EuroTimes April 2022, Volume 27, Issue 3

Page 24

CATARACT & REFRACTIVE | CORNEA | RETINA | GLAUCOMA PAEDIATRIC OPHTHALMOLOGY April 2022 | Vol 27 Issue 3
SLAWA UKRAJINI

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 Operations Director ESCRS

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P.X EUROTIMES | APRIL 2022 As certified by ABC, the EuroTimes average net circulation for the 10 issues distributed between February and December 2019 was 47,863
EDITORIAL: THE ESCRS CONDEMNS IN THE STRONGEST TERMS THE RUSSIAN INVASION OF UKRAINE. pg. 03 CLOSER LOOK: LASER VISION CORRECTION 04 Laser Vision Correction Recovers 06 Impressive Results with VisuMax 800 07 Mini-PRK for Myopia in Patients with Thin Corneas 08 Refractive Laser EDOF CATARACT & REFRACTIVE 10 Bilateral Cataract Surgery 11 One-Year Results for Juvene IOL 12 Continuing the Evolution in Presbyopia-Correcting IOL Technology CORNEA 13 Increased Acanthamoeba Risk 14 Corneal Disease Treatment Nothing but Magnetic 16 SMILE for Corneal Scar RETINA 18 Remote Diabetic Retinopathy Screening: Ready for Prime Time? 19 Advanced Retinal Implants 20 Real-World Experience with Anti-VEGF Injections during COVID-19 21 Wireless Epiretinal Prosthesis for Patients with Retinal Degenerative Disease 22 Treatment for Severe Nonproliferative Diabetic Retinopathy 23 Assessing Impact of COVID-19 Lockdown on Patients with Neovascular AMD PAEDIATRIC OPHTHALMOLOGY 24 Batten Disease Treatment OCULAR UPDATE 26 Teprotumumab for Thyroid Eye Disease 27 Adaptions for Low Vision REGULARS
Editorial: The ESCRS Condemns in the Strongest Terms the Russian Invasion of Ukraine 03 Ukraine: ESCRS Coordinating Critical Medical Supplies 28 Developing a PanCoronavirus Vaccine 29 In Practice: Returning after COVID 30 JCRS Highlights 31 Industry News 32 Calendar
02

MEDICAL EDITORS

The ESCRS Condemns in the Strongest Terms the Russian Invasion of Ukraine

The attack on Ukraine invokes the worst memories of a geopolitical conflict in Europe and beyond, which we had hoped was consigned to the past and would remain there.

Since its foundation more than 30 years ago, the core principle of the ESCRS has been to transcend national borders in a spirit of collegiality, teaching, and learning from one another—for the betterment of all. The ideal of the ESCRS is that we are united in a common purpose to improve the lives of our fellow humans through improving their vision and preventing blindness. This unifies us across cultures, language, and international borders.

The Ukrainian Society of Ophthalmic Surgery is one of 19 national affiliates of the ESCRS. Their annual meeting had been scheduled for the beginning of March, with participation from ESCRS members and an ESCRS symposium. War destroys more than lives and property—it also destroys the exchange of ideas and the progress of science.

We want to emphasise our solidarity with our Ukrainian colleagues. We will do whatever we can to help them now, and in the future, during the inevitable painful rebuilding that will be required. The ESCRS Executive is working with non-governmental organisations and via our charitable activities to support Ukraine.

We join the rest of the free world in hoping for rapid cessation of hostilities.

Oliver Findl President

Paul Rosen Chairman of Trustees

Tom Kohnen Treasurer

Filomena Ribeiro Secretary

Rudy Nuijts Immediate Past President

Trustees: José Güell, Roberto Belluci, John Bateson, Till Staffeldt, Béatrice Cochener-Lamard, David Spalton

INTERNATIONAL EDITORIAL BOARD

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)

EUROTIMES | APRIL 2022 EDITORIAL 2
Paul Rosen José Güell Thomas Kohnen Chief Medical Editor Oliver Findl
GUEST EDITORIAL

Ukraine: ESCRS Coordinating Critical Medical Supplies

ESCRS has taken the initiative to coordinate the supply of ophthalmic surgical materials into Ukraine. We have been in continuous contact with ESCRS members Professor Oksana Vitovska, the head of the Ukrainian Alliance of Ophthalmologists, and Dr Volodymyr Melnyk, the head of the Society of Ukrainian Ophthalmic Surgeons, who both have a good understanding of the local situation of their fellow eye surgeons.

We have contacted several industry partners who were all responsive and willing to help. We then defined the supplies most urgently needed for ophthalmic trauma care, in collaboration with several anterior segment surgeons from ESCRS and vitreoretinal surgeons from EURETINA (as well as input from the European Society of Ophthalmic Plastic and Reconstructive Surgery). The St John Eye Hospital in Jerusalem (which has a branch in Gaza) as well as NATO surgeons with Afghanistan and Iraq experience have also been consulted on what is most likely to be needed not only during the present conflict but also in the weeks and months that follow. These supplies are now being put together by our industry partners.

The biggest challenge is the logistics of then getting the supplies to our fellow surgeons in Ukraine. With the help of Polish colleagues, foremost former ESCRS council member Ewa Mrukwa-Kominek, we are actively seeking a suitable storage facility in Poland near the border with Ukraine and have it up and running within the next week. From that hub we will organise onward transportation to Ukraine.

Dear ESCRS friends,

From the first day of the beginning of the War against Ukrainian people, principals of democracy and humanism, we, Ukrainian ophthalmic surgeons, felt your support. Every day you ask me about the situation in my country, and every day you propose possible help. We feel it and we are very appreciative. My country, our citizens, and our army show unbelievable examples of heroism. We are the first barrier on the way in Europe of Russian Federation dictation, military aggression, and inhuman suffering. And we believe that truth will win.

We feel your support and we count on your sympathy in future! THANK YOU!

Kindest regards,

I would like to thank the many people who have been instrumental in starting this mission, with their enthusiasm and around-the-clock availability for numerous videoconferences, phone calls, and hundreds of emails. I would like to mention in particular a few names for their wholehearted support with organising donations from industry: Lawrence Willis and Stephan Eigenmann (Alcon), Ralph Lugbauer (Askin), Aldo Liparulo (B&L), Warwick Strand (BVI), Erin McEachren (Johnson & Johnson), and Thomas Huggler and Christoph Bosshard (Oertli). In addition, I’d like to mention Alistair Laidlaw and Dana Conlon from EURETINA and David Verity from St John (and the occuloplasty society), who are using their own contacts from pharmaceutical companies to help. Lastly, our ESCRS managing director Tom Ogilvie-Graham has contributed significantly with his expertise in helping in such crisis situations (and whose wife is presently leading the UN emergency mission in Moldova) and who is being ably supported by James Hampton from our ESCRS office.

We invite all our industry partners and sister societies to help to support this mission – please just contact our office directly.

Lastly, I hope that all our Ukrainian colleagues have managed to keep their families safe and that they are able to deliver the healthcare so urgently needed. Our thoughts are with you and we shall support you to the best of our ability!

We are grateful to the ESCRS for collaboration for many years and strong support from the first days of the Russian Federation’s war against independent Ukraine. We highly appreciate every step that ESCRS is doing to help Ukrainian Ophthalmologists to fulfil their work and organise eyecare in this difficult period.

But also let me write some words now on behalf of the members of the Ukrainian Alliance of Ophthalmologists, on behalf of hundreds of doctors.

The principles of the development of European and International medicine have always been close and clear to Ukrainian Ophthalmologists. We tried to replicate and develop the most effective technologies. Your activity and purposefulness in the development of technologies and the dissemination of special knowledge have always been an example and an incentive for our development.

But the time has come when the principles of our development have been violated, the principles of any civilised society have been completely destroyed, as well as basic principles of life. This time came along with the beginning of the military aggression of the Russian Federation against sovereign Ukraine with the destruction of what we have been creating for years and decades. Today, the best representatives of our people are being killed on the streets of our cities by military action.

We all appreciate the support of the ESCRS at this extremely difficult time for Ukraine and Ukrainian Ophthalmologists.

EUROTIMES | APRIL 2022 EDITORIAL 3

Laser Vision Correction Recovers

Masks, extra disposable income drive volumes higher.

After coming to a standstill during COVID-19 lockdowns in early 2020, laser vision correction (LVC) rebounded smartly in 2021. In many markets around the world, 2021 volume of LASIK, PRK, SMILE, and other laser and lenticular refractive procedures well exceeded 2019 and may be on track to continue this year, according to observers across Europe and the USA.

“Everyone I have spoken to, all of my peers in the refractive space, have seen two things happen: there’s been growth in laser vision correction and there has also been growth in premium IOLs,” said Arthur B Cummings MMed(Ophth), FCS(SA), FRCS(Edin), who runs the private Wellington Eye Clinic in Dublin, Ireland. “Looking at the Market Scope numbers and the Refractive Surgery Alliance forum, everyone has seen the growth.”

Dr Cummings attributed growth to two factors. First, with fogging and eye dryness, spectacles and contacts don’t work well with masks. “That really brought people in. We always ask, and in the last 18 months, at least half have mentioned spectacle problems,” he said.

Second, “the whole pandemic has made people think about life differently. People are a lot more interested now in looking after themselves and are more likely to spend money on self-care than [material] things,” Dr Cummings said.

EXTRA CASH

Economics also played a role, said Boris Malyugin MD, PhD, of the S Fyodorov Eye Microsurgery State Institution, Moscow, Russia. “With the financial stimulus in many countries, people had a little extra money.” After a down year in 2020, he saw an increase in refractive surgery of about 25% to 30% in 2021 over 2019. The increase was mostly driven by younger people, who

tended not to be as afraid of COVID-19, he said. Cataract surgeries were also down during the same period, possibly due to greater COVID-19 concern in the older population.

Marguerite McDonald MD, clinical professor of ophthalmology at New York University’s (NYU) medical school in New York City, USA, added another economic factor, the availability of more funds for stay-at-home workers due to reduced commuting, clothing, lunch, and other costs of going to an office every day.

Dan Z Reinstein MD, MA(Cantab), FRCSC, DABO, FRCOphth agreed. Positive LVC factors included “more disposable income given lack of spending opportunities—holidays, restaurants, cinema, bars, etc.—and more flexible working hours making it easier to attend appointments. This does seem to be a global phenomenon with an increase in refractive surgery in virtually all countries.”

In the USA, many patients also have tax-free medical spending accounts they can use for refractive surgery, noted Dr McDonald, who also saw volume increase in 2021. She believes the upward trend may continue through 2022 as many people are only returning to in-person work on a limited schedule.

Overall, USA LVC volume hit 833,000 procedures in 2021, including a 32% increase in the fourth quarter, according to the Refractive Surgery Council. This marked the highest volume since the council began tracking LASIK, SMILE, and PRK procedures in 2015 and may be the first time LVC volume topped 800,000 in the USA since 2008 after hovering around 1.4 million annually in the early 2000s, according to estimates by Stephen N Joffe MD.i

Not every area saw the same level of increase. “In Europe and Greece in particular, we did see a boost in cases in late 2020 and early 2021, although we did not quite reach the levels of market

EUROTIMES | APRIL 2022 4 CLOSER LOOK: LASER VISION CORRECTION

recap that the USA experienced,” said A John Kanellopoulos MD, who directs LaserVision.GR Institute in Athens, Greece, and is clinical professor of ophthalmology at NYU.

In Greece, intermittent lockdowns in 2021 slowed the market, Dr Kanellopoulos said. But he expects COVID-19 restrictions to ease in the second quarter of 2022. “We feel there will be a new surge of mainly younger people who will seek spectacle independence.”

NEW TECHNOLOGIES, NEW OPTIONS

Germany also saw a rise in refractive procedures of all kinds in 2021, said Michael C Knorz MD, professor of the Medical Faculty Mannheim at the University of Heidelberg and head of FreeVis LASIK Zentrum—both based in Mannheim, Germany. He is currently seeing about a 10% annual increase in LVC with most of the growth in SMILE myopic procedures. “LASIK alone is declining, as it is replaced by SMILE and even PRK. We have transepithelial PRK available for some years now, which led to an increase in PRK surgeries.” However, LASIK remains the procedure of choice for high astigmatism and hyperopia.

By contrast, Dr Knorz reports a 20% annual growth rate in lens implants. These include both the Visian Implantable Contact Lens (ICL), which he recommends for most myopes needing more than -5.0 D correction, and trifocal IOLs for refractive patients over age 50. “So even a -2.0 D myope at age 55 is today a potential candidate for refractive lens exchange with a trifocal IOL.”

Recent developments in IOL technology such as the ZEISS AT LISA® trifocal, the Alcon PanOptix®, and the Johnson & Johnson Vision Tecnis Synergy™ show excellent results in these patients, he said.

Dr Reinstein says he has used Presbyond LASIK for the last 15 years instead of refractive lens exchange for the vast majority of his presbyopic patients, adding his practice has remained very busy and stable both before and after the pandemic lockdowns and restrictions. The growth in his practice since the pandemic has been mostly in younger patients, and he believes SMILE has played a role in it. Patients like the idea of a flapless procedure that heals in a few hours. SMILE has replaced LASIK in 80% of his cases where both procedures would be indicated because of the rapid recovery, next-day return to all activities with no restrictions, less dry eye, and “extremely good spherical aberration control.” LASIK is still used for patients requiring customised ablations or Presbyond presbyopia corrections, while ICLs are used for about 2% of patients who have corneas not suitable for corneal surgery. In his practice, refractive lens exchange is reserved for those not suitable for ICL monovision due to a shallow anterior chamber or other reasons.

However, Dr Reinstein stressed his clinic prefers to be able to offer all refractive procedures. “We prefer to be in the position to offer the patient the best possible option for their eyes—rather than perceiving one procedure as competing against another.”

Dr Cummings amplified this sentiment. Surgeons should stress the safety and efficacy of the entire range of refractive technologies—and their own skill in helping patients choose the best option.

“When you board an airplane, you don’t ask if it’s made by Boeing or Airbus, you assume it is safe because it meets the general standards, and the pilot has the skill to get you there safely. It should be the same for refractive surgery,” Dr Cummings said.

Dr McDonald agreed. She noted LASIK is still unmatched in precision and quite safe—and has a large installed base that won’t go away soon. Indeed, the current comeback in LASIK “underlines the safety and efficacy of this brilliant procedure,” Dr Kanellopoulos said. Still, patients today are better informed than ever about technology, so ophthalmologists need to be ready to have the discussion, Dr McDonald said.

BLESSING IN DISGUISE

While COVID-19 forced practices worldwide to adopt stringent infection control and social distancing measures that tend to slow patient flow, for some, it sparked changes that actually improved efficiency. For example, Dr Knorz has gone to a paperless office, collecting most patient information electronically before the appointment. Dr Cummings has completely reworked his patient pathway around online surveys and virtual consultations that greatly improved office efficiency and increased patient flow. “These improvements were always on the wish-list, but the pandemic forced the issue.”

However, virtual visits are not for everyone, Dr McDonald said. While colleagues in California tell her they have successfully incorporated virtual pre-op visits, she believes local culture may limit it. “Our patients value face-to-face time,” she said.

i Clinical Ophthalmology. 2021; 15: 1163–1172.

Michael Knorz knorz@eyes.de

Arthur Cummings abc@wellingtoneyeclinic.com

A John Kanellopoulos ajk@laservision.gr

Marguerite McDonald margueritemcdmd@aol.com

Boris Malyugin boris.malyugin@gmail.com

Dan Z Reinstein dzr@londonvisionclinic.com

Stephen Joffe stephen@sjoffe.com

EUROTIMES | APRIL 2022 5 CLOSER LOOK: LASER VISION CORRECTION
Belong to something inspiring. Join us. Visit escrs.org for information about membership & benefit

Impressive Results with VisuMax 800

Upgraded laser system delivers good results in SMILE procedures.

Virtual Winter Meeting 2022

Small incision lenticule extraction (SMILE) with a new enhanced laser platform proved an effective and safe refractive corneal procedure and provided predictable and stable correction of myopia and myopic astigmatism, according to a recent study.

“Our initial results performing SMILE with the VisuMax® 800 (Carl Zeiss Meditec) demonstrated very good results in terms of visual acuity, efficacy, and safety. No eyes had more than one line loss of corrected-distance visual acuity (CDVA), demonstrating a good safety profile. The quality of vision and interface clarity also showed a minimal increase in scatter, which is expected to improve over time,” Supriya Sriganesh MD told a Cornea Day session.

Compared to previous versions of the laser, the VisuMax 800 incorporates a faster laser source, enabling the user to cut a complete lenticule in approximately 8 to 10 seconds.

“This means a shorter suction time and, therefore, [lower] risk of suction loss. The VisuMax 800 features computer-assisted centration as well as cyclotorsion adjustment by digital rotation of the cutting pattern. In addition, the new laser has a smaller footprint and therefore needs less space in the operating room,” Dr Sriganesh explained.

Additionally, the VisuMax 800 is now fully integrated into the refractive workflow and offers enhanced cyclotorsion control.

“The laser is connected via ZEISS FORUM® with other devices such as the Pentacam® (OCULUS) and MEL® 90 excimer laser (Carl Zeiss Meditec), which allows remote planning of the surgical procedures. The OcuLign pattern rotation for cyclotorsion alignment automatically recalculates the treatment pattern and helps counter any cyclotorsion that may occur,” she said.

The study data presented by Dr Sriganesh included 180 eyes operated using the new system, out of which 136 eyes were

available for the two-week follow-up evaluation. The mean patient age was 27 years. Mean preoperative sphere was -3.90 D, cylinder was -0.99 D, and spherical equivalent (SE) was -4.39 D. The preoperative mean Ocular Scatter Index (OSI) reading was 0.57.

The key postoperative parameters at 15 days showed a mean uncorrected distance visual acuity (UCDVA) of -0.08 D (logMAR), with a mean sphere of 0.001 D and a mean cylinder of -0.02. The mean spherical equivalent was -0.01 D. The mean OSI changed from postoperative day one mean of 1.23 to 0.77 by day 15.

Efficacy, as determined by preoperative CDVA versus the postoperative UDVA, was very good, Dr Sriganesh reported.

“The results were impressive, with 100% of eyes 6/9 or better at two weeks and 99% of eyes 6/6 or better at two weeks. The efficacy index was 1.0,” she said.

Safety outcomes were also very good, with 66% of eyes recording unchanged CDVA, while 22% of eyes gained one line of vision and 11% of eyes lost one line. The safety index was 1.01.

Predictability was also impressive, said Dr Sriganesh, with 95% of eyes within 0.25 D of target refraction and 100% of eyes within 0.5 D at the two-week follow-up point.

“When we look at the predictability graph showing attempted versus achieved change in spherical equivalent, the average deviation is only -0.01 D, which is excellent,” she said.

Supriya Sriganesh MD practices at the Nethradhama Super Specialty Eye Hospital, Bengaluru, India. samak.supriya@gmail.com

EUROTIMES | APRIL 2022 6 CLOSER LOOK: LASER VISION CORRECTION
Dermot McGrath reports from the ESCRS
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Mini-PRK for Myopia in Patients with Thin Corneas

Enhanced comfort with customised PRK technique.

Dermot McGrath reports from the 2022 ESCRS Winter Meeting.

Anew minimally invasive customised myopic photorefractive keratectomy (PRK) technique delivers rapid visual rehabilitation and a more comfortable postoperative recovery when compared to traditional PRK and may offer an attractive alternative to either LASIK or SMILE for myopic corrections in appropriate patients, according to A John Kanellopoulos MD.

“This novel PRK technique may minimise pain and visual debilitation by accelerating re-epithelialization and early visual recovery. By using this approach, we make patients very happy because this is a very seamless procedure similar to LASIK or SMILE. It gives us another option for patients with thin corneas, as not every eye is made for a lamellar refractive procedure,” Dr Kanellopoulos told a Cornea Day session.

The mini-PRK procedure aims to essentially bypass some of the known disadvantages of traditional PRK, particularly in terms of visual recovery and postoperative comfort, Dr Kanellopoulos explained.

“The question is why we would consider doing PRK in a practice that we have advocated throughout the years as mainly focused on lamellar procedures? And the answer is that looking at the epithelial maps of patients where the corneal thickness is shallowing abruptly and living and practicing in a country where one out of 20 people has keratoconus, we need to have other options for these thinner corneas that are not suitable for LASIK or SMILE,” he said.

Dr Kanellopoulos’ prospective case series included 104 eyes of 52 patients who underwent PRK for bilateral myopia or myopic astigmatism. Epithelial removal was performed using the Epi Clear™ epikeratome (ORCA Surgical) using customised shape and diameter to denude a 6.5 mm to 7.0 mm disk from the central cornea.

“This is really the only key difference from the classic PRK protocol: We use the epikeratome to de-epithelialize the cornea, but only the diameter of the central cornea necessary for the ablation. We’re looking at a very small amount of corneal epithelium being removed, and the trick is to make sure to be

able to see the shiny, polished surface of Bowman’s membrane, because otherwise, the surgeon may leave an island of epithelium behind that will interfere with the ablation. So, there is a little bit of a learning curve, and you cannot always obtain the exact deepithelialization you require,” Dr Kanellopoulos noted.

The results showed minimal postoperative pain and discomfort for most patients. All eyes were re-epithelialized by day four and all eyes

attained 20/25 immediately after the procedure and out to day four.

“The pain scores clearly showed the eyes that [received] the mini-PRK treatment greatly outperformed those [with] the epithelium removed [through] the transepithelial approach or alcohol de-epithelialization,” he said.

Visual recovery was also extremely rapid after mini-PRK treatment.

“All of the eyes were at least 20/25 when the patient walked out of the laser room after mini-PRK. And this is very different from traditional PRK, at least in my experience practicing all these years, where visual rehabilitation is much slower after surgery,” he said.

Dr Kanellopoulos concluded by saying this minimally invasive PRK approach offers clear advantages over traditional PRK and could provide a viable alternative to either SMILE or LASIK for select cases.

A John Kanellopoulos MD is Clinical Professor of Ophthalmology at New York University Medical School, USA, and Medical Director of LaserVision Clinical & Research Institute, Athens, Greece. ajk@brilliantvision.com

EUROTIMES | APRIL 2022 7 CLOSER LOOK: LASER VISION CORRECTION
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“The question is why we would consider doing PRK in a practice that we have advocated throughout the years as mainly focused on lamellar procedures?”

Refractive Laser EDOF

Positive outcomes with blended vision for presbyopia correction. Dermot McGrath eports from the 2022 ESCRS Winter Meeting

Using laser vision correction to create customised blended vision may offer surgeons a safe and effective treatment option for presbyopic patients in the absence of cataract, according to the results of a study presented at the Cornea Day session.

“We believe that this approach, which we called PresbyEDOF, is an interesting alternative procedure of suitable excimer laser presbyopia correction. Using a method safer than wearing contact lenses, we were able to improve quality of life for every patient,” said Detlev Breyer MD.

Explaining the background to the study, Dr Breyer noted there are currently two laser platforms on the market designed to achieve a depth of focus effect on the cornea: Presbyond® (Carl Zeiss Meditec) and PresbyMAX® (Schwind).

“We have over 10-years’ experience with Presbyond laser surgery inducing positive spherical aberrations to achieve an EDOF effect with the addition of 1.5 D and inducing an anisometropia of -1.5 D,” he said.

Although the PresbyMAX software on the Amaris 1050RS laser routinely offers an anisometropia of -0.89 D and 1.25 D negative spherical aberration, Dr Breyer said this was

EUROTIMES | APRIL 2022 8
CLOSER LOOK: LASER VISION CORRECTION
Dr Breyer goes under the laser himself. Treatment using PresbyMAX software on the Amaris 1050RS laser. PresbyEDOF
“We believe that this approach, which we called PresbyEDOF, is an interesting alternative procedure of suitable excimer laser presbyopia correction.
Using a method safer than wearing contact lenses, we were able to improve quality of life for every patient.”

insufficient to deliver true spectacle independence for his patients, particularly for near vision.

“We therefore increased the anisometropia using PresbyMAX to 1.5 D and an extended depth of focus effect of 1.5 D using negative spherical aberrations,” he said.

Summing up, Dr Breyer said the everyday experience, subjective optical quality, subjective optical side effects, and quality of life improved significantly in all patients—all of whom said they would recommend the procedure to a friend.

Furthermore, Dr Breyer said he fully expected the ninemonth and one-year follow-up data to be even better due to neuroadaptation.

“I was so impressed by the results that I underwent the same surgery myself. I am very happy with the outcome, but I definitely noticed a difference in the quality of my vision between three, six, and nine months,” he said.

Dr Breyer also stressed these were the first patients to be treated with these modified parameters on the PresbyMAX platform.

“There is a little bit of a learning curve, so next year we will show new data, which should be even more impressive,” he said.

For the study, 20 patients answered the National Eye Institute Visual Function Questionnaire concerning everyday experience, subjective optical quality, subjective optical side effects, and quality of life one to three months after surgery.

At three months, more than 85% of patients said they could read a newspaper without visual aids, more than 90% said they didn’t use glasses for various hobbies, and more than 90% said they had no problems when shopping. Most of the patients said they now drove their cars without needing glasses and that their comfort with night driving had also improved significantly.

Detlev Breyer MD is an ophthalmologist and owner, PremiumEyes and Breyer-KaymakKlabe Eye Surgery, Düsseldorf, Germany. dr.detlev.breyer@gmail.com

EUROTIMES | APRIL 2022 9 CLOSER LOOK: LASER VISION CORRECTION
“I was so impressed by the results that I underwent the same surgery myself. I am very happy with the outcome, but I definitely noticed a difference in the quality of my vision between three, six, and nine months.”

Bilateral Cataract Surgery

Superior cost-effectiveness builds the case for immediate sequential procedure. Howard Larkin reports

Will we all be doing immediate sequential bilateral cataract surgery (ISBCS) in the near future? For appropriate cases, probably yes, according to Dutch investigator Rob WP Simons MD.

Refractive outcomes and complication rates are similar between immediate sequential bilateral cataract surgery (ISBCS, same-day bilateral cataract surgery) and delayed sequential bilateral cataract surgery (DSBCS, surgery on both eyes delayed by days or even weeks), according to a multicentre randomised clinical trial in the Netherlands. However, ISBCS significantly reduces costs and slightly improves patient quality of life compared with DSBCS.

The BICAT-NL study results involving 865 patients at 10 hospitals confirm findings of several non-randomised studies comparing the safety, efficacy, and costs of the two approaches. Together they increase pressure to adopt ISBCS for select patients on the grounds of superior cost-effectiveness—though barriers including restrictions in national guidelines and lower payments for immediate sequential procedures also must be overcome.

SIMILAR OUTCOMES

Questions about ISBCS versus DSBCS involve the trade-off between the potential advantages and disadvantages. Results of the Dutch study suggest the advantages of ISBCS, primarily improved quality of life and lower costs, outweigh the disadvantages, primarily risk of a “refractive surprise” or bilateral complications.

To assess “refractive surprise” and overall efficacy, BICATNL used a non-inferiority design with a primary outcome of postoperative refraction of the second eye within 1.0 D of target. Of 834 second eyes treated, 96.9% of ISBCS eyes and 97.6% of BSBCS eyes were within 1.0 D, while 79.4% and 77.2% were within 0.5 D, respectively.

These refractive findings are similar to published studies, of which two found between 91% and 97% of ISBCS eyes and 90% to 97% of DSBCS eyes were within 1.0 D. Three studies found 63% to 71% of ISBCS eyes and 61% to 81% of DSBCS eyes within 0.5 D.

Regarding safety, no cases of endophthalmitis occurred in either BICAT-NL group. As for serious bilateral complications, one DSBCS patient developed corneal decompensation 6 weeks after surgery, another developed bilateral cystoid macular oedema 4.5 weeks after surgery, and one ISBCS patient developed bilateral uveitis 10.5 weeks after surgery. Mild adverse events such as dry eye and dysphotopsias were similar between the two groups. These results also are consistent with five other studies in which complication rates were similar between the two approaches—with one study finding one unilateral case of endophthalmitis in 10,494 ISBCS eyes and two unilateral cases in 38,736 BSBCS eyes.

“We can conclude ISBCS is not inferior to DSBCS when it comes to refractive outcomes and the rate of complications,” Dr Simons said.

LOWER COSTS

BICAT-NL took a comprehensive approach to measuring costeffectiveness associated with both cataract procedures, Dr Simons said. Costs were approached from a societal perspective with all costs over a three-month period included, no matter who incurred them. These included healthcare costs, such as operating

room time, outpatient visits, medication, and home care, as well as patient costs for travel, informal care, and loss of productivity for both patients and any caregivers. Data were collected using questionnaires and patient records.

Overall, mean ISBCS total cost was €1,561 per patient, or €403 less than the €1,964 mean cost per DSBCS patient, a savings of 20.5%. One less admission day and fewer postoperative visits accounted for €354 of the total savings. These results were in line with the 12% to 30% savings for ISBCS reported by five other studies using various methodologies Dr Simons summarised.

Effectiveness was measured using the EQ-5D-5L survey, which assesses five quality of life domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and the HUI-3 survey, which assesses eight quality of life domains, including vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. Slightly higher HUI-3 scores translated into 0.193 quality-adjusted life years (QALYs) for the ISBCS group compared with a 0.186 QALYs for ISBCS out of a maximum achievable 0.25 during 13 weeks of follow up. Results were similar for EQ-5D-5L findings, with ISBCS resulting in 0.215 QALYs, slightly more than DSBCS with 0.212 QALYs. Further analysis of the costs and QUALYs showed a probability of 100% that ISBCS is cost-effective compared with DSBCS, leaving very little uncertainty about the results of the study Dr Simons said.

“Will we all be doing ISBCS because it is more cost effective? I think the answer is ‘yes,’ but in a select group of patients,” Dr Simons said. Patients should have no increased risk of endophthalmitis, refractive surprise, or other complications. “Patients with previous refractive surgery or severe blepharitis may not be suitable candidates.” Surgeon experience is also an important factor, he added.

To make ISBCS safer and reduce the risk of bilateral complications, Dr Simons stressed the importance of adhering to the International Society for Bilateral Cataract Surgery’s general principles for excellence. These include strict aseptic preparation, use of separate instruments from different sterilisation cycles, different lot numbers for medications for each eye, and use of intracameral antibiotics.

This study was presented at the 39th Congress of the ESCRS in Amsterdam, the Netherlands.

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Rob WP Simons MD is an ophthalmologist at Zuyderland Eyescan Oogzorgkliniek, SittardGeleen, the Netherlands. robsimons87@gmail.com
CATARACT & REFRACTIVE
Participating testing centres across the Netherlands.

One-Year Results for Juvene IOL

12-month data show refractive stability, promising functional outcomes.

Cheryl Guttman Krader reports

One year follow-up data from the GRAIL study indicate that the modular, shape-changing Juvene® IOL (LensGen®) provides a full range of vision from distance to near with good refractive stability over the longer term.

The GRAIL study is an international, multicentre, noncomparative trial. Arturo S Chayet MD presented the 12-month results. The study analysed data from 51 (88%) of 58 implanted eyes, including 14 (88%) of 16 bilaterally implanted subjects. Mean manifest refractive spherical equivalent (MRSE) at 12 months was -0.85 D ± 1.00 D.

Dr Chayet noted all the surgeries were performed using a preliminary theoretical A-constant.

“Results have improved in a subsequent cohort of patients operated on using a refined A-constant, and I also believe there is more nuance to refract patients who have this shape-changing lens,” Dr Chayet said.

Refractions stabilised by month three. The mean absolute change from month three to month 12 was 0.38 ± 0.58 D, and there were no statistically significant differences in mean MRSE between any visits in the study.

At 12 months, monocular visual acuity with distance correction was ≥20/25 at distance for all eyes, ≥J2 at intermediate in 98% of eyes, and ≥J3 at near in 82% of eyes. In binocular testing with distance correction, all bilaterally implanted patients achieved ≥20/25 visual acuity at distance and ≥J1 at intermediate, and 92% saw ≥J3 at near.

With distance correction, the monocular defocus curve showed the Juvene IOL provided distance vision comparable to a monofocal lens, intermediate vision comparable to an extended depth of focus (EDOF) IOL, and near vision superior to the EDOF lens. The binocular defocus curve from the bilaterally implanted patients showed improved performance with binocular summation and results comparable to an EDOF IOL at intermediate and superior at near.

FUTURE PLANS

Sumit “Sam” Garg MD is a member of the LensGen Scientific Advisory Board. He told EuroTimes, “The Juvene lens has

the promise to deliver excellent range of vision without significant dysphotopsia, and this potential is supported by the data available so far. In addition, patient satisfaction has been excellent, with many patients achieving spectacle independence. Furthermore, with attributes that include modularity (which allows for exchange and/or upgradeability amongst other things) and filling of the capsular bag (which minimises posterior capsule opacification), the Juvene holds the opportunity for changing the current paradigm of cataract surgery.”

The Juvene IOL consists of a capsule-filling base lens and a fluid lens that fits into the base lens and has a shapechanging anterior surface. The GRAIL study used a singlesize base lens implanted through a 3.0 mm incision that researchers expect to fit at least 90% of eyes. A source from LensGen told EuroTimes different size lenses to satisfy a wider range of eyes will be pursued through a post-marketing study conducted after receipt of initial PMA approval.

LensGen recently received approval to begin enrolment in a US FDA trial. The company is planning a study for CE approval and targeting its launch in the second quarter of 2022.

Dr Chayet presented the study at the AAO21 conference in New Orleans, Louisiana, USA.

Arturo S Chayet MD is Director of the CODET Vision Institute, Tijuana, Mexico. arturo.chayet@gmail.com

Sumit Garg MD is Professor of Ophthalmology, Gavin Herbert Eye Institute, University of California, Irvine, USA. He is a scientific advisor for LensGen. gargs@hs.uci.edu

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YOUNG OPHTHALMOLOGISTS ESCRS Contact: YO@ESCRS.org YO.ESCRS.org ESCRS Young Ophthalmologist Ad_178x75mm.indd 1 11/15/21 4:49 PM

Continuing the Evolution in Presbyopia-Correcting IOL Technology

Hybrid lens delivering high rates of complete spectacle independence.

Cheryl Guttman Krader reports

Amajority of patients receiving the Tecnis® Synergy™ IOL (Johnson & Johnson Vision) are spectacle-free at all distances, suggest follow-up results from a US FDA trial presented by Daniel H Chang MD.

The Tecnis Synergy IOL is a presbyopia-correcting lens with a hybrid design combining multifocal and extended depth of focus (EDOF) technologies.

Dr Chang was an investigator in the FDA trial and presented outcomes from defocus curve testing and patient-reported outcome questionnaires. He also reported clinical success using the Technis Synergy IOL since its commercial launch, highlighting a case involving his research optometrist.

“My research optometrist, Dr Laura Huggins, has been evaluating participants in clinical trials with new presbyopia-correcting technologies for years. She sees many of my surgical patients postoperatively. By age 46, Dr Huggins noticed decreased visual quality from nuclear changes and decided she was tired of glasses, so had surgery with bilateral Technis Synergy IOLs. She now has uncorrected vision of 20/15 at distance and 20/12.5+2 at near, picking letters off of the 20/10 line. She is thrilled with her vision, her full spectacle independence, and (thankfully) her surgeon!” Dr Chang reported.

DEFOCUS TESTING

The US FDA clinical trial compared the Tecnis Synergy IOL with the Tecnis one-piece aspheric monofocal IOL (model ZCB00). The Synergy IOL used in the study (model ZFR00V) was not preloaded. The commercially available lens (model DFR00V) now comes preloaded in the Simplicity® injector.

Bilateral distance-corrected defocus curve results at one month showed the ZFR00V maintained at least 0.2 logMAR (20/32) visual acuity from 0.0 D through approximately -3.5 D and showed at least ~2.3 D greater range than the ZCB00. Results from monocular testing at six months were similar, with the ZFR00V maintaining 0.2 logMAR visual acuity for ~3.3 D with ~2.4 D greater range than the ZCB00.

“The Tecnis Synergy IOL does not have an add power or focal length because it is a hybrid lens. It has a range of clear focus, so patients can hold materials where they want and not where the lens dictates. Because testing is performed at 4 m, clinical defocus curves do not show the real-world near vision bolstered by an accentuated magnification effect as objects move closer than 40 cm.”

SUBJECTIVE DATA

Spectacle independence was evaluated at six months. Using a stringent five-point scale to measure how often patients actually wore spectacles for far, intermediate, near, and overall vision—87.8% of patients in the Synergy group answered “none of the time” for all four conditions compared to only 3.1% of patients in the control group. When asked about whether they felt they needed glasses, at least 91% of patients in the Synergy group reported not needing glasses for far, intermediate, or near vision.

“The latter question shows that patients didn’t wear glasses because they didn’t need them,” Dr Chang explained. “This is

the highest level of spectacle independence I have ever seen in a clinical trial. Considering the FDA study did not allow for correction of postoperative refractive error, real-world spectacle independence should be even higher.”

EARLY IMPRESSIONS

Douglas D Koch MD—Baylor College of Medicine, Houston, Texas, USA—noted he implanted the Synergy IOL in several patients since it became commercially available and was very impressed that all patients in his limited series were spectacle independent. He added he was particularly impressed by the quality of vision at all three distances, assuming one hits the refractive target. In contrast, some patients implanted with the PanOptix® IOL (Alcon) need glasses for near because the PanOptix only focuses 25% of light for near.

Sumit Garg MD—University of California, Irvine, USA—said the patients he has implanted with the Synergy IOL are very happy with their range of vision. However, Dr Garg noted patients may not achieve their best distance vision right away and can still experience dysphotopsia.

“There has to be some compromise with any IOL that splits light. But once my patients reached their best vision, there have been essentially no complaints about quality of vision, other than modest halos or glare,” Dr Koch commented.

Dr Chang told EuroTimes that his research optometrist does note dysphotopsia symptoms but is not bothered by them and functions comfortably in all lighting conditions. “Dr Huggins knew exactly what to expect, so she is quite happy with her visual quality, range of vision, and level of dysphotopsias.” Referring to data from the US FDA trial, he noted only a few of the collected reports of optical/visual symptoms were “severe.” The highest rate of the most bothersome symptom was 5.3% for starbursts.

“The dysphotopsia results are not surprising and even expected for a lens that provides this great a range of vision and spectacle independence. The Tecnis Synergy’s OptiBlue™ chromophore and HD lathing techniques have ameliorated but not eliminated these symptoms. Appropriate preoperative and postoperative counselling is key for the successful clinical adoption of any presbyopia-correcting IOL. For higher patient satisfaction, I prefer to implant the Synergy in the non-dominant eye first. Additionally, I like to use the Synergy in combination with the new Tecnis Symfony™ OptiBlue™ IOL, a lens designed to further reduce dysphotopsias and provide the best balance of visual quality, range of vision, and dysphotopsias.”

The presentation and discussion occurred at the AAO 2021 conference in New Orleans, Louisiana, USA.

Daniel H Chang MD is in private practice in Bakersfield, California, USA. He is also a consultant and investor in Johnson & Johnson Vision. dchang@empireeyeandlaser.com

Sumit Garg, MD gargs@hc.uci.edu

Douglas D Koch, MD dkoch@bcm.edu

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CATARACT & REFRACTIVE

Increased Acanthamoeba Risk

Ruling out infection essential in minors using orthokeratology contact lenses.

Roibeárd O’hÉineacháin reports from the ESCRS Virtual Winter Meeting 2022

Myopic patients using orthokeratology lenses can be at increased risk of sight-threatening acanthamoeba keratitis. Such cases require close management to ensure an optimum outcome, advises Magdalena Niestrata-Ortiz MSc, PhD.

“Acanthamoeba keratitis is an emerging complication of orthokeratology in young myopes. Although myopia progression remains a significant public health issue, the proportion of acanthamoeba keratitis amongst minors using orthokeratology lenses appears to exceed the expected risk profile,” she told delegates.

At a Cornea Day session of the meeting, Dr Niestrata-Ortiz described the case of a 14-year-old female patient who presented at a specialist corneal clinic with a one-week history of painful, red, photophobic eyes. She had been using rigid gas permeable (RGP) orthokeratology lenses for myopia overnight only. She was not using other contact lenses and followed rigorous contact lens hygiene, with no reported use of tap water.

During a close follow-up at the cornea clinic, the patient showed signs of improvement of her symptoms two days after starting the treatment. However, one week later, her eyes were more inflamed with significant bilateral radial perineuritis. Therefore, the clinicians increased the strength of topical PHMB prescription to 0.06%.

Within one week, the patient started to improve symptomatically. She underwent epithelial debridement in the right eye to remove any infected surface cells and promote better drop penetration. She continued to improve symptomatically and clinically throughout the next three months, at which point Brolene was stopped, and monotherapy with PHMB 0.06% continued. Four months after commencing treatment, her symptoms improved significantly with a normal corneal appearance and best-corrected vision with glasses of logMAR 0.30 (pinhole 0.12) and 0.24 (pinhole 0.08) in the right and left eye, respectively. She continues to improve on current treatment.

The patient’s symptoms failed to improve when she discontinued using the lenses immediately following the onset of symptoms and despite having used topical antibiotics. Her vision at presentation was logMAR 1.0 (pinhole 0.7) and 1.0 (pinhole 0.8) in the right and left eye, respectively. Slit-lamp biomicroscopy showed pseudodendritiform epitheliopathy, radial perineuritis, and severe limbitis.

Dr Niestrata-Ortiz and her associates made a clinical diagnosis of acanthamoeba keratitis, which they subsequently confirmed by PCR taken at presentation. They proceeded with treatment through hourly topical administration of Polyhexamethylene Biguanide (PHMB) 0.02% and Brolene 0.1% to both eyes.

Dr Niestrata-Ortiz noted that this patient developed acanthamoeba keratitis despite using the orthokeratology contact lenses as recommended. That is, she always used the contact lens solution and never tap water to clean and store the lenses, never took showers with the lenses on, and only wore them at night. A recent review in the US showed an incidence of acanthamoeba keratitis of 13% among minors using the orthokeratology lenses. “Caution should be exercised when selecting appropriate treatment options for myopia, and alternatives should be considered. In young patients using orthokeratology who develop keratitis, there is a high index of suspicion of acanthamoeba. Prompt diagnosis and treatment is paramount for good clinical outcomes,” Dr Niestrata-Ortiz concluded.

Magdalena Niestrata-Ortiz MSc, PhD, is in the Department of Ophthalmology, Western Eye Hospital, London, UK. smgxnie@ucl.ac.uk

EUROTIMES | APRIL 2022 13 CORNEA
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Ready when you are.
“Caution should be exercised when selecting appropriate treatment options for myopia, and alternatives should be considered.”

Corneal Disease Treatment Nothing but Magnetic

Positive results experienced with surgery that addresses underlying nerve loss.

While there are multiple supportive surgical and nonsurgical treatments for neurotrophic keratopathy, corneal neurotisation is the only intervention addressing the underlying loss of corneal innervation and has shown corneal sensation improvement in humans, according to Ilya M Leyngold MD.

“Corneal neurotisation reinnervates the cornea through the transfer of an intact donor sensory nerve. It thereby re-establishes lost or impaired corneal sensation and supportive trophic functions, leading to restoration of corneal integrity,” Dr Leyngold said.

First described in the peer-reviewed literature in 2009, corneal neurotisation is a relatively new procedure. But already, several technique modifications have been introduced that use different nerve sources and transfer approaches. The technique used in the first published report involved extensive facial dissection with contralateral supraorbital nerve and supratrochlear nerve harvesting through a coronal incision and tunnelling the nerves across the bridge of the nose to the limbus for direct neurotisation. Subsequently, various groups developed minimally invasive approaches for performing direct corneal neurotisation that used palpebral or sub-brow incisions for harvesting and transferring the donor nerve, including Dr Leyngold and colleagues.

Indirect corneal neurotisation with an interpositional nerve autograft was first reported in 2014 literature by Canadian surgeons who used a sural nerve autograft coapted to the supratrochlear nerve. Others have performed the indirect transfer using other nerves for the autograft. As first reported by Dr Leyngold and colleagues, the indirect transfer approach has also been performed using processed nerve allograft to eliminate the need for donor harvesting.

“There are multiple factors to consider when deciding on the surgical approach for corneal neurotisation. There are also questions that remain—including which is better, direct or indirect transfer, or allograft versus autograft; what is the

effect on the outcome with the use of nerve growth factors; and how should the fascicles be positioned around the cornea,” he noted.

SURGICAL SUCCESS

Dr Leyngold discussed outcomes after corneal neurotisation by reviewing a recently published study that he co-authored.i The research analysed data from 24 eyes of 23 patients having a minimum follow-up of six months after minimally invasive direct corneal neurotisation or indirect corneal neurotisation using processed nerve allograft.

Among 13 eyes that presented with a persistent epithelial defect, 11 eyes (85%) achieved complete closure maintained at the last available follow-up. In the total series, 23 eyes (92%) had improvement in ocular surface quality. CochetBonnet aesthesiometry measurements of corneal sensation showed a median gain of 2.3 cm. Most of the improvement in aesthesiometry measurements occurred within the first six months, but individual responses varied. Partial or full return of skin sensation around the donor site was reported by 94% of patients who provided self-assessment. Mean visual acuity did not change significantly after surgery.

“Patients must be counselled that corneal neurotisation does not result in overnight success. Improvements usually occur in 6 to 12 months, but it can take two or three years. In addition, the surgery does not necessarily result in visual improvement because patients may have scarring or other comorbid ocular conditions that limit visual potential,” Dr Leyngold emphasised.

“However, corneal neurotisation can allow for other procedures, such as corneal transplantation, that will restore vision. And in our study, all 17 patients who provided a selfassessment of their outcome said they would go through the surgery again if they had the choice.”

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14 CORNEA
Indirect corneal neurotisation with interpositional nerve graft.

PRACTICAL PEARLS

Dr Leyngold presented a schematic of his current algorithm for deciding on the corneal neurotisation approach that takes into account the availability of a donor nerve with sensory function and the aetiology of the neurotrophic keratopathy. Other issues considered when choosing candidates for the surgery include previous treatments tried and local or systemic factors that can affect the surgery or its outcome, such as the conjunctiva’s condition and whether the patient is currently undergoing local radiation or chemotherapy.

Considering the risk of amblyopia, Dr Leyngold said he tends to be more aggressive performing the surgery sooner versus later in paediatric patients.

For surgeons interested in performing corneal neurotisation, Dr Leyngold suggested using a team approach that either combines the expertise of corneal and oculoplastic surgeons or includes physicians who specialise in otolaryngology or plastic surgery. For greater technical ease, he advised choosing patients who have an available ipsilateral donor nerve to help avoid the need to do cross-face transfer of a contralateral nerve and starting with patients who do not have conjunctival scarring, which makes dissection more complicated.

“Preferably also start with healthier patients because they tend to have better outcomes,” he added.

This presentation was made at AAO 2021 in New Orleans, Louisiana, USA.

Rafailov L, et al. Cornea. 2021; 40: 1377–1386.

Ilya M Leyngold MD is an oculofacial plastic surgeon at the Leyngold Institute for Plastic Surgery, Meridian, Idaho, USA. ileyngo1@gmail.com

EUROTIMES | APRIL 2022
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Successful PKP at 2 years post-CN and 18 months post-PKP.

SMILE for Corneal Scar

O’hÉineacháin reports from the ESCRS Virtual Winter Meeting 2022

In patients with chronic recurrence of herpetic keratitis, removing a corneal scar with small lenticule extraction (SMILE) procedure and replacing it with a healthy lenticule of equal volume from a donor undergoing a myopic SMILE procedure can restore corneal clarity, improve vision, and may also reduce the likelihood of further recurrence of the condition, reported Anita Syla Lokaj MD, ophthalmologist at Eye Hospital in Kosovo.

At a Cornea Day session, Dr Syla Lokaj described the case of a 45-year-old male patient who underwent a tissue extraction procedure for recurrent herpetic keratitis in his right eye. Prior to surgery, the eye’s corneal thickness—as measured by anterior segment optical coherence tomography (AS-OCT)—and decimal visual acuity were 0.1. AS-OCT also revealed the presence of dead keratinocytes within the scar tissue.

Scan Angle: 0’ Spacing: 0.26 mm

Length: 3mm

The herpetic keratitis patient and the patient undergoing refractive SMILE surgery underwent their surgery on the same day by Dr Faruk Seimz. The donor patient underwent the usual serology tests to ensure the absence of any transmissible disease. The extracted donor lenticule were placed in BSS solution for five minutes. The surgeon then prepared the stromal pocket with the femtosecond laser and implanted the lenticule through a side-pocket incision. The lenticule was over 100 µm in thickness to include live keratinocytes.

At a follow-up of 36 months, the cornea thickness remained stable, and slit-lamp biomicroscopy showed good organisation of collagen fibres. Corneal topography also showed a beneficial decrease in improvement in keratometric values. In addition, by three months, decimal visual acuity improved to 0.3 and by six months, it had improved further to 0.5 and has since remained stable throughout follow up.

“The stromal haze has cleared, and at a followup of three years, we detected no sign of recurrence of herpetic keratitis. We implanted the donor lenticules with live keratinocytes not only in this case but in all cases so they could produce collagen. We have found good transparency of the cornea in all the [patients] in which we have performed this procedure,” Dr Syla Lokaj said.

Scan Angle: 0’ Spacing: 0.25 mm

Length: 3mm

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Stromal lenticule implantation may reduce recurrence of herpetic keratitis. Roibeárd
16 CORNEA
“Our early findings suggest [using] corneal stromal lenticules with stromal stem cells and live keratocytes [can] be a safe and efficient surgical treatment for stromal scar after herpetic keratitis.”
Three years postoperation,
Corneal opacity before surgery.
showing clear cornea.

She noted herpetic eye disease is the most common infectious cause of corneal blindness in developed countries and accounts for 60% of corneal ulcers in developing countries, affecting 10 million people worldwide. In addition, the rate of ocular recurrence after one episode is about 10% at one year and 50% at 10 years. And although oral acyclovir reduces the risk of any form of recurrence of ocular herpes by 41% and stromal keratitis by 50%, it still leaves a lot of patients with recurrences. Moreover, acyclovir’s protective effect does not persist after withdrawal of the treatment.

“Our early findings suggest [using] corneal stromal lenticules with stromal stem cells and live keratocytes [can] be a safe and

efficient surgical treatment for stromal scar after herpetic keratitis. This is a relatively simple and low-cost procedure that offers advantages over corneal transplantation as a definitive procedure in the treatment of this disease,” Dr Syla Lokaj concluded.

Anita Syla Lokaj MD is an ophthalmologist and PhD candidate at the Eye Hospital in Pristina, Kosovo. anitasylaj@live.com

EUROTIMES | APRIL 2022 17 CORNEA C M Y CM MY CY CMY K 178x130 AAFF.pdf 3 26/07/2021 8:53:05
Schematic representation of the diameter of the lenticule to be implanted, the diameter of the intrastromal pocket, incision width, and the implanted position of the lenticule in the recipient cornea.

Remote Diabetic Retinopathy Screening: Ready for Prime Time?

Experts debate widespread implementation of telemedicine-based strategy.

Leading retina specialists agree a telemedicine-based approach holds tremendous promise for increasing diabetic retinopathy (DR) screening. However, their opinions diverge about its readiness for large-scale expansion.

In a debate held at the AAO in New Orleans, Jennifer I Lim MD, FARVO, FASRS took up the argument in favour of telemedicine screening for DR being ready for expansion now. She argued it addresses the growing burden of screening for DR and is efficient, effective, and accurate.

The discrepancy between the growing population of patients in need of DR screening and the number of eyecare providers available to provide the service combined with the low rate at which patients with diabetes receive standard-of-care ophthalmic screening establishes the rationale for a telemedicine approach, she asserted.

“Telemedicine will allow us to address the shortage of eyecare providers, and specifically to address the mismatch between the numbers of providers serving patients in rural areas or who are socioeconomically disadvantaged, which leads to disparities in care,” Dr Lim said.

ther evidence that telemedicine screening for DR is ready to go. In fact, it has already gone,” Dr Lim said.

OBSTACLES ON THE PATH TO WIDESPREAD ADOPTION

Taking the opposing side, Christina Y Weng MD, MBA agreed that telemedicine DR screening has tremendous potential. But then she outlined several obstacles necessary to overcome before it can become the primary method for screening.

She began with a case example illustrating the limited accuracy of a telemedicine screening programme for detecting diabetic macular oedema (DME).

“DME affects over half a million people in the US, and telemedicine-based detection of DME is simply not as robust as detection of DR. While we could integrate OCT into teleretina screening, it would drive up cost, which is already a challenge in this space.”

Dr Weng continued, “Care must also be taken when interpreting the reported sensitivity rates for telemedicine DME screening as they are often compared to reading centre fundus photographs as the reference rather than OCT, which is the real gold standard.”

Economic considerations are also limiting the expansion of telemedicine screening for DR. Dr Weng cited cost analyses from her group and others that estimated the cost of non-AI-based teleretina screening to be between $25 and $50 per patient.

“Data for AI-based screening are more limited because of [how new] this approach [is to the industry]. However, a camera for one of the available autonomous AI systems costs about $18,000 and $34 to $50 per reading.”

Furthermore, reimbursement rates in the United States for teleophthalmology do not cover or barely cover the associated costs, she said.

As another concern for clinicians, the medicolegal landscape of teleretina screening is ambiguous.

She cited evidence demonstrating the effectiveness of telemedicine DR screening programmes for increasing the screening rate. For example, data from the Appalachian Diabetic Eye Network, a primary care-embedded programme established to extend DR screening access for underserved populations in Kentucky, showed the screening rate increased from 29.9% in the year before the programme started to 47.7% after only one year. Other analyses showed more than 75% of the acquired screening images were gradable, and a significant proportion of those (22%) showed DR, including a need for specialist referral in 15.2%.

“Other studies also show telemedicine screening for DR conducted at primary care offices can be very effective. That is important because only 30% to 50% of diabetics see an eyecare provider. However, most diabetics visit their primary care provider at least once per year,” Dr Lim said.

More recently artificial intelligence (AI) screening has become available that allows ophthalmologists to treat patients and not screen. Two autonomous AI systems are approved by the US FDA, and both have proven to have very high sensitivity, high specificity, and high imageability for detecting both more than mild DR and vision-threatening retinopathy, Dr Lim stated.

“Recognising the accuracy of these systems, the Centers for Medicare and Medicaid Services in the US granted final approval for a CPT code (billing code) for AI detection of DR. This is fur-

“There are not a lot of precedents, and medicolegal protection will become trickier with AI incorporation,” Dr Weng said.

Lastly, telemedicine DR screening success relies on in-clinic follow-up compliance from individuals who have disease detected outside ophthalmology. Available data indicate this is an important weak link.

“Looking at our data for a four-year period, we were shocked to find that the attendance rate of screened patients who were referred for an in-clinic exam was only 52%. We need to improve the transition between telemedicine and in-person care before the telemedicine approach becomes our primary way of DR screening.”

The debate took place at the AAO 2021 Retina Subspecialty Day in New Orleans, Louisiana, USA.

Jennifer I Lim MD, FARVO, FASRS, is Professor and the Marion Schenk Chair, Vice Chair, and Director of the Retina Service, Department of Ophthalmology, University of Illinois, Chicago, USA. jennylim@uic.edu

Christina Y Weng MD, MBA, is an Associate Professor of Ophthalmology, Baylor College of Medicine, Houston, Texas, USA. christina.weng@bcm.edu

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Cheryl Guttman Krader reports
18 RETINA
“Telemedicine will allow us to address the shortage of eyecare providers, and specifically to address the mismatch between the numbers of providers serving patients in rural areas or who are socioeconomically disadvantaged.”

Advanced Retinal Implants

Retinal prosthesis pioneer Mark Humayun MD, PhD, described two exciting new approaches now in clinical trials during his Charles L Schepens MD Lecture at a recent meeting of the American Academy of Ophthalmology.

Dr Humayun discussed recent results from two projects he leads. One is the development of a 256-channel epiretinal visual prosthesis for patients with end-stage retinitis pigmentosa (RP) known as the Intelligent Micro Implant Eye (IMIE 256, IntelliMicro Medical Co). The other is a regenerative medicine approach using a bioengineered retinal pigment epithelial (RPE) monolayer (California Project to Cure Blindness-Retinal Pigment Epithelium [CPCB-RPE1], Regenerative Patch Technology, LLC) for patients with severe vision loss secondary to advanced dry age-related macular degeneration (AMD).

EPIRETINAL IMPLANT

The IMIE 256 was developed to overcome the limitations of existing retinal prosthetics and deliver better efficacy and safety.

“With the original Argus II (Second Sight Medical Product), which is a 60-electrode system, patients with end-stage RP showed improvements from light perception or hand motion vision to 20/1200 visual acuity (VA). Through software enhancements, achieved VA improved to 20/480, but that probably represents the maximum potential given the implant’s low electrode density and high stimulation threshold,” Dr Humayun said.

Not only does the IMIE 256 provide the opportunity for better visual function with its greater number of electrodes, but thanks to engineering innovations, it is much smaller in size than the Argus II. Surgical implantation of the IMIE 256 is both easier and safer because the device fits in only one quadrant instead of two.

Initial results from the first five patients implanted with the IMIE 256 were published in August 2021 and showed there were fewer serious adverse events related to the surgery or the device relative to experience with the Argus II.i Outcomes from several functional tests provided evidence the IMIE 256 provides better visual performance.

“The results are limited and early, and there are many challenges ahead. But we are encouraged and having fun. Please stay tuned,” Dr Humayun said.

REGENERATIVE MEDICINE APPROACH

Findings from a one-year follow-up in a phase 1/2a clinical trial investigating the CPCB-RPE1 were published simultaneously with the report on the IMIE 256.ii The article describes outcomes for VA and functional tests along with safety data for 16 implanted subjects who were legally blind from advanced dry AMD. Dr Humayun reported that at one year, VA improved in 27% of implanted eyes, whereas control eyes recorded VA losses of 8 to 21 letters.

“There are too few subjects to reach any conclusions about efficacy, but these preliminary findings are exciting considering VA improvement in eyes with GA is unheard of,” he said.

The CPCB-RPE1 cultures a monolayer of hESC-RPE cells on a synthetic parylene membrane—a highly biocompatible, nonerodible substrate. Development of the parylene membrane was done in collaboration with colleagues at the California Institute of Technology and involved micromachining the material to enable surgical implantation and cell retention while allowing for diffusion of macromolecules.

The membrane is foldable to retract into a specialised introducer used to deploy the implant at the target site. Laboratory testing confirmed folding and unfolding the membrane did not result in cell dislodgement.

“Making the membrane foldable allows us to keep the retinotomy size to around 1.5 mm, which is important for minimising the risk of scarring (PVR) and retinal detachment,” Dr Humayun noted.

He added that histological examination was performed on the donated globe from one study subject who passed away from unrelated causes. The evaluations showed that donor cells were present and properly oriented.

Dr Humayun described the implantation surgery as “pretty straightforward”. It involves a small gauge pars plana vitrectomy, posterior hyaloid removal, and retinotomy, followed by implant deployment into the subretinal space. Once the implant unfolds, it is positioned away from the retinotomy. Perfluorocarbon heavy liquid is instilled to flatten the macula, and silicone oil is instilled for long-term tamponade.

Dr Humayun noted the parylene membrane’s design includes a refractive index of 1.5 mm to distinguish it from native tissue on optical coherence tomography.

“Post-implantation imaging shows good coverage of the transplant over the area of GA. At two months post-implant, new formation of external limiting membrane is visible, and it has been seen to persist at follow-up at six months,” he said.

This presentation appeared at the Retina Subspecialty Day of the annual meeting of the American Academy of Ophthalmology in New Orleans, Louisiana, USA.

Xu H, et al. Translational Vision Science & Technology. 2021; 10(10): 14.

ii Kashani AH, et al. Translational Vision Science & Technology. 2021; 10(10): 13.

Mark Humayun MD, PhD, is a Professor of Ophthalmology and Biomedical Engineering, University of Southern California, Los Angeles, USA. humayun@med.usc.edu

EUROTIMES | APRIL 2022
Early results promising for next-generation treatments. Cheryl Guttman Krader reports
19 RETINA
High magnification view of a portion of the CPBP-RPE1 implant. CPBP-RPE1 implant.

Real-World Experience with Anti-VEGF Injections during COVID-19

Decreases in retina care seen in the early days of the COVID-19 lockdown showed considerable variation among countries in the extent and duration of the care interruptions, visual outcomes, and treatment maintenance, a multi-country analysis found.

The study used the observational database of the Fight Retinal Blindness! Registry that contains entries from hundreds of clinicians practicing around the world. It identified patients in Australia, New Zealand, and six European countries (France, Ireland, Italy, the Netherlands, Spain, Switzerland) receiving treatment for neovascular age-related macular oedema (nAMD), retinal vein occlusion (RVO), or diabetic macular oedema (DME) who had a baseline visit within three months of the lockdown in March 2020. The analyses evaluated changes in visual acuity, injection and visit numbers, and dropout rates from six months before the lockdown to six months after the lockdown.

Data from the study included a total of 5,782 eyes of 4,708 patients. A large majority of the study group (80% of both eyes and patients) were receiving treatment for nAMD. Another 11% of patients had DME, and 8% of eyes had RVO. The patients had been treated for an average of 2.2 years prior to the pandemic and received a median of 12 to 14 injections across all three diagnosis subgroups. Approximately 25% of patients were treated every 4 to 6 weeks before the pandemic, and another 25% every 12 weeks for injection.

INJECTION DATA

The decrease in injection numbers was greater in countries hit harder by the pandemic in terms of having higher disease prevalence and severity, longer lockdowns with more stringent restrictions, and a greater negative impact on ophthalmic care delivery. Worse visual outcomes correlated with greater reduction in injections, but patients with DME and RVO did better than those with nAMD despite the DME and RVO subgroups experiencing a greater decrease in injection frequency.

The information provides guidance for future adaptations in care delivery, said study director Mark Gillies MD.

“We have all had to restructure our clinical practices because of the COVID-19 pandemic, including repurposing resources to increase capacity and implementing strategies to limit transmission risk in the clinic environment. At the same time, we have had to provide ongoing care with reorganisation of monitoring and treatment protocols, and in many cases, we have had to prioritise people in need,” he commented.

“The findings from this analysis provide some evidence to suggest prioritising anti-VEGF injections for patients with nAMD may be an appropriate response in situations such as occurred with the lockdown resulting from COVID-19.”

Data for all countries showed a reduction in injection numbers six months after the initial lockdown. The change was greatest in Ireland, Italy, Spain, and New Zealand. Analyses considering the indication for treatment showed fewer injections were being given for RVO and DME than for nAMD after the lockdown.

Treatment intervals extended by a median of 1 to 3.5 weeks after the lockdown compared to the pre-pandemic period. The change, which represented approximately one missed injection, was most extreme in Italy, Spain, and France.

Analyses of patient return visits at six months showed a high rate of dropouts across all indications (nAMD 20%, DME 27%, RVO 28%). Furthermore, between 11% and 16% of patients across the three diagnostic subgroups were lost to follow-up, having no without any further visits after the lockdown.

FUNCTIONAL IMPACT

Visual acuity remained relatively stable (≤1 letter loss) among patients in Australia across all three diagnostic subgroups. For patients with nAMD, visual acuity was also generally stable among patients in France, New Zealand, and the Netherlands whereas patients in Ireland, Italy, and Spain experienced mild to moderate loss of vision six months after the lockdown. Among patients with nAMD, visual acuity decreased by -0.4 to -3.8 letters across the various countries, Dr Gillies reported.

Despite having higher dropout rates and greater reductions in the number of injections received, patients with DME and RVO generally had stable vision or milder loss than their nAMD counterparts. Again, however, the functional outcomes for patients with DME and RVO varied by country. A mild to moderate loss of vision was seen for patients with DME in Italy and Switzerland. In the RVO subgroup, mild vision loss was seen among patients in Ireland, the Netherlands, Switzerland, and New Zealand.

For more information on the Fight Retinal Blindness! Registry, please visit frbresearch.org.

Professor Gillies presented this study at the American Academy of Ophthalmology 2021 Conference, Retina Subspecialty Day, in New Orleans, Louisiana, USA.

Mark Gillies MD is a Professor of Ophthalmology, Save Sight Institute, University of Sydney, Australia.

mark.gillies@sydney.edu.au

EUROTIMES | APRIL 2022
Differences in treatment patterns and outcomes offer insights for future care.
Cheryl Guttman Krader reports
20 RETINA

Wireless Epiretinal Prosthesis for Patients with Retinal Degenerative Disease

Awireless epiretinal visual prosthetic device (NR600, Nano Retina) appears promising in early clinical trials, providing improvements in visual capabilities—as demonstrated by daily life task performance in patients with end-stage retinitis pigmentosa.

Peter Stalmans MD, PhD is an investigator in the first in-human study of the prosthetic system and has performed five of the eight implantations completed so far. He presented follow-up data from five patients seen between 30 days and 20 months post-surgery.

“All eyes tolerated the implantation procedure and had a good postoperative recovery. There have been no cases of device migration, the fundus remains clear with no signs of fibrosis around the implant, and OCT imaging shows only slight tissue elevations immediately adjacent to the implant in some cases. However, there is no thinning or morphological changes of the retina in the vicinity of the device,” Professor Stalmans reported.

Prof Stalmans illustrated the fixation method and implantation of the prosthesis through a surgical video. He also demonstrated the clinical benefit of the prosthetic system through a video showing a patient walking, eating, locating his refrigerator, and retrieving an item from inside the refrigerator while wearing the NR600 eyeglasses.

“Of course, patients need to follow a very intensive rehabilitation programme. In addition, functioning with the system is mentally challenging and fatiguing, so patients do not use it all day. However, this particular patient told me he had an unannounced visit from friends and was so happy that by using the prosthesis, he was able to open the door and welcome them inside,” Prof Stalmans said.

STUDY OUTCOMES

The clinical trial is evaluating safety as its primary outcome. So far, adverse events considered related to the surgery or the device consist of mild postoperative corneal oedema, elevated IOP, and mild scleritis.

“All of the events were transient and responded to medication,” Prof Stalmans said.

NOVEL DESIGN

The epiretinal prosthesis is an all-in-one system comprised of an onboard camera powered by infrared panels, an image processing unit, and 600 isolated electrodes that penetrate the retina. It has no cables exiting the eye. Instead, dedicated rechargeable eyeglasses worn by the patient provide power to the device and modulate the stimulus via an infrared signal.

Describing other unique features of the system, Prof Stalmans noted the electrodes penetrating the retina allow focal activation and at thresholds two orders of magnitude lower than what is required for the Argus II retinal prosthesis. Also, in distinction to competing epiretinal prostheses attached to the retina with a tack, the NR600 implant is fixed using an alternative method that does not involve application of direct force onto the retina. Instead, helical springs extending from a ring sutured into the anterior sulcus keep the implant in place.

When asked about their visual capabilities using the prosthesis, two of the five patients with follow-up data reported being highly satisfied with their improvements, one was satisfied, and the remaining two patients were neutral.

The study was presented at the 2021 American Academy of Ophthalmology Retina Subspecialty Day in New Orleans, Louisiana, USA.

Prof Peter Stalmans MD, PhD, is a member of the Department of Ophthalmology and Vitreoretinal Surgeon at UZ Leuven, Belgium, and Associate Professor of Ophthalmology at KU Leuven, Belgium. peter.stalmans@uzleuven.be

Images courtesy of Prof Peter Stalmans MD, PhD.

EUROTIMES | APRIL 2022 RETINA 21
Encouraging early outcomes in subjects with no or minimal light perception. Cheryl Guttman Krader reports
“Patients need to follow a very intensive rehabilitation programme. In addition, functioning with the system is mentally challenging and fatiguing, so patients do not use it all day.”
The wireless epiretinal visual prosthetic device (NR600, Nano Retina) implanted in the eye. Patient using the rechargeable external spectacles.

Treatment for Severe Nonproliferative Diabetic Retinopathy

Is anti-VEGF therapy the best option for managing severe nonproliferative diabetic retinopathy (NPDR) without diabetic macular oedema (DME)? Two noted retina specialists debated the pros and cons of the question at a recent conference of the AAO.

Speaking in favour of routinely treating severe NPDR with anti-VEGF injections, Diana V Do MD provided an update on the scientific evidence supporting intervention. Ramin Tadayoni MD, PhD, offered several reasons defending the position that the best treatment for severe NPDR without DME is regular observation.

ARGUING FOR ACTION

Dr Do began by offering an analogy between DR and coronary artery disease.

“Diabetic retinopathy is a chronic condition that is very similar to coronary artery disease as both conditions progress over time. Our colleagues in medicine routinely prescribe and proactively treat patients who have coronary artery disease with statins to lower the risk of complications,” she said.

“We know if left untreated, DR most likely will progress and lead to vision loss. If we have effective therapy, why are we not offering it to our patients?”

Underscoring the risk of not intervening, Dr Do cited data showing 50% of eyes with severe NPDR followed with observation will progress to proliferative disease within one year.

“Wouldn’t it be more beneficial to stop this progression? There is incontrovertible evidence demonstrating the benefit of anti-VEGF therapy for reversing DR severity,” she said.

The evidence included findings from the RISE and RIDE studies investigating ranibizumab for DME as well as subsequent PANORAMA study results showing aflibercept injected every 16 weeks significantly reversed retinopathy.

Data from studies investigating anti-VEGF injections for DR also show the treatment reduces the risk of vision-threatening complications or DME formation.

“In fact, the number needed to treat to prevent one of these complications is only three,” Dr Do said.

In addition, anti-VEGF therapy provides a vision benefit compared with observation. An analysis of mean area under the curve for change in BCVA from baseline to week 100 in the PANORAMA study showed a significant difference favouring the aflibercept group versus sham-treated controls.

“Severe NPDR should be routinely treated with anti-VEGF therapy because it targets the pathophysiology and has so many obvious benefits. Let’s be proactive and offer this effective and safe treatment to our patients rather than watching them get worse,” Dr Do concluded.

THE EVIDENCE FOR ESTABLISHED TREATMENT

In 1968, participants in the Airlie House Symposium created the base for performing fundus examinations of diabetic patients. Subsequently, the Early Treatment Diabetic Retinopathy Study Research Group clarified methods for observing patients with DR and criteria for intervening with laser photocoagulation.

Tasked with proving that the long-established recommendations are as good as or better than the newer approach using anti-VEGF injections, Dr Tadayoni said the most important information comes from DRCR.net Protocol W—a two-year randomised trial that found no visual acuity benefit comparing eyes receiving preventive anti-VEGF therapy to controls managed with observation plus antiVEGF therapy if complications developed.

“Observation with photographic documentation every three months is less burdensome and is less invasive than anti-VEGF therapy. It is not surprising, therefore, that patients who begin antiVEGF treatment, even for PDR, are often lost to follow-up,” he said.

In another randomised trial of PDR treatment, approximately half of the patients in the anti-VEGF arm were lost to follow-up over five years. This is much worse than with regular observation, he noted.

Cost of care also weighs in favour of regular observation.

Highlighting the cost of anti-VEGF therapy, Dr Tadayoni cited data from one cost-effectiveness analysis that found the cost of anti-VEGF treatment versus panretinal photocoagulation exceeded $700,000 per quality-adjusted life-year.

He also pointed out a lack of strong evidence to show anti-VEGF treatment improves DR beyond its impact on indirect signs. Two studies performed by Dr Tadayoni and colleagues showed vessel reperfusion was not found on imaging using ultra-widefield fluorescein angiography and widefield OCT angiography, respectively, despite improvement in the DRSS on colour fundus photography.

Dr Tadayoni said anti-VEGF therapy for NPDR may protect against PDR as long as the treatment continues. Once it stops, the consequences may still include the development of neovascular glaucoma and significant loss of vision.

“Observation is non-inferior to anti-VEGF injections in terms of effect on visual acuity and non-perfusion, and it is superior to antiVEGF therapy because it is less invasive and available worldwide. Regular observation leading to timely treatment has already prevented blindness in millions of patients, and as the less expensive option, it could save money that could be used to prevent blindness in other patients. Clearly the best treatment for severe NPDR without DME is regular observation,” he concluded.

The debate took place during the 2021 Retina Subspecialty Day at the AAO conference in New Orleans, Louisiana, USA.

Diana V Do MD is a Professor of Ophthalmology and Vice Chair of Clinical Affairs, Byers Eye Institute, Stanford University School of Medicine, Palo Alto, California, USA. dianado@stanford.edu

Ramin Tadayoni MD, PhD, is a Professor of Ophthalmology at Paris University and chairman at Lariboisière, St Louis, and Rothschild Foundation hospitals, Paris, France.

ramin.tadayoni@lrb.aphp.fr

EUROTIMES | APRIL 2022 22 RETINA
Role of anti-VEGF therapy remains controversial.
Cheryl Guttman Krader reports

Assessing Impact of COVID-19 Lockdown on Patients with Neovascular AMD

EUROCOVCAT study shows decline in care with corresponding loss of vision.

Cheryl Guttman Krader reports from the 2022 ESCRS Virtual Winter Meeting

The early days of the COVID-19 pandemic in Europe saw a significant drop in intravitreal injections and follow-up visits among patients with neovascular age-related macular degeneration (nAMD).

New data from the nAMD EUROCOVCAT study indicates a slow return to care by six months after the first lockdown. But it did not recover to the pre-lockdown levels, and mean BCVA at six months post-lockdown was significantly lower than at six months before lockdown.

“Intravitreal anti-VEGF injections are an effective treatment for nAMD, but any delay or suspension of the injections can lead to significant and rapid vision impairment that may be irreversible,” said Julia Cañas Martín MD, University Hospital Príncipe de Asturias, Alcalá de Henares, Madrid, Spain.

“Because six months is a very short follow-up period, further studies will be necessary to better understand the amount of visual recovery of this patient population,” Dr Cañas reported in a moderated poster session.

The retrospective multicentre observational study analysed data from patients under routine clinical care for nAMD receiving anti-VEGF injections during the three to six months before lockdown. It included 546 patients seen at six centres in Italy, Poland, Spain, Russian Federation, Switzerland, and Turkey. Almost all patients were white/Caucasian. They had a mean age of 79.4 years, were predominantly female (55%), and the majority had type 1 choroidal neovascularisation (71.5%).

Almost two-thirds of the patients discontinued followup care during the lockdown, either not attending a visit or failing to return for treatment. Twelve percent of the initial cohort still discontinued visits and treatment at six months post-lockdown. Mean BCVA was 60.7 letters at both threeand six-months pre-lockdown and fell to 57.0 letters at six months post-lockdown.

CALL FOR ENTRIES

The mean number of intravitreal injections decreased from 2.65 during the six months pre-lockdown to 0.38 during the lockdown and rose to 1.84 at six months post-lockdown. The mean number of injections per month was 1.18 during the six months pre-lockdown, 0.18 during lockdown, and 0.84 at six months post-lockdown; corresponding values for mean number of visits per month were 1.40, 0.12, and 1.05, respectively.

PRIZE

Analyses comparing patients who continued with care during lockdown and those who did not showed no differences between the two groups with respect to age, sex, duration of the lockdown, or having only one functional eye. However, the group that continued follow-up during lockdown had a significantly higher mean BCVA at six months before lockdown and included a significantly higher percentage of patients with active CNV lesions.

“There was no statistically significant difference in the mean change in BCVA after the lockdown comparing patients who continued follow-up care during the lockdown and those who did not. However, it is important to note the number of both intravitreal injections and visits was significantly higher in the group that maintained their scheduled visits and injections during the lockdown,” Dr Cañas said.

Julia Cañas Martín MD practices at the University Hospital Príncipe de Asturias, Alcalá de Henares, Madrid, Spain. julia.cmartin93@gmail.com

EUROTIMES | APRIL 2022 RETINA
23
JOHN HENAHAN
2022
Young
ophthalmologists are invited to write an essay on “What can the field of ophthalmology do to meet the pressing challenges of climate change, sustainability and social equity?”
The winner of the prize will receive a €500 bursary and a specially commissioned trophy. The prize will be awarded during the ESCRS Video Competition Awards ceremony during the 40th Congress of the ESCRS in Milan, Italy in September.
Visit congress.escrs.org/programme/john-henahan-writing-prize
to obtain the application form and review previous winning essays.
“Any delay or suspension of the injections can lead to significant and rapid vision impairment.”

Batten Disease Treatment

Enzyme therapy now under trial for preventing blindness in patients.

Roibeárd O’hÉineacháin reports

Acompassionate use programme evaluating the safety and efficacy of the intravitreal administration of the recombinant enzyme, cerliponase alfa (Brineura®, BioMarin Pharmaceuticals), in preserving vision in children with CLN2related late infantile Batten disease is now underway at Great Ormond Street Hospital in London, UK.

“This first intravitreal enzyme replacement programme is an exciting opportunity that we hope will preserve both vision and quality of life for children with this devastating disorder,” Mr Robert Henderson, the study’s lead investigator, told EuroTimes

The 18-month programme involves eight CLN2 Batten disease patients aged between five and 10 years. All are undergoing intravitreal injection of Brineura under general anaesthesia in one eye every two months for a minimum of 12 months. The primary endpoint is safety in this first-in-man intravitreal enzyme replacement treatment.

The investigators will, additionally, compare the central macula volume derived from Heidelberg Flex OCT measurements taken in the operating room. They will also evaluate visual acuity and electroretinogram preservation.

Batten disease is an umbrella term for a group of hereditary neurodegenerative lysosomal storage disorders called neuronal ceroid lipofuscinoses (NCL). The CLN2 type results from autosomal recessive mutations in the gene that codes for Tripeptidylpeptidase 1 (TPP1), a lysosomal protease that breaks down waste products in neuronal lysosomes. The resulting absence of the enzyme allows the waste products to build up in the neurons, ultimately resulting in neuronal apoptosis.

The symptoms of CLN2 disease first appear between ages two and four years, commonly with seizures and both motor and cognitive regression. This is followed at around five years of age by progressive visual impairment secondary to a cone-rod retinal degeneration that culminates in total blindness. Children with late infantile Batten disease generally die by 10–12 years of age.

ENZYME REPLACEMENT THERAPY

Brineura is a recombinant form of the missing TPP1 enzyme and is the first treatment to show efficacy in slowing disease progression in children with CLN2. The enzyme replacement therapy was approved by the FDA on 27 April 2017 and by the UK NHS in 2019, where it is available under a managed access agreement. The current protocol for administering Brineura is through direct intracerebroventricular infusion using a reservoir device implanted under the scalp with a catheter placed into the ventricles. Patients receive the infusions every two weeks.

“This approach has proven effective in slowing the pace of developmental decline and, in some children, restoring lost motor skills. It does not, however, prevent blindness, as it is believed the recombinant enzyme does not appear to cross the blood retinal barrier,” Mr Henderson noted.

INNOVATIVE INTRAVITREAL APPROACH

Intravitreal injection of Brineura has proven effective in preventing retinal degeneration in a study using the canine model of CLN2. In dogs that received periodic intravitreal injections of Brineura in one eye and vehicle in the other, the Brineura-treated eye retained greater retinal function and more normal morphology than the contralateral vehicle-treated eyes, which exhibited the loss of inner retinal neurons and the photoreceptor disorganisation typical of CLN2 disease.

Furthermore, the treatment effect from a single injection lasted several months. Inflammation was the only side effect detected and was controllable with topical steroids.

“Given the success of treating the dog model, families of patients with the disorder were naturally extremely keen to gain access to an intravitreal treatment for their children. Clinicians at Great Ormond Street applied to the hospital ethics committee for permission to undertake a compassionate use programme, in the absence of any other treatment and considering the rapid deterioration of vision, which was granted,” Mr Henderson said.

Residual cerliponase, left in the vial from the ICV infusions, is prepared for intravitreal injection in the hospital’s pharmacy using similar dosages to the dog model (0.2 mg in 0.05 mL). All children receive topical steroids for one month after treatment and undergo monitoring for signs of uveitis at each visit.

The Great Ormond Street Hospital compassionate use programme, which started in July 2021, has been made possible thanks to a huge fundraising campaign led by the families of children affected by the disease as well as the Batten Disease Family Association (BDFA), a UK charity that aims to support families, raise awareness, and facilitate research into the various types of Batten disease.

Formal drug company-sponsored clinical trials are also underway in Columbus, Ohio, USA, with more planned in Hamburg, Germany.

robert.henderson@gosh.nhs.uk

EUROTIMES | APRIL 2022
PAEDIATRIC OPHTHALMOLOGY 24
RetCam EnvisionTM (Natus Medical) colour image of the right eye of a patient with advanced CLN2-related retinal dystrophy — there is a marked optic nerve pallor and retinal vascular attenuation. The OCT (Heidelberg Engineering GmbH) demonstrates profound retinal thinning, loss of the normal retinal lamination, and highly fragmented ellipsoid.

2022

Applications are open for the Peter Barry Fellowship 2022. This Fellowship commemorates the immense contribution made by the late Peter Barry to ophthalmology and to the ESCRS.

The Fellowship of €60,000 is to allow a trainee to work abroad at a centre of excellence for clinical experience or research in the field of cataract and refractive surgery, anywhere in the world, for 1 year.

Applicants must be a European trainee ophthalmologist, 40 years of age or under on the closing date for applications and have been an ESCRS trainee member for 3 years by the time of starting the Fellowship.

The Fellowship will be awarded at the ESCRS Annual Congress in 2022, to start in 2023.

To apply, please submit the following:

A detailed up-to-date CV

A letter of intent of 1-2 pages, outlining which centre you wish to attend and why

A letter of recommendation from your current Head of Department

A letter from your potential host institution, indicating that they will accept you if successful

Closing date for applications is 2 May 2022

Applications and queries should be sent to escrs@mci-group.com

• • • •

Teprotumumab for Thyroid Eye Disease

Treatment decisions consider benefits, risks, cost, and logistics.

Intravenous teprotumumab (TEPEZZA®, Horizon Therapeutics) can improve signs and symptoms related to thyroid eye disease (TED) in most patients. However, it is not a miracle drug—it is very expensive, and there are a variety of logistical issues accompanying its use, according to oculoplastic surgeon Anne Barmettler MD.

Dr Barmettler reviewed topline results from a clinical trial that supported US FDA approval of teprotumumab for the treatment of TED and shared her insights gleaned from some oculoplastic surgery colleagues who had clinical experience with the drug.

“There has been a lot of excitement about teprotumumab among physicians and patients. However, it is important for patients to understand it involves a six-month commitment involving eight infusions and is not a one-time treatment,” Dr Barmettler said.

“In addition, not all patients respond to teprotumumab, some patients still need surgery, and relapses occur. Furthermore, all patients should be monitored for side effects. A course of teprotumumab costs $300,000, and the need to obtain prior authorisation leads to a delay in starting treatment.”

Based on these considerations, Dr Barmettler said she mostly uses teprotumumab for treating TED in patients with very active, clinically severe disease. She noted she is also using it for treating TED-related optic neuropathy—although research is needed to determine the role of teprotumumab for that purpose and for treating chronic, non-inflammatory TED.

“Once I discuss the logistics of teprotumumab with patients, it may not be so appealing. Most patients who ask about teprotumumab do not choose it if they do not have severe TED.”

Rachel K Sobel MD does not offer teprotumumab to most patients she sees for TED.

“I think the TED needs to be quite severe, and this approach is being confirmed by some of the requirements set by insurers. The stakes are higher with teprotumumab. Therefore, we need to be good stewards of our healthcare system and offer teprotumumab only to patients who we think are really in need and will benefit.”

WHAT PHYSICIANS AND PATIENTS CAN EXPECT

Premarketing clinical trials of teprotumumab were conducted in patients with recent-onset active TED. Reviewing outcomes for the teprotumumab group in one double-blind, randomised, placebo-controlled clinical triali, Dr Barmettler noted 83% of patients achieved the primary endpoint (≥2 mm reduction in proptosis from baseline at week 24), 68% of those with diplopia achieved an improvement of ≥1 grade, and 59% of patients achieved a Clinical Activity Score of 0 to 1 (a composite score ranging from 0 to 7 that assesses inflammation, oedema, redness, and pain).

“However, it is important to note the response rates were not 100%. Furthermore, only 53% of proptosis responders maintained the improvement at 1.5 years, and proptosis generally improves more than lid retraction or inflammation,” Dr Barmettler said.

Side effects during the study included increased blood glucose in 10% of patients, of whom two-thirds had pre-existing diabetes or

impaired glucose tolerance. Other side effects included hearing loss or hearing changes (such as muffled hearing) in 10% of patients, inflammatory bowel (IBD) exacerbation, and amenorrhea.

Dr Barmettler said the oculoplastic surgeons she polled felt the side effect profile of teprotumumab was better than immunosuppressant agents such as mycophenolate mofetil used to treat TED. Less encouraging, however, are reports that hearing-related side effects are occurring at rates of 14% to 50% and are not always reversible. In addition, more reports of IBD exacerbation are emerging, and the blood glucose increases can be very high.

“We have had patients requiring hospitalisation for a blood glucose in the 700s,” Dr Barmettler said.

CLINICAL CONSIDERATIONS

Because of its associated risks, some clinicians are checking for hyperglycaemia prior to starting teprotumumab. Experts recommend monitoring for elevated blood glucose during treatment. In addition, some clinicians are testing hearing prior to starting treatment in patients with existing hearing loss while other clinicians are sending all patients for an audiology evaluation.

Monitoring for IBD flares is also recommended in patients with pre-existing disease. Because of its mechanism of action— insulin-like growth factor 1 receptor inhibition—teprotumumab can affect growth in children and cause foetal harm. Therefore, it should not be used in children, and it is recommended women use contraception while receiving teprotumumab, including for six months after the last infusion.

Logistical issues in the US also relate to the prior authorisation process that is extensive and very time consuming for the clinical and business staff. Compounding the complexity, approval criteria vary among insurers. In addition, the authorisation process may need to start again if there is a desire to change the physical site (hospital, outpatient infusion centre, home) where the patient is receiving the infusion.

The study was presented at the AAO 2021 conference in New Orleans, Louisiana, USA.

i Douglas RS, et al., New England Journal of Medicine. 2020; 382: 341–352.

Anne Barmettler MD is Director of Oculoplastic Surgery, Montefiore Medical Center, New York, USA. abarmett@montefiore.org

Rachel K Sobel MD is an oculoplastic and reconstructive surgeon at Vanderbilt University, Nashville, Tennessee, USA. rachel.k.sobel@vanderbilt.edu

EUROTIMES | APRIL 2022 OCULAR UPDATE 26
Cheryl Guttman Krader reports
“There has been a lot of excitement about teprotumumab among physicians and patients.”

Adaptations for Low Vision

Magnification aids are what most ophthalmologists think about when discussing compensatory measures with patients suffering from low vision. However, the industry should not overlook the need for adaptations to address environmental challenges created by visual function deficits. Ophthalmologists have a valuable role in referring these individuals to other professionals who can provide advice on simple strategies that help low vision patients live safely and independently.

“I think that as ophthalmologists we can have our greatest success helping patients with low vision by becoming part of a vision rehabilitation team,” said low vision specialist Donald C Fletcher MD. “Our role is not to teach patients the tools and skills they can use to confront environmental challenges, but we should identify how the multiple parameters of their visual function are impacted, talk with them about the difficulties they can encounter because of their deficits, and use that discussion as a springboard to introduce team members such as occupational therapists or orientation and mobility specialists who can help them with recommendations on adaptations.”

Dr Fletcher provided examples of how decreased visual acuity, visual field loss, and reduced contrast sensitivity interact with the environment to create hazards and difficulties with localisation and navigation. In addition to talking to patients about where they might encounter these issues, Dr Fletcher said he educates family members about the challenges using simple tools. For example, he has them look through empty cardboard tubes from toilet tissue, paper towels, and wrapping paper, simulating differing degrees of visual field constriction.

ASK PATIENTS WHAT MATTERS

Occupational therapist Michele Vandendooren provided specific examples of how to help low vision patients overcome environmental challenges encountered in the home. The adaptations consider comorbidities, such as problems with balance, tremors, and cognition. The first step, however, is understanding the patient’s goals, including whether the individual actually wants to stay in the home.

“Occupational therapists ask, what matters to you, not what is the matter with you,” Ms Vandendooren said.

Offering examples for increasing contrast to improve safety and accessibility, she discussed selecting items that contrast with the surroundings, such as furniture that contrasts with the walls and floor or towels that contrast with the bathroom walls. Marking the edges of stairs, thresholds between rooms, and the leading edge of a bathtub or shower entry are other ways to increase contrast. Installing grab bars in the bathroom or a tub chair serve as helpful aids for patients with comorbid balance issues. Contrasting colour choices or markings that provide contrast are also needed to increase visibility.

Placing tactile labels on appliances and the dials on the stove fashioned of a contrasting colour and with lettering in large print enables functioning and safety in the kitchen. Other useful kitchen adaptations include talking thermometers that alert individuals when their food is properly cooked. Choosing dishes solid in colour and contrast with the table is another recommendation.

“Patterns or designs on dishes may look like food to someone with low vision and make it hard for them to locate food on the plate,” Ms Vandendooren explained.

As a simple measure to increase safety in the kitchen, lowvision patients should be advised to pour hot beverages after first placing the cup or bowl in the sink. Two-toned cutting boards that are black on one side and white on the other are useful for assisting with safe preparation of light- and darkcoloured foods, respectively.

Rugs that contrast with the floor colour or tablecloths chosen to contrast with the floor can be helpful for persons with low vision by providing a reference point for orientation. With safety in mind, all rugs should have a nonslip backing.

Adequate lighting, including in closets, and the need for good task lighting should also be assessed. Keeping a flashlight handy will also help patients find what they need. Increasing illumination, however, may create problems with glare reflecting off walls and floors. Not all patients experience issues with glare, but Ms Vandendooren said she often gives patients glare control filters so they can see if they are helpful. Locating computer monitors and televisions away from windows is also recommended to reduce problems with glare.

Strategies focusing on improving organisation can also make life easier for the low-vision patient. These include labelling food containers, creating a filing system using large print tabs, or simply pinning socks together.

Magnification, including handheld magnifiers and magnifying mirrors, can also be recommended along with home technology devices—e.g., Amazon Echo or Google Home—that can help individuals with a variety of tasks.

This information was presented during the AAO21 conference in New Orleans, Louisiana, USA.

EUROTIMES | APRIL 2022 OCULAR UPDATE 27
Donald C Fletcher MD is a retinal specialist and low vision specialist at Retina Consultants of Southwest Florida, Fort Myers, USA. Michele A Vandendooren is the founder of Low Works, Sarasota, Florida, USA, a company specialising in low vision rehabilitation.
Improving quality of life and targeting challenges. Cheryl Guttman Krader reports
“Occupational therapists ask, what matters to you, not what is the matter with you.”

Developing a Pan- Coronavirus Vaccine

Protection

sought against SARS-CoV-2 variants and future coronavirus outbreaks.

The rapid development of COVID-19 vaccines is a stunning accomplishment that shows the power of science. But now there appears to be less efficacy against emerging variants of SARS-CoV-2. And what if there is a future pandemic caused by another type of coronavirus? Immunologist Dr Lbachir BenMohamed and colleagues are working to develop a pre-emptive pan-coronavirus vaccine.

“Over the last 10 to 20 years, there has been an acceleration of emerging coronavirus diseases. Therefore, COVID-19 is not the first coronavirus pandemic, and it likely will not be the last,” Dr BenMohamed said.

“Once the COVID-19 pandemic is behind us, we need to learn our lesson and do something today that will make us prepared for the future with a vaccine that will protect us from all coronaviruses.”

DESIGN TARGETS

The currently available COVID-19 vaccines are engineered to induce a B cell response with the development of antibodies to the spike protein found on the surface of SARS-CoV-2. A major limitation of this strategy is it focuses on the viral protein most subject to mutation, Dr BenMohamed said.

“Although available COVID-19 vaccines recognise the spike protein with high affinity, the antibodies they induce will not be effective in neutralising viral variants with a mutated spike protein,” he explained.

“The currently available COVID-19 vaccines have a very minor effect on inducing CD4+ and CD8+ T cell responses. Optimal efficacy for neutralising and eliminating the virus depends on inducing all three arms of immunity,” Dr BenMohamed said.

INITIAL EVIDENCE

Preclinical research conducted using a transgenic mouse model as well as hamsters provides proof of principle for this approach developing a pan-coronavirus vaccine. In an initial study of a first candidate vaccine targeting one of the seven protein antigens, vaccinated animals exposed to multiple SARS-CoV-2 variants (including the original Wuhan virus and the mutated UK, delta, and South African variants) resisted infection, COVID-19like disease, and survived. In contrast, 80% of control animals pretreated with a placebo vaccine died within six to seven days after virus exposure.

Dr BenMohamed said that his group is now proceeding with testing the other six candidate vaccines.

This research was presented at the AAO 2021 Retina Subspecialty Day in New Orleans, Louisiana, USA.

To circumvent that issue, Dr BenMohamed and colleagues are working to develop a vaccine based on additional antigenic targets that are both less prone to mutation and highly conserved among coronaviruses isolated from bats (the originating natural reservoir for all coronaviruses) and intermediate carrier animals. Applying immunoinformatics and sequence alignment approaches, they have identified seven epitope proteins that meet these criteria. These specific proteins are also highly conserved in all SARS-CoV-2 variants found among the more than 3.5 million available genome sequences.

Another feature of the additional proteins is they are highly recognised by CD4+ and CD8+ T cells isolated from individuals who seem to have “natural protection” against COVID-19, i.e., people who became infected with the virus (COVID-19 test positive) but were asymptomatic.

Lbachir BenMohamed PhD is the Director of the Laboratory of Cellular and Molecular Immunology, Gavin Hebert Eye Institute, University of California, Irvine, USA. Dr BenMohamed founded a start-up biotechnology company named TechImmune, LLC at UC Irvine. The company will be responsible for a future clinical trial of a multi-antigen, pan-Coronavirus, vaccine-Coronavirus vaccine. lbenmoha@uci.edu

EUROTIMES | APRIL 2022 28 COVID
Cheryl Guttman Krader reports
“Over the last 10 to 20 years, there has been an acceleration of emerging coronavirus diseases. Therefore, COVID-19 is not the first coronavirus pandemic, and it likely will not be the last.”

IN PRACTICE

Returning after COVID

Resources may address transient anxiety, de-skilling after cataract surgery hiatus.

Feeling a little nervous? You’re not alone. Transient anxiety was reported by more than half of all cataract surgeons upon returning to surgery after as little as eight weeks hiatus due to COVID-19 restrictions, according to a survey of UK ophthalmologists reported by Laura Maubon MBBS, FRCOphth. Technical issues with capsulorhexis, phacoemulsification, main incisions, and posterior capsular rupture (PCR) management also were common, with operating difficulties more likely among trainees, Dr Maubon said. Negative experiences were commonly reported across the board, though more frequently by female and trainee surgeons. Concerns about longer operating times and patient safety were more frequently reported by trainees as well.

The study was based on 232 surveys completed of those emailed to all UK registered ophthalmologists. It asked questions about return to surgery after a hiatus for any reason, though the vast majority cited COVID-19. Given the highly technical nature of cataract surgery and studies showing surgical skills can decline significantly with just a few months’ disuse, its findings suggest procedures for returning surgeons to work could be strengthened.

RETURN PLAN MAY HELP

Learning resources were available to help transition back to practice, including simulators, online videos, and dry labs. However, less than half of all surgeons reported using them, with trainees more likely to access them than experienced surgeons. And while female surgeons were more likely to use such resources, they were five times more likely to report barriers in accessing them due to childcare compared with male colleagues, Dr Maubon said.

Do you have ideas for any stories that might be of interest to our readers?

Overall, the Eyesi simulator, shown to improve trainees’ surgical performance, was the most desirable resource. Though it was available to nearly half, less than one-third actually used it, with many citing COVID-19 or physical distance as the main barrier. Online videos were the most accessed resource, and low-complexity lists, dry labs, and wet labs were among the most requested, Dr Maubon said.

At the same time, less than one-third of responding surgeons were aware of the UK Royal College of Ophthalmology guidelines for returning cataract surgeons—though 63% of those using them found them helpful. Overall, though, just 11.6% had a formal return plan.

Dr Maubon suggested requiring adherence to return plans, much as airline regulators do of returning pilots, may help surgeons address anxiety and de-skilling risk. “Guidance is available in the UK but lacks specificity and compulsion,” she said.

Dr Maubon presented at the 39th Congress of the ESCRS in Amsterdam, Netherlands.

The full report was published in August 2021 and is available free of charge (Maubon, L et al., Eye, 2021, https://doi.org/10.1038/s41433-02101717-5).

Laura Maubon MBBS, FRCOphth, is senior resident ophthalmologist at King’s College Hospital NHS Foundation Trust, London, UK, and young ophthalmologist lead for the UKISCRS. lauramaubon@nhs.net

EUROTIMES | APRIL 2022 29 IN PRACTICE
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European Registry of Quality Outcomes for Cataract and Refractive Surgery

JCRS HIGHLIGHTS

INTRAOPERATIVE OCT USEFUL IN PAEDIATRIC CATARACT

Posterior lens opacity in paediatric cataract surgery remains a considerable challenge because of the higher risk of posterior capsule rupture. Yet, the different morphological patterns associated with the integrity of the posterior capsule in posterior lens opacity in these patients are largely unknown. A new study used intraoperative optical coherence tomography (iOCT) to look for patterns. The researchers looked at 62 eyes of 53 patients, mean age of 3.8 years. They report iOCT helped to classify posterior lens opacity into four types based on the morphology of the posterior lens cortex and posterior capsule. Imaging helped to distinguish posterior polar cataract and posterior lenticonus. They believe iOCT can help guide surgical strategies and approaches in paediatric cataract surgery. W Chen et al., “Intraoperative OCT for the assessment of posterior capsule integrity in paediatric cataract surgery”, 48(3): 261–266, March 2022.

TORIC IOL REPOSITIONING IN THE REAL WORLD

European Cornea and Cell Transplantation Registry

EuReCCa

European Registry for Childhood Cataract Surgery

Accountability. Benchmark. Patient Care. Research. Outcomes & Risks.

registries.ESCRS.org

Toric IOLs have a unique performance issue regarding astigmatic axis alignment, as the IOL must be implanted and remain at the proper astigmatic meridian to optimise visual outcomes. A recent study mined the American Academy of Ophthalmology’s IRIS Registry to learn more about the real-world incidence of monofocal toric IOL postoperative repositioning. Of the 6,482 eyes, 1.3% required repositioning within the first postoperative year. Tecnis toric IOLs were more likely to require repositioning than AcrySof toric IOLs. Younger patients had higher rates of postoperative toric IOL repositioning. BA Kramer et al., “Real-world incidence of monofocal toric intraocular lens repositioning: analysis of the American Academy of Ophthalmology IRIS Registry”, 48(3): 298–303, March 2022.

LONG-TERM FOLLOW-UP

How well do patients undergoing standard phacoemulsification cataract surgery do in the long-term in visual function and manifest refraction? Japanese researchers evaluated the long-term changes in manifest refraction in three categories of patients—59 years or younger, 60–69 years, and 70 years or older. The study looked at 300 eyes of patients that had undergone cataract surgery more than seven years ago and 300 control eyes. Spherical power did not change significantly after stabilisation of surgically induced change over the seven-year follow up. Phakic eyes did develop hyperopia and against-the-rule astigmatism over the same period. The refractive changes did not differ according to patient age in pseudophakic eyes, whereas the hyperopic and ATR astigmatic shifts differed significantly according to patient age. K Hayashi et al., “Long-term changes in manifest refraction subsequent to cataract surgery”, 48(3): 322–327, March 2022.

EUROTIMES | APRIL 2022 JCRS HIGHLIGHTS JCRS is the official journal of ESCRS and ASCRS 30
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Santen opens glaucoma research lab in London

Santen announced the creation of its first external research laboratory in Europe. In partnership with the University College London Institute of Ophthalmology, the lab will support the work of young ophthalmology researchers.

“The aim of this research laboratory is to investigate how to prevent and reverse damage that glaucoma causes to the optic nerve and retina and to support some of the brightest minds in the field to find solutions to ophthalmology’s most pressing challenges,” the company said in a press release.

“This is an exciting new development in our strategic partnership with Santen, which has been going from strength to strength since the original memorandum of understanding in 2016,” said Professor Andrew Dick, Director, UCL Institute of Ophthalmology. “I’m grateful to everyone involved for their enthusiasm and dedication to foster the research potential of this partnership; and to UCL Translational Research Office (TRO) for supporting the Institute’s vision to expand our translational research to generate better therapies, diagnostics, and knowledge of eyecare.”

Santen also recently launched the Santen Eyecare Education portal, an interactive medical education platform for ophthalmologists. For more information, please visit https://santensee.eu.

HAAG-STREIT FOCUSES ON OPHTHALMOLOGY

Haag-Streit reported it will focus solely on ophthalmic surgery, pulling out of its other areas of involvement, including plastic and reconstructive surgery and neurosurgery. HaagStreit products include surgical microscopes, slitlamps, Lenstar biometers, Octopus perimeters, Goldmann tonometers, and surgical simulation solutions. All the products are developed and manufactured in Switzerland, Germany, the UK, and the USA.

Your Professional Dry Eye Assistant

LENSAR NOD FROM US FDA

Lensar announced the US FDA accepted its 510(k) submission for its next-generation ALLY™ Adaptive Cataract Treatment System for substantive review. The submission seeks marketing clearance for the ALLY Adaptive Cataract Treatment System and is the first stage of a planned, two-step commercial release strategy. As part of this strategy, the company plans to submit an additional 510(k) application seeking clearance for the phacoemulsification features within the integrated ALLY system later in 2022. The company believes ALLY will set a new standard of femtosecond laser cataract technology.

OCULUS Keratograph 5M with JENVIS Pro Dry Eye Report: All relevant information at a glance!

The new JENVIS Pro Dry Eye Report helps you perform comprehensive screenings, using the measuring results as a basis for diagnosing dry eye syndrome. The workflow is optimized for time saving and patient friendliness. All results are documented and summarized for you and your patient in a neat and easily understandable printout.

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INDUSTRY NEWS 31 EUROTIMES | APRIL 2022
The availability of products and features may vary by country. OCULUS reserves the right to change product specifications and design.
INDUSTRY NEWS

MAY

ARVO

1 – 4 May

Denver, CO, USA

JUNE

15th European Glaucoma Society Congress

4 – 7 June

Athens, Greece

EUCornea

25 – 26 June

Athens, Greece

SEPTEMBER

EURETINA

1 – 4 September

Hamburg, Germany

40th Congress of the ESCRS

16 – 20 September

Milan, Italy

EUROTIMES | APRIL 2022 CALENDAR 32
THIS MONTH
American Society of Cataract and Refractive Surgery Annual Meeting
– 26 April Washington, DC Keep learning. Whenever, wherever. Learn more at https://elearning.escrs.org
The ASCRS Annual Meeting is scheduled to be held in Washington, DC.
APRIL
22

Fundus image acquisition with macula and disc capture in one image on OCT, for enhanced screening and clinical efficiency

FAF model

Standard model

Retina map

Denoising technique

Widefield image capture in a single shot

High definition OCT image for all scans

Denoising technique with deep learning

www.nidek.com
NEW
Images courtesy of Rodrigo Abreu González, MD, PhD, FEBO, University Hospital of La Candelaria, Spain

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