EuroTimes July/August 2022, Volume 27, Issue 6

HEAD-UP 3-D HELMET COULD INCREASE SURGICAL PRECISION WHILE ENHANCING SURGEON COMFORT

Research Education Innovation

ESCRS’s vision is to educate and help our peers excel in our field. Together, we are driving the field of ophthalmology forward.

Publishers Therese Dolan

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Contributing Editors

Contributing Editors

Cheryl Guttman Krader

Cheryl Guttman Krader

Howard Larkin

Howard Larkin

Dermot McGrath

Dermot McGrath Roibeárd O’hÉineacháin

Roibeárd O’hÉineacháin

Contributors

Contributors

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Published by the European Society of Cataract and Refractive Surgeons, Temple House, Temple Road, Blackrock, Co Dublin, Ireland. No part of this publication may be reproduced without the permission of the executive editor.

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ESCRS EuroTimes is not responsible for statements made by any contributor. These contributions are presented for review and comment and not as a statement on the standard of care. Although all advertising material is expected to conform to ethical medical standards, acceptance does not imply endorsement by ESCRS EuroTimes ISSN 1393-8983

Friend or Foe?

As ophthalmologists, we value our independence and pride ourselves on our ability to practice as free-thinking and innovative clinicians. Every day we make decisions that directly impact the health and well-being of our patients. We may not always make the right decisions, but we know the responsibility for these decisions lies with us as ophthalmologists.

However, financial aspects of delivering healthcare are correctly becoming increasingly important. Money should always have mattered to the delivery of our services, but doctors did not see it as their responsibility for many years. Every clinical action we take has a financial impact—whether in revenue, cost, or, ultimately, bottom line—which in turn determines investment in innovative clinical models or technology. Purchasers and providers of services now place much importance on “value”.

Therefore, the landscape of ophthalmology is rapidly changing. We now face a scenario where, in recent years, practitioners in both public and private practice face increasing financial pressure from CFOs and investors to deliver their services “profitably”. Specified healthcare has become very attractive to private investors who have seen the benefits of including ophthalmology in their portfolios. Investors range from ophthalmologists to large private equity groups, but the latter has become increasingly active, taking over practices or small groups.

The ESCRS Practice Management & Development Committee has watched this occurring either directly or indirectly, and on

Monday, September 19 at the 40th Congress of the ESCRS in Milan, Italy, we will deliver a one-hour workshop on the topic “Who Owns Ophthalmology?”

During this workshop, we will examine the relationship between clinicians and large corporate entities and explore how ophthalmologists should respond, “friend” or “enemy”.

This issue is important not only for ophthalmologists currently working in public and private practices but the young ophthalmologists embarking on their careers in the coming years.

Private investors must always seek a return on their investment, but will they ignore less financially attractive procedures and focus only on premium services? If this is the case, these decisions will have major repercussions for both ophthalmologists and patients.

During our workshop at this year’s Congress, we will ask a number of questions that may help us draw up a roadmap for the future: What is private equity, and how does it work? What is the difference between independent and corporate practices? How can we consolidate ophthalmology practices—by ophthalmologists and for ophthalmologists? Who will train our future surgeons?

The answers to these questions will have a major impact on our profession in future years, and we are delighted the ESCRS plays a leading role in driving this debate. The COVID-19 pandemic has changed the way we think about our profession and how we deliver services to our patients.

As Chairman of the ESCRS Practice Management & Development Committee, I look forward to seeing you in Milan and hope you will help us be part of an exciting new future for the ESCRS and global ophthalmology.

Paul Rosen is Chairman of the ESCRS Trustees, Chairman of the ESCRS Practice Management & Development Committee, and Past President of the ESCRS.

ESCRS PRESIDENT

INTERNATIONAL EDITORIAL BOARD

MEDICAL EDITORS

Noel Alpins (Australia), Bekir Aslan (Turkey), Roberto Bellucci (Italy), Hiroko Bissen-Miyajima (Japan), John Chang (China), Béatrice Cochener-Lamard (France), Oliver Findl (Austria), Nino Hirnschall (Austria), Soosan Jacob (India), Vikentia Katsanevaki (Greece), Daniel Kook (Germany), Boris Malyugin (Russia), Marguerite McDonald (USA), Cyres Mehta (India), Sorcha Ní Dhubhghaill (Ireland), Rudy Nuijts (The Netherlands), Leigh Spielberg (The Netherlands), Sathish Srinivasan (UK), Robert Stegmann (South Africa), Ulf Stenevi (Sweden), Marie-José Tassignon (Belgium), Manfred Tetz (Germany), Carlo Enrico Traverso (Italy)

During our workshop at this year’s Congress, we will ask a number of questions that may help us draw up a roadmap for the future...

Paul Rosen José Güell Thomas Kohnen Chief Medical Editor

Ukraine Update

The latest news on the Russian offensive strongly suggests the war will continue for months, if not years. ESCRS support, along with that of WSOPRS and BSOPRS, will remain important and frequently critical throughout this period. With this in mind, the ESCRS is making every reasonable effort to ensure the vital equipment donated by our industry partners—and drugs largely purchased from either ESCRS’s own reserves or through generous donations from both sister societies and members—reaches the right hands.

All stages of the distribution are closely monitored, administrative costs are kept to a minimum, and we try to ensure that we do not flood clinics with unnecessary material. We intend to meet the immediate need as best we can while also harbouring our resources so we can sustain our support in the long term.

The ESCRS Managing Director Tom Ogilvie-Graham once again visited Ukraine—travelling not only to clinics in Lviv but two in Kyiv and one in Irpin. We delivered an endoscope donated from BVI to Professor Marian Sarakhman at the Lviv Ophthalmic Regional Eye Trauma Centre. Professor Marian’s son, Dmetro, is also a cataract and VR surgeon to whom the Managing Director is particularly grateful for chauffeuring him between Lviv and the Polish border.

We also delivered an endoscope to the ophthalmic department of Kyiv military hospital, where it was particularly sad to see young soldiers, who were fully fit only a week or two previously, now totally blind despite all the best efforts to salvage at least some sight.

Professor Andriy Ruban, who runs the Kyiv Centre of Clinical Ophthalmology, helped set up these visits and has been immensely helpful throughout, as have been Dr Lyubomyr Lytvynchuk in Giessen, Germany, and Aneliya Nehanova (who has volunteered to oversee the storage in Krakow and transport across Poland).

In addition to checking on the distribution chain and storage, the ESCRS ensures all administrative costs remain as low as possible. For example, the storage in Krakow is provided at a fraction of the market rate, and the storage and local distribution in Lviv is provided for free by Dr Goriachev and Professor Novytsky. There is a great deal of self-help when it comes to onward distribution in Ukraine, and whilst some clinics may feel we could do more, I am confident we are reaching as many as reasonably possible under the circumstances.

Other initiatives include the development of a consultant network under the direction of Dr David Verity and James Hampton in ESCRS head office. This is well underway and could be of particular use in the long term, with Ukrainian surgeons being able to discuss more complicated cases, including reconstructive surgery and facial maxillary cases.

I would like to mention one initiative in particular. We now have nearly 20 applicants for observerships from Ukrainian trainee surgeons, mainly from trauma centres, all across the country—including Kyiv, Lviv, Kharkiv, and Odesa. We do, of course, already have a scheme for observerships with a number

of institutions very helpfully providing these. However, this is a large addition to that scheme and for this year only (hopefully), so I would appeal to other institutions, including private clinics, to accept one or even two Ukrainians for up to two weeks this summer. Their training in Ukraine is quite limited at present, so any experience working in a modern, fully functioning clinic would be most valuable.

The institution does not need to be a teaching establishment, providing there is a consultant who is willing to give up some of his or her time to offer explanations. The experience does not have to be related to trauma, and, of course, their travel and accommodation would be covered by ESCRS funds. Whilst we shall offer these applicants grants to attend the Congress in Milan (where the ESCRS Young Ophthalmologist committee members shall take particular care of them), if we cannot find them placements, it would be even better if Members could find places for them this year. If you can help, please let me or the Head Office know as soon as possible.

The ESCRS is also offering free registration to Ukrainian surgeons to attend the Congress and issuing grants for travel and accommodation. The reality is that only a small number of surgeons may be able to attend in person, as most will be too busy in Ukraine or not able to travel, as with any male under the age of 60. Nevertheless, it is an important gesture.

A particular acknowledgement is due to Bausch + Lomb who will be supplying two combined Stellaris machines—both of which will go to centres dealing with trauma and shall go to immediate use. However, all donations are gratefully received and shall be spent wisely.

As always, we shall do all we can to support our Ukrainian colleagues and their patients now and for as long as necessary.

Oliver Findl, President of the ESCRS

Delivering slit lamps to the ophthalmic department of the children’s hospital in Irpin.

HEAD-UP 3-D HELMET COULD INCREASE SURGICAL PRECISION WHILE ENHANCING SURGEON COMFORT

HOWARD LARKIN REPORTS

Surgeons have been hunching over their operating microscopes for a century, suffering lifelong ergonomic problems as they treat their patients. Now, with the appearance of digital microscopy and heads-up displays, relief may be at hand.

After more than 15 years of anterior segment ophthalmic surgery, Jonathan D Solomon MD has made a big investment in preserving his neck and back—and his future practice. He and a partner have purchased a Beyeonics One™ digital surgical exoscope for a new surgery centre they are building near Washington, DC, USA.

The digital device’s 3D visor allows Dr Solomon to hold his head up straight and relax during surgery, he explained. “I have to be a little bit more focused now on my ergonomics. Before, being younger, I could muscle on through. But now, after a day or two of surgery, my body starts to feel it.”

As a taller surgeon, Dr Solomon has always had difficulty getting comfortable behind an analogue binocular surgical microscope. It is hard to get the operating table high enough to fit his legs, and he has to slump to reach both the patient and the oculars.

Digitally enhanced 3D imaging and data overlays available on big-screen displays make surgery easier and possibly safer, Dr Solomon said. So, he was an early adopter of head-up surgical technology.

But while large-screen 3D displays definitely help, they still have to be set up in a particular place to maintain a consistent view of the surgical field, limiting surgeon movement and OR setup flexibility. The visor is an improvement because it projects a 3D image from one temporal field to the other regardless of head position, making it both more immersive and more relaxing.

“Now [the surgical field image] is anywhere you turn your head. Everything downstream tends to relax, your lower body relaxes, your lower back relaxes, your neck and shoulders tend to drop. It takes it to the next level, delivering what was initially intended when we went to a 3D television,” said Dr Solomon, who has done about 50 procedures with the visor.

The visor’s digitally enhanced image also increases depth of field, making fewer changes of focus necessary and enhancing visualisation of tissue planes and edges, Dr Solomon added. The device can be programmed to activate functions with head gestures or pedal movements. Producing the digital image also requires less light than direct visualisation, potentially reducing the risk of retinal light damage.

“As somebody who has used a lot of 3D systems—you name it, I’ve used it—from the vantage point of the surgeon, the ergonomics, the image quality—there is just nothing I’ve seen to date that even compares,” Dr Solomon said.

COMPRESSED VERTEBRAE

Dr Solomon is far from alone in his concern for his neck and back health.

In a 2005 study of musculoskeletal symptoms in USA ophthalmologists, 51% reported neck or back pain, and 15% limited their

work as a result.i In a similar 1994 UK study, 54% reported back pain, with those longest in the field having it more frequently.ii A 2011 study of ophthalmic plastic surgeons found 72.5% had pain associated with operating, causing 42.5% to modify their operating room practice and 9.2% to stop operating altogether.iii

Indeed, in a presentation on head-up displays at the 2022 ASCRS Annual Meeting, Nicole R Fram MD showed a neck scan of one of her older partners, showing compressed cervical vertebrae. “I want to emulate him in every way, but not this way.”

Dr Fram’s practice investigated three head-up systems, noting strengths and weaknesses of each. The Alcon Ngenuity® system attaches to any microscope, integrates diagnostic and other patient data, and displays ORA intraoperative aberrometry. However, it has a large footprint, so integrating it into the operating theatre required getting everyone on board, though “being able to see everything in front of you on this big screen is great for you and the team.”

Advantages of the Zeiss Artevo 800 system include two 4K cameras, integration with the microscope offering a hybrid mode

with oculars, and intraoperative OCT, but it also has a large footprint. Dr Fram showed a video of removing interface fluid during a DSAEK, watching it in real time on OCT. “I’ve never seen this in real time, so this is amazing.”

The BVI Beyeonics headset has a small footprint and allows for easy adaption, Dr Fram said. “It was really easy to implement, but the red reflex and saturation are different and are being optimised to reflect our current microscope experience.” By contrast, Dr Solomon feels it offers better visualisation of tissue planes and edges.

Dr Fram noted that head-up surgical technology is still in its infancy and will continue to develop. “The winning technology will be the one that has data integration but also the smallest footprint,” she said.

OPERATING EFFICIENCY

Presenting on behalf of Robert J Weinstock and colleagues at the 2022 ASCRS Annual Meeting, Caroline Watson MD reported on a study comparing the Beyeonics One with an Alcon Ngenuity and a conventional binocular analogue microscope for manual and femtosecond laser-assisted cataract surgery using singlepiece monofocal and multifocal non-toric lenses. For a total of 533 eyes of 412 patients operated by one experienced surgeon and two inexperienced surgeons, surgical times were similar among the three groups, nor were any significant differences reported for manual cataract surgery or FLACS. No complications were reported in any of the 533 cases.

These results were similar to those reported by Dr Weinstock and colleagues in a 2019 study comparing a 3D head-up screen system with manual surgery on 2,320 consecutive surgeries, which found no difference in surgical time and similarly low complication rates.iv However, another series involving 343 eyes found a 3D external display system added nearly two minutes to surgical time compared with manual surgery, though safety outcomes were similar.v

“Heads-up cataract surgery may assist in avoiding development of occupational musculoskeletal injuries,” Dr Watson said. The 3D visualisation systems also offer a much better teaching tool for early surgical training, she added.

Dr Fram noted that adjusting to a headup system takes some effort. But surgeon’s necks are worth the discomfort of adapting to a new way to operate. “We really need to worry about this, whether it is difficult or easy, because it is the wave of the future,” she said.

The Beyeonics systems are now available in the USA. In Europe, enrolment of evaluation and training sites for the device is scheduled to begin early next year.

i American Journal of Ophthalmology. 2005; 139: 179–181.

ii Eye (London) 1994; 8(Pt 4): 473–4.

iii Ophthalmic Plastic and Reconstructive Surgery. Jan–Feb 2011; 27(1): 28–32.

iv Journal of Refractive Surgery. 2019; 35(5): 318–322.

v Indian Journal of Ophthalmology. 2021 Sept; 69(9): 2304–2309.

