILE
Dr Alio: Small incision lenticule
extraction (SMILE) has become
one of the top issues in refractive
surgery. The possibility to use
only one femtosecond laser for
all refractive surgery, avoiding
excimer costs, is attractive on top
of the minimal invasiveness of
the procedure.
However, SMILE has not yet
been demonstrated to be superior
to LASIK or to provide evidence
about its better performance
than excimer laser surgery.
This is indeed an obstacle to its
progression and, in my case, an
obstacle for patients to choose
the technique as it is less known.
Following the innovation
that came with the invention of
SMILE, now is the time to bring
evidence about its superiority
or not. If not superior, then
SMILE will have the advantage
of costs as once the hyperopia is
accomplished, one femtosecond
laser will fit all corneal
procedures, including refractive
ones.
DR JORGE ALIO
E: [email protected]
DR ALBERT J AUGUSTIN
E: [email protected]
Dr Augustin declares no financial interests.
DR GÁBOR HOLLÓ
E: [email protected]
Dr Holló declares interests with Alcon Laboratories,
Optovue, and Santen.
DR MED OMID KERMANI
E: [email protected]
Dr Kermani declares no financial interests.
DR EINAR STEFÁNSSON
E: [email protected]
The views in this article are those of the respective
European physicians expressing personal opinions of the
results they have seen to date and do not represent the
views of Ophthalmology Times Europe or UBM Medica.
9
cataract & refractive
AD-IOL mimics natural lens movement
Novel concept for accommodating IOLs captures, transforms zonular movement
By Cheryl Guttman
Krader;
Reviewed by
Dr Paul M Beer
lmost a decade ago, Dr Paul M Beer,
set out to develop a pseudophakic IOL
for in-the-bag implantation that would
replicate the movement of the young
crystalline lens.
At the XXXIV Congress of the European Society
of Cataract and Refractive Surgeons in Copenhagen,
Dr Beer reported on his success using “Zonular
Capture Haptics” (ZCH) to create accommodatingdisaccommodating IOLs (AD-IOLs).
Two AD-IOL prototypes are in development.
The first is based on axial shift of a single
foldable monofocal optic that would meet FDA
label requirements.
It has been implanted in six animal eyes so far,
demonstrates continued efficacy after more than
1 year of follow-up, and is ready for resizing for
human eyes.
The second, which is at an early prototype stage,
is a dual-mode AD-IOL that combines axial shifting
and optic shape changing mechanisms. Based
on “in silico” studies, the dual-mode implant is
estimated to produce 10 to 14 D of accommodation.
Preclinical animal studies are targeted to begin in
the first quarter of 2017.
“ZCH is an enabling technology that harnesses
the fibrosis of the capsular bag and responds to
ciliary muscle contraction in an unprecedented
way, converting zonular forces into optic
movement,” said Dr Beer, founder and chief
A
Split image
comparing
accommodated and
disaccommodated
position of the optic.
executive officer, Z Lens LLC, St. Petersburg,
Florida, USA. Dr Beer, who is a retina specialist,
noted that compared with a cataract surgeon, he
approached the development of an accommodating
IOL with a fundamentally different perspective
about the capsular bag.
“Because my encounter with capsular bags is
usually months or years after cataract surgery, I
see the capsule as a tangibly stiff disc that holds
an IOL in a rigid straitjacket, restricting implant
movement,” he explained.
His solution for enabling axial shift was to
cut the fibrosed capsule into sections that could
separate, thereby activating optic movement.
In addition, Dr Beer thought to harness the
fibrosis of the capsular bag so that the tissue could
be utilised like Velcro straps to attach the zonules
to individually mobile haptics.
IN SHORT
Accommodating-disaccommodating
IOLs are being developed that mimic the
movement of the young crystalline lens
through the use of “Zonular Capture Haptics”
technology.
Axial Shift = 3.96 – 3.49 = 0.47mm
VIDEO
Ophthalmology
Times.com/
AD-IOL
(Image and video courtesy
of Dr Paul M Beer)
10
DECEMBER 2016 :: Ophthalmology Times Europe
It's Time to
make a Move
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Augencentrum Zytglogge,
Dr. Baumann, Berne, Switzerland
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The FEMTO LDV Z8 is CE marked and FDA cleared for the use in the United States. For other countries,
availability may be restricted due to regulatory requirements; please contact Ziemer for details.
cataract & refractive
A
B
C
D
A. The foldable implant is positioned into the capsular bag during cataract surgery with a restraining device that keeps
the optic temporarily in a flat position. After allowing 4 to 6 weeks for the capsule to collapse, fibrose, and adhere
to the haptics, radial capsulotomies are created in a non-invasive procedure using a laser (Nd:YAG or femtosecond),
releasing optic mobility for restoration of accommodation. B, C, and D. The activated optic then mimics the movement
of the crystalline lens, vaulting forward when the ciliary body contracts with accommodation and flattening out during
disaccommodation.
(Images courtesy of Dr Paul M. Beer)
His first prototype AD-IOL is a
foldable implant positioned into
the capsular bag during cataract
surgery with a restraining device
that keeps the optic temporarily
in a flat position. In its resting
state, the IOL functions like a
monofocal lens.
After allowing 4 to 6 weeks for
the capsule to collapse, fibrose,
and adhere to the haptics, radial
capsulotomies are created in a noninvasive procedure using a laser
(Nd:YAG or femtosecond), releasing
optic mobility for restoration of
accommodation.
The activated optic then mimics
the movement of the crystalline
lens, vaulting forward when
the ciliary body contracts with
accommodation and flattening out
during disaccommodation.
12
The activated optic
vaults forward when the
ciliary body contracts
with accommodation
and flattens out during
disaccommodation.
Findings from animal
research
Animal studies evaluating the
AD-IOL were conducted by Dr Paul
Kaufman and Mary Ann Croft at
the Wisconsin National Primate
Research Center, University
of Wisconsin-Madison, USA.
Using electrode stimulation of
the Edinger-Westphal midbrain
nucleus to stimulate physiologic
levels of accommodation and
carbachol for pharmacologic
stimulation, optic axial shift,
haptics flexion, and refractive
change were measured using
anterior segment OCT, ultrasound,
Scheimpflug imaging, and
Hartinger objective refraction.
The collected data confirmed that
the AD-IOL moves as intended after
initial activation and at 1 year after
cataract surgery. With electrode
stimulation in a series of eyes, the
AD-IOL demonstrated a maximum
axial shift of 0.8 mm and maximum
haptic flexion of 20°.
“Using monkey biometric data,
we would predict about 1 mm of
axial shift translates into about
1 D of accommodation,” Dr Beer
said. “Using Hartinger refraction,
however, we observed mean
DECEMBER 2016 :: Ophthalmology Times Europe
A Masterpiece
of Dry Eye
Diagnostics
Dual mode AD-IOL: Small and simple fluid-filled optic
vesicle gets thicker during accommodation.
Re-engineered “Zonular Capture Haptics” technology
(based on dynamometer experiments).
(Photos courtesy of Dr Paul M. Beer)
accommodation of about 2 D using electrode stimulation and
up to 4 D using carbachol.”
Second-generation device
The Dual Mode AD-IOL incorporates a small, reservoir-free,
fluid-filled optic vesicle that is thicker at the apex. The optic
is pulled flat by stretched haptics during disaccommodation.
During accommodation, the haptics come closer together
so that the optic is compressed and its curvature increases.
DR PAUL M BEER
E: [email protected]
Dr Beer holds two patents on the AD-IOLs. Dr Kaufman and Ms Croft have no relevant financial interest
to disclose.
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cataract & refractive
Evolutions in laser technologies
making cataract surgery safer
Superior outcomes can be achieved precisely, consistently, predictably
By Dr H Burkhard
Dick
lthough femtosecond laser-assisted
cataract surgery is now commonplace,
using laser to assist with the steps of
cataract surgery is still a relatively
new concept. The first platforms reached the
commercial market only about 5 or 6 years
ago. Since then, however, they have undergone
remarkable innovations that have served to refine
their functionality and performance.
The incorporation of laser cataract surgery
(LCS) into regular practice has fundamentally
changed how the surgery is done, while also
introducing the possibility of performing new
techniques. These new techniques have, in
turn, made the platforms more versatile and the
surgery safer, while also making cataract surgery
accessible to populations who may have been
previously disqualified.
As important as LCS has been for the cataract
surgery field, there are important differences
in the platforms available on the market. The
individual features of a platform affect how it
functions in the operating room: the features
interact and complement each other to add to the
platform’s overall capabilities.
A
Rationale and benefits
for cataract surgery
I was one of the first surgeons in Europe to start
performing LCS on a routine basis, because I
believed it was a better way to do the surgery.
For example, a perfectly cut and centred
capsulotomy gives a better chance of achieving
the IOL’s optimal effective lens position after
implantation. Pristine sideport, main, and arcuate
incisions offer a means to address astigmatism at
the time of surgery and reduce surgically induced
astigmatism.
I was also intrigued by the possibility of using
the laser to fragment the lens and thereby reduce
ultrasound power while potentially lowering the
time spent performing intraocular manoeuvres.
As to whether the LCS lived up to my
14
expectations, the short answer is yes. In fact,
in my hands, LCS is an upgrade over manual
techniques for several reasons.
Although my LCS cases did take a little longer
while I was getting used to the new way of
operating and figuring out the platform, in the
long term, LCS actually improved my surgical
efficiency. There is no difference in the time
taken for the procedure with LCS (from suction
on to wound closure) compared with manual,1
and no difference in cortex removal time.2 The
‘In my hands, LCS is an upgrade
over manual techniques for
several reasons.’
