EuroTimes May 2024, Volume 29, Issue 4

Page 1

ALSO IN THIS ISSUE

What Is Stopping Digital OR Adoption?

Going digital could streamline clinical work and help your back.

The EHDS is Ready for the Green Light Balancing the risks to data and patients.

Escaping Our Limitations Addressing current social issues in ophthalmology.

New techniques and technologies add to surgeons’ difficult decisions.

G L AUCOMA TREAT M E N T U NDER PRESSUR E mmHg
MAY 2024 | VOLUME 29 | ISSUE 4

(SmPC)

Vabysmo

indicated for

treatment of adult patients with neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DME). Dosage & Administration: nAMD: The recommended dose is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks (monthly) for the first 4 doses. Thereafter, an assessment of disease activity based on anatomic and/or visual outcomes is recommended 20 and/or 24 weeks after treatment initiation so that treatment can be individualised. In patients without disease activity, administration of faricimab every 16 weeks (4 months) should be considered. In patients with disease activity, treatment every 8 weeks (2 months) or 12 weeks (3 months) should be considered. There is limited safety data on treatment intervals of 8 weeks or less between injections. Monitoring between the dosing visits should be scheduled based on the patient’s status and at the physician’s discretion, but there is no requirement for monthly monitoring between injections. DME: The recommended dose is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks (monthly) for the first 4 doses. Thereafter, treatment is individualised using a treat-and-extend approach. Based on the physician’s judgement of the patient’s anatomic and/or visual outcomes, the dosing interval may be extended up to every 16 weeks (4 months), in increments of up to 4 weeks. If anatomic and/or visual outcomes change, the treatment interval should be adjusted accordingly, and interval reduction should be implemented if anatomic and/or visual outcomes deteriorate (see full SmPC). Treatment intervals shorter than 4 weeks between injections have not been studied. Monitoring between the dosing visits should be scheduled based on the patient’s status and at the physician’s discretion, but there is no requirement for monthly monitoring between injections. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in the SmPC, active or suspected ocular or periocular infections, active intraocular inflammation. Warnings & Precautions: The name and the batch number of the administered product should be recorded to improve traceability of biological products. Intravitreal injection-related reactions including those with faricimab, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment and retinal tear (see full SmPC). Proper aseptic injection techniques must always be used when administering Vabysmo. Patients should be instructed to report any symptoms, such as pain, loss of vision, photophobia, blurred vision, floaters, or redness, suggestive of endophthalmitis or any of the above-mentioned adverse reactions without delay, to permit prompt and appropriate management. Patients with increased frequency of injections may be at increased risk of procedural complications. Intraocular pressure increases Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including those with faricimab (see full SmPC). Special precaution is needed in patients with poorly controlled glaucoma (do not inject Vabysmo while the IOP is ≥ 30 mmHg). In all cases, both the IOP and perfusion of the optic nerve head must be monitored and managed appropriately. Systemic effects including arterial thromboembolic events have been reported following intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors and there is a theoretical risk that these may be related to VEGF inhibition. A low incidence rate of arterial thromboembolic events was observed in the faricimab clinical trials in patients with nAMD and DME. There are limited data on the safety of faricimab treatment in DME patients with high blood pressure (≥ 140/90 mmHg) and vascular disease, and in nAMD patients ≥ 85 years of age. Immunogenicity As this is a therapeutic protein, there is a potential for immunogenicity with faricimab (see full SmPC). Patients should be instructed to inform their physician of any signs or symptoms of intraocular inflammation such as vision loss, eye pain, increased sensitivity to light, floaters or worsening eye redness, which might be a clinical sign attributable to hypersensitivity against faricimab (see full SmPC). Bilateral treatment the safety and efficacy of faricimab administered in both eyes concurrently have not been studied. Bilateral treatment could cause bilateral ocular adverse reactions and/or potentially lead to an increase in systemic exposure, which could increase the risk of systemic adverse reactions. Until data for bilateral use become available, this is a theoretical risk for faricimab. Concomitant use of other anti-VEGF there are no data available on the concomitant use of faricimab with anti-VEGF medicinal products in the same eye. Faricimab should not be administered concurrently with other anti-VEGF medicinal products (systemic or ocular). Withholding treatment Treatment should be withheld in patients with: Rhegmatogenous retinal detachment, stage 3 or 4 macular holes, retinal break; treatment should not be resumed until an adequate repair has been performed. Treatment related decrease in Best Corrected Visual Acuity (BCVA) of ≥ 30 letters compared with the last assessment of visual acuity; treatment should not be resumed earlier than the next scheduled treatment. An intraocular pressure of ≥ 30 mmHg. A subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is ≥ 50%, of the total lesion area. Performed or planned intraocular surgery within the previous or next 28 days; treatment should not be resumed earlier than the next scheduled treatment. Retinal pigment epithelial tear risk factors associated with the development of a retinal pigment epithelial tear after anti-VEGF therapy for nAMD, include a large and/or high pigment epithelial detachment. When initiating faricimab therapy, caution should be used in patients with these risk factors for retinal pigment epithelial tears. Retinal pigment epithelial (RPE) tear is a complication of pigment epithelial detachment (PED) in patients with nAMD. RPE tears are common in nAMD patients with PED, treated with IVT anti-VEGF agents including faricimab. There was a higher rate of RPE tear in the faricimab group (2.9%) compared to aflibercept group (1.4%). The majority of events occurred during the loading phase, and were mild to moderate, without impact on vision. Populations with limited data There is only limited experience in the treatment of nAMD patients ≥ 85 years, and DME patients with type I diabetes, patients with HbA1c over 10%, patients with high-risk proliferative diabetic retinopathy (DR), high blood pressure (≥ 140/90 mmHg) and vascular disease, sustained dosing intervals shorter than Q8W, or nAMD and DME patients with active systemic infections. There is limited safety information on sustained dosing intervals of 8 weeks or less and these may be associated with a higher risk of ocular and systemic adverse reactions, including serious adverse reactions. There is also no experience of treatment with faricimab in diabetic patients with uncontrolled hypertension. This lack of information should be considered by the physician when treating such patients. Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”. Fertility, Pregnancy & Lactation: Women of childbearing potential should use effective contraception during treatment and for at least 3 months following the last intravitreal injection of faricimab. Pregnancy There are no or limited amount of data from the use of faricimab in pregnant women. The systemic exposure to faricimab is low after ocular administration, but due to its mechanism of action (i.e. VEGF inhibition), faricimab must be regarded as potentially teratogenic and embryo-/foetotoxic (see full SmPC). Faricimab should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus. Breast-feeding It is unknown whether faricimab is excreted in human milk. A risk to the breast-fed newborn/infant cannot be excluded. Vabysmo should not be used during breast-feeding. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from faricimab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility No effects on reproductive organs or fertility were observed in a 6-month cynomolgus monkey study with faricimab (see full SmPC). Adverse reactions: The most frequently reported adverse reactions were cataract (11%), conjunctival haemorrhage (7%), IOP increased (4%), vitreous floaters (4%), eye pain (3%) and retinal pigment epithelial tear (nAMD only) (3%). The most serious adverse reactions were uveitis (0.5%), vitritis (0.3%), endophthalmitis (0.3%), retinal tear (0.2%), and rhegmatogenous retinal detachment (< 0.1%) (see section 4.4). Prescribers should consult the SmPC for a full list of adverse reactions. Marketing Authorisation Holder (MAH): Roche Registration GmbH, Germany. VABYSMO® is a registered trade mark. Date: September 2022

Excipients: L-histidine, acetic acid, L-methionine, polysorbate 20, sodium chloride, sucrose, water for injections Prescription only medicine. Contact MAH for more details.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 on the Summary of Product Characteristics (SmPC) for details on how to report adverse reactions.

Full prescribing information should be consulted prior to prescribing.

Shift the
in
of
and DME with DUAL - PATHWAY INHIBITION ©2023 F. Hoffmann-La Roche Ltd M-XX-00014965 Date of preparation: October 2023 1. Regula JT, et al. EMBO Mol Med. 2016;8:1265–88 2. Heier JS, et al. Lancet. 2022;399(10326):729-40. 3. Wykoff CC, et al. Lancet. 2022;399(10326):741-755 References VABYSMO® ▼(Faricimab) 120 mg/mL solution for injection Date of Preparation: October 2023 ABBREVIATED PRESCRIBING INFORMATION Important note: Before prescribing, consult full prescribing information. VABYSMO® ▼(Faricimab) 120 mg/mL solution for injection Each vial contains 28.8 mg faricimab in 0.24 mL solution.
to VABYSMO
paradigm
the treatment
nAMD
Refer
Summary of Product Characteristics
for full prescribing information. Indications:
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www.escrs.org

12 Cover

2 Contents G L AUCOMA TREAT M E N T U NDER PRESSUR E mmHg EUROTIMES | MAY 2024 04 Editorial: Escaping Our Limitations 06 Inside ESCRS: Barry Fellowship Opens Up ‘Whole New Field of Thought’ 07 ESCRS Update: ‘Wall’ Honours FEBOS-CR Recipients; Video Journal Marks 40th Anniversary 08 ESCRS Analysis: The EHDS Is Ready for the Green Light Mor Dickman MD, PhD 10 ESCRS Education: ESCRS to Release Guidelines for Cataract and Refractive Surgery 15 Outside the Box, Inside the Pipeline CATARACT & REFRACTIVE 16 Analysing Laser Refractive Procedures Artemis Matsou MD, MRCP(UK), FEBO, PgDip CRS; Alfredo Borgia MD,FEBO; Riccardo Vinciguerra MD; and Sorcha Ní Dhubhghaill MBBCH, FEBOS-CR, PhD 18 Digitalising the OR—Experience and Perspectives Wolfgang J Mayer FEBO and Kjell Gunnar Gundersen MD, PhD 20 Dynamic Measures Needed for Quality of Vision Nino Hirnschall MD, PhD 22 Time to Move Beyond Monofocal IOLs? Dominique Monnet MD, PhD 24 Evaluating the EDOF Effect Myriam Böhm MD 25 ICL Implantation for More Myopes Milad Modabber MD, FRCSC DIGITAL OPHTHALMOLOGY 26 What Is Stopping Digital OR Adoption? H Burkhard Dick MD, PhD 27 Integration for Better Digitalisation Bruce Allan MD, FRCS CORNEA 28 Knowing Iris Repair: Post-Therapeutic PK for Corneal Ulcer Soosan Jacob MS, FRCS, DNB GLAUCOMA 30 Applying Artificial Intelligence to Glaucoma Felipe A Medeiros MD, PhD RETINA 32 Anti-Complement Therapy Debate Jordi Monés MD, PhD and Michaella Goldstein MD 34 Extending the Long-Acting Debate Anat Loewenstein MD, PhD and Gemmy Cheung MBBS, FRCOphth, FAMS, MCI
Glaucoma Treatment Under Pressure New techniques and technologies add to surgeons’ difficult decisions. May 2024 | Vol 29 Issue 4
3 Publisher Filomena Ribeiro Executive Editor Stuart Hales Editor-In-Chief Sean Henahan Senior Content Editor Kelsey Ingram Creative Director Kelsy McCarthy Graphic Designer Jennifer Lacey Circulation Manager Nicola Lodge Contributing Editors Cheryl Guttman Krader Howard Larkin Dermot McGrath Roibeárd O’hÉineacháin Contributors Laura Gaspari Soosan Jacob Timothy Norris Colour and Print W&G Baird Printers Advertising Sales Roo Khan MCI UK Tel: +44 203 530 0100 | roo.khan@wearemci.com EuroTimes® is registered with the European Union Intellectual Property Office and the US Patent and Trademark Office. Published by the European Society of Cataract and Refractive Surgeons, Suite 7–9 The Hop Exchange, 24 Southwark Street, London, SE1 1TY, UK. No part of this publication may be reproduced without the permission of the executive editor. Letters to the editor and other unsolicited contributions are assumed intended for this publication and are subject to editorial review and acceptance. ESCRS EuroTimes is not responsible for statements made by any contributor. These contributions are presented for review and comment and not as a statement on the standard of care. Although all advertising material is expected to conform to ethical medical standards, acceptance does not imply endorsement by ESCRS EuroTimes. ISSN 1393-8983 34 30 27 16 08 2024 MAY | EUROTIMES Learn more about EuroTimes or connect with ESCRS at ESCRS.org ALSO IN THIS ISSUE 36 Newsmaker ESCRS Heritage Programme 38 Industry News 39 JCRS Highlights 40 Citation Index 41 Upcoming Events ALSO IN THIS ISSUE

Escaping Our Limitations

This year, the ESCRS embarks on a programme of increasing awareness of the issues of diversity, equity, inclusivity (DEI), and unconscious bias in the field of ophthalmology to address them in concrete terms.

Currently, gender disparities, underrepresentation of minorities, and large-scale implicit bias limit the potential of our field. It is crucial for ophthalmology that we promote diversity because it allows us to experience different perspectives and opinions. This can drive research and innovation and improve patient care, resulting in better long-term outcomes. We want to ensure the medical world mirrors the public it serves.

We must also remove barriers to access to surgical training programmes, mentorship, career development, and leadership opportunities. For example, we know that—while the percentage of women training in ophthalmology has increased in Europe—the number of women in leadership positions remains low. We need a revolution. We want to be aware of the barriers that prevent us from having a more diverse leadership in ophthalmology.

One of these barriers is unconscious bias: None of us is immune to these attitudes that we may not even be aware influence many areas of our lives—including clinical decision making. To this end, we have been working within the ESCRS to create training instruments for leadership and all delegates. In one initiative, we have teamed up with a group at Harvard University called Project Implicit. I recommend using their online tool to measure your own level of bias. You might be surprised. (https://implicit.harvard.edu/implicit/takeatest. html) Understanding our biases is the first step to creating an inclusive community.

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)

The ESCRS is also undertaking a membership survey to establish a baseline of where we are now with DEI. Once we determine how we are doing in our Society, we can develop specific approaches to address the relevant issues.

Looking ahead to our annual Congress in Barcelona (6–10 September), we will have a symposium on DEI. We will also have a workshop with Project Implicit to introduce our delegates to these concepts. As with our Frankfurt meeting, we are working to ensure equitable representation on the podium and in courses. We are introducing new formats and opportunities for sharing experiences, mentoring, and making connections.

This year’s ESCRS Winter Meeting in Frankfurt featured some innovative approaches to encouraging learning, including small discussion groups with experts and delegates, “unconference” sessions, a medical writing workshop, and a live Heritage Project panel discussion with pioneers in cataract surgery.

Perhaps the most unusual (and the most fun) learning opportunity at the meeting was the escape room experience. Small groups of delegates would meet in a room and receive several clues—only by working together could they solve the puzzle and escape.

The escape room is a good metaphor for how we can approach issues associated with DEI in ophthalmology. Working together, bringing our different life experiences to the problem, we can solve the issues of lack of diversity, inequity, and inadequate inclusivity.

Marguerite McDonald (US)

Cyres Mehta (India)

Sorcha Ní Dhubhghaill (Ireland)

Rudy Nuijts (The Netherlands)

Filomena Ribeiro (Portugal)

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)

EDITORIAL 4
EUROTIMES | MAY 2024
Thomas Kohnen Chief Medical Editor José Güell Medical Editor Paul Rosen Medical Editor

Apply for the

John Henahan Writing Prize

Burnout is a chronic issue in ophthalmology, leading a growing number to abandon the field early in their careers. What should be done to reduce unnecessary stress in training and practice, allowing for a successful long-term career?

Young ophthalmologists are invited to submit their answer to that question in an 800-word essay for the John Henahan Writing Prize. The author of the winning essay will receive a €500 bursary and a specially commissioned trophy, awarded during the 2024 ESCRS Congress in Barcelona, Spain. The winning essay will be published in EuroTimes.

The competition is open to ESCRS members (including the free membership available to trainees) age 40 or younger on 1 January 2024.

DEADLINE APPROACHING!

Essays must be received by 14 June.

For details, please see the dedicated page on our website

https://www.escrs.org/eurotimes/john-henahan-writing-prize

Barry Fellowship Opens Up ‘Whole New Field of Thought’

The 2022 recipient combines theoretical and practical to learn new treatments.

As Jascha Wendelstein saw it, the path linking scientific knowledge of intraocular lenses and refractive surgery with hands-on experience performing laser vision correction ran through Zurich, Switzerland, and the Institute for Refractive and Ophthalmic Surgery (IROC). The question was how to afford the journey.

“I knew that Switzerland is pretty expensive,” he said. “I needed a scenario where I had some patients of my own but also had time to pick up on all the ideas that went into evolving laser vision correction.”

Dr Wendelstein decided to apply for the Peter Barry Fellowship, a one-year grant that allows 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. Sponsored by ESCRS, the fellowship is offered to a European trainee ophthalmologist who is no older than 40 years of age on the closing date for applications and has been an ESCRS trainee member for at least three years at the time of starting the fellowship.

Dr Wendelstein applied for the fellowship early in 2022 and began his fellowship later that year, finishing in August 2023. Looking back at his experience, he feels the fellowship is ideal for someone who wants to bridge the gap between the theoretical and the practical.

“I think the people who benefit most from it are doctors who are not purely scientists and not purely clinicians but want to combine an interest in both fields,” he said. “The fellowship gives you the opportunity to do both because the money gives you some free time from the clinical duties you would have to do if you were hired full time.”

‘Experience the full scenario’ The Barry Fellowship is named for Peter Barry, who served as president of ESCRS in 2012–2013 and was head of the Department of Ophthalmology at St Vincent’s University Hospital in Dublin and senior retinal surgeon at the Royal Victoria Eye and Ear Hospital (also in Dublin). The fellowship was launched in 2016 and first awarded in 2017 in the amount of €50,000. It is now awarded for €60,000.

The fellowship appealed to Dr Wendelstein because he realized there was a gap in his education and training he needed to fill. While he wasn’t familiar with Peter Barry’s legacy, he knew how the grant could benefit his career.

“I was very interested in intraocular lenses and refractive surgery, but I had no laser in my Austrian university clinic,” he said. “And I wanted a full understanding of the anterior segment. I think refractive surgery, lens surgery, and corneal surgery are a triplet that cannot really be divided. If you only understand one or two of the three, you will not experience the full scenario. That’s where IROC fit in.”

The particular draw of IROC was Dr Theo W Seiler, who specializes in laser vision correction, corneal surgery, keratoconus and CXL and cataract surgery, and corneal transplantation.

“If you are interested in laser vision correction, refractive surgery, and corneal surgery, you will stumble upon his name,” Dr Wendelstein said. “He invented cross-linking. He invented laser vision correction, or at least was among the pioneers to do so. So I had the idea that I wanted a chance to be able to work with him before he retired.”

Working with Dr Seiler and his son, who also practices at IROC, not only taught Dr Wendelstein how to use a laser but also provided him with

insights into how to interpret certain situations and rethink traditional practices and treatments.

“I think I have some new schemes for treating various diseases that lead to irregular astigmatism and all the things that deteriorate your optical quality,” he said. “So many processes I saw as purely refractive or purely therapeutic came together, like combining IOL surgery with laser vision correction and making use of ablation depth and target refraction. It really opened up a whole new field of thought for me.”

6 EUROTIMES | MAY 2024 INSIDE ESCRS

Solving scientific problems

With his fellowship year behind him—and new opportunities to explore—Dr Wendelstein has some advice to share with young ophthalmologists considering applying for the Peter Barry Fellowship.

“Ponder the choice of your clinic and see if it supplies what you need,” he said. “Also, I think you will get the most from it if you figure some new problems out of a project you need to solve. So make use of the spare time you get and look into some scientific projects.”

Dr Wendelstein also has something to say to ESCRS, which sponsors the fellowship.

ESCRS Update

‘Wall’ Honours

FEBOS-CR Recipients

ESCRS has created a “Wall of Honour” on its website to recognize the 38 (and counting) surgeons who have passed the Subspecialty Exam in Cataract and Refractive Surgery and earned the FEBOS-CR honorific.

The exam, developed by ESCRS and the European Board of Ophthalmology, certifies the expertise and advanced knowledge of experienced cataract and refractive surgeons. Along with exams for glaucoma, paediatric ophthalmology, and strabismus, the cataract and refractive exam is designed to harmonize ophthalmic education in Europe and define the expected level of knowledge and skills a subspecialist should acquire to solve complex, difficult cases.

By acknowledging the achievements of previous candidates who successfully passed the examination, ESCRS hopes to inspire potential new exam candidates and thereby sustain the examination in the long term.

The FEBOS-CR exam is open to cataract and refractive subspecialists from UEMS member countries; ESCRS membership is not required. Candi dates must be independent surgeons with a varied case mix who regularly deal with complex situations and are willing to be challenged by a rigorous theoretical examination and interviews with opinion leaders in European and worldwide ophthalmology.

The FEBOS-CR Wall of Honour is located at https://www.escrs.org/edu cation/educational-resources/febos-crwall-of-honour/.

Video Journal Marks 40th Anniversary

The Video Journal of Cataract, Refractive, & Glaucoma Surgery is celebrating its 40th year of production in 2024 with an issue titled “It’s All About Science.” Originally published in 1985, the Video Journal pioneered video-based surgical education to serve the needs of cataract and refractive surgeons. In 2018, the Video Journal’s scope expanded to include glaucoma surgery in line with the evolving trends in anterior segment surgical management.

Founded by Dr Robert H Osher, professor of ophthalmology at the College of Medicine of the University of Cincinnati and medical director emeritus of the Cincinnati Eye Institute, the Video Journal is a free benefit of ESCRS membership. Surgical videos submitted by ophthalmologists from around the world are reviewed by a distinguished editorial board to ascertain they demonstrate excellent skill

Survey Seeks Input on Issues Affecting Medicine

“One thing I would really love to say is a big thank you to the issuers for making this possible and for not only choosing me but having the whole programme available, not only for me but for others,” he said. “It’s a very nice opportunity, and it’s a good amount of money to really make something work.”

The ESCRS Leadership, Business & Innovation Committee wants to hear from ophthalmologists, practice managers, and staff on what they see as the critical issues affecting medicine today and in the months ahead. Share your opinion by clicking on the link below or scanning the QR code. Completing the survey will enter you into a drawing for free registration to the 2024 Annual Congress in Barcelona (up to 3) or a 2024 Leadership, Business, and Innovation Weekend (up to 2)! (All answers are anonymous, unless respondents provide their email address to be entered into the drawing.)

https://survey.alchemer.eu/s3/90687098/ESCRS-Leadership-Business-Innovation-Survey

7 2024 MAY | EUROTIMES
Jascha Wendelstein (at right) with Dr Theo G Seiler MD, FEBO, and Prof Maya Müller MD.

The EHDS Is Ready for the