Jonathan D Solomon MD is an anterior segment surgeon and medical director at Solomon Eye Physicians and Surgeons in Bowie and Greenbelt, Maryland, USA. jgriffin@solomoneye.net

Caroline Watson MD is an advanced anterior segment fellow at The Eye Institute of West Florida, Clearwater, Florida, USA. carolinewatsonmd@gmail.com

Nicole R Fram MD is an anterior segment ophthalmologist with Advanced Vision Care in Los Angeles, California, USA, a clinical instructor of ophthalmology at the Stein Eye Institute, University of California, Los Angeles, and a consultation section editor for the Journal of Cataract and Refractive Surgery. nicfram@yahoo.com

Now finishing an anterior segment surgery fellowship with Robert J Weinstock MD, a pioneer in 3D headsup surgery, Dr Watson has extensive experience using 3D heads-up devices for all her procedures since her fourth year in residency. These include the Alcon Ngenuity, the Zeiss Artevo, and the BVI Beyeonics One 3D systems throughout her fellowship year. To date, she has performed more than 1,000 procedures using 3D heads-up technology.

Her preference? “At the moment I don’t have a preference. All the 3D systems are far superior to a conventional operating microscope with oculars. All these devices allow the surgeon to break free from the microscope and deliver a better view in a more comfortable operating position. My goal is to help other surgeons understand what a tremendous benefit this technology is to both the patient and the surgeon.”

Dr Watson sees the broader and deeper view offered by 3D operating technology as a patient benefit. “The depth of focus and immersive view definitely makes me a safer surgeon. With a 3D system, you get a very large image in perfect detail. You can see everything from the anterior corneal plane to the posterior lens capsule, so you are able to anticipate

what is happening more quickly and avoid mistakes. There is no longer the need to look away from the surgical field as instruments are passed and then readjust to looking through the oculars.”

By allowing more ergonomic body positioning, 3D systems can help avoid back and neck injuries, potentially improving productivity and extending surgical careers, Dr Watson said. “Surgeons tend to think they are invincible, but many suffer from chronic neck and back pain that limits their ability to perform more surgery in a day. Many surgeons have had to end their careers early due to occupational health issues. Heads-up surgery will help prevent this.”

Adjusting to 3D does take some effort, she said. “It takes about 20 cases, not just three or four. Additionally, proper OR setup is crucial for success with this technology.”

As 3D technology continues to advance and integrate more data and capabilities such as intraoperative OCT, younger surgeons will need to make the transition to keep up,” Dr Watson predicted. “Why would you drive a 1950s car around when what you want is a Tesla? I’ll never use a regular microscope with oculars again.”

Caroline Watson MD has seen the future of anterior segment surgery, and it is in 3D.

“I’ll never use a regular microscope with oculars again”

40th Congress of the ESCRS

MILAN 16–20 September 2022

MiCo, Milano Convention Centre Milan Italy

Using AI to Predict Cataract Surgery Success

Algorithm could help identify best candidates for premium IOLs. Dermot McGrath reports from Paris

Performances of the Algorithm to Predict Cataract Surgery Success

OF THEALGORITHM TO

Amachine learning algorithm has shown promise in predicting cataract surgery success and could potentially help identify patients at risk of obtaining less-than-optimal outcomes, reported Cédric Schweitzer MD at the French Implant and Refractive Surgery Association (SAFIR) Annual Meeting.

“The algorithm showed good performance in determining the overall success of cataract surgery but still needs external validation and further improvement of certain parameters before it could be used clinically,” he said.

Dr Schweitzer explained the algorithm was developed in

conjunction with the National Institute for Research in Digital Science and Technology (INRIA) at the University of Bordeaux using data derived from the FEMCAT study, a two-year French multicentre trial that compared femto-cataract surgery to standard phacoemulsification.

“We wanted to see if we could use artificial intelligence to predict the success of cataract surgery based on the data in FEMCAT. Cataract surgery has a high level of anatomical and visual reproducibility, and there has been a clear trend towards refractive cataract surgery in recent years, driven by patient demand and the development of premium IOLs. There is a clear need to be able to identify those patients who can expect the full benefits of modern cataract surgery,” said Dr Schweitzer.

The original FEMCAT study defined success as a combination of four factors: absence of pre- or postoperative complica-

tions three months after surgery, best-corrected visual acuity (BCVA) of 0.0 logMAR at three months, refractive error less than 0.75 D at three months, and corneal astigmatism less than 0.5 D at three months.

The algorithm developed with INRIA uses random forest AI, an ensemble learning method for classification, regression, and other tasks that constructs a host of decision trees at training time.

“We used 80% of the relevant FEMCAT data as a training data set and 20% for the actual testing,” Dr Schweitzer said.

The algorithm was given preoperative and intraoperative data taken from 1,497 eyes of 909 patients. A total of 29 parameters were selected, including demographic, biometric, anatomical, visual, and refractive preoperative data and total intraoperative data.

Looking at the results, the parameters with the greatest impact on the overall success rate included age, cataract grade, IOL power, intraoperative complications, surgeon factors, and keratometry.

“The algorithm performed well in determining the total success of cataract surgery, but this could be improved in the future. The sensitivity of individual criteria was in the range of 92.5% to 100%, which was very good, but around 60.3% for the overall criteria. We plan to improve the algorithm by refining the selected parameters and validating it externally, as well as enlarging the database for a more heterogenous population,” Dr Schweitzer said.

When properly tested and validated, the algorithm could be used to help determine those patients who might not obtain their expected target outcomes—especially for those implanted with premium toric or multifocal lenses where expectations tend to be higher, he concluded.

Cédric Schweitzer MD is an ophthalmologist at Bordeaux University Hospital in France and the principal investigator of the FEMCAT trial. cedric.schweitzer@chu-bordeaux.fr

“There is a clear need to be able to identify those patients who can expect the full benefits of modern cataract surgery.”

Cédric Schweitzer MD

Here Come the Robots

Robotic surgery applications in ophthalmology are expanding. Dermot McGrath reports from Paris

The future of cataract surgery is robotic, enabled by artificial intelligence and advanced technology, which will offer unparalleled precision and accuracy for enhanced patient outcomes, according to Jean-Pierre Hubschman MD.

In a keynote address at the French Implant and Refractive Surgery Association (SAFIR) Annual Meeting, Dr Hubschman said robot-assisted surgery could help overcome the physical limitations of fixed surgical instruments, reduce surgeon fatigue, and deliver improved quality of patient care.

“Major technological advances have been made in recent years and robotic assistance will play an increasing role in ocular surgeries in the very near future. It will help overcome limitations of the human body such as hand tremor, fatigue, and our ability to react correctly and quickly in stressful situations,” he said.

Although robotic devices have already proven utility and safety in fields such as laparoscopic and cardiac surgery, their application in ophthalmology has lagged, Dr Hubschman said.

“This is probably due to the specificity of the field of ophthalmology with direct and accurate visualisation of anatomical structures and ready access to minimally-invasive surgical instruments,” he said.

Dr Hubschman went on to explain the three main concepts of robotic design: all-in-one handheld devices, co-manipulator systems, and telemanipulation systems.

Handheld devices are focused on tremor cancellation and depth locking and geared towards improving the surgeon’s dexterity. Co-manipulator systems are designed to perform specific tasks— with the surgeon holding and controlling the surgical instrument simultaneously with the robot that provides assistive compensation for the surgeon’s hand tremor. Telemanipulation systems are a class of robotics that enable the operator to work remotely by a computerised human-machine interface.

Robotics can intervene at a variety of levels during surgery, Dr Hubschman said. The first level increases precision by filtering tremors and modifying the scale of movements. Two robotic

The second level of robotic intervention corresponds to technology integration such as OCT and microscope imaging to enable enhanced detection and feedback capacities. The third level takes the same information from imagery but adds artificial intelligence to guide the surgeon and potentially automate specific surgical gestures.

“Similar to the way autonomous cars can reduce the risk of accidents by 94% simply by eliminating human error, robotic surgery systems will initially allow for improved surgical precision and decreased complication rates but eventually perform autonomous surgery for specific tasks such as cataract removal,” Dr Hubschman said.

For cataract surgery, femtosecond lasers have already automated the initial part of the surgery by performing the incision, capsulorhexis, and lens fragmentation.

“The other surgical steps, such as nucleus extraction, cortical clean-up, capsular bag polishing, and IOL implantation, can also potentially be automated, allowing a significant reduction in complication rates as well as reducing the duration of the surgery through the use of artificial intelligence,” he said.

platforms—MyNutia and Preceyes Surgical System—have already been used for this purpose in vitreoretinal surgery.

“Both of these platforms have been tested in humans and have demonstrated significant improvement in manipulative accuracy during vitreoretinal surgical manoeuvres. In addition, they confirmed the possibility of performing robotic-assisted surgery under local anaesthesia,” he said.

Despite the clear advantages of robotic surgery in ophthalmic surgery, significant barriers remain to their widespread adoption, concluded Dr Hubschman, including costs, safety concerns, and human acceptance.

Jean-Pierre Hubschman MD is associate professor of ophthalmology, Stein Eye Institute, David Geffen School of Medicine, University of California Los Angeles (UCLA), USA. hubschman@jsei.ucla.edu

“Major technological advances have been made in recent years and robotic assistance will play an increasing role in ocular surgeries in the very near future.”

Jean-Pierre Hubschman MD

Non-Diffractive EDOF IOLs Gaining Ground

Distance and intermediate vision improve with less glare and halos than diffractive alternatives. Howard Larkin reports from the 2022 ASCRS Annual Meeting

Minimonovision with EDOF #2 (Vivity)

• 59 patients (97 eyes)

• Dominant eye emmetrope und non-dominant eye -0.5 D

• 87% reported complete spectacle independence

• Binocular defocus curve

A) minimonovision

B) emmetropia

When it comes to treating presbyopia, non-diffractive extended depth of focus intraocular lens (EDOF IOL) technology is the “new kid on the block,” according to Thomas Kohnen MD, PhD, FEBO. These lenses can reduce optical disturbances such as glare and halos while offering similar depth of focus gains compared with diffractive EDOF and some multifocal IOLs.

For example, in a study Prof Kohnen conducted, 25% of patients implanted with the non-diffractive AcrySof® IQ Vivity™

Curves

IOL (Alcon) reported halos compared with rates of 60% to 70% reported for diffractive IOLs.i The non-diffractive Vivity scored better on night visual acuity and produced less glare and halos than the same manufacturer’s PanOptix® trifocal—though the trifocal provided better near visual acuity, he added.

Other studies have found bilateral Vivity patients have similar rates of spectacle independence with some diffractive multifocals.ii

MINI-MONOVISION

Implanting the Vivity targeting mini-monovision, with the dominant eye emmetropic and the non-dominant eye at -0.50 D, expanded the effective defocus range, resulting in 87% spectacle independence in a study Prof Kohnen co-authored—comparable to the bilateral PanOptix spectacle independence rate.iii A similar study also showed better near vision targeting -0.25 D to -0.50 D in the non-dominant eye.iv

“You can have an advantage using mini-monovision in these patients,” Prof Kohnen said.

In some studies, diffractive EDOF IOLs deliver similar patientreported quality of vision as similarly designed monofocal lenses. For example, Mini WELL® IOL (SIFI Medtech) uses an engineered aspheric wavefront optic to extend depth of focus, broadening the defocus curve to offer better intermediate and near vision than the same manufacturer’s monofocal Mini 4, with low optical disturbances. Measurements of internal higher order aberrations revealed a greater negative primary spherical aberration in the EDOF group at pupil sizes of 2.0 to 5.0 mm. At 5.0 mm, total internal HOAs did not differ significantly between the two groups.v

While patients tend to be satisfied with their better intermediate and even near vision with any EDOF IOLs, “the basic message always comes to how are these diffractive lenses and other types of lenses actually working in terms of visual disturbances,” Prof Kohnen said. And non-diffractive models may hold the edge.

“I think non-diffractive lenses will be a choice in the future, and mini-monovision with non-diffractive EDOF lenses may make some patients spectacle independent. So, it’s a good choice for patients who want less spectacle dependence after cataract or refractive surgery,” he concluded.

i Kohnen T et al. Journal of Cataract & Refractive Surgery. 2022 Feb 1; 48(2): 144–150.

ii Hovanesian J et al. Clinical Ophthalmology. 2022 Jan 18; 16: 145–152.

iii Coassin M et al. European Journal of Ophthalmology. 2021 Nov 26; 11206721211064018.

iv van Amelsfort T et al. Journal of Cataract & Refractive Surgery. 2022 Feb 1; 48(2): 151–156.

v Greve D et al. Journal of Cataract & Refractive Surgery. 2021 Sep 1; 47(9): 1139–1146.

Thomas Kohnen MD, PhD, FEBO is professor and chair, Department of Ophthalmology, Goethe University, Frankfurt, Germany, and ESCRS treasurer.

Mini-monovision with non-diffractive EDOF IOLs improves near vision and can increase spectacle independence.

“I think non-diffractive lenses will be a choice in the future, and minimonovision with non-diffractive EDOF lenses may make some patients spectacle independent.”

Thomas Kohnen MD, PhD, FEBO

FOCAL TRABECULAR MICRO-BYPASS PRODUCES CIRCUMFERENTIAL DILATION OF SCHLEMM’S CANAL

The anatomical effect of iStent inject® trabecular micro-bypass on Schlemm’s canal and the role of preserving trabecular structures in the treatment of mild-to-moderate glaucoma

With the development of minimally invasive glaucoma surgery (MIGS), the question of whether to bypass, dilate, stent, cleave, tear or preserve Schlemm’s canal and the trabecular meshwork TM has become a hot topic in glaucoma.

In a study published in the Journal of Glaucoma(1), we used anterior segment OCT to assess the anatomical effect of iStent inject® implantation combined with cataract surgery on angle anatomy in 54 eyes with mild-to-moderate openangle glaucoma.

Twelve months after surgery, we observed a significant dilating effect of Schlemm’s canal in operated eyes. Compared to unoperated fellow eyes, Schlemm’s canal’s major diameter was 74.5% greater next to the bypass, and 45.7% greater at the opposite limbus(1). This suggests that a focal trabecular bypass may achieve circumferential Schlemm’s canal dilation solely through an increase in aqueous flow, as opposed to a mechanical dilation as can be seen in some techniques involving viscodilation or the use of scaffolding devices.

“iStent inject® trabecular micro-bypass may achieve circumferential Schlemm’s canal dilation solely through an increase in aqueous flow”

While concurrent cataract surgery may have had a contributing effect, Zhao et al.(2) observed a more modest dilation of Schlemm’s canal following standalone cataract extraction. However, Yang and colleagues’(3) observation that high intraocular pressures and glaucoma cause the collapse of Schlemm’s canal, with structural adhesions and herniations, leads us to hypothesise that the effect may become less as glaucoma progresses. Nevertheless, this ability to restore Schlemm’s canal dimensions is particularly relevant as Allingham et al.(4) showed that its reduced diameter accounts for nearly half of decreased outflow facility in glaucoma.

Mean dimensions of Schlemm’s canal measured 500 micrometers away from the sites of iStent inject® implantations (left) and at the temporal limbus in unoperated fellow eyes (right)(1)

In fact, seeking to restore the TM’s physiological functions as a therapeutic strategy, rather than simply trying to bypass or remove it, may have several benefits. First, Johnstone et al.(5) have described how aqueous outflow is an active process driven by a mechanical pump relying on trabecular motion and interconnected inlet/outlet valves. Therefore, removing one side of this intricate system may be counterproductive in promoting outflow. Then, some authors have speculated that the TM and its cells’ intense phagocytic activity may play a key role in preventing more distal outflow obstructions. Finally, preserving the blood-aqueous-barrier at the level of the TM may reduce the inflammatory component involved in some types of glaucoma and ocular pathologies.

In conclusion, increasing aqueous outflow facility through a very focal intervention such as the implantation of an iStent inject® micro-bypass may be sufficient to produce circumferential dilation of Schlemm’s canal in mild-tomoderate glaucoma. Focal interventions have the added advantage of preserving the integrity and physiological functions of angle structures that may contribute to aqueous outflow through different mechanisms.

References:

1. Gillmann, Kevin, et al. “A prospective analysis of iStent Inject microstent implantation: surgical outcomes, endothelial cell density, and device position at 12 Months.” Journal of Glaucoma 29.8 (2020): 639-647. 2. Zhao, Zhennan, et al. “Schlemm’s canal expansion after uncomplicated phacoemulsification surgery: an optical coherence tomography study.” Investigative Ophthalmology & Visual Science 57.15 (2016): 6507-6512. 3. Yang CY, Liu Y, Lu Z, Ren R, Gong H. Effects of Y27632 on aqueous humor outflow facility with changes in hydrodynamic pattern and morphology in human eyes. Invest Ophthalmol Vis Sci 2013;54:5859-5870. 4. Allingham, Rand R., Annelies W. de Kater, and Ross C. Ethier. “Schlemm’s canal and primary open angle glaucoma: correlation between Schlemm’s canal dimensions and outflow facility.” Experimental eye research 62.1 (1996): 101-110. 5. Johnstone, Murray A. “The aqueous outflow system as a mechanical pump: evidence from examination of tissue and aqueous movement in human and non-human primates.” Journal of glaucoma 13.5 (2004):

421-438. PM-EU-0205

Mean dimensions of Schlemm’s canal measured 500 micrometers away from the sites of iStent inject® implantations (left) and at the temporal limbus in unoperated fellow eyes (right)(1)

Mean difference in Schlemm’s canal major diameter in operated eyes 12 months after iStent inject® implantation and cataract surgery (left) compared to unoperated fellow eyes (right)(1)

“Seeking to restore the trabecular meshwork’s physiological function may have several benefits”

Kevin Gillmann MD, MBBS, MBA, FEBO, March, PgCert. (Harvard) is a glaucoma specialist, an honorary fellow at Moorfields Eye Hospital, and the editor of the upcoming Elsevier textbook “The Science of Glaucoma Management”.

Combined Surgery for Cataract and ERM—Yes or No?

Better patient visual outcomes, safety, and convenience favour combined surgery, though refractive considerations may warrant a sequential approach. Howard Larkin reports from the 2022 ASCRS Annual Meeting

If a patient has both a cataract and an epiretinal membrane (ERM), and one is minimal, should both be addressed in a combined procedure, or should they be handled sequentially? Christina Y Weng MD, MBA and Richard Tipperman MD debated the pros and cons.

Arguing for a combined approach, vitreoretinal surgeon Dr Weng asked, “Why risk a suboptimal outcome? We know that patient expectations are higher than ever. If you only do one, you risk not meeting those expectations.” She gave three reasons to consider combined surgery.

Anterior segment surgeon Dr Tipperman mostly agreed with Dr Weng but suggested refractive considerations may warrant a sequential approach. He offered a simple algorithm for selecting patients for combined surgery.

BETTER TOGETHER

Dr Weng’s first reason for combining surgeries was that doing only one surgery often leads to a suboptical visual outcome due to the other pathology. For example, if only the cataract is treated, patients may still have metamorphopsia, blurriness, or worsened cystoid macular oedema (CME) from the ERM. If only the ERM is treated, virtually 100% will see their cataract worsen after vitrectomy, usually in the first year or two.

Pearls for Successful Combined Phaco-Vitreoretinal Surgery

Preoperative discussion of wound placement to stay out of each other’s way

Limit retrobulbar block to 3cc and apply globe pressure immediately to reduce posterior pressure

Consider placing infusion line first to avoid iris prolapse

Suture main corneal wound to prevent leakage during vitrectomy trocar insertion

Go easy on wound hydration to keep cornea clear for posterior visualisation

Check IOL placement after vitrectomy

Consider extended course of postoperative topical steroids/NSAIDs to reduce inflammation, which may be greater and last longer with combined surgery

Source: Christina Y Weng MD, MBA, 2022

Algorithm for Considering Combined PPV/Cataract Surgery

Poor Visual Prognosis

Low Visual Demands

Good Visual Prognosis

High Visual Demands

Consider Combined Surgery

Source: Richard Tipperman MD, 2022

Backing her point, Dr Weng cited a study finding post-cataract surgery CME rates were more than six times higher in 812 eyes left with primary ERM than in more than 159,000 reference eyes without ERM.i Patients undergoing combined surgery also achieved their best-corrected visual acuity 15 months sooner when compared to sequential surgery with similar complication rates and greater cost-effectiveness.ii As a bonus, she said combined surgery eliminates floaters that often worsen after cataract surgery and IOL implant.

Second, combined surgery is safe. With today’s small-gauge instruments, the risk of retinal tear or detachment from vitrectomy is less than 2%, and endophthalmitis risk is 0.03–0.11%. There is no evidence combined surgery increases CME, Dr Weng noted.iii

Third, with planning between the two surgeons, the procedures do not have to interfere with each other, Dr Weng said. She recommended a preoperative discussion of wound place-

Consider Sequential Surgery

ment, limiting retrobulbar block volume to reduce posterior pressure, placing an infusion line first to avoid iris prolapse, suturing corneal wounds to prevent leakage during vitrectomy, and going easy on wound hydration to prevent corneal clouding.

“Not only is combined surgery safe and likely to improve visual outcomes, but doing the two surgeries together is no harder— and arguably easier—than doing them separately,” Dr Weng said.

“My patients are happy to have to two-in-one surgery that meets their expectations. . . . Combined surgery is a really great approach for the right patients.”

REFRACTIVE CONSIDERATIONS

While acknowledging Dr Weng’s points, Dr Tipperman noted the decisions required for successful cataract refractive surgery

could sometimes tip the scales in favour of a sequential vitreoretinal then cataract approach. He offered five reasons.

First, significant ERM can degrade patients’ fixation ability, which compromises axial length measurement and, therefore, IOL power calculation accuracy. Peeling first may improve fixation and visual outcomes for those with mild ERM.

Second, some patients have a hard time understanding the difference between blur from cataracts and blur from residual metamorphopsia from macular changes, particularly patients with previous macular hole surgery.

“If you peel first and give it a chance to settle down before doing cataract surgery, they have a better understanding of how each pathology affects their vision,” Dr Tipperman said.

Third, while multifocal IOLs are contraindicated for patients with macular pathology, some improve enough after vitrectomy and ERM peeling to become viable candidates. Retinal surgery first allows them to make the decision, he said.

Similarly, patients with ERM and astigmatism may have an easier time judging if paying extra for a toric lens is worth it if the membrane is peeled first. If they end up with poor quality of vision after a peel, it may not be worth it.

Finally, an ERM makes it harder to determine if monovision is an option.

“If they don’t have good vision after peeling, you don’t want to leave them with permanent monovision,” he said.

Patients who form an advanced or mature cataract days or weeks after vitrectomy or intravitreal injection should always have combined surgery, Dr Tipperman said.

“It’s pretty likely the capsule has been violated, and they are going to need a vitrectomy.”

In general, Dr Tipperman’s algorithm suggests those who have a poor visual prognosis and low visual demands should be considered for combined surgery. Those with a good visual prognosis and high visual demands should consider sequential surgery to allow the patient to decide on advanced technology lenses, he concluded.

JAMA Ophthalmology. 2018 Feb 1; 136(2): 148–54.

ii Graefe’s Archive for Clinical and Experimental Ophthalmology. 2021, 259: 45–52.

iii Retina. 2013; 33(1): 136–42; Retina. 2019; 39(5): 844–52; Graefe’s Archive for Clinical and Experimental Ophthalmology. 2021 Jul; 259(7): 1731–40. European Journal of Ophthalmology. 2021 Mar; 31(2): 673–8.

Christina Y Weng MD, MBA is associate professor of ophthalmology and director of the vitreoretinal diseases and surgery fellowship program at Baylor College of Medicine, Houston, Texas, USA. christina.weng@bcm.edu

Richard Tipperman MD is an Attending Surgeon and ophthalmologist specialising in refractive surgery, cataract surgery, and management of complications of cataract surgery at Wills Eye Hospital, Philadelphia, Pennsylvania, USA. rtipperman@mindspring.com

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Explanted Multifocal IOLs in a Very Demanding Patient

Potential role for functional magnetic resonance imaging (fMRI).

Dermot McGrath reports from Paris

Functional MRI Protocol

Functional magnetic resonance imaging (fMRI) may prove a useful tool in assessing neuroadaptation to multifocal intraocular lenses—particularly in the small minority of patients who complain of debilitating visual symptoms that persist in the long term, according to David Touboul MD, PhD.

“Our experience has shown that fMRI may prove useful for monitoring neuroadaptation with multifocal IOLs and justifying certain explantations in cases where the patient is unhappy with the outcome despite satisfactory visual acuity results,” he said.

Professor Touboul presented the case of a 72-year-old male patient who was referred to the University Hospital in Bordeaux complaining of visual symptoms that got progressively worse since his cataract surgery seven years previously. The surgery had been without complication, and he had trifocal AcrySof® IQ ReSTOR® Toric IOLs implanted in both eyes. The patient subsequently underwent a YAG capsulotomy and laser peripheral iridotomy in both eyes, as well as a posterior vitrectomy for floaters. He regularly took pilocarpine drops to “improve his vision” and had undergone a cerebral-orbital MRI scan that revealed nothing out of the ordinary.

“The patient described his vision as distorted and said it was having a detrimental impact on his quality of life. He asked for the IOLs to be explanted,” Prof Touboul said.

On clinical examination, the patient’s uncorrected visual acuity (UCVA) was 10/10 in both eyes with a small, residual refractive error. The IOLs were centred correctly, with clear optics, and the patient’s intraocular pressure was normal.

Prof Touboul said they decided to replace the multifocal lenses with monofocal AcrySof MA50BM intraocular lenses, targeting emmetropia in both eyes for distance.

“This was a very demanding patient, so we ensured the goals of the surgery were very clear. We proposed using fMRI to understand and follow the functional signs postoperatively and ensured that the patient was in full agreement before proceeding with the surgery,” he said.

Although fMRI is not routinely used in ophthalmology, Prof Touboul partnered with the neurology department at University Hospital of Bordeaux to use a series of visual stimuli transmitted to the patient using a retro-projector, mirror, and screen setup.

To test the neuroadaptation, Prof Touboul proposed three main types of stimulation: scrolling words, flashes, and checkerboard patterns. He then compared the results pre- and postoperatively from multifocal to monofocal implants.

“There was no change in cortical activation in the reading test, but there was a clear reduction in activity for both the flash and checkerboard tests after the first eye was explanted. This cortical response reduced to practically zero for both of the latter tests after the second eye was explanted,” he said.

The few studies on neuroadaptation in the literature typically demonstrate a reduction of cortical activation one month after surgery for diffractive IOLs, Prof Touboul said.

“To our knowledge, this is the first case report comparing cortical activation of the same pseudophakic individual before and after diffractive IOL implantation as measured by functional MRI. Our experience with this patient suggests that there may exist an over-activated cortical response in certain cases, which translates to disturbed vision that persists over time with no neuroadaptation,” he said.

Prof Touboul presented the study at the French Implant and Refractive Surgery Association (SAFIR) Annual Meeting in Paris.

David Touboul MD, PhD is a Professor of ophthalmology at Bordeaux University, France, Head of the National Reference Center for Keratoconus, and President of the SAFIR society. In collaboration with Morgan Ollivier MD, neuroradiology department, Bordeaux University. david.touboul@chu-bordeaux.fr

Subtle Differences but Similar Performance for Multifocal IOLs

Halos and glare remain common complaints. Dermot McGrath reports from Paris

Two of the more recent diffractive multifocal implants on the market deliver consistently good visual outcomes with a low level of side effects and a high rate of spectacle independence, according to Pascal Rozot MD.

“The two implants we studied were very well tolerated and resulted in a high level of patient satisfaction with a very low incidence of side effects,” Dr Rozot told a session of the French Implant and Refractive Surgery Association (SAFIR) Annual Meeting.

Dr Rozot presented the results of a comparative retrospective study of two multifocal IOLs: the AcrySof® IQ PanOptix® trifocal lens (Alcon) and the TECNIS Synergy™ multifocal IOL (Johnson & Johnson Vision) implanted between 2015 and 2021.

lens. There was no statistically significant difference between the lenses for corrected visual acuity at all distances. The monocular defocus curve, however, showed a statistically significant difference in performance in favour of the Synergy lens for intermediate and near vision. Although there was no difference between the IOLs for contrast sensitivity testing at 100% and 25% contrast, the PanOptix showed slightly better performance at 9% contrast.

SIMILAR COMPLAINT RATES

Visual symptoms, which are a common complaint with multifocal implants, showed a similar level of disturbance for both IOL models: halos were deemed bothersome in 33% of patients for PanOptix and 35% for Synergy, while glare was an issue in 39% for PanOptix and 28% for Synergy.

“We tend to see a maximum of complaints of halos and visual symptoms up to about one month or so after the surgery—but these issues typically resolve over time with neuroadaptation,” Dr Rozot said.

Patient satisfaction was high for both lenses, although more patients implanted with PanOptix (51%) said they were “very satisfied” compared to Synergy (26%). And while both patient groups also achieved a high level of spectacle independence, three patients in the Synergy group said they needed glasses for some near vision tasks.

Both patient groups were well matched in terms of age and refractive error. The PanOptix was implanted in 38 eyes of 33 patients with a mean age of 66 years and a preoperative mean visual acuity of 0.2 D. Just over one-fifth of patients were clear lens extraction cases (21%), and the rest were cataract cases. The Synergy group included 46 eyes of 36 patients with a mean age of 62.5 years and a mean preoperative visual acuity of 0.15 D. Clear lens extraction was performed in 8% of the Synergy patients.

The results showed a slightly better performance for uncorrected visual acuity at intermediate and near distances for the Synergy

“I wouldn’t put too much emphasis on this difference as a lot depends on the lifestyle of the patient and whether they read a lot,” Dr Rozot added.

Overall, he said that both IOLs delivered very good visual outcomes, with no incidence of secondary cataract, a low level of side effects, and high patient satisfaction.

Pascal Rozot MD is an ophthalmologist in private practice in Marseille, France. pascal.rozot@dr-rozot.com

“The two implants we studied were very well tolerated and resulted in a high level of patient satisfaction with a very low incidence of side effects.”

Pascal Rozot MD

Milan—Fashion, Food, Finance…and Ophthalmology

What’s on the menu at the 40th Congress of the ESCRS?

The ESCRS annual Congress returns to full strength in Milan, September 16–20. After a yearlong diet of Zoom calls and virtual symposia, those attending the conference will now have a full menu of enticing in-person educational and social opportunities. You will find the main courses of the main symposia and clinical research symposia, along with a smorgasbord of educational courses and an abundance of videos, free papers, posters, and workshops. There will something for everybody.

The ESCRS last met in Milan in 2012. Last year’s Congress in Amsterdam demonstrated the benefits of again meeting in person with friends and colleagues. This year’s Congress will be in the MiCo, the largest conference centre in Milan, located a short metro ride from the city centre.

The conference gets underway on Friday with several interesting offerings. These include the premier of iNovation, an ESCRS symposium that looks to the future of ophthalmology from the clinical, research pipeline, and business perspectives (see the related article on the next page).

Friday also includes Cornea Day, offering a series of presentations and case reports, and the first of the Main Symposia—a combined presentation with EuCornea that will cover “Emerging Treatment Options for Corneal Endothelial Disease”. Drs Béatrice Frueh and Massimo Busin will chair the session, which features talks of endothelial cell loss, the role of DMEK and DSAEK, and the potential of ROCK inhibitor therapy.

Also on Friday, the World Society of Paediatric Ophthalmology and Strabismus (WSPOS) will hold their Subspecialty Day in conjunction with the ESCRS Congress. Be sure to catch up on glaucoma research at Glaucoma Day, cosponsored by the ESCRS and the European Glaucoma Society.

You will not want to miss the opening ceremony of the Congress on Saturday, which will highlight the ESCRS’s efforts to create a sustainable future for ophthalmology. Dutch ophthalmologist Sjoerd Elferink will conduct a thoughtprovoking talk on sustainability in cataract surgery, with some sobering facts but also some positive sug gestions for addressing the global climate situation.

For the first time, the opener will bring togeth er the winners of the prizes for best poster, best video, and the Henahan Essay Contest. Béatrice Cochener-Lamard MD, PhD will then deliver the annual Ridley Medal Lecture, speaking on “How the digital world is entering our practice”.

The topics of subsequent Main Symposia during the conference will include “Demystifying IOL Optics”; “Fast track Cataract”; and “How Not to Be Surprised by Refractive Surprise”.

The Clinical Research Symposia are always a must-see at the conference. Four sessions throughout the day on Saturday will take a closer look: “Digital Medicine—6 steps for a better future”; “Ocular tissue engineering, artificial Cornea”; “Advancement of IOL optics—how far can we

go?”; and finally, “Gene Therapy”. The latter will cover gene therapy throughout the field of ophthalmology, including Stargardt disease, Fuchs’ and other corneal dystrophies, Leber Congenital AmaurosisRPE65, and AMD.

Young ophthalmologists will also find plenty to keep them busy. The YO Programme has become an essential part of the conference. This year will look at the many challenges of learning phaco surgery. Each step in phaco surgery will be discussed by a leading clinician and accompanied by video cases submitted by young ophthalmologists—a format that has proven very popular at past meetings.

The associated YO session will closely examine the intersection between cataract surgery and other eye diseases, including ocular surface and eyelid disease, cornea ectasia, and endothelial dystrophy. Additionally, it will look between cataract surgery and other eye diseases following corneal transplantation and following refractive surgery.

The Practice Management & Development Masterclass takes place on Sunday. This will be a full day of presentations and discussions covering everything from business and management skills to AI and sustainability—see related article

iNovation is Coming Soon

What does the future hold for cataract and refractive surgery? How should we approach presbyopia? What is happening with robotics, AI, and the digital operating room? How will these developments be regulated, and which companies will prevail? These are just some of the topics featured at iNovation, the full-day ESCRS symposium on Friday, September 16 in Milan, immediately before the opening of the main ESCRS Congress.

Hundreds of clinicians, industry innovators, and financial professionals from around the globe will convene to discuss these and other topics in free-flowing panel discussions and emerging company presentations. The symposium also offers an excellent chance to hear the latest developments in the European commercial and capital markets.

“We have put a great deal of effort into designing a programme that is as stimulating and interactive as possible and where doctors play a major part throughout. The intention is to stimulate debate, get answers to hard questions, and really get to the heart of the matter,” said ESCRS President Oliver Findl.

Sessions throughout the day will focus on the most urgent clinical needs and barriers to success in anterior segment care. The format includes expert panel discussions on key clinical and regulatory issues as well as presentations from many emerging companies that will give attendees a chance to see what’s in the pipeline and network directly with leaders in their fields.

The sessions will be moderated by a who’s who of international ophthalmology, including Thomas Kohnen, Eric Donnenfeld, Ike Ahmed, Filomena Ribeiro, Rudy Nuijts, and Paul Rosen.

Highlights include:

• The latest ESCRS survey results on current practice trends

• Managing presbyopia from the earliest stage through to cataract

• Impact of the EU Medical Device Regulations and reimbursement trends on ophthalmic innovation

• Advanced cataract extraction—now and in the future

• The digital clinic—diagnostic data integration, EMRs, and Artificial Intelligence

• The business future of European ophthalmology

• Glaucoma in the cataract practice—new drugs, sustained release, and MIGS

The iNovation symposium also shares the primary goal of the entire ESCRS Congress: improving sustainability in all areas of ophthalmology. The penultimate session, chaired by Dr Findl, addresses improving sustainability, from manufacturing to the operating room. Panelists will discuss long-term strategies for managing clinical waste.

“A sustainable iNovation Day requires commitment and collective action from participants, exhibitors, sponsors, organisers, and suppliers. Our approach is to engage, inspire, and catalyse collective action to make a zero-impact event,” Dr Findl said.

For more information, please visit https://inovation.escrs.org

ESCRS symposium looks to the future of ophthalmology.

Practice Management & Development Masterclass

Sunday 18 September | 08.30–18.00

Beyond Bedside Manner—How Ophthalmologists Can Optimise the Patient Experience

In this highly interactive and didactic workshop, Shareef Mahdavi will explain the importance of redefining the doctor-patient relationship by describing what patients really want and how ophthalmologists and their staff in public and private practice can lead their teams to create innovative and patient-centred practices.

Contributing panel: Paul Rosen, Sheraz Daya, Arthur Cummings, Daniel Kook, Pavel Stodulka, Kris Morrill, Julien Buratto, Amanda Carones

Practice Management & Development Workshops

Monday 19 September | 08.30–18.00

TOPICS INCLUDE:

● The Art of Negotiation

● Building and Developing Your Private Practice

● Managing and Developing a Public Ophthalmology Department

● Who Owns Ophthalmology?

● Using Automation and Artificial Intelligence to Grow Your Practice

● Maximising the Patient Journey

● Why Young Ophthalmologists Need to Learn Business and Management Skills

● Sustainability in Ophthalmology— What Does It Mean for You?

● Ask the Experts

Shareef Mahdavi, US

Chairman Paul Rosen, UK

Understanding Glaucoma Genetics

Methods for gene discovery and implications for understanding disease mechanisms and improving patient care.

Cheryl Guttman Krader reports from ARVO 2022 in Denver, Colorado, USA

Genetic investigations are providing new insights on glaucoma pathophysiology, disease risk, and therapeutic opportunities, said Janey Wiggs MD, PhD, during her Mildred Weisenfeld Award for Excellence in Ophthalmology at this year’s ARVO conference.

“Glaucoma is the leading cause of irreversible blindness throughout the world, and elevated IOP—which is commonly monitored as a sign of glaucoma—is an important risk factor. But many patients with glaucoma do not have elevated IOP,” said Dr Wiggs.

“Importantly, the disease mechanisms responsible for regulating IOP and optic nerve degeneration are poorly understood. So, our group and others have used a genetic approach to try to understand more about the pathophysiology of glaucoma: where the discovery and characterisation of genes that cause or contribute to glaucoma susceptibility can help us identify the molecular events that define disease mechanisms and, therefore, identify potential therapeutic targets that allow the development of therapies that approach the root cause of glaucoma.”

Additionally, an important part of finding genes for glaucoma is their use for genetic testing to identify people at high risk for the disease so they can have tailored surveillance and monitoring and receive timely treatment that will potentially prevent the development of irreversible blindness, she noted.

In reviewing glaucoma gene discovery research and its clinical applications, Dr Wiggs divided her talk into discussions of early- and adult-onset forms of glaucoma. The early-onset glaucomas—which include juvenile open-angle glaucoma, congenital glaucoma, and developmental glaucomas—are inherited as Mendelian autosomal recessive or dominant traits and caused by rare mutations that have very large biologic effects.

“If someone has one of these mutations, chances are the person has the disease,” she said.

Notable progress has been made in research focusing on the genetics of early-onset glaucomas. To date, 15 causative genes for early-onset glaucomas have been discovered using linkage analysis, whole exome, and whole genome sequencing, Dr Wiggs reported.

All the known genes for early-onset glaucoma can be used for genetic testing. The results can help with risk assessment, inform genetic counselling, enable tailored surveillance for at-risk persons, and identify those who can benefit from timely treatment. Researchers are also beginning to identify therapeutic targets that could spell promise for gene-based therapies, Dr Wiggs said.

However, genetic testing using the early-onset glaucoma genes discovered so far only detects a mutation in about 20% of families. Since most of the known genes were found by studying families in European Caucasian populations, research seeking to find additional genes has turned to populations with greater ethnic diversity. Dr Wiggs discussed this effort, mechanisms by which certain mutations cause early-onset glaucoma, and potential therapeutic targets that include increasing TEK signalling and knocking down myocilin expression.

ADULT-ONSET GLAUCOMAS

Dr Wiggs explained adult-onset glaucomas have complex inheritance and are not caused by single mutations. Instead, DNA sus-

ceptibility variants that individually have small biological effects influence disease development.

She noted the formation of US-based and international consortiums to acquire the large data sets of cases and controls needed to give genome-wide association studies adequate statistical power for detecting the DNA susceptibility variants associated with adult-onset glaucomas. Thus far, the consortiums have identified hundreds of susceptibility genes.

Findings from the genome-wide association studies have been used to derive polygenic risk scores for risk stratification in adult populations. Such a tool has already proved important in identifying patients at the highest risk for severe disease, thereby enabling tailored surveillance and treatment.

Dr Wiggs also provided an example of how identification of genetically defined subgroups among patients with primary openangle glaucoma suggests a possible therapeutic intervention.

FUTURE GOALS

“We still have so much work to do. We really need a better understanding of the genetics of early-onset open-angle glaucoma. This involves new gene discovery; but also perhaps better annotation and understanding of genes already known. For the latter reason, we have joined the ClinGen consortium,” she said.

“We are also very interested in looking at noncoding effects, whole-genome sequencing, and polygenic effects in the earlyonset glaucomas. In addition, we need a lot more research on the clinical outcomes of polygenic risk scores for primary open-angle glaucoma and other types of adult-onset glaucoma and how to implement that in our clinical design. And always, we need better and more animal and cell models to define disease mechanisms for glaucoma and test therapeutics,” she concluded.

Janey Wiggs MD, PhD

is the

Paul Austin Chandler Professor of Ophthalmology; Co-Director, Glaucoma Center of Excellence; Vice Chair, Clinical Research; and Associate Director, Ocular Genomics Institute at Harvard Medical School, Boston, Massachusetts, USA. janey_wiggs@meei.harvard.edu

A Vision for a New Era in Combined Glaucoma and Cataract Treatment

TO ELLIOT

Tell readers about Elios Vision and its background. Elios Vision was founded in partnership with MLase, a world leader in excimer laser technology. We shared a goal to create a glaucoma procedure that was safe and effective and optimised for use during routine cataract surgery. Elios Vision was formed to drive the global clinical and regulatory strategy for the novel excimer laser platform and procedure with a dedicated team.

What specific value are you hoping to bring to physicians and their patients?

Despite a decade of MIGS innovation, we are still seeking to improve surgical options to treat glaucoma at the time of cataract surgery, which affords such a perfect opportunity to access tissues implicated in glaucoma.

However, we estimate that only 15% of glaucoma patients worldwide receive a glaucoma treatment at the time of cataract surgery. Whilst access and reimbursement certainly have a role to play—especially outside of the US—we know predictable IOP and medication lowering is a must. And we have also learned that surgeons do not want to compromise cataract surgery safety and visual outcomes with glaucoma procedures that are overly complex or cause trauma. In addition, glaucoma implants during cataract surgery can be unappealing for many surgeons.

With around 6 million glaucoma and ocular hypertension patients being treated for cataract each year worldwide, we believe the ELIOS™ procedure is well placed to address these unmet needs because it is “implant free”, avoids thermal and mechanical trauma, and has a low level of intra- and postoperative complications. We’ve also observed a learning curve that can make the ELIOS procedure widely adoptable.

So what is the ELIOS procedure, and how does it work?

We know that bypassing the TM is a proven way to lower IOP. But as Murray will explain, it’s important to consider the physiology of the TM in order to restore or augment outflow predictably and with an enduring effect.

The ELIOS procedure bypasses the TM using precision laser ablation, creating ten 210-micron microchannels. This maximises the potential flow into the collector channels.

The ELIOS procedure has demonstrated strong safety and efficacy in OUS studies. Can you describe this data and how you think it differentiates your approach?

We have data on over 600 eyes from 14 studies which we find encouraging on several levels. Firstly, it appears the clinical effect is still present in more than 50% of patients assessed eight years after their procedure. Another observation is the extremely low incidence of severe complications thanks, at least in part, to the atraumatic mechanism of action of the excimer laser.

The University of Zurich just published eight-year follow-up results of ELIOS combined with cataract surgery, showing a >20% reduction in mean IOP at eight years post-operation [Figure 1]. Another study in Spain showed more than 80% of patients were “medication free” at 12 months following the ELIOS procedure [Figure 2].

Can you share your regulatory, reimbursement, and commercial plans?

The ELIOS technology is CE marked, and we have started a focused commercial rollout in Europe to generate data, establish our perprocedure fee model, expand our reimbursement coverage, and grow our key opinion leader base.

In the United States, our combination cataract ELIOS pivotal trial is well underway, and we expect to launch in 2024. We have just filed an IDE for standalone treatment and been granted our own unique reimbursement code for the ELIOS procedure.

In China and Canada, we have commenced data generation activities to support regulatory filings in the near term.

TO MURRAY

Murray, for those not familiar with your work, could you summarise your research area of expertise and share the main appeal of the ELIOS procedure?

My research focuses on aqueous outflow regulation and what goes wrong in glaucoma.

The research points to aqueous outflow regulation by a mechanical mechanism like the lymphatic and venous pumps present throughout the vascular system [Figure 3].

Studies show that SC is a collapsible chamber with inlet and outlet valves.

A Q&A with Elliot Friedman CEO, Elios Vision, Inc. and Murray Johnstone MD Clinical Professor, University of Washington

Figure 1: Sustained IOP lowering effect observed unto eight years.

Figure 2: Significant reduction in medications observed at one year.2

The pumping mechanism fails in glaucoma. Ideally, we want to restore the normal pump function without causing damage.

The appeal of the ELIOS procedure is that it creates small openings in the outflow system by vaporizing tissue [Figure 4]. The procedure does not tear away or burn trabecular tissue, and does not require introducing and leaving foreign objects in the canal.

What are the main structural and functional changes that have been observed in the TM and SC in patients with glaucoma (versus non-glaucomatous eyes)?

As glaucoma progresses, there is a loss of normal trabecular tissue elastance. Because of the increased stiffness, the TM tissues can’t distend and recoil properly in response to pressure changes [Figure 5]. Loss of elastance causes the TM to lose its ability to resist pressure, and it expands outward, occluding SC and collector channels.

Is there an optimal “time” in the disease course to enhance/ restore Schlemm’s canal physiology? Is there a point beyond which the opportunity is lost?

Pulsatile flow and TM motion stop as glaucoma progresses.

The pulsatile flow and TM motion loss are associated with the TM distending into SC, closing the lumen, and preventing flow.

Early intervention is likely to be valuable in preventing chronic apposition and eventual adhesion between SC walls.

Early treatment is a likely key to preventing this cascade of negative events.

The caveat is that the benefits of earlier intervention need to outweigh the risks.

Some MIGS procedures rely on physical removal of the TM by excision—Is the impact of these techniques on Schlemm’s canal and the angle understood in the mid-/long-term?

SC is not a pipe but instead a delicate organ with compressible chamber containing valve-like inlet and outlet structures that can control aqueous flow.

Removal of the TM or instrumenting SC can damage structures in the distal outflow system that normally control aqueous outflow and IOP.

What has the industry learned (from MIGS?) about stenting the TM in the past 10 years, and how does ELIOS build on this?

Procedures that tear away the TM or instrument the lumen of SC can damage the physiologic regulatory structures.

Although they reduce IOP, they rely on non-physiologic mechanisms.

The ELIOS procedure creates a series of small openings into SC while leaving most of the pressure regulatory apparatus intact.

The idea that the procedure may minimise damage to the normal physiologic mechanism, combined with the fact that it is an adoptable technique, is attractive.

TO ELLIOT

So in closing, how do you think glaucoma treatment will be different five years from now based on the introduction of the ELIOS procedure?

We think combining glaucoma and cataract will be the standard of care in five years, and we certainly hope the professional community will embrace these benefits of the ELIOS technology and make it the procedure of choice for their patients.

Disclaimer:

Elios Vision GmbH is the EU distributor of the ELIOS Console manufactured by MLase AG located at 82110 Germering, industriestr 17, Germany and the FIDO laser applicator manufactured byWEINERT Fiber Optics GmbH, Mittlere- Motsch-Strasse 26, 96515 Sonneberg, Germany. The ELIOS Console and FIDO Laser Applicator are CE marked and licensed for use in adult patients with glaucoma. Product feedback should be sent to productsurveillance@eliosvision.com

References:

Figure 1 Riesen M, Funk J, Töteberg-Harms M. “Long-term treatment success and safety of combined phacoemulsification plus excimer laser trabeculostomy: an 8-year followup study”. Graefes Arch Clin Exp Ophthalmol. 2022 Jan 16.

Figure 2 Moreno-Valladares A, Puerto Amorós N, Mendez Llatas M, Pazos-López M, Ahmed IIK. “Combined excimer laser trabeculostomy and phacoemulsification: One year follow-up real world data of a laser-based MIGS”. Arch Soc Esp Oftalmol (Engl Ed). 2021 Dec; 96(12): 631–639.

Figure 3 & 5. Carreon T, van der Merwe E, Fellman RL, Johnstone M, Bhattacharya SK. “Aqueous outflow - A continuum from trabecular meshwork to episcleral veins”. Prog Retin Eye Res. 2017 Mar; 57: 108–133.

Figure 3

Figure 5: The representative BM changes in the intra-trabecular space in transmission electron micrographs (TEM) en-bloc staining with uranyl acetate (Alcian Blue 8GX). 3 As indicated, control (55-year-old) and primary open-angle glaucoma (POAG; 55-year-old), both male cadaver donor eyes respectively. (F) Assessment of intratrabecular BM thickness from 50 locations each from individual TEM images from 6 control and POAG donors each (age 55–59, equal distribution of genders). Asterisk indicate significance (p<0.05) using two-tailed equal variance t-test.3

Pulse dependent tissue motion of the aqueous outflow system3

Thickening and loss of elasticity of the TM in glaucoma

Figure 4

Ménage à Trois: Sex, Sex Steroids, and Dry Eye Disease

“Ménage à Trois: Sex, Sex Steroids, and Dry Eye Disease”; the audience could be forgiven for speculating that a wild departure away from those topics normally covered in corneal disease was about to take place. This suggestive title was on the program at the Ocular Surface Disease Symposium at the annual Irish College of Ophthalmologists conference.

Alas, the “sex” referred to in the title was the demographic variable. Nevertheless, David A Sullivan PhD, a former Associate Professor at Harvard Medical School, delivered an insightful discussion of the associations between sex (male or female), sex hormones, and dry eye disease.

“The influence of sex on the eye has been known since the time of Hippocrates. Indeed, in the late 1800s, there was widespread belief among European physicians that ocular health was dramatically influenced by sex, and that males were by no means as prone to diseases of the eye from sexual causes as females,” Dr Sullivan said.

Dry eye disease burden is a major problem. In the United States, because of diminished productivity, the annual cost exceeds 55 billion dollars, he noted.

Female sex is known to be a significant risk factor for dry eye disease, with women comprising about two-thirds of those with the disease. Some of this association has been attributed to sex steroids.

Given the widespread action of sex steroids, they can contribute to the pathogenesis of both aqueous deficient and evaporative dry eye disease. Indeed, as well as females having more dry eye than males, studies found males with androgen deficiency to develop more dry eye. Sullivan described epidemiologic study findings in which men who have their androgen activity pharmacologically inhibited—for example, during treatment with anti-androgens for prostatic hypertrophy management—go on to develop dry eye.

“When men get over the age of 55, 60, their androgens start to drop, and that’s when they start to develop dry eye disease,” Dr Sullivan said.

Given this, and the predominantly female population with dry eye, the question becomes, “Should we consider investigating a male patient who has dry eye disease in case they have androgen deficiency that could benefit from treatment?”

“No,” Dr Sullivan said. “The measurement of testosterone in the blood for a woman or a man really doesn’t mean anything. Blood levels of androgens grossly underestimate the total body levels, especially in women, as the androgens are synthesized in peripheral tissues.”

HARMFUL COSMETICS?

One area Sullivan did not get to cover in his presentation, but that he spoke to EuroTimes about it in discussion afterwards, was the probable negative effect of oestrogen on the meibomian glands, which may occur with the use of some cosmetics.

Sex steroids act on the meibomian gland, lacrimal gland, conjunctiva, and cornea. These hormone actions occur most likely after local intracrine synthesis and appear to be mediated primarily through nuclear—and possibly membrane—receptors. Sex steroids impact multiple structural and functional aspects of the ocular surface and adnexa.

The actions of sex steroids on the lacrimal system and ocular surface are widespread, including tissue architecture, gene expression, and protein synthesis. Androgens also inhibit keratinisation pathways and suppress the immune response, he explained.

SEX AND SJÖGREN’S

In Sjögren’s disease, an even stronger sex association is seen, with more than 90% of cases seen in women. The autoimmune disease features lymphocytic infiltration of the lacrimal gland, with loss of tear secretion and secondary dry eye.

“In Sjögren’s syndrome, we have shown a significant decrease in the androgen pool in women. In autoimmune diseases, sex hormones can modulate the immune response. Androgens are known typically to suppress that immune response and the development of autoimmune disease,” he said.

“There are a number of eye makeup ingredients—such as parabens, tea tree oil, and soy products—that contain oestrogen activity. Oestrogens, in turn, may promote meibomian gland dysfunction. A reason is that meibomian glands are large sebaceous glands, and oestrogens are known to suppress sebaceous gland function. This negative oestrogen action on meibomian glands may help to explain why oestrogen replacement therapy in postmenopausal women is a significant risk factor for the development of dry eye disease.”

The sex association with dry eye is not a simple topic. In addition to being mediated through sex steroids, the association may also be due to autosomal genetic and epigenetic factors. Complicating the analysis of the sex association, women report pain differently and exhibit different care-seeking behaviour compared to men. This may further influence the sex association of dry eye.

What about therapeutic approaches utilising our knowledge of the influence of sex in the pathogenesis of dry eye disease?

“We believe that such understanding may be translated into new insights into the physiological control of ocular tissues, as well as the generation of novel therapeutic strategies to treat DED,” Dr Sullivan said.

david@tearfilm.org

David A Sullivan PhD is the Chairman of the Board of Directors of the Tear Film & Ocular Surface Society (TFOS) in Boston, Massachusetts, USA, and former Associate Professor in the Department of Ophthalmology, Harvard Medical School.

New insights could lead to therapeutics innovations. Clare Quigley MD reports from Kilkenny, Ireland

“The influence of sex on the eye has been known since the time of Hippocrates.”

David A Sullivan PhD

DMEK + Light Adjustable Lens

LAL may improve visual outcomes in combined DMEK-cataract surgery. Howard Larkin reports from the 2022 ASCRS Annual Meeting

Predicting refractive outcomes in combined Descemet membrane endothelial keratoplasty (DMEK) and cataract surgery is difficult due to the uncertainty of the refractive impact of DMEK. Implanting a Light Adjustable Lens (RxSight, LAL) could help, reducing the need for two separate procedures, according to David A Price MD.

“Staging phaco after DMEK can improve [refractive] precision. We were looking for an alternative to that,” said Dr Price, who co-authored the presentation with Francis W Price Jr. That alternative may be the LAL, which allows tuning lens power days or weeks after implant.

Previous research shows performing phaco after DMEK results in 94% of eyes within 1.0 D of target refraction—compared with just half for conventional combined DMEK-phaco.i

To see how the LAL fares, Dr Price conducted a retrospective single-centre study of 14 eyes in 9 patients receiving the LAL with DMEK. All had Fuchs’ endothelial dystrophy, the most common DMEK indication, and 12 eyes targeted a plano refractive outcome.

STABILISATION BEFORE LOCK-IN

Following DMEK, corneal topography can change due to oedema resolution, Dr Price noted. Therefore, patients had at least three refractions to ensure refractive stability before adjusting the

LAL’s power. Most patients had one to two adjustments, with 14% requiring three. Adjustments were made one week apart and locked in once they were within 0.25 D of the target. Patients wore UV-blocking sunglasses until the final lock-in.

Initial vision results are very positive, Dr Price said. For the 12 eyes targeting plano, 92% ended up with 20/20 uncorrected distance visual acuity and 100% with 20/25. Half of the eyes also reached 20/30 near vision uncorrected and 67% 20/40 near vision. Before surgery, just 25% reached 20/20 distance vision corrected. Residual refractive error was minimal as well, with 93% within 0.25 D sphere and 100% within 0.5 D cylinder after lock-in, Dr Price reported. The results were as good or better than previously reported staged procedures. The study is ongoing for longer follow-up time and additional eyes, he concluded.

i Journal of Cataract & Refractive Surgery. 2015; 41: 1182–9.

David A Price MD is a resident in ophthalmology at Indiana University School of Medicine, Indianapolis, Indiana, USA. price30@iupui.edu

Francis W Price Jr, MD is an ophthalmologist at Price Vision Group, Indianapolis.

LAL/DMEK appears to perform as well or better than staged phaco/DMEK procedures.

Dexamethasone Intracanalicular Insert for Episodic DED

Early clinical trial results suggest 2–3 weeks of sustained and tapering corticosteroid therapy possible.

Howard Larkin reports from the 2022 ASCRS Annual Meeting

In a phase II clinical study, two strengths of a hydrogel dexamethasone insert for episodic dry eye disease reached the study’s primary endpoint—reducing bulbar conjunctival hyperaemia in the worst ocular zone compared with vehicle 15 days after insertion.

Both the 0.2 mg and 0.3 mg doses of OTX-DED (Ocular Therapeutix) also reduced overall hyperaemia scores. No serious ocular adverse events were reported among the 111 treated and 55 control patients, said Lisa Nijm MD, JD.

Consisting of a biodegradable polyethylene glycol hydrogel delivery platform and dexamethasone, OTX-DED is designed to deliver two to three weeks of sustained tapering therapy, Dr Nijm said. Inserted into the punctum, OTX-DED uses two common strategies to reduce dry eye—primarily through antiinflammatory therapy and potentially by preserving tears through punctal occlusion. The insert may help avoid potential overuse or misuse of steroid eyedrops, which can lead to intraocular pressure (IOP) elevation and cataract formation, she added.

Though the study was not powered to show statistical significance, the change from baseline in worst-zone conjunctival hyperaemia reached significance against vehicle control in both strengths individually and combined, Dr Nijm said. A sensitivity analysis yielded similar results. Similarly, hyperaemia grade scores improved more in the treatment group than the control group for the total, nasal, temporal, and frontal zones, reaching statistical significance in all except the frontal zone for the 0.3 mg dose.

The symptom endpoint—eye dryness scores using the visual analogue scale—improved in both treatment groups and the vehicle control group. The differences were not statistically significant. However, a post-hoc analysis identified opportunities to differentiate the treatment and control group by developing an appropriate vehicle comparator, Dr Nijm said.

The most common ocular adverse events were epiphora/ lacrimation (8.1% in the treatment groups and 3.6% in

the control) and IOP elevation (3.6% in the treatment groups and 0% in the control group). Ocular pain, discomfort, and irritation rates were low in all groups.

Lisa Nijm MD, JD is a corneal and cataract and refractive surgeon at Warrenville Eyecare and LASIK, Warrenville, Illinois, USA, assistant clinical professor of ophthalmology at the University of Illinois Eye and Ear Infirmary in Chicago, and founder of RealWorldOphthalmology.com.

LNijm@RealWorldOphthalmology.com

DMEK Outcomes after Glaucoma Surgery

What accounts for problems in these cases?

Howard Larkin reports from the 2022 ASCRS Annual Meeting

Rebubbling, primary graft failure, and endothelial cell loss rates all appeared to trend higher in a recent review of Descemet membrane endothelial keratoplasty (DMEK) performed after tube or trabeculectomy surgery, reported Mark A Terry MD at the 2022 ASCRS Annual Meeting.

In a study of 1,501 consecutive DMEK cases, the 25 performed after trabeculectomy or filtration tube surgery for glaucoma experienced more complications than those without previous glaucoma filtration surgery. But while the differences were notable, they did not rise to statistical significance, possibly due to the small post-glaucoma sample size.

One thing previous glaucoma surgery did not affect was unscrolling time during DMEK, Dr Terry said. Mean unscroll time in the post-glaucoma surgery group was 2.9±3.0 minutes compared with 3.4±5.2 minutes for the control group (p=0.53), indicating the DMEK surgery in post-glaucoma eyes was generally not any more difficult than in Fuchs’ dystrophy eyes.

Rebubbling rates were higher for the post-glaucoma group at 24% compared with 13% for the control group (p=0.11). Primary graft failure rates were 4% for the post-glaucoma surgery group compared with 1.4% for the control group (p=0.28). Endothelial cell loss three to six months after surgery came closest to statistical significance at 39.1% for the post-glaucoma surgery group and 30.4% for the control group (p=0.09).

Dr Terry’s rebubble rates are consistent with studies of postglaucoma surgery DMEK in the literature, while his endothelial cell loss and graft failure rates were about half that of other studies. They include a 2019 study finding a 22% rebubble rate, 71% endothelial cell loss, and 9% primary graft failure rate one year after DMEK in 23 patients with glaucoma drainage devices.i

“These cell loss and failure rates are high,” he said.

Another study reviewed 51 post-glaucoma surgery DMEK cases and found lower graft survival rates and higher endothelial cell loss rates at 12, 24, 36, and 48 months after DMEK compared with controls without previous glaucoma surgery.ii In a third study, 27 eyes with DMEK after a glaucoma drainage device also

had lower graft survival rates and higher endothelial cell loss than 39 eyes with DMEK after trabeculectomy.iii

INFLAMMATION AND REDUCED AQUEOUS MAY PLAY A ROLE

Dr Terry discussed several possible reasons for the higher rates of rebubbling, primary graft failure, and endothelial cell loss for DMEK after glaucoma surgery. Rebubbling rates may be higher due to more frequent hypotony and loss of bubble support due to gas moving up the tube or bleb. Chronic inflammation and reduced aqueous nutritional support may also be factors affecting graft failure and endothelial cell loss.

i American Journal of Ophthalmology. 2019; 199: 150–158.

ii American Journal of Ophthalmology. 2020; 218: 7–16.

iii Graefe’s Archive for Clinical and Experimental Ophthalmology. 2022 May; 260(5): 1573–1582.

Mark A Terry MD is Director of Corneal Services at Devers Eye Institute and Professor of Clinical Ophthalmology at Oregon Health & Science University in Portland, Oregon, USA.

mterry@deverseye.org

Source: Mark A Terry MD, 2022

Making Brown Eyes Blue

Laser treatment shows promise for permanent iris colour change.

Dermot McGrath reports from the French Implant and Refractive Surgery Association (SAFIR) Annual Meeting in Paris

Initial trials of a promising new technology to permanently change iris colour suggest the treatment is safe and effective and will probably be available on the international market in two to three years, according to David Touboul MD, PhD.

“Whether we are in favour of this type of cosmetic procedure or not, the reality is that changing iris colour is of interest to a sizeable proportion of the population, and this technology will probably arrive on the market in the next few years. As a profession, we need to prepare for it,” Professor Touboul said.

Several proposed techniques change iris colour, including artificial iris implants, corneal tattooing, and cosmetic contact lenses. However, there are significant aesthetic limitations as well as serious safety concerns for some of these techniques, with iris implants and cosmetic contact lenses associated with high rates of corneal decompensation, glaucoma, and infections.

By contrast, the laser depigmentation approach advocated by Strōma Medical Corporation has been over a decade in development, having accumulated convincing safety and efficacy data in animal and human studies to date.

“Although we clearly need more long-term studies, the early results are encouraging in terms of effectiveness and safety. This is a credible approach to permanent minimally-invasive iris depigmentation, which avoids a lot of the safety issues we have seen with iris implants and contact lenses,” he said.

Prof Touboul explained the technique works through laser macrophage photoactivation, where a low-fluence, frequencydoubled Nd:YAG laser raises and lowers the temperature of the anterior iris pigment multiple times over a period of less than 30 seconds.

iris pigment, inducing a macrophagic activation that progressively eliminates the pigmented cells in a few weeks,” he said. “As the pigment is removed, light is backscattered by the underlying stromal fibres, resulting in a blue or green iris.”

After initial trials in rabbits, validation studies in humans started with partial iris treatments in Mexico, Costa Rica, and Panama, followed by full iris treatments in Panama in 30 healthy patients with no history of ocular pathology and IOP less than 21 mmHg. Patients were followed up every month for a minimum of one year.

“It took four sessions on average, each spaced at least three weeks apart, to attain the desired result. The results were stable over the follow-up period, and no complications were observed, including quantity and quality of vision, iridocorneal angle, assessment of atrophy and transillumination defects, pupillary health, endothelial loss, iris function, corneal transparency, crystalline lens health, retinal function, and IOP,” he said.

One unexpected side effect of the treatment was an average decrease of 20% in IOP, Prof Touboul said. “The researchers were very surprised by this. One hypothesis is it may be caused by iridial tissue retraction that diffuses to the iridocorneal angle, with perhaps an opening of the trabecular meshwork due to changes in the iris tension,” he said.

Prof Touboul added that a separate company formed by Strōma’s founder is currently exploring the possibility of applying the technology as a treatment for glaucoma.

“The target is the anterior monocellular layer composed of fibroblasts and melanocytes. The photoactivation stimulates the anterior iris pigment, with controlled heating of the superficial

Prof Touboul doesn’t have financial interest in this presentation.

David Touboul MD, PhD is a Professor of ophthalmology at the University of Bordeaux, France, Head of the National Reference Center for Keratoconus, and President of the SAFIR society. david.touboul@chu-bordeaux.fr

“Although we clearly need more long-term studies, the early results are encouraging in terms of effectiveness and safety.”

David Touboul MD, PhD

Topical Biologic Treatment for

Severe Sjögren’s Dry Eye

rhNGF advances to pivotal trials based on favourable results in phase 2 studies.

Cheryl Guttman Krader reports from ARVO 2022

Phase 2 study results of recombinant human nerve growth factor (cenegermin-bkbj ophthalmic solution 0.002%, Dompé) have shown promise for treating moderate to severe dry eye disease (DED) related to Sjögren’s disease, opening the way to phase 3 studies, reported Melissa Toyos MD.

“There is a lack of FDA-approved treatments for Sjögren’s DED, and treatment with rhNGF holds special interest for this condition. Alterations in corneal innervation are particularly prevalent among patients with Sjögren’s DED, and NGF acts to improve ocular surface sensory nerve function that can, in turn, induce improvements in reflex tear secretion and blink rate,” she said.

In the phase 2 study, comparison of results across rhNGF dosing groups helped establish that rhNGF 0.002% administered three times daily (TID) provided the most clinically relevant enduring effects, which led to the TID dosing regimen selection for future studies.

The phase 2 study was a multicentre, double-masked trial including 261 patients randomised to rhNGF 0.002% twice daily (BID), rhNGF 0.002% TID, or vehicle TID. Eligible patients were at least 18 years of age with DED for 6 months or longer, a National Eye Institute corneal/conjunctival fluorescein staining score above 3, Symptom Assessment in Dry Eye (SANDE) score ≥25, Schirmer I (unanaesthetised) score >2 to 10 mm/5 minutes, and tear breakup time <10 seconds in the worse eye. Patients used their assigned study treatment for 4 weeks and were followed for an additional 12 weeks.

The enrolled patients were predominantly middle-aged Caucasian females. At baseline across the three study groups, mean Schirmer I score ranged from 4.7 to 5.3, and mean SANDE score was ~75.

The study’s primary endpoint assessed change in Schirmer I score from baseline to week 4, and the analysis for statistical significance set a challenging threshold of p=0.025. While improve-

ment in the Schirmer I score was greater in both rhNGF groups versus the vehicle group, the differences were not statistically significant. Results from an analysis of percentage of responders (patients achieving a Schirmer I score >10 mm/5 minutes) similarly showed better outcomes in the rhNGF group but without statistical significance.

SANDE score improved at 4 weeks in all groups, but the benefit was maintained during follow-up only in the TID group, and a difference favouring the TID group versus vehicle was seen at weeks 8, 12, and 16.

“Efficacy results were generally comparable between subgroups of patients with Sjögren’s and non-Sjögren’s DED,” Dr Toyos said.

The topical biologic was generally well-tolerated with no differences in adverse event profiles between the Sjögren’s and non-Sjögren’s groups. There were no serious adverse events, discontinuation rates due to an adverse event were low across all groups, and most treatment-emergent adverse events were mild and transient.

Ocular and lid pain or discomfort were the most commonly reported adverse events. Rates of discontinuation due to eye pain were similar across the three study groups.

“Treatment with NGF causes nociceptor sensitisation. Because of this known mechanism of action of the medication, eye pain was not an unexpected adverse event,” Dr Toyos said.

Two phase 3 trials (PROTEGO-1 and PROTEGO-2) are now underway in patients with severe dry eye related to Sjögren’s disease. Eligible patients will be randomised and self-administer the investigational medication or placebo three times a day for four weeks and followed for 90 days.

Melissa Toyos MD is in private practice in Nashville, Tennessee, USA. mtoyos@toyosclinic.com

Oculoplastics and the Orbit

Ocular signs can reveal systemic disease. Clare Quigley MD reports from Kilkenny, Ireland

The important systemic associations of ocular pathology featured in the European Society of Ophthalmology honorary lecture delivered by Dr Elizabeth McElnea at the Irish College of Ophthalmologists annual conference.

She began by presenting the case of an overweight 35-year-old man who presented with a corneal abrasion and a complaint of discharge from both eyes each morning. The patient had diffuse punctate corneal epithelial defects and easy eyelid eversion in keeping with Floppy Eyelid Syndrome (FES). Dr McElnea discussed anterior segment complications encountered in FES, including corneal ulceration—which may progress to descemetocele formation and frank perforation—and posterior segment associations, including non-arteritic anterior ischaemic optic neuropathy. She moved on to the main systemic association of FES that carries an increased risk of mortality for the patient.

“The association of floppy eyelid syndrome with obstructive sleep apnoea is so strong that, with discovery of the former, a sleep study should be considered. While nearly all floppy eyelid syndrome patients have obstructive sleep apnoea, not all patients with obstructive sleep apnoea have floppy eyelid syndrome. Those that do however tend to be younger and more obese, with higher indices of severity of sleep apnoea,” she noted.

Onward referral for a polysomnogram, or sleep study, is required for diagnosing sleep apnoea. Once confirmed, management techniques such as weight loss and continuous positive airways pressure (CPAP) can reduce associated morbidity and mortality. Approaches differ for managing the lids in FES. The surgeries adopted for floppy eyelid syndrome tend to be variations of upper lid wedge resections and tarsal strips, she explained.

Among the other cases discussed, Dr McElnea included a pair of patients with bilateral ptosis with poor levator function. These patients were found to have reduced ocular movements, cataract, and corneal decompensation in addition to their droopy upper eyelids, with the possibility of systemic myopathy acknowledged. Muscle biopsy yielded an important finding: cytochrome oxidase (COX)-negative fibres, indicating mitochondrial cytopathy. Ophthalmologists know mitochondrial disorders to cause ocular movement disorders such as Chronic Progressive External Ophthalmoplegia (CPEO) and optic neuropathy such as Leber Hereditary Optic Neuropathy (LHON), but corneal complications in mitochondrial pathology are less well known.

“Corneal endothelial cells maintain corneal stromal deturgescence and have large numbers of mitochondria to support the high metabolic activity that this function demands. Despite this, corneal endothelial involvement in mitochondrial disease is not typical and, to date, only sporadically reported. In the cases described the diagnosis of a mitochondrial disorder could account for all the patients’ clinical features—ophthalmoplegia, corneal endothelial dystrophy, cataract, and, in the first case, sensorineural deafness. Ophthalmologists should consequently be cognisant of the possibility of corneal endothelial involvement in mitochondrial disease,” she advised.

Elizabeth McElnea is a Consultant Ophthalmic and Oculoplastic Surgeon at University Hospital Galway, Ireland. mcelneaelizabeth@gmail.com

“While nearly all floppy eyelid syndrome patients have obstructive sleep apnoea, not all patients with obstructive sleep apnoea have floppy eyelid syndrome.”

Elizabeth McElnea MD

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Optimising Long-Term Visual Outcomes for Patients with Neovascular AMD

High compliance of at-home monitoring with AI PHP system. Cheryl Guttman Krader reports from ARVO 2022

Patients with intermediate age-related macular degeneration (AMD) who convert to neovascular disease while participating in the ForeseeHome AMD Monitoring Program report excellent visual acuity at conversion and maintain good vision long-term, according to Mariam Mathai MD, reporting results from the retrospective ALOFT study.

perimetry (PHP) with patient support and physician notification of a device-identified alert through a remote monitoring centre. The retrospective review included data collected between August 2010 and July 2020 from 3,334 eyes of 2,123 real-world patients seen at five retina clinics.

Over the study period, patients consistently used the monitoring device 5.2 times per week. During a mean monitoring duration of 3.1 years, 285 eyes converted to nAMD, with 52% of the conversions detected after a system alert, 48% during a routine visit, and one triggered by self-realised symptoms.

Median visual acuity for the 285 eyes was 20/30 at baseline and 20/39 at the time of conversion. After a mean anti-VEGF treatment duration of 2.7 years, median acuity at last followup was 20/32 and 20/40 or better in 82% of eyes. An analysis of real-world data from the AAO IRIS® Registry showed visual acuity at diagnosis of neovascular disease predicts longterm acuity. Visual acuity was 20/40 or better in only 34% of patients monitored for conversion with standard of care relying on office visits and patient self-reported symptoms, Dr Mathai noted.

The ForeseeHome AMD Monitoring Program is a strategy for early detection of neovascular AMD (nAMD) that combines at-home use of an AI-enabled preferential hyperacuity

“ALOFT is the first long-term, large-scale study evaluating visual outcomes of patients with exudative AMD diagnosed while on the ForeseeHome AMD Monitoring Program. Its results

“I believe the role of a monitoring centre that uses cloud computing and artificial intelligence with a medically trained staff is a pivotal reason for the high ForeseeHome compliance.”

Mariam Mathai MD

clearly demonstrate the importance of early detection of nAMD and establish the ForeseeHome program as an indispensable safety net for early detection as well as giving patients good longterm outcomes,” she told EuroTimes

In addition, the persistence with anti-VEGF treatment shown by patients in ALOFT is testament to how, with early treatment for nAMD, patients can have a great visual outcome that further motivates them to continue treatment long-term, she emphasised.

Dr Mathai also commented that the data on the frequency with which patients performed at-home PHP testing is another key finding from ALOFT. Practicing physicians, she noted, know patient participation in self-managed tasks is low, which has challenged remote care and telemedicine.

“I believe the role of a monitoring centre that uses cloud computing and artificial intelligence with a medically trained staff is a pivotal reason for the high ForeseeHome compliance. In addition, ALOFT establishes the ForeseeHome program as a model for providing remote care by combining modern technology with personal attention to patients.”

She concluded by emphasising how patient support is essential for both patient and researcher to benefit from these types of programmes.

“We have to remember that ForeseeHome is a monitoring program and not just a device. Patients work with compassionate clinical partners who educate and support them in this journey. This certainly allows patients to not only be more compliant to their testing, but also vigilant to their symptoms,” she said.

Results of the ALOFT study were published online in April 2022.i

i Mathai M, et al. Ophthalmology Retina. 2022 Apr 25: A2468-6530(22)00193-2.

Mariam Mathai MD is a clinical researcher at the Retina Group of Washington, Washington, DC, USA. mmathai@rgw.com

Systematic Review Award 2022 – 2023

The 2022/2023 ESCRS Systematic Review Award (“SRA”) is a new initiative sponsored by the ESCRS to produce a high quality body of research aimed to prepare, collate, analyse, synthesise and report medical research.

Debate: Should Steroids Be Used Early in Refractory Diabetic Macular Oedema?

Two retina experts face off in Washington, DC.

Howard Larkin reports

About 8 million people are currently diagnosed with diabetic retinopathy in the USA alone, and about 10% of these have diabetic macular oedema (DME). But while anti-VEGF therapies can be an effective first-line treatment, DME persists after two years in about 40% of eyes—an unmet need that raises the question of when to introduce corticosteroids to reduce inflammation. The issue was debated at the 2022 ASCRS Annual Meeting in Washington DC, USA.

Potential Indications for Corticosteroids in DME

Pregnancy

Recent cardiovascular event

Inability or unwillingness to adhere to monthly injections

Awaiting cataract surgery

Arguing for early steroid intervention, Rajesh C Rao MD noted inflammation is a hallmark of diabetic retinopathy. CD4 and CD8 T-cells infiltrate vitreous haemorrhage that are not present in nondiabetic vitreous.i In eyes with DME, several inflammatory cytokines may be present, including IL-6, IL-10, MCP-1, ICAM-1, and IP-10.ii

Source: William F Mieler MD, 2022

three or six anti-VEGF injections or waiting longer? And does refractory mean lack of visual recovery or no decline in central macular thickness?

Dr Rao’s own research confirms the role of inflammation in diabetic retinopathy, highlighting it as a potential pharmacologic target for anti-inflammatory agents distinct from corticosteriods.

“We hope there will be a renaissance in thinking about inflammation in diabetic retinopathy and using targeted drugs developed for other purposes or in development.”

Current FDA-approved intravitreal corticosteroid agents include a dexamethasone implant (Ozurdex®), which is active for about four months, and two triamcinolone acetonide suspensions (Triesence and Trivaris), which are active for about three months, Dr Rao said. A fluocinolone acetonide implant (Iluvien®) lasts about 36 months.

Several clinical trials are underway assessing corticosteroid versus standard therapies. Generally, corticosteroid treatments improve vision by 15 to 30 letters more often than sham. But they also lead to higher rates of cataract formation and greater need for IOP-lowering drugs or incisional glaucoma surgery. However, anti-VEGF injections monthly carry their own risks, including infection and compliance, and can be much more expensive and burdensome to patients than steroid therapy, Dr Rao added.

Still, the risk of corticosteroids means they are not a firstline treatment for DME. In his practice, Dr Rao first uses bevacizumab (Avastin®) followed by aflibercept (Eylea®) for three months each. If the eyes do not respond, he considers adding corticosteroids.

Factors he considers include previous steroid use and whether it affected IOP, lens status, pregnancy status, history of cardiovascular events, and adherence with monthly injections.

“These can help us optimise the use of what really is a secondline therapy but shouldn’t be overlooked,” he concluded.

SPECIAL CIRCUMSTANCES

Arguing against early use of steroids for refractory DME, William F Mieler MD emphasised the importance of defining “early” and “refractory.” Does early mean going to corticosteroids after

“How that is defined is really important and can play a role in the decision-making process of when to intervene with steroids on a secondary basis.”

Dr Mieler noted anti-VEGF therapy has been proven through numerous controlled clinical trials and is the mainstay of initial DME treatment. Yet there is a probable role for corticosteroids, whether triamcinolone, dexamethasone, and (rarely) fluocinolone. They have anti-inflammatory and anti-oedematous properties and help reduce treatment burden, he said.

“But we have to weigh the benefit and risk ratio in terms of IOP and inducement of cataract formation.”

He referenced a study in which intravitreal triamcinolone acetonide with focal or grid laser did well in visual outcome and anatomic results after two years compared with ranibizumab and laser in pseudophakic, non-vitrectomised patients. However, cataract progression in phakic eyes and a need for repeated treatment in vitrectomised eyes were concerns.iii

Similarly, a study of a dexamethasone implant against sham showed substantial visual improvement until the need for cataract surgery, and 41% required IOP-lowering medications. The implant was intended for six months but lost potency after about four months, leading to oedema

recurrence in many cases, Dr Mieler said. After two years, visual outcomes were just 1.5 letters better than sham.iv

Other studies comparing corticosteroids with anti-VEGF agents found similar visual results with reduced treatment burden.v–vi A three-year study comparing fluocinolone found almost all phakic eyes needed cataract surgery and about 5% to 8% needed glaucoma surgery.vii

However, Dr Mieler allowed that using corticosteroid as a primary DME treatment may be indicated for patients with a recent history of cardiovascular events, pregnancy, an inability or unwillingness to undergo monthly treatment, and those undergoing cataract surgery.

Dr Mieler looks forward to better guidelines for using corticosteroids in DME based on well-designed prospective trials. But even then, their use may continue to be controversial, he concluded.

Arch Ophthalmol. 2004; 122(5): 743–9.

ii International Journal of Molecular Sciences. 2021; 22(7).

iii Ophthalmology. 2011; 118: 609–14.

iv Ophthalmology. 2014; 121: 1904–14.

v Graefe’s Archive for Clinical and Experimental Ophthalmology. 2017; 255: 463–73.

vi Ophthalmology. 2016; 123: 399–404.

vii Ophthalmology. 2011; 118: 426–35.)

Rajesh C Rao MD is the Leonard G Miller Professor in the department of ophthalmology, University of Michigan, and Director of the Retina Service at the VA Ann Arbor Healthcare System, Ann Arbor, Michigan, USA. rajeshr@med.umich.edu

William F Mieler MD is the Cless Family Professor of Ophthalmology, Director of the Ocular Oncology Clinic, and an expert in diseases of the macula, retina, and vitreous at the University of Illinois Hospital and Health Sciences System, Chicago, Illinois, USA. wmieler@uic.edu

Ophthalmic YAG and SLT Laser System

Right on the Mark

“Precision treatments with the YAG/SLT laser”

NIDEK, a leading manufacturer of modern YAG lasers, introduces the advanced YAG and SLT combination laser, YC-200 S plus, and the enhanced YAG laser, YC-200.

A suite of technologies has been incorporated in these lasers to achieve seamless function and greater precision. Features for targeting pathology, accurate energy delivery, and operative assist functions allow the surgeon to deliver treatments “Right on the Mark”.

Oxygen Breathes New Protocol into KC Management

Since the approval of corneal collagen cross-linking (CXL) for keratoconus (KC) management, several modifications of the original epithelium-off Dresden CXL protocol have been described to overcome the shortcomings of treatment duration and patient discomfort while aiming for equal outcomes. Amongst the most popular changes have been the accelerated and epithelium-off (transepithelial) protocols. Meanwhile, a number of assistive devices and adjuncts for oxygen delivery have been designed to enhance the pharmacological effectiveness of riboflavin, and pulsed, higher-fluence UVA regimes are used to improve oxygen diffusion.

In this regard, Dr Brendan Cronin and colleagues published their one-year outcomes of a modified accelerated, epithelium-on, oxygen-supplemented CXL protocol. A combination of methods was employed to increase riboflavin permeability through corneal epithelium and enhance stromal oxygen concentration while reducing oxygen consumption. Key components were the use of two riboflavin types (0.25% with BAK, 4 minutes; 0.22% BAK-free, 6 minutes), a wearable oxygen delivery device to induce a hyperoxic periocular environment, and accelerated, pulsed, high-fluence UVA irradiance of 10 J/cm2 total energy used for 11 minutes 6 seconds in total.

Fifty-three eyes of patients between 13 and 45 years old with progressive KC of all grades that underwent CXL were studied retrospectively. The authors demonstrated mean CDVA improvement, with no change in any of the keratometric and refractive parameters or higher-order aberrations, with no complications, concluding the protocol is safe and effective in achieving KC stabilisation at 12 months.

DISCUSSION WITH CORNEAL EXPERTS

The ESCRS Eye Journal Club discussed the protocol and study outcomes with cornea specialists Dr David Lockington (Glasgow) and Dr Vasilios Diakonis (Athens). Amongst the observations made by the experts were the need to use contemporary grading systems for KC severity, such as the Belin ABCD staging system, and apply universal criteria to define KC progression—an area with apparent lack of consensus in the cornea community. Consolidating terminology and criteria is essential to facilitate larger, combined studies and meta-analyses, especially considering the plethora of emerging modified CXL protocols that claim good outcomes but are hampered by small sample sizes, short follow-up, and mixed populations (paediatric/adult).

Regarding the study’s primary outcomes—CDVA and Kmax— both Drs Lockington and Diakonis concurred the vision correction method (spectacles versus rigid contact lenses) is a key determinant of CDVA assessment in a KC population of varied severity and therefore essential information in the article. They noted how CDVA improved significantly in this cohort while none of the studied parameters changed. Kmax was reported

Kmax at 12 months

AAll groupsMild groupModerate groupSevere group

Gain and loss of CDVA (logMAR)

All groupsMild groupModerate groupSevere group

stable over 12 months of follow-up, although five eyes (about 10%) experienced Kmax deterioration of less than 1 D. This was not considered significant in view of stable CDVA, an approach the experts were sceptical about, as the primary aim of CXL treatment is keratometric stability rather than CDVA improvement.

While there are certain advantages in epithelium-on CXL protocols, their efficacy in attaining KC stability remains debatable. Increasingly, more adjunct devices are developed to overcome the epithelium’s barrier function, with several studies—some of which industry-funded—reporting promising outcomes. When asked about their personal preference, both Drs Lockington and Diakonis apply epithelium-off accelerated protocols in their practice and anticipate that robust, comparative future studies with longer follow-up should facilitate decisions on CXL protocol choices.

EyeJC, the ESCRS Journal Club, can be watched live online every month. The hosts include Artemis Matsou, Imran Yusuf, and Basak Bostanci. It is archived at https://player.escrs.org.

Reference:

Cronin B, Ghosh A, Chang C. “Oxygen-supplemented Transepithelial Accelerated Corneal Crosslinking with Pulsed Irradiation for Progressive Keratoconus: One-Year Outcomes.” Journal of Cataract & Refractive Surgery 2022 Apr 4.

Optimising the Patient Experience

How can ophthalmologists optimise the patient experience in their public and private practices?

Mr Shareef Mahdavi will deliver an answer to this question as he presents the Practice Management & Development Masterclass at the 40th ESCRS Congress in Milan.

In this highly interactive and didactic workshop, Shareef will explain the importance of redefining the doctor-patient relationship, describing what patients really want and how ophthalmologists and their staff—in public and private practice—can lead their teams to create innovative and patient-centred practices.

Shareef will be joined by an expert panel including Sheraz Daya (UK), Arthur Cummings (Ireland), Daniel Kook (Germany), Pavel Stodulka (Czech Republic), Kris Morrill (France), Julien Buratto (Italy), and Amanda Carones (Italy) for the day-long session, which takes place on Sunday, 18 September, from 08.30 to 18.00 at the MiCo Milano Convention Centre.

BEYOND BEDSIDE MANNER

The session is open to all delegates attending the 40th ESCRS Congress: both MDs and office managers/administrators are encouraged to attend, and we would particularly welcome young ophthalmologists.

The Patient Experience Masterclass will show ophthalmologists and their practice managers and staff how to tell the transformation story to their patients, better retain employees, and restore the joy of practicing medicine.

Shareef is the author of the highly acclaimed book Beyond Bedside Manner, which outlines how the success of medical practices depends on the commitment to five-star patient experience. This business book for medical practices shows how doctors, nurses, clinicians, and staff can learn to treat patients as customers and make the patient experience a part of their culture. The book also describes how prioritising the patient experience in healthcare leads to happier patients and more fulfilled internal teams.

As chairman of the ESCRS Practice Management & Development Committee, I highly recommend attendance at this masterclass.

As I have stated, everything we do as ophthalmologists has a cost. While this must not be the prime determinant of how we deliver healthcare, it clearly has a major impact. Doctors do not make natural business people, but they need to know about the business of ophthalmology in its broadest sense, and this applies to both the public and private systems.i

WHO OWNS OPHTHALMOLOGY?

In addition to Sunday’s masterclass, we will also hold a number of workshops on Monday, September 19.

One of the key topics we will address in these workshops is “Who Owns Ophthalmology?”

Private equity groups have recently taken great interest in ophthalmology. Throughout Europe, large corporate entities have become major providers of ophthalmic services traditionally provided by public hospitals or independent private practices. Sheraz Daya, Pavel Stodulka, and Kris Morrill will examine this relationship and how ophthalmologists should respond.

If ophthalmologists wish to retain flexibility and autonomy in their practices, it is essential to start providing the answers to these questions and working together to discuss this key question.

SUSTAINABILITY

I am also delighted to announce the President of the ESCRS, Prof Oliver Findl, will chair a workshop called “Sustainability in Ophthalmology”. Dr David Chang, Clinical Professor at the University of California, San Francisco, USA, will be one of the key faculty joining him.

In this workshop, Oliver and David will discuss why ophthalmology as a specialty needs to play its part in fighting climate change and developing more sustainable practices. They will also offer practical examples of how this can be achieved in both public and private practice ophthalmic surgeries.

In a recent article in this magazine, Dr Soosan Jacob pointed out that ophthalmic patients often need multiple outpatient visits for chronic disorders, each contributing to carbon emissions. She further noted the needed surgical solutions and faster, more ophthalmic surgeries can lead to increased waste generation through the high use of disposables.ii

ESCRS is already playing its part in encouraging the development of more sustainable practices. And under Prof Findl’s leadership, the society is working with its partners to organise a socially and environmentally responsible Congress.

The vision of the ESCRS is that by 2023, we will have a Congress with zero waste to landfills, zero net carbon emissions, and will be a role model for social responsibility.

EXCITING PROGRAMME

I do not have the space in this article to outline in detail the other exciting initiatives we will discuss during the workshops on Monday, but other topics include a special industry session called “Using Automation and Artificial Intelligence to Grow Your Practice”. I also highly encourage joining these discussions: Building and Developing a Private Practice, Managing and Developing a Public Ophthalmology Department, and Why Young Ophthalmologists Need to Learn Business and Management Skills.

Building on the learning from Sunday’s masterclass, our “Maximising the Patient Value Journey” workshop will examine how ophthalmologists need to align their objectives across departments, merge their patients’ interests with their public and private practices, and establish a shared vocabulary.

The full programme will be available on the society’s website at www.escrs.org, and I look forward to seeing you in Milan.

i “Chasing Perfection—Editorial from Dr Paul Rosen”, EuroTimes, May 2020.

ii “Sustainability and Waste Reduction in Ophthalmology”, EuroTimes, March 2022.

Paul Rosen is Chairman of the ESCRS Trustees, Chairman of the ESCRS Practice Management & Development Committee, and Past President of the ESCRS.

Dr Paul Rosen announces Mr Shareef Mahdavi will present the Practice Management & Development Masterclass at the 40th ESCRS Congress in Milan.

EuroTimes looks at the stories behind the names.

Ernst Fuchs (1851–1930)

The name Ernst Fuchs is perhaps most familiar to modern ophthalmologists for the several ocular diseases that bear his name, such as Fuchs’ endothelial dystrophy. However, generations of ophthalmologists from around the world have regarded him as the father of modern ophthalmology and his book, Textbook of Ophthalmology, as the Bible of their field of medicine.

Ernst Fuchs, born in 1851 in Vienna, was the eldest of three children. In 1860, Fuchs entered the Scott’s Gymnasium in Vienna, graduating in 1868. He began his study at the School of Medicine in Vienna, attending lectures by many preeminent teachers of his time, such as Joseph Hyrtl, Ernst Wilhelm von Brücke, Karl Rokitansky, Joseph Škoda, Christian Billroth, and Carl Ferdinand von Arlt. He received his medical doctorate in 1874.

In 1881, Fuchs became professor of ophthalmology at Liege, Belgium, the youngest Austrian-trained graduate to become a professor. In 1885, he returned to Vienna, succeeding Eduard Jaeger Ritter von Jaxtthal (1818–1884) as clinical director at the Vienna eye hospital, later known as Fuchs’ Eye Hospital.

PIONEER IN OCULAR PATHOLOGY

Fuchs was not only an excellent clinical observer but also a skilled microscopist whose research laid the foundation for modern ocular pathophysiology. His collection of microscopic 40,000 samples was the largest of its kind. In 1906, Fuchs described a chronic, unilateral iridocyclitis characterised by iris heterochromia—now known as “Fuchs’ heterochromic uveitis”.

In 1910, he was the first to describe a condition characterised by central corneal clouding, loss of corneal sensation, and formation of epithelial bullae. He called this condition “dystrophia epithelialis corneae.” Subsequent research by Alfred Vogt and

others showed the condition to be primarily a disease of the endothelium with later epithelial manifestations. It is now known as Fuchs’ endothelial dystrophy.

Fuchs published the first edition of his Textbook of Ophthalmology in 1889. During the following 21 years, he edited 12 of the 18 English editions of the textbook himself. Maximilian Salzmann, his oldest pupil, edited the later versions. The textbook was also translated into numerous languages, including Japanese, Chinese, Spanish, French, Russian, and Italian. The final edition was published in German in 1945.

Fuchs’s international reputation extended beyond his famous textbook. His groundbreaking research, reported in more than 250 scientific publications, attracted ophthalmologists to his clinic from around the world. Fuchs also delivered lectures at meetings in Indonesia, East Africa, and South America and conducted a coast-to-coast lecture tour in the US. In addition, he had many international patients, including the wife of Naser al-Din, the Qajar Shah of Persia, who came to him for treatment of cataracts.

Ernst Fuchs was also an honorary member of 39 scientific societies, served as President of Honour of the Ophthalmological Society of Madrid, and held numerous honorary doctorates. In 1929, towards the close of his life, the American delegation at the Amsterdam International Ophthalmological Congress held a special banquet in his honour. He died on November 21, 1930, at 79 years old and was buried in Kritzendorf, a small Austrian village on the Donau River.

Reference: A Muller et al. “Professor Ernst Fuchs—A defining career in ophthalmology.” Arch Ophthalmol. 2003; 121(6): 888–891. doi:10.1001/ archopht.121.6.888

Belong to something inspiring. Join us.

Visit escrs.org for information about membership & benefit

The Viennese ocular physician and pathologist who wrote the book.

Visual Field Test for European Drivers

Haag-Streit has become the first company offering a visual field test that fully complies with the EU Commission Directive 2009/113/EC on driving licenses. Until now, none of the existing methods—for example, the Esterman test—completely fulfils the requirements of this directive. As a result, legislative bodies of European countries and eyecare practitioners have struggled with its implementation. The company’s EyeSuite i9.10 perimetry update features a new driving perimetry test for the Octopus 900. This test is now being offered as an option in Norwegian law for driving licences, and more countries are expected to follow.

NEWS IN BRIEF

PRESBYOPIA-CORRECTING IOLS GAIN MOMENTUM

The rate of premium IOL implantation showed “dramatic growth” around the world in 2021, industry researcher Market Scope reported. The “2022 IOL Market Report” predicts the trend will continue, with a 42% increase in global revenue for 2022. The trend is driven in part by the increasing use of EDOF and trifocal lenses, which accounted for the majority of presbyopia-correcting IOLs implanted last year. Not surprisingly, presbyopia-correcting IOLs are more commonly implanted in wealthy countries. Presbyopia-correcting IOLs were slow to catch on in the US, but they now account for 10% of cases. The report predicts six million premium IOLs will be implanted in 2027.

FIRST-LINE GLAUCOMA LASER TREATMENT

BELKIN Vision announced that it had received the CE mark for the first automated, non-contact glaucoma laser treatment available within Europe. The company will roll out the Eagle™ laser in Europe in the second half of 2022.

“The health economic impact of DSLT technology is potentially significant and is anticipated to allow for greater access to high-quality, contactless glaucoma treatment across Europe. Current treatment options are more complex, and DSLT can change the first-line glaucoma treatment paradigm improving patient quality of life while at the same time improving access and allowing us to contribute to lower healthcare costs for both patients and health systems,” said Professor Sir Peng Tee Khaw of Moorfields Eye Hospital and UCL, London, and member of the BELKIN Scientific Advisory Board.

The UK National Institute for Healthcare Excellence (NICE) has recently recommended laser treatment as a first-line treatment for newly diagnosed glaucoma patients, following similar guidelines by the European Glaucoma Society (EGS).

SLIT-LAMP COMPETITION

Haag-Streit invites eyecare professionals to participate in this year’s “Slit Lamp Imaging Competition 2022”. The company encourages participants to showcase their slit-lamp imaging skills. Judging criteria will include image quality, technical execution, and disease interest. The competition is open until 12th August 2022. Applicants should send their images to hsimagingcomp@gmail.com. Participation terms, rules, and regulations can be found at https://bit.ly/imagerules.

THOMAS KOHNEN European Editor of JCRS

JCRS HIGHLIGHTS

NEVER TOO LATE TO LIFT

The time between initial laser-assisted in situ keratomileusis (LASIK) procedures and enhancement procedures does not influence the success of re-lifting the LASIK flap, according to the findings of a retrospective observational case series. The study included 73 eyes of 68 patients who underwent LASIK enhancement procedures with flap re-lifting between January 1, 1997, and July 31, 2019. The mean interval between primary LASIK to re-lift was 8.6 years (range 0.2 to 22.2 years). The study showed the flap re-lifting was successful in 71 eyes (97.3%). Among the eyes with successfully re-lifted flaps, 12 (16.9%) developed epithelial ingrowth (EI), which was clinically significant in three (4.2%) eyes. However, none of those eyes lost lines of best-corrected visual acuity following the ingrowth removal. There was no significantly significant association with re-lift success or EI development and factors such as the interval between the primary and enhancement procedures and primary LASIK flap creation method (microkeratome versus femtosecond laser). J Chang et al., “Effect of time since primary laser-assisted in situ keratomileusis on flap re-lift success and epithelial ingrowth risk”, 48(6): 705–709.

LESS VISUAL IMPROVEMENT IN EYES WITH RETINAL VEIN OCCLUSION

Patients with retinal vein occlusion have poorer visual outcomes after cataract surgery than patients without the condition, as well as a higher risk of postoperative cystoid macular oedema (CME). A retrospective, multicentre cohort study compared cataract surgery outcomes of 1,796 eyes with RVO preoperatively and 177,060 eyes without RVO. The study found 55.1% of eyes with RVO achieved a postoperative gain in visual acuity of 0.35 logMAR or more at four to 12 weeks postoperatively, compared to 64.55% in eyes without the condition. In addition, the RVO group had a significantly higher rate of postoperative CME (3.02% versus 0.87%). C M Ponder et al., “Intraoperative complications and visual outcomes of cataract surgery in patients with retinal vein occlusion: multicentre database study”, 48(6): 697–704.

ICLS OKAY FOR SOLDIERS

Implantation of the implantable collamer lens (ICL) appears to be a safe and effective option for active-duty military personnel, according to a new study. The retrospective longitudinal observational study involved 1,485 patients with a median age of 25 years (range 22–29) who underwent ICL implantation between 2007 and 2019. All were unsuitable for LASIK because of high myopia or topographic abnormalities. The study showed the proportion achieving the targeted refractive correction was 97% at one year and 90% at eight years. In addition, at one year postoperatively, 80.3% of patients (663 eyes) achieved an uncorrected visual acuity of 20/20 or better, and 79.2% of patients had a UDVA of 20/25 or better at eight years. Complications included visually significant anterior subcapsular cataracts requiring ICL removal and cataract extraction in 36 eyes, glaucoma in two eyes, and retinal detachments in three eyes. K T Packer et al., “U.S. military implantable collamer lens surgical outcomes: 11-year retrospective review”, 48(6): 649–656.

UPCOMING EVENTS

SEPTEMBER

EURETINA

1 – 4 September

Hamburg, Germany

ESCRS iNovation Day

16 September

Milan, Italy

WSPOS Subspecialty Day

16 September

Milan, Italy

40th Congress of the ESCRS

16 – 20 September

Milan, Italy

The 40th Congress of the ESCRS will be held in Milan, Italy

2022 ESCRS iNovation Day

Friday 16 th September 2022

MiCo Milano Convention Centre, Milan, Italy

Reasons to Attend

Learn of the latest innovative technologies, including presentations from several emerging companies, and perspectives on how they will change the future of European ophthalmology over the next several years.

56 Faculty Members

Including leaders from the medical, industry and financial communities

30 Minute Panel Discussions on

• Presbyopia • Cataract extraction • MDR

• Digital health

• Glaucoma • Sustainability

• Industry leadership • Financial future of eyecare

Multiple Networking Opportunities

Review Results of ESCRS

Clinical Trends Survey

Data from over 1,000 delegates will be reviewed on key clinical opinions and practice patterns impacting the integration of the latest technologies

Participate in onsite attendee survey of prevailing trends and barriers

www.inovation.escrs.org

Participate in this first iNovation meeting in European Ophthalmology