— Dr H Burkhard Dick
overall procedure time is equivalent to manual
because ophthalmic viscosurgical device (OVD)
use can be minimised or elimated1 and the need
for ultrasound to emulsify the lens is significantly
reduced.3
My hunch about the intrastromal incisions
also proved correct. Histology studies indicate
that laser-cut incisions are precise and accurate,
with no apparent damage to the cornea.4 LCS is
associated with faster visual rehabilitation, less
deviation from the refractive target and earlier
postoperative refractive stability than manual
surgery.5
IN SHORT
Laser techniques have fundamentally
changed the cataract surgery landscape.
New, versatile platforms have made surgery
safer and provided superior clinical outcomes
precisely, consistently and predictably.
DECEMBER 2016 :: Ophthalmology Times Europe
cataract & refractive
A
B
C
D
(FIGURE 1) A. Posterior laser capsulotomy. B. Full fragmentation. C. Anterior capsulotomy. D. Live OCT Intrastromal
incision. (Images courtesy of Dr H Burkhard Dick)
Performing LCS may increase
prostaglandin levels in the eye,
which could induce miosis,6
particularly when cutting the
anterior capsulotomy.7
To counteract this and
maintain mydriasis, it is highly
recommended to use a nonsteroidal anti-inflammatory
drug three times on the day of
surgery.7
However, this is a relatively
minor concern, especially
considering that LCS does not
induce any additional endothelial
cell loss 8 and can reduce
www.oteurope.com
postoperative inflammation
compared with manual surgery.9
Platform benefits
When I became interested in
adding laser to my cataract
surgeries in 2011, I chose the
Catalys system (Abbott) because it
offered several features I believed
would be advantageous for the
surgery.
For instance, the the system was
introduced with a non-applanating
liquid interface that holds the eye
firmly in place to minimise eye
movement during the procedure.
This is important, as respiratory
movement of the eye during
the capsulotomy step has been
suggested as a potential risk factor
for capsule tear.10 The liquid optic
interface also minimises increases
in IOP.11
The system also came equipped
with an advanced imaging
system, which I foresaw would be
important for scanning the eye and
preparing the treatment plan.
The accuracy of the imaging
would also be crucial for individual
capsulotomy centration. Over the
years, 3-D spectral-domain optical
15
cataract & refractive
coherence tomography (OCT) has
been added to make the imaging
capabilities even stronger.
The system is also extremely
fast, with the ability to achieve
a full lens fragmentation in less
than 30 seconds in most kinds
of cataracts. Treatment time may
be a little longer in higher-grade
cataracts.
However, the laser fragmentation
option is much more gentle than
the turbulence that would be
created by using ultrasound energy
to emulsify dense cataracts, and
so a slightly longer fragmentation
cycle with laser is still preferable
over manual techniques in these
cases.
These features on their own
are important; how they can be
used in tandem to complement
one another may be even more
important.
I have been involved in
to protect the corneal endothelium
during the capsulotomy and
fragmentation steps.1 An intraindividual comparison of 74 eyes
of 37 patients randomised to
either standard phaco with OVD
or LCS without OVD indicated no
difference in endothelial cell loss
and a trend toward lower IOP in
the group without OVD.12
Another example is to use
laser-cut capsulotomies as a rescue
technique in cases in which the
initial capsulotomy is too small.
A case series demonstrated the
ability to safely perform phaco and
IOL insertion before using laser to
enlarge the capsulotomy without
causing a capsule tear.13 Such a
technique may be applicable and
beneficial for eyes in which there is
a small anterior capsule opening.
A potential benefit of laser-cut
capsulotomies is the ability to
achieve an IOL’s effective lens
A potential benefit of laser-cut
capsulotomies is the ability to
achieve an IOL effective lens position
more rapidly after implantation.
several research efforts aimed at
understanding how the various
features can be utilised to optimise
patients’ outcomes and facilitate
greater efficiency in the operating
room. As I have learned, the
features can be harnessed to create
new surgical techniques that
make the surgery safer and easier
to perform in routine cases and
especially in complex ones.
One example is the ability to
perform cataract surgery without
the use of OVDs. Because the
femtosecond laser can be used to
emulsify the lens, which in turn
reduces the reliance on ultrasound
energy, OVDs may not be necessary
16
position more rapidly after
implantation, thus ensuring
faster visual recovery and more
predictable outcomes.14
However, while all of the
femtosecond laser platforms on
the market offer the ability to cut a
capsulotomy, the onboard imaging
capabilities of the Catalys with
regard to its 3-D SC-OCT creates
particularly precise positioning.
Another example of
complementary functions and
their application to cataract
surgery is in the ability to
perform a posterior capsulotomy.
Because this platform’s imaging
system can map anterior and
posterior capsulotomies, there
are several ways to perform a
primary posterior capsulotomy
with the Catalys, both in adults15
and in paediatric eyes.16 The
fluid interface means that it is
also possible to first aspirate the
cataract then safely re-dock the
eye, cut a posterior capsulotomy
and perform a bag-in-the-lens
implantation.17
Overall, the unique features
of Catalys have permitted the
expansion of indications for LCS
and have made the procedure
safe for even complex cases, such
as brunescent18 and intumescent
white cataracts,19,20 in paediatric
patients with Marfan syndrome,21
eyes with a small pupil 22 and
following trauma cases involving
penetrating injury to the cornea
and capsule.23
The future of cataract
surgery
The Catalys system recently
underwent a software upgrade
to version cOS 3, which served
to strengthen the existing
functionality while improving
workflow.
The biggest upgrade is the
addition of streaming OCT,
which is of particular benefit
to detect eye movement during
the incision stage. Aided by an
internal guidance system, the
cOS 3 upgrade reduces the time
needed for incision computation
and requires fewer operator
adjustments and modifications to
the baseline protocols.
The usability of the system with
the cOS 3 upgrade is enhanced by
the addition of several automated
treatment plans, including an
option to align the capsulotomy
over the scanned capsule using
the live OCT feature. The wealth
of additions is not overwhelming,
however, and the system can be
easily integrated for use in all types
of cases, from routine to complex.
DECEMBER 2016 :: Ophthalmology Times Europe
cataract & refractive
‘My hunch about intrastromal incisions proved correct. Histology
studies indicate laser-cut incisions are precise and accurate.’
The capsulotomy is performed in
less than 1 second with minimal
cavitation bubbles and even dense,
grade 4 cataracts can be fully
fragmented with the laser.
The docking process has also
been enhanced in an effort to
reduce residual forces during
the “lock” step. This feature
has implications for reducing
micromovements of the eye during
the procedure to minimise the risk
of capsule tears. These additions
add to the already innovative and
validated liquid optics interface,
which induces minimal changes in
IOP and no corneal folds, thereby
yielding a clear optical path for
laser delivery.
What these upgrades add to
an already innovative platform is
an increased chance to achieve
superior clinical outcomes
precisely, consistently and
predictably. I have found the cOS
3 upgrade easy to integrate and
having it available is a tremendous
benefit when I am implanting
a premium IOL for which the
accuracy of each step is crucial.
When I am able to deliver on the
results promised to my patients
after surgery, it yields a premium
experience, whereby the surgeon
can feel satisfied with the result
and patients go home happy with
their new postsurgical vision.
REFERENCES
1. Dick HB, Gerste RD, Rivera RP, Schultz T.
Femtosecond laser-assisted cataract surgery
without ophthalmic viscosurgical devices. J
Refract Surg 2013; 29: 784–87.
2. Conrad-Hengerer I, Schultz T, Jones JJ, Hengerer
FH, Dick HB. Cortex removal after laser cataract
surgery and standard phacoemulsification: a
critical analysis of 800 consecutive cases. J
Refract Surg 2014; 30: 516–20.
3. Dick B, Schultz T. On the way to zero phaco. J
Cataract Refract Surg 2013; 39: 1442–44.
www.oteurope.com
4. Schultz T, Tischoff I, Ezeanosike E, Dick HB.
Histological sections of corneal incisions in
OCT-guided femtosecond laser cataract surgery.
J Refract Surg 2013; 29: 863–64.
5. Conrad-Hengerer I, Al Sheikh M, Hengerer
FH, Schultz T, Dick HB. Comparison of visual
recovery and refractive stability between
femtosecond laser-assisted cataract surgery
and standard phacoemulsification: six-month
follow-up. J Cataract Refract Surg 2015; 41:
1356–64.
6. Schultz T, Joachim SC, Kuehn M, Dick HB.
Changes in prostaglandin levels in patients
undergoing femtosecond laser-assisted cataract
surgery. J Refract Surg 2013 ; 29: 742–47.
7. Schultz T, Joachim SC, Stellbogen M, Dick HB.
Prostaglandin release during femtosecond
laser-assisted cataract surgery: main inducer. J
Refract Surg 2015; 31: 78–81.
8. Conrad-Hengerer I, Al Juburi M, Schultz T,
Hengerer FH, Dick HB. Corneal endothelial cell
loss and corneal thickness in conventional
compared with femtosecond laser-assisted
cataract surgery: three-month follow-up. J
Cataract Refract Surg 2013; 39: 1307–13.
9. Conrad-Hengerer I, Hengerer FH, Al Juburi
M, Schultz T, Dick HB. Femtosecond laserinduced macular changes and anterior segment
inflammation in cataract surgery. J Refract Surg
2014; 30: 222–26.
10. Schultz T, Joachim SC, Tischoff I, Dick HB.
Histologic evaluation of in vivo femtosecond
laser–generated capsulotomies reveals a
potential cause for radial capsular tears. Eur J
Ophthalmol 2015; 25: 112–18.
11. Schultz T, Conrad-Hengerer I, Hengerer FH,
Dick HB. Intraocular pressure variation during
femtosecond laser-assisted cataract surgery
using a fluid-filled interface. J Cataract Refract
Surg 2013; 39: 22–27.
12. Schargus M, Suckert N, Schultz T, Kakkassery
V, Dick HB. Femtosecond laser-assisted
cataract surgery without OVD: a prospective
intraindividual comparison. J Refract Surg
2015; 31: 146–52.
13. Dick HB, Schultz T. Femtosecond laserassisted capsulotomy rescue for capsulorhexis
enlargement. J Cataract Refract Surg 2014;
40: 1588–90.
14. Dick HB, Schultz T. Intraocular lens fixated in
the anterior capsulotomy created in the line of
sight by a femtosecond laser. J Refract Surg
2014; 30: 198–201.
15. Dick HB, Schultz T. Primary posterior laserassisted capsulotomy. J Refract Surg 2014;
30: 128–33. doi: 10.3928/1081597X20140120-09.
16. Dick HB, Schelenz D, Schultz T. Femtosecond
laser-assisted pediatric cataract surgery:
Bochum formula. J Cataract Refract Surg
2015; 41: 821–26.
17. Dick HB, Canto AP, Culbertson WW, Schultz
T. Femtosecond laser-assisted technique for
performing bag-in-the-lens intraocular lens
implantation. J Cataract Refract Surg 2013;
39: 1286–90.
18. Hatch KM, Schultz T, Talamo JH, Dick HB.
Femtosecond laser-assisted compared with
standard cataract surgery for removal of
advanced cataracts. J Cataract Refract Surg
2015; 41: 1833–38.
19. Conrad-Hengerer I, Hengerer FH, Joachim
SC, Schultz T, Dick HB. Femtosecond laserassisted cataract surgery in intumescent white
cataracts. J Cataract Refract Surg 2014; 40:
44–50.
20. Schultz T, Dick HB. Laser-assisted minicapsulotomy: a new technique for intumescent
white cataracts. J Refract Surg 2014; 30:
742–45.
21. Schultz T, Ezeanosike E, Dick HB.
Femtosecond laser-assisted cataract surgery
in pediatric Marfan syndrome. J Refract Surg
2013; 29: 650–52.
22. Conrad-Hengerer I, Hengerer FH, Schultz T,
Dick HB. Femtosecond laser-assisted cataract
surgery in eyes with a small pupil. J Cataract
Refract Surg 2013; 39: 1314–20.
23. Conrad-Hengerer I, Dick HB, Schultz T,
Hengerer FH. Femtosecond laser-assisted
capsulotomy after penetrating injury of the
cornea and lens capsule. J Cataract Refract
Surg 2014; 40: 153–56.
DR H BURKHARD DICK
E: [email protected]
Dr Dick is chairman of the Ruhr University Eye Hospital in
Bochum, Germany. He did not indicate financial interest
relevant to the subject matter.
17
retina
Managing complex challenges
in giant retinal tear re-attachment
Unique case involves incidental subfoveal perfluorocarbon heavy liquids
By Laird Harrison;
Reviewed by Dr Gerardo
Ledesma-Gil
iant retinal tears pose outsize challenges
for physicians, including the risks of
hemorrhage, heavy fluid droplets, and
macular holes, according to Dr Gerardo
Ledesma-Gil.
“These surgeries are complicated and you have
to take your time,” said Dr Ledesma-Gil, a retina
fellow at the Instituto de Oftalmología Fundación
Conde de Valenciana, Mexico City, Mexico.
“If something goes wrong, be calm and make
another plan.”
Giant retinal tears are rare, he added.
In 2010, the British Giant Retinal Tear
Epidemiology Eye Study (Invest Ophthalmol Vis
Sci. 2010;51:4781-4787) found an incidence of
0.094 retinal tears per 100,000 people. Although
retinal attachment was achieved in 94.7% of
patients, only 42.1% achieved vision of 20/40
or better.
G
CASE STUDY
VIDEO As part of a treatment regimen
for this 29-year-old male, surgeons used
incidental subfoveal perfluorocarbon heavy liquids
after vitrectomy for a giant retinal tear.
(Video courtesy of Dr Gerardo Ledesma-Gil)
Go to OphthalmologyTimes.com/RetinalTear
Patient case
Dr Ledesma-Gil’s patient was a 29-year-old male
who underwent phacoemulsification in 2009 as
treatment for injuries from blunt trauma to the
eye.
Five years later, the man presented with a giant
retinal tear and retinal detachment. Surgeons
began their treatment with pars plana vitrectomy
(PPV). They used perfluorocarbon heavy liquids
to flatten the retina, allowing them to observe its
anterior edge.
After an air fluid exchange, they tried to
re-attach the anterior edge. During this procedure,
a subretinal hemorrhage occurred. However, the
surgeons were able to control it and remove all
the clots.
“In that part of the surgery, the heavy
liquids came under the retina incidentally,”
Dr Ledesma-Gil said.
When the surgeons noticed the heavy liquid
under the retina, they drained it surgically and
performed another air fluid exchange.
18
‘These surgeries are complicated
and you have to take your time. If
something goes wrong, be calm
and make another plan.’
— Dr Gerardo Ledesma-Gil
Using an endoprobe to deliver laser, they
re-attached the retina, then infused silicone oil as a
long-acting tamponade.
During a follow-up to this surgery, the surgeons
noticed two elevations on the retina. Investigating
with optical coherence tomography (OCT), they
found one subfoveal perfluorocarbon droplet and
one under the nasal region of the retina.
Fearing that the droplets could damage the
retina, the surgeons performed a PPV revision,
giving them a clear view of the droplets.
DECEMBER 2016 :: Ophthalmology Times Europe
Surgeons made a second hole and
drained the second droplet from the
nasal area of the retina. Finally, they
used gas for a temporary tamponade and
achieved complete macular attachment.
Using a 42-gauge needle, they made a small hole in the
area surrounding the droplet under the macula to attempt its
removal, but were fearful of making the hole too close to the
fovea.
As a consequence, they could not reach the droplet
with the needle and had to use a silicon-tipped cannula to
move the droplet to the needle. After several attempts, they
succeeded in draining the droplet.
They made a second hole and drained the second droplet
from the nasal area of the retina.
Finally, they used gas for a temporary tamponade and
achieved complete macular attachment.
However, in a postoperative exam the patient’s final visual
acuity in the affected eye was 20/400. Although this was
an improvement over his vision before the surgery, it was
disappointing, Dr Ledesma-Gil said.
Using OCT, the surgeons confirmed that they had
completely removed the droplets. Though they found a
macular hole, they decided to take no further action.
“It was probably the droplet itself and the retinotomy that
made the hole,” Dr Ledesma-Gil said. “A combination of
factors led to the hole formation.”
What to do differently?
If he had to do the procedure over, Dr Ledesma-Gil said he
would take a slightly different approach, perhaps using gas
to move the droplet rather than a cannula.
The physicians explained to the patient what happened,
and because he has good vision in his other eye, he is
satisfied, Dr Ledesma-Gil said.
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DR GERARDO LEDESMA-GIL
This article was adapted from Dr Ledesma-Gil’s presentation at Retina Subspecialty Day during
the annual meeting of the American Academy of Ophthalmology. He has no financial interest in the
subject matter.
www.oteurope.com
www.haag-streit.com
retina
SD-OCT enhances visualisation
earlier in disease process
Detailed imaging facilitates evaluation of foveal disorders
By Lynda Charters;
Reviewed by
Dr Anat Loewenstein
pectral-domain optical coherence
tomography (SD-OCT) has become
indispensable for visualising the
fovea and diagnosing retinal diseases.
Importantly, detailed visualisation facilitates
diagnosis during the early disease stages,
according to Dr Anat Loewenstein.
S
Solar maculopathy
The first case (Figure 1 on page 22) illustrating the
importance of high-detailed imaging was that of a
29-year-old male, as described by Dr Loewenstein.
The patient’s past ocular medical and family
histories were not remarkable.
The patient reported blurry vision in both eyes
over the past 4 days with a yellow spot centrally.
He denied any recent exposure to drugs, however,
he had used cocaine and cannabis “crystal” 1 year
previously.
SD-OCT examination showed a normal flat
macula with a small yellow spot. However, there
was a stop in the photoreceptor continuity in the
ellipsoid and inter-digitation zones.
“A hyper-reflective material was seen emerging
from the retinal pigment epithelium [RPE] toward
the outer nuclear layer,” said Dr Loewenstein,
professor of ophthalmology, deputy dean of the
medical school, Sackler Faculty of Medicine,
Tel Aviv University, Israel, and chairman of
ophthalmology, Tel Aviv Sourasky Medical Center,
Tel Aviv.
The patient later admitted to lying on the
beach exposed to sunlight for the entire day
when symptoms began. The diagnosis was solar
retinopathy, secondary to sun gazing.
During follow-up, SD-OCT showed the hyperreflective material was absorbed with abrupt
continuation of the photoreceptor layer in the fovea
and the external limiting membrane (ELM) was
preserved. This status was maintained at 2 and 4
months of follow-up.
“Solar retinopathy occurs mainly during celestial
events—such as eclipses, religious rituals, and
20
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sunbathing—and in psychiatric patients,” Dr
Loewenstein said. “The light is of low power but
exposure was usually for a long duration. The
light intensity is amplified by the cornea and the
lens by a factor of 10,000. The pathophysiology
includes both thermal and photochemical damage.
While recovery is possible, permanent damage is a
possibility.”
The importance of SD-OCT is underscored in
this case by the defects that were visible in the
ellipsoidal zone as well as the strong correlation
between the disruption of the inner photoreceptor
junction and the worsened vision.
Laser-induced retinopathy
A second case (Figure 2 on page 22) was that
of a 15-year-old boy who experienced an acute
IN SHORT
Spectral-domain optical coherence
tomography facilitates detailed evaluation
of foveal disorders even in the very earliest
disease stages.
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retina
CASE 1: 29-year-old male
20/60
20/60
Macula is flat, foveal
yellow spot
(FIGURE 1) This 29-year-old male had no relevant previous of family history but had blurry vision in both eyes for the past 4 days, seeing a yellow
spot in the center. The macula is flat and there is a small yellowish spot, which, in OCT, looks like a stop in the photoreceptor continuation in
the ellipsoid and interdigitation area. There is also some hyperreflective material from the retinal pigment epithelium toward the outer nuclear
layer. (Images courtesy of Dr Anat Loewenstein)
CASE 2: 15-year-old boy
20/20
20/20
Macula is flat, foveal
yellow spot
(FIGURE 2) This 15-year-old boy presented no relevant past of family history. He did admit to staring with one eye and then with the other at a
laser pointer, following which he experienced an acute decrease in vision. (Images courtesy of Dr Anat Loewenstein)
decrease in vision in both eyes
after staring at a laser pointer.
The patient’s medical and ocular
histories and that of his family were
unremarkable.
The macula was flat with a
yellow spot in the fovea. Similar
22
to the first case report, SD-OCT
showed the contour of the fovea
was normal with a stop in the
photoreceptors continuity in
the ellipsoid and interdigitation
zones and the presence of a
hyperreflective material emerging
from the RPE toward the outer
nuclear layer.
SD-OCT follow-up of this
patient showed the reabsorption
of the hyperreflective material,
abrupt discontinuation of the
photoreceptor layer in the fovea,
DECEMBER 2016 :: Ophthalmology Times Europe
retina
and preservation of the ELM.
“The size of the outer macular
hole in the right eye decreased
between the examinations at
2 weeks and 2 months,” Dr
Loewenstein said.
“Laser-induced retinopathy
is caused by the coherent,
monochromatic, unidirectional,
minimally divergent laser beam,”
she said. “The exposure to the light
is short, about 0.25 second, as a
result of the blink reflex. The light
intensity is intensified by the cornea
and lens by a factor of 10,000. The
pathophysiology includes thermal
damage primarily in the RPE, and
photochemical and mechanical
plasma formation damage.”
The vast majority of patients
(95%) with laser-induced
retinopathy experience
improvement; 32% have vision
better than 20/40.
In this case, SD-OCT showed
defects in the ellipsoid zone,
hyper-reflectivity at the
retinal surface, and retinal or
intraretinal hemorrhages and even
neovascularisation.
Hydroxychloroquine
retinopathy
Another case was a 29-year-old
woman who had been treated
for 13 years with prednisone,
azathioprine (Imuran, Aspen
Australia), and hydroxychloroquine
for systemic lupus erythemathosus.
The patient presented with the
complaint of a central visual defect.
Examination showed a
paracentral scotoma that developed
between 2004 and 2013. This was
the consequence of retinal toxicity
resulting from hydroxychloroquine.
“In this case, SD-OCT showed
loss of the perifoveal and macular
ellipsoid zones, thinning of the
outer nuclear layer, and sparing
What’s Trending
of the fovea with establishment
of the ‘flying saucer’ sign,” Dr
Loewenstein said.
“Hydroxychloroquine
maculopathy is characterised by a
bull’s eye appearance and a dense
central scotoma,” she said.
The drug was discontinued but
the damage was permanent.
Dr Loewenstein summarised that
SD-OCT has dramatically enhanced
the ability to diagnose foveal
disorders even during the stage
when they are not visible using
other technologies.
DR ANAT LOEWENSTEIN
E: [email protected]
Dr Loewenstein in a consultant to Allergan, Alcon
Laboratories, Bayer Healthcare, Notal Vision, and Novartis.
Michaela Goldstein, MD, and Dafna Goldenberg, MD, from
Dr Loewenstein’s department participated in the care of the
patients under discussion.
Video
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ADDRESSING
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PROVIDING A FORUM
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driving optimized, compassionate patient care.
The Ophthalmology Global Preceptorship
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Date of Prep: August 2015 L.GB.MKT.08.2015.12302 G.SM.STH.04.2015.0500
retina
Targeting refractory vitreous seeds
in retinoblastoma cases
Intravitreal topotecan found impressive for both its efficacy, safety
By Cheryl Guttman
Krader;
Reviewed by Dr Raksha
Rao
IN SHORT
ri-weekly injection of topotecan is
safe and effective as monotherapy for
management of refractory vitreous seeds
in retinoblastoma. Such findings are
according to a retrospective study conducted by
ocular oncologists at the National Retinoblastoma
Foundation, Centre for Sight Superspecialty Eye
Hospital, Hyderabad, India.
The review included 17 eyes, all International
T
A retrospective study reviewing outcomes
of 17 consecutive eyes with retinoblastoma
treated for refractory vitreous seeds found
intravitreal topotecan was safe and resulted in
complete regression in all eyes after a mean
of three injections.
A
B
C
D
(FIGURE 1) Technique of intravitreal topotecan chemotherapy. A. Transconjunctival pars plana intravitreal injection
of topotecan at a dose of 30 μg in 0.15 ml with a 30-gauge needle. B. Needle withdrawal through the first ice
ball of cryotherapy. C. Triple freeze-thaw cryotherapy at the injection site. D. Forceps-assisted jiggling of the
eyeball following the injection for an even dispersion of topotecan. (Images courtesy of Dr Santosh G Honavar)
26
DECEMBER 2016 :: Ophthalmology Times Europe
retina
“Our results . . . are
comparable to those
previously reported for
intravitreal melphalan.’
— Dr Raksha Rao
Classification for Intraocular
Retinoblastoma Group C or D, with
persistent or recurrent vitreous
seeds after standard intravenous
chemotherapy ± local therapy. Triweekly topotecan 30 mcg/0.15 mL
was administered until there was
complete regression of the seeds
and was followed by an additional
injection for consolidation of
probable microscopic residual
seeds.
Complete regression of vitreous
seeds was achieved in all eyes
after a mean of three injections,
and 7 eyes (41%) required just
two injections. No ocular/systemic
complications were noted during a
mean follow-up of 12 months.
“To our knowledge, we are
reporting the first case series
of intravitreal topotecan as
monotherapy in the management
of refractory vitreous seeds in
retinoblastoma, and our results
indicate topotecan is a potent
agent providing impressive control
of refractory vitreous seeds,” Dr
Raksha Rao said.
“Our results . . . are comparable
to those previously reported
for intravitreal melphalan,” Dr
Rao said. “However, the mean
number of injections required
was lower using topotecan than
with melphalan, and according
to previous reports and our own
experience, intravitreal melphalan
also causes few ocular side effects.”
Treatment protocol
The treatment protocol for
retinoblastoma at the center
www.oteurope.com
A
B
C
D
E
F
(FIGURE 2) Vitreous seed control with intravitreal topotecan monotherapy. A. Recurrent diffuse
vitreous seeds in the only eye of a patient with bilateral retinoblastoma. B. Thirteen months after
two doses of intravitreal topotecan injections with complete control of vitreous seeds. C. Massive
recurrence of diffuse vitreous seeds in the only eye of a patient after six cycles of chemotherapy
and three periocular carboplatin injections. D. Eighteen months after two doses of intravitreal
topotecan injections with total regression of vitreous seeds. E. Recurrent focal vitreous seeds in
unilateral retinoblastoma after six cycles of chemotherapy. F. At 12 months follow-up after two
doses of intravitreal topotecan. (Images courtesy of Dr Santosh G. Honavar)
where the study took place begins
with triple drug intravenous
chemotherapy or superselective
intra-arterial chemotherapy.
Periocular carboplatin or topotecan
are administered if viable diffuse
vitreous seeds are present
after three cycles. Intravitreal
chemotherapy is administered
in eyes that have persistent or
recurrent vitreous seeds after the
completion of intravenous or intraarterial chemotherapy.
“Initially, we were using
melphalan for intravitreal therapy,
but we switched to topotecan
because of the need for multiple
injections with melphalan and the
27
retina
development of complications,
including iritis, posterior synechiae,
and retinal pigment epithelial
mottling,” Dr Rao said.
vitreous seeds and 14 had recurrent
vitreous seeds. The vitreous
seeds were diffuse in 13 eyes and
focal in 4 eyes. The intravitreal
The treatment protocol for retinoblastoma at the
center where the study took place begins with triple
drug intravenous chemotherapy or superselective
intra-arterial chemotherapy.
“Topotecan has known activity
as a treatment for retinoblastoma
when given by intra-arterial
injection, periocular injection, or
with melphalan in an intravitreal
injection,” she said. “The latter
combined treatment was also . . .
associated with minimal ocular or
systemic side effects.”
Patients in the series were
predominantly female (76.5%) and
had a mean age of 35 months. All
patients had at least 6 cycles of
intravenous chemotherapy with a
mean of 10 cycles.
Three eyes had persistent
topotecan was given through a
tranconjunctival pars plana route
using a 30-gauge needle at a site
based on patient age.
A safety-enhanced technique
was used wherein the needle was
withdrawn through the first ice ball
formation of cryotherapy, followed
by two more cycles of freeze and
thaw.
Then, forceps-assisted jiggling of
the eye was done to disperse the
drug evenly in the vitreous cavity.
One eye with a recurrent retinal
tumor was enucleated at 5 months’
follow-up, and histopathology
showed no tumor cells in the
needle track.
“We have extended the use of
intravitreal topotecan to Group E
eyes for refractory vitreous seeds
following intravenous and intraarterial chemotherapy,” said Dr
Santosh G Honavar, director,
ophthalmic and facial plastic
surgery and ocular oncology,
Centre for Sight Superspeciality
Eye Hospital. “To date, 36 eyes
have received intravitreal topotecan
monotherapy at our center, and
we have achieved 100% success in
vitreous seed control, and 98% eye
salvage in these advanced tumors.”
DR RAKSHA RAO
E: [email protected]
This article was adapted from Dr Rao’s presentation at the
American Academy of Ophthalmology meeting. She and
her co-investigators have no relevant financial interests
to disclose.
OphthalmologyTimes.com Online Exclusive
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retina
Exploring the effects of anti-VEGF
therapy on retinal diseases
Physicians weigh in on role of aflibercept in treatment interval extensions
By Lisa Stewart
he pathogenesis of diabetic macular oedema
and retinal vein occlusion is associated with
increased levels of vascular endothelial
growth factor (VEGF), placental growth
factor (PGF), and other inflammatory factors that
are key targets for the treatment of retinal disease.
Aflibercept, which was specifically designed to
bind VEGF and PGF with high affinity, can enable
treatment interval extensions in the clinic with
vision gains comparable to those seen in clinical
trials. Aflibercept provides rapid and sustained
vision gain in both ischaemic and non-ischaemic
retinal vascular diseases and significantly reduces
the severity of diabetic retinopathy.
T
Unravelling the role of cytokines
in retinal disease
Dr Aude Ambresin from Lausanne University
and the Jules Gonin Eye Hospital provided a
brief description of how retinal vascular disease
develops.
Impaired retinal blood flow leads to hypoxia,
then the hypoxic cells release inflammatory
cytokines, such as interleukin-6 (IL-6) and
upregulate VEGF, PGF and VEGF receptor (VEGFR)
1. This causes activation of microglial cells,
apoptosis of endothelial cells, and pericyte drop
off, coupled with opening of tight junctions and
neovascularisation—all of which lead to chronic
inflammation and breakdown of the blood–retinal
barrier.
The end results are vessel leakage, oedema, and
vision loss. The pathogenesis is similar for diabetic
macular oedema and retinal vein occlusion in that
both involve inflammation and ischaemia leading to
endothelial damage.
Dr Ambresin went on to summarise the
evidence, both preclinical and clinical, for the
involvement of VEGF and PGF in retinal vascular
disease.
VEGF-A overexpression promotes vascular
permeability and angiogenesis; PGF has also
been shown to be pro-angiogenic, and promotes
leukocyte infiltration and vascular inflammation.
www.oteurope.com
Preclinical animal models have demonstrated
that VEGF and PGF contribute to the breakdown of
the blood–retinal barrier in two ways: first, via the
loss of pericytes from retinal capillaries and second,
by increasing vascular permeability, which leads
to exudation of fluid into the subretinal space and
results in macular oedema.
A preclinical model of diabetic retinopathy in
mice, the Akita mouse, showed that when PGF is
knocked out all measures of diabetic retinopathy
decrease almost to the level seen in wild-type mice.
VEGF-A and PGF synergise to
activate VEGFR-1, leading to
angiogenesis, neovascularisation,
and inflammation.
Experimentally induced choroidal
neovascularisation (CNV) in mice is associated with
significantly elevated levels of VEGF-A and PGF.
The elevation of VEGF and PGF has been
further examined in clinical studies: the degree of
ischaemia and severity of disease correlates with
levels of VEGF-A and PGF in both retinal vein
occlusion and diabetic retinopathy. Levels of PGF
and VEGF are significantly higher in the vitreous of
patients with active diabetic retinopathy than those
with quiescent disease.
VEGF-A and PGF synergise to activate
VEGFR-1, leading to angiogenesis,
IN SHORT
Aflibercept, an anti-VEGF agent, can enable
treatment interval extensions and provide
rapid and sustained vision gain in retinal
vascular diseases as well as significantly
reducing the severity of diabetic retinopathy.
29
retina
(FIGURE 1) The structure of aflibercept
VEGFR-2
domain
VEGFR-1
domain
Fc fragment
of lgG
Aflibercept binds more tightly
to VEGF than the native VEGF
receptors2
Aflibercept molecule
Aflibercept–VEGF complex
Aflibercept was specifically
designed for high-affinity binding
to VEGF and PGF1
Aflibercept is a fusion protein for
intravitreal injection that ‘traps’ VEGF-A
and PGF molecules2
Fc, fragment, crystallizable; lgG, immunoglobulin G; PGF, placental growth factor; VEGF, vascular endothelial growth factor; VEGFR,
vascular endothelial growth factor receptor.
1. Papadopoulos N et al. Angiogenesis 2012; 15 (2): 171-185. 2. EYLEA 40 mg/mL solution for injection in a vial –summary of
product characteristics. Bayer plc; Newbury, Berkshire, UK, November 2015. (Courtesy of Bayer)
neovascularisation, and
inflammation. This synergy has
been demonstrated in several
preclinical studies.
For example, whereas inhibition
of VEGF-A significantly reduced
the increases in vessel density
in a mouse model of CNV,
inhibition of PGF had no real
effect. However, co-inhibition of
VEGF-A and PGF reduced vessel
density by significantly more than
inhibition of VEGF-A alone.1
Dr Ambresin finished by
touching on galectin-1, which
is a potential modulator of
neovascular retinal disease.
Expressed in endothelial cells,
it interacts with VEGFR and its
30
overexpression has been linked to
pathological neovascularisation.
Elevated levels of galectin-1 have
been reported in the plasma of
patients with type 2 diabetes.
In cultured retinal endothelial
cells, galectin-1–mediated
phosphorylation of VEGFR-2 was
inhibited by aflibercept and this
inhibition was associated with
reduced cell proliferation.
The dual action
of aflibercept
While currently available antiVEGF agents inhibit the VEGF-A
isoforms, aflibercept is up to 92
times more potent an inhibitor
than bevacizumab or ranibizumab,
with higher affinity and a faster
association rate; moreover,
unlike the other two inhibitors,
aflibercept also binds PGF and
VEGF-B.2
Professor Thomas Langmann of
the University Hospital of Cologne
described the structure and mode of
action of aflibercept and discussed
how they affect its clinical function.
Aflibercept is a fusion protein
that comprises two VEGFbinding portions derived from the
extracellular domains of human
VEGFR-1 and -2, connected via
a human IgG antibody fragment
[Figure 1].
Aflibercept binds the active
dimers of VEGF-A or PGF on both
DECEMBER 2016 :: Ophthalmology Times Europe
retina
sides: once bound, they cannot
interact with other molecules.
Comparing duration of action,
ranibizumab has been reported
to suppress VEGF-A levels in the
aqueous humour—VEGF levels in
the aqueous humour correlate well
with those in the vitreous and the
retina—for a mean of 36 days.3
Accordingly, bimonthly injections
are not appropriate. Aflibercept,
however, suppresses VEGF-A levels
for a mean of 71 days,4 which
means that most patients are still
experiencing suppression at the
end of the recommended injection
interval of 8 weeks.
A small crossover study of
seven patients allowed aflibercept
and ranibizumab to be compared
directly:5 patients who had
persistent active neovascular AMD
with ranibizumab were switched
to aflibercept. Suppression of VEGF
levels lasted twice as long with
aflibercept as with ranibizumab.
These extended cytokine
suppression times suggest that
treatment intervals can be extended.
This was tested in clinical
studies, where bimonthly dosing
of aflibercept delivered similar
improvements in visual acuity
to monthly ranibizumab, and
is supported by real-life clinical
data: patients had vision gains
comparable to those seen in
clinical trials, which were
maintained using a treat-andextend protocol with mean
injection intervals of approximately
3 months. Treatment intervals can
be extended with aflibercept even
in patients with a poor response to
other anti-VEGF agents.
The action of aflibercept
on retinal disease
Professor Peter Kaiser from the
Cole Eye Institute in Cleveland,
Ohio, USA, explored aflibercept’s
action on retinal disease.
He reiterated that VEGF is not
the only cytokine elevated in retinal
www.oteurope.com
disease and diabetes, but so too
are others including PGF, IL-6, and
IL-8, and showed clinical data that
backed up the mostly preclinical
data Dr Ambresin had shared.
He emphasised that levels of
VEGF, PGF, and other inflammatory
cytokines correlate with increasing
severity of disease, such that
patients with high ischaemic loads
have extremely high levels of both
VEGF and PGF.
Clinical studies in retinal vein
occlusion or diabetic macular
oedema using aflibercept have
demonstrated a very rapid gain in
visual acuity—improvements were
seen after the first injection—that
persists to at least 3 years. As
well as the visual acuity gains,
a dramatic reduction in retinal
thickness is seen after just one
injection. This gain is maintained
such that the majority of patients
actually have normal retinal
thickness at 3 years.
Professor Kaiser emphasised that
rapid treatment is important for
central retinal vein occlusion.
“Historically we were taught
that it didn’t really matter when
you treated a patient because the
outcomes were rather similar,” he
said. “But if we look at the phase
III studies with aflibercept this
doesn’t hold . . . there’s a dramatic
difference if you wait more than 2
months from diagnosis to institute
treatment.”
Phase III studies showed a
clinically significant improvement
in diabetic retinopathy severity
scores with aflibercept treatment,
which continued to improve with
longer treatment. About one-third
of patients had an improvement
after 1 year, which had increased to
almost half by 3 years.
Retrospective studies examined
the effect of switching to aflibercept
in patients with retinal vein
occlusion and diabetic macular
oedema who were resistant to
treatment with bevacizumab or
ranibizumab. Patients who are
hard to treat tend to have very
elevated levels of VEGF and other
cytokines, which is believed to be
one reason why they don’t respond.
Improvements in visual acuity
and central retinal thickness were
noted as well as extensions in the
injection intervals.
In summary, aflibercept, which
is a more potent inhibitor of VEGF
than its competitors, with higher
affinity and a faster association
rate, and which also binds PGF
and VEGF-B, can enable treatment
interval extensions and provide
rapid and sustained vision gain in
retinal vascular diseases as well as
significantly reducing the severity
of diabetic retinopathy.
REFERENCES
1. Y. Li, et al., Cell Physiol. Biochem. 2015; 35:
1787-1796. doi:10.1159/000373990.
2. N. Papadopoulos, et al., Angiogenesis 2012;
15: 171-185.
3. P.S. Muether, et al., Am. J. Ophthalmol.
2013; 156(5): 989-993.e2. doi:10.1016/j.
ajo.2013.06.020.
4. S. Fauser, V. Schwabecker and P.S. Muether.
Am. J. Ophthalmol. 2014; 158(3): 532-536.
doi:10.1016/j.ajo.2014.05.025.
5. S. Fauser and P.S. Muether. Br. J. Ophthalmol.
2016; 100(11): 1494-1498. doi:10.1136/
bjophthalmol-2015-308264.
DR AUDE AMBRESIN
E: [email protected]
PROFESSOR THOMAS LANGMANN
E: [email protected]
PROFESSOR PETER KAISER
E: [email protected]
This article was adapted from physician presentations
at a Bayer symposium at the 16th EURETINA congress
in Copenhagen. They did not indicate any proprietary interest
relevant to the subject matter. The event was chaired by
Professor Francine Behar-Cohen of the Jules Gonin Eye
Hospital in Switzerland.
31
glaucoma
Seeking evidence-based answers
to lifestyle modification questions
Exercise, nutrition, acupuncture may be topics to discuss with glaucoma patients
By Cheryl Guttman
Krader;
Reviewed by
Dr Yvonne Ou
s patients are turning to the Internet
for health and medical information,
ophthalmologists are increasingly facing
the need to separate myth from fact on a
variety of disease-related issues.
Dr Yvonne Ou, assistant professor of
ophthalmology, University of California-San
Francisco, USA, reviewed evidence regarding the
effects of various lifestyle practices on glaucoma
and IOP.
A
LIFESTYLE MODIFICATIONS
Exercise
Results from a number of studies indicate that
aerobic exercise is associated with IOP lowering,
and according to the findings of a meta-analysis
[Clin J Sport Med. 2014;24:364-372], the change is
greater among sedentary individuals than those
who were already active and independent of
exercise duration or intensity.
“Based on this evidence, I encourage my
patients to get moving, especially if they are not
already,” Dr Ou said. “For those who feel they
cannot incorporate exercise into their lifestyle,
I tell them that any kind of movement, even
walking, may be beneficial. However, I also
tell them they have to maintain their regimen
because there is evidence showing as well that
the effect of exercise on IOP does not persist when
deconditioning occurs.”
Dr Ou added that advising patients to find
an exercise partner is helpful as it can be a
motivator for starting and adhering to an exercise
program. In addition, it can enable patients with
impediments to exercising, such as reduced visual
acuity or visual field defects, to be more active.
Another common exercise-related concern
pertains to the effect of head-down yoga poses
on IOP. While it is already known that shoulder
stands or headstands increase IOP, a recent study
evaluating the effects of four common yoga
positions on IOP was recently published [PLoS
ONE. 201;10(10):e0144505].
Dr Ou noted that changes in IOP were the same
32
VIDEO Dr Yvonne Ou talks about
her research on how minor lifestyle modifications
may impact patients with glaucoma.
Go to OphthalmologyTimes.com/Lifestyle
‘There is evidence showing that
the effect of exercise on IOP does
not persist when deconditioning
occurs.’ — Dr Yvonne Ou
among subjects with and without glaucoma, and
among the positions evaluated, downward dog
(Adho Mukha Svanasana) was associated with the
greatest increase in IOP. However, the study also found the effect on
IOP is transient, and there are no data showing
IN SHORT
Regular exercise and consumption of
green leafy vegetables may positively affect
glaucoma progression. Effects of acupuncture
and inverted yoga poses are also discussed.
DECEMBER 2016 :: Ophthalmology Times Europe
glaucoma
that the yoga position-induced IOP
changes are a factor for glaucoma
progression.
Given this information, she
acknowledged that it is difficult to
advise patients. Until more data
are available, the best thing is to
consider any potential risk in the
context of the individual’s stage of
glaucoma and commitment to yoga.
“I have a patient with glaucoma
who is a yoga instructor,” she said.
“It is hard to tell someone whose
livelihood depends on yoga to
avoid head-down positions.”
Diet
Based on the results of several
studies, Dr Ou encourages patients
to eat a healthy diet that includes
a variety of fruits and vegetables,
especially green leafy vegetables.
This advice comes from studies
showing that consumption of a
diet rich in green leafy vegetables,
or with a higher dietary nitrate
intake (for which green leafy
vegetables are an excellent
source), seemed to protect against
glaucoma.
There is a biologic basis for
the association considering that
in one study, the reduced risk of
glaucoma with increased dietary
nitrate intake was greatest for
glaucoma with early paracentral
visual field loss at diagnosis, which
has been associated with vascular
dysregulation [JAMA Ophthalmol.
20015;134:294-303].
“We still need prospective
studies to determine how eating
green leafy vegetables affects
glaucoma progression,” Dr Ou
explained. “In the meantime, there
is no harm to increasing intake of
green leafy vegetables–although
patients on blood thinners, such
as warfarin, need to be aware that
green leafy vegetables are high in
vitamin K and should discuss any
increase in their intake with their
doctor so that medication dosages
can be adjusted.”
www.oteurope.com
Acupuncture
Patients interested in alternative
therapies may ask about
acupuncture for managing their
glaucoma. Based on available
evidence, the simple answer
seems to be that it is unlikely to be
beneficial.
Dr Ou noted that a recently
published, well-designed
prospective, randomised, masked,
crossover study found that overall,
diurnal IOP was unchanged in
patients who underwent a series of
12 acupuncture sessions involving
needle placement at eye- and
non-eye-related acupoints [Am J
Ophthalmol. 2015;160:255-265].
“This was a small study, and
more data are needed,” she said.
“At this time, however, we can’t
say that acupuncture will help
glaucoma patients.”
Proactive practitioner
In the interest of identifying
low-ocular perfusion pressure
as an underlying issue for
glaucoma progression despite
good IOP control, Dr Ou advised
ophthalmologists to ask their
patients about treatment for
systemic hypertension.
Recently published results of
the randomised SPRINT study [N
Engl J Med. 2015;373:2103-2116]
showed that in a population
of patients with increased
cardiovascular risk, intensive
treatment targeting a systolic
blood pressure (SBP) <120
mm Hg, significantly reduced
cardiovascular events and
cardiovascular event-related
morbidity compared with
standard treatment targeting SBP
<140 mm Hg.
Although there was no difference
between the two treatment arms
in the incidence of serious adverse
events, patients who had more
intensive SBP lowering were more
likely to report hypotension and
syncope, Dr Ou said.
“These safety findings, which
are not unexpected, are very
relevant to patients with glaucoma
because blood pressure drives optic
nerve blood flow,” Dr Ou added.
“We know from epidemiologic
studies that lower ocular perfusion
pressure (mean, systolic and
diastolic) is associated with worse
glaucoma prognosis.
“So when glaucoma is
progressing despite good IOP
control, ask patients to keep a
blood pressure log so that you can
identify diurnal fluctuation,” she
said. “Then, communicate with the
internist if you have any concern
and think the patient’s glaucoma
might benefit from less aggressive
blood pressure control.”
Dr Ou added that while exercise
also lowers blood pressure,
ophthalmologists are not doing
their patients harm by encouraging
them to be physically active,
considering data from the EPICNORFOLK eye study showing that
active people had a lower risk
of having low-ocular perfusion
pressure compared with non-active
individuals [Invest Ophthalmol Vis
Sci. 2011;52:8186-8192].
The analysis also showed
the difference between groups
was mediated by diastolic blood
pressure rather than IOP.
DR YVONNE OU
E: [email protected]
This article is adapted from Dr Ou’s presentation during
the Glaucoma Symposium CME at the 2016 Glaucoma
360 meeting. Dr Ou has no relevant financial interests to
disclose.
33
cornea
Exploring Bowman layer graft
in eyes with keratoconus
Surgical transplantation showing potential to reduce, stabilise corneal ectasia
By Laird Harrison;
Reviewed by
Dr Jack Parker
34
solated Bowman layer transplantation can
reduce and stabilise corneal ectasia in eyes
with progressive advanced keratoconus,
according to researchers.
The technique “flattens the cornea into a
more normal position,” said Dr Jack Parker,
a researcher at the Netherlands Institute for
Innovative Ocular Surgery (NIIOS), Rotterdam,
The Netherlands. “It doesn’t give [these patients]
perfect vision, but it keeps them from getting
worse. It lets them continue wearing their
contact lenses.”
In a published study, the procedure produced
an average flattening of about 8 D in 20 eyes,
and stabilisation after that (van Dijk K, Liarakos
VS, Parker J, et al. Bowman layer transplantation
to reduce and stabilise progressive, advanced
keratoconus. Ophthalmology. 2015;122:909–917).
There were two complications.
In keratoconus, the cornea gradually bulges
outward in the shape of a cone, distorting
patients’ vision. Glasses and contact lenses
can correct mild cases, and hard contact lenses
as well as implantation of intracorneal ring
segments can help in moderate cases.
However, in severe cases, the distortion of the
cornea may progress to the point that contact
lenses become too uncomfortable to wear.
“The problem with patients who have
keratoconus is that the cornea is changing
shape,” Dr Parker said. “A lot of times you can
help them with contact lenses, but if the cornea
is getting worse they’ll outgrow their lenses.”
At that point, penetrating keratoplasty (PK) or
deep anterior lamellar keratoplasty (DALK) may
restore some vision. These procedures, however,
can come with the risk for infection and other
complications; may not halt the progress of the
disease; and can make the cornea vulnerable to
injury, Dr Parker noted.
More recently, surgeons have used ultraviolet
A radiation to induce collagen crosslinking in
patients with mild-to-moderate keratoconus. This
I
BOWMAN LAYER TRANSPLANTATION
VIDEO Watch the procedure,
plus learn more about this new surgical option
for patients with advanced keratoconus.
(Videos courtesy of Netherlands Institute
for Innovative Ocular Surgery and UAB Medicine)
Go to OphthalmologyTimes.com/Bowman
procedure can halt the progression of the disease,
but patients with advanced keratoconus are not
eligible for the treatment, Dr Parker said.
Bowman layer grafts
Dr Parker and colleagues are proposing Bowman
layer grafts as an alternative. The Bowman
layer—a smooth, acellular, nonregenerating
membrane composed of collagen fibrils—lies
between the superficial epithelium and the
stroma in the cornea.
DECEMBER 2016 :: Ophthalmology Times Europe
Eye-to-Eye
Innovation Video Series
Brought to you by Ophthalmology Times Europe, in
conjunction with our industry partners, to provide
the latest information & insights into cutting-edge
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For further details & to watch our latest videos, please go to
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brought to you by
cornea
IN VIEW: Bowman
layer graft
immediately before
implantation,
seen from above
with the operating
microscope and
in profile using
intraoperative
optical coherence
tomography (A).
Subsequently, the
graft is placed atop
the surgical glide,
pushed into the
stromal pocket, and
unfolded (B). (Images
A
B
courtesy of Dr Jack Parker)
Because it has no cells, the
layer does not provoke a graft
rejection when transplanted, Dr
Parker said.
At baseline, their eyes had a Kmax
of more than 67.5 D and a best
spectacle-corrected visual acuity
(BSCVA) of worse than 20/60.
‘The problem with patients who have keratoconus
is that the cornea is changing shape.’
— Dr Jack Parker
Co-author, Dr Gerrit RJ Melles,
MD, PhD, an ophthalmologist at
the NIIOS in Rotterdam, came
up with the idea of transplanting
it into eyes with keratoconus,
according to Dr Parker.
About the study
For the current study, the researchers
operated on 22 eyes in 19 patients
with progressive, advanced
keratoconus. Ten of the patients
were male and nine were female,
ranging in ages from 17 to 72 years,
with keratoconus stages III to IV.
36
All the eyes had documented
evidence of keratoconus
progression, defined as ≥1 D
change in simulated keratometry
(SimK) values, ≥2 D change in Kmax,
or both, and a history of subjective
decline in visual acuity.
The surgeons removed the
Bowman layers from donor
corneas and created mid-stromal
pockets up to the limbus over 360°
under air using manual dissection.
This procedure was similar to the
procedure used to create a lamellar
dissection plane in DALK, except
that the dissection went to the
mid-stroma.
The surgeons inserted the donor
Bowman layer into the stromal
pocket, then unfolded and centred
it using a cannula and balanced
salt solutions to manipulate the
tissue.
The procedure is less invasive
than PK or DALK “because you are
doing no cutting or sewing,” Dr
Parker said.
Although it is technically
feasible to place a donor Bowman
layer in its true, anatomic position
in a keratoconic cornea, it cannot
be fixated with currently available
sutures or glues—making it
difficult to obtain sufficient
traction force across the cornea to
flatten the central cone.
As the corneas healed, the donor
Bowman layers attached to the
patients’ corneas, and the incisions
closed without sutures.
“We’re not really sure why it
works,” Dr Parker said. “It seems
DECEMBER 2016 :: Ophthalmology Times Europe
cornea
to provoke a healing response in
the cornea.”
Out of the 22 transplantations, 2
resulted in complications. In both
of these, the Descemet membrane
was perforated during manual
dissection. Both patients declined
PK, preferring to wait for corneal
clearance after re-endothelialisation
for the perforation.
from 64.0 before surgery to 58.9 at 1
month after surgery. Posterior mean
keratometry decreased from –10.1
D to –9.0 D. The changes were
statistically significant (p < 0.001).
After the first postoperative
month, Kmax stabilised. SimK and
posterior keratometry showed
a small regression from 1 to 6
months after surgery (p < 0.028),
The main value of the procedure may be that it
preserved an acceptable contact lens corrected
vision while stabilizing the cornea.
After initial clearance, 1 eye
showed progressive corneal
decompensation for which PK
has been scheduled. The cornea
of the other eye cleared slowly
and BSCVA improved during the
first postoperative 6 months. The
researchers excluded the 2 eyes
from postoperative evaluation.
Flattening effect
Of the remaining 20 eyes, a mean
follow-up of 20 months (range 12
to 36 months) showed a flattening
effect in 18 eyes.
On average, maximum
keratometry (Kmax) decreased from
77.2 D to 69.2 D a month after the
surgery. Anterior SimK decreased
then also stabilised. In 2 eyes,
the corneal curvature continued
steepening for reasons that were
not clear.
One eye had low visual potential
because of a cataract, and another
had preoperative visual acuity
measured only with a contact lens.
In the remaining 18 eyes, BSCVA
changed from 1.27 logarithm of
the minimum angle of resolution
(LOGMAR) before surgery to
0.90 LOGMAR 12 months after
the transplantation, a statistically
significant different (p < 0.001).
After that, no change in BSCVA
was observed.
Average best contact lenscorrected visual acuity (BCLVA)
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showed no change from before
surgery to any time point after.
The transplantation caused the
most flattening in corneas with
a relatively steep Kmax, combined
with a flatter SimK and a small
corneal apex-to- Kmax distance.
This means the procedure worked
best in the most advanced cases
with the most central cones,
researchers said.
Because the procedure resulted
in stabilisation, it might be useful
in managing keratoconus cases
ineligible for ultraviolet crosslinking, Dr Parker said.
The main value of the procedure
may be that it preserved an
acceptable contact lens corrected
vision while stabilising the cornea,
he said.
Researchers have continued
to transplant Bowman layers
into patients with advanced
keratoconus, Dr Parker noted, and
now have follow-up data on 65 or
more cases.
DR JACK PARKER
E: [email protected]
This article was adapted from Dr Parker’s presentation
of the Howard Lieberman Memorial Paper at the 2016
meeting of the American Society of Cataract and Refractive
Surgery. Dr Parker has no financial interest relevant to the
subject matter.
Articles must be original work that
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Articles are considered for publication with the understanding that they
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37
plastics
Orbital surgery aided by 3-D printing
Computerised preop planning, intraop models can help fracture-repair precision
By Laird Harrison;
Reviewed by Dr Paul
Langer
hree-dimensional (3-D) printing can
produce models of facial skeletons and
guides to help orbital surgeons plan repair
of complicated fractures, according to Dr
Paul Langer.
“In the cases where we have used it, the
alignments have been excellent,” said Dr Langer,
professor of ophthalmology, Rutgers New
Jersey Medical School, Newark, USA. “In our
experience it’s been very, very helpful.”
Dr Langer and a resident, Dr Leon Rafailov,
described their experience with the new
technology.
“Typically, the fracture cases where we’ve
used this technology are those with severe
comminution or with fragments missing,” Dr
Langer said. “That’s when the technology is
most useful because we can anticipate what
we’ll find at the time of the surgery.”
In simple trauma cases where there are
only one or two fractures, 3-D printing is not
necessary, he said.
Dr Langer’s institution does not own its own
3-D printer; it contracts with private companies
that print the guides.
T
How it works
The process begins with computed tomography
(CT) of the injury. The CT must have slices of 1.25
mm or thinner, Dr Langer said.
“Five-mm cuts will not be able to transmit
enough information,” he said.
The surgeon then must send the CT scan by
compact disc using overnight delivery to the 3-D
printing company, which downloads it to make
the virtual model. The surgeon then meets in a
web-based conference with engineers from one
of the companies. Together the surgeon and
the engineer manipulate the images of the bone
fragments to plan the surgery.
“It helps us to know ahead of time by moving
the pieces virtually what will be missing or how
the bones will fit together,” he said.
Moving actual bone fragments during surgery
is difficult because they are connected to
muscles and arteries.
Typically, the engineer will call back the
38
next day with images of guides for approval. Dr
Langer sometimes asks for more adjustments,
such as space for more screws. When Dr Langer
has approved the guides, the company prints
them out in polyamide.
The 3-D printing company sends the guides
to its representative, who delivers them to the
hospital. Intraoperatively, Dr Langer lays the
guides over the fracture to align the segments
and screws the guide in place to temporarily
hold the fracture segments in place. Then he
screws a metal plate over the fracture and
removes the guide.
The technology has also
been used in surgery to aid
in facial reconstruction after
tumor removal.
“Otherwise, while you’re putting screws and
plates on the bone fragments, you may move
them and not get the contour or curvature you
want,” Dr Langer said.
The 3-D printers can also produce acrylic
facial skeletons, which are sterilised and used
intraoperatively to guide fracture reduction, for
example, by helping shape a metal plate.
“I can shape an implant exactly to the contour
I want, then pull it off the printed skull and put
it in the patient,” Dr Langer said.
Case example
In one case, Dr Langer operated on a 19-year-old
IN SHORT
Preoperative computer-assisted
manipulation of computed tomography
images—with three-dimensional printing of
anatomic models and intraoperative guides—
can be a powerful tool in managing complex
periorbital fractures.
DECEMBER 2016 :: Ophthalmology Times Europe
plastics
(FIGURE 1) Coronal and axial CT images of a 19-year-old man with multiple periorbital fractures and significant
comminution and misalignment of bones following a gun shot to the right face.
(FIGURE 2) The CT of the patient is uploaded to create a 3-D computerized
representation of the bone fragments with the bone fragments highlighted
in purple.
man with multiple periorbital
fractures and significant
comminution and misalignment
of bones following a gunshot
to the right face. After virtually
manipulating the CT images on a
computer, Dr Langer discovered
www.oteurope.com
there was a large bone fragment
missing. He then worked with
an engineer to design guides
to realign the larger fracture
segments.
The printing company then
produced a model of the
reconstructed facial skeleton
showing the bone fragments
realigned in their optimal
locations. It also produced guides
for the procedure.
Dr Langer corrected the defect
in the right inferior orbital rim
with a porous polyethylene
implant. Postoperative CT
showed excellent symmetry and
alignment.
The technology has also been
used in surgery to aid in facial
reconstruction after tumor
removal.
Currently, several companies
are competing to provide this
technology.
One drawback to this approach
is the time required to send the
CT scans by mail to the company,
planning by web conference, and
then shipping the 3-D models back
to the hospital, Dr Langer said.
“If I see a patient today, I can’t
operate tomorrow,” he said. “It’s
usually 4 to 5 days.”
As the technology becomes
more widely available, more
hospitals may buy their own 3-D
39
plastics
(FIGURE 3) The bone fragments are then virtually realigned in this 3-D
representation and custom templates are designed to reproduce the
natural contours of the desired reduction.
(FIGURE 4) (top) A 3-D model of the reconstructed
facial skeleton, with bone fragments realigned in
their ideal locations, is printed using a 3-D printer.
Missing bone of the right cheek and inferior orbital
rim is demonstrated. (bottom) Polyamide guides are
also 3-D printed for intraoperative use.
(FIGURE 5) (left) The polyamide guides are sterilized and placed over
fracture lines intraoperatively to ensure proper alignment of fracture
fragments in 3-D.
(FIGURE 6) (right) Anticipated bony defect of right inferior orbital rim
corrected with porous polyethylene implant.
(FIGURE 7) Postoperative CT images showing excellent symmetry and
alignment. (Images courtesy of Dr Paul Langer)
40
printers, making this approach even more available,
he said.
Dr Langer has also used 3-D printing to create
implants.
For example, he recently operated on a woman
who had been in a car accident years earlier. The
original surgery to reassemble fragments of her skull
left a divot in her forehead.
“So,” he said, “we created an implant that would
smooth out that defect into an arc rather than a
divot.”
DR PAUL LANGER
E: [email protected]
This article was adapted from Dr Langer’s presentation at the 2015 meeting of the American
Academy of Ophthalmology. He did not indicate any proprietary interest in the subject matter.
DECEMBER 2016 :: Ophthalmology Times Europe
product news
Haag-Streit fundus device
enhances clinical workflow
Haag-Streit UK (HS-UK) has announced the launch of the new Fundus Module 300
(FM 300) imaging device. The FM 300 allows the integration of non-mydriatic retinal
imaging into a regular slit lamp examination, enhancing clinical workflow.
The instrument can be quickly mounted on the slit lamp, ready to capture an image.
The compact fundus imaging solution provides high-quality retinal images that
can rival those of a fundus camera, making it very cost-efficient, according to
the company. Images can be transferred to the EyeSuite software, allowing easy
documentation and increasing the quality and accuracy of referrals.
Sam Laidlaw, HS-UK Product Manager, said, “The FM 300 is an exciting addition
to the HS-UK portfolio. It allows users of all Haag-Streit slit lamps to access simple
and instant documentation of the retina, enhancing and extending the functionality
of the slit lamp.”
For more information, go to www.haag-streit.com/haag-streit-uk
Allergan receives FDA clearance for gel stent,
a surgical treatment for refractory glaucoma
Allergan plc announced the FDA has cleared the XEN Glaucoma Treatment System (consisting of the XEN45 Gel Stent and the XEN Injector)
for use in the United States. The XEN Glaucoma Treatment System reduces IOP in patients and is indicated for the management of
refractory glaucomas, where previous surgical treatment has failed or in patients with primary open-angle glaucoma, and pseudoexfoliative
or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy. XEN is implanted through an ab
interno approach and reduces IOP by creating a new drainage channel with a permanent implant that becomes flexible. This provides a new
treatment option for millions of Americans with refractory glaucoma.
“Allergan has a deep, long-term commitment to developing treatments for patients with glaucoma, a sight-threatening disease that
affects millions in the United States and worldwide. We are thrilled to receive FDA clearance for the XEN Glaucoma Treatment System,
which will provide a new treatment option for patients struggling to bring down their intraocular pressure,” said David Nicholson, Chief
R&D Officer at Allergan.
In the U.S. pivotal trial conducted in refractory glaucoma patients, XEN reduced IOP from a mean medicated baseline of 25.1 (+ 3.7)
mm Hg to 15.9 (+ 5.2) mm Hg at the 12 month visit (n = 52). The mean baseline number of IOP-lowering medications was 3.5 (± 1.0)
versus an average use of 1.7 (± 1.5) medications at 12 months. XEN also allows for keeping post-operative options open, allowing
physicians to utilize other IOP-reduction techniques in the event that they are still needed after surgery.
“XEN is a new option that provides an opportunity for surgical intervention in refractory glaucoma patients. XEN can effectively lower
IOP, in fact, studies have shown that at 12 months using XEN, patients used, on average, less IOP lowering drops than they did before
XEN was implanted,” said Dr Robert N Weinreb, chairman and distinguished professor of ophthalmology at the University of California,
San Diego, USA.
Allergan plans to launch the XEN Glaucoma Treatment System in the United States in early 2017, according to a prepared statement.
More than 10,500 XEN Gel Stents have already been distributed worldwide. XEN is CE marked in the European Union, where it is
indicated for the reduction of IOP in patients with primary open-angle glaucoma where previous medical treatments have failed. It is
also licensed for use in Canada, Switzerland, and Turkey.
For more information, go to www.Allergan.com
www.oteurope.com
41
product news
Oculus next-generation trial frame available
Lighter, trendier, simpler, more comfortable – this describes the new
Universal Trial Frame from OCULUS, according to the company. For the new
generation of the OCULUS Trial Frame, many suggestions from users were
taken into consideration in order to create an even more comfortable method
of subjective refraction for customers and eye care professionals, said the
company.
New in an OCULUS Trial Frame are the 12 total slots for trial lenses: 6 for
each side of the frame, 4 in front and 2 behind. This makes fine adjustment,
with sph +/- 0,12 D or refraction with circular/linear polarizing filters, easier to
carry out.
The new design with its optimized material mix is, like the rest of the UB 6,
100 % “Made by OCULUS.” All 166 individual parts of the new Trial Frame are
crafted by hand with attention to detail, for guaranteed quality, according to the
company.
Unique to this design: the gradation of the axis scales at 2.5° intervals. These are easy to read even in dark rooms. The operating
elements have a new design and appear in a trendy, grey colour tone. The nose bridge can be adjusted in height and angle, and the
nose piece is anatomically formed for better distribution of pressure.
The thumb wheel for adjustment of the earpieces has also been modified and can now be gripped more firmly. The earpieces have
been changed substantially: the new flexible double earpieces adapt perfectly to every ear shape.
The optionally available polarizing filters can be easily clipped on. There are two versions, linear and circular. Both offer an expanded
viewing area for distance and near vision.
All OCULUS trial and special lenses in standard size 38 mm diametre are compatible with the new UB 6.
For further information, go to www.oculus.de
Avellino Labs to introduce keratoconus screening test;
expected to predict elevated risk in Asian populations
Avellino Labs announced it will launch a keratoconus screening test in Korea, Japan, and China in the first quarter of 2017.
In a recent study, Avellino Labs used next-generation sequencing (NGS) to examine DNA collected from more than 200 keratoconus
patients from different clinics and institutions from around the world, according to the company.
The company said it was able to identify four DNA variants within three different genes that conferred genetic risk factors in 9% to 21%
of patients within the study group from Korea. These percentages imply a statistically significant increased risk for keratoconus. Avellino
Labs intends to launch a test to screen for these four mutations for use in Korea, Japan, and China in the first quarter of 2017, according to
a prepared statement.
Dr John Marshall, PhD, FRCPath, FMedSci, concurrently medical advisory board member at Avellino Labs and Frost Professor of
Ophthalmology at UCL Institute of Ophthalmology and Moorfields Eye Hospital, commented, “At Avellino Labs we are excited to be able to
offer the first genetic predictor of relative risk of keratoconus in Asian eyes, which often hits in the prime of life and progressively impairs
vision over time. Most importantly, the Avellino DNA Test represents a sea change detecting keratoconus early in order to inform surgeons
performing laser vision correction and to improve keratoconus patient care.”
For more information, go to www.avellinolabs.com
42
DECEMBER 2016 :: Ophthalmology Times Europe
ZEISS Cataract Suite markerless
// PRECISION
MADE BY ZEISS
The direct way to precise2 toric IOL alignment.
You can now skip the manual pre- and intra-operative marking steps and skip manual
data transfer. ZEISS Cataract Suite markerless, products designed to work together
for markerless toric IOL alignment, assisting you to reach your desired outcomes.
www.zeiss.com/markerless
1. Clinical data of Dr. Daniel Black presented at ASCRS 2015 based on 161 eyes
2. Clinical data of Prof. Findl / Dr. Hirnschall presented at ESCRS 2013 – technically verified pre- / intraoperative matching precision ± 1.0° in mean
Achieving up to 99% of
patients within +/– 0.5 D
1
post-op astigmatism.
The next summit in
refractive performance.
At 12 months, Contoura™ Vision Topography-Guided LASIK patients,
without the aid of glasses or contacts, experienced the following results:*,1
98.4%
off patients sai
said
they
hey would have
the procedure
again
30.9%
of eyes gained 1
or more lines ov
over
ve
baseline
BSCVA
a
VA
34.4%
64.8%
92.6%
could
20/12.5
uld see 20/12
or better
could
20/16
ould see 20/1
ou
or better
could
20/20
ould see 20/
or better
For additional information or to schedule a demonstration, contact your Alcon representative.
*Post hoc analysis of postoperative UCVA compared to preoperative BSCVA of 230 eyes contained in the FDA T-CAT pivotal trial at 12 months. The primary end point evaluated changes in BSCVA.
1. Results from FDA T-CAT-001 clinical study for Topography-Guided vision correction (with the 400 Hz ALLEGRETTO WAVE® Eye-Q Excimer Laser).
WaveLight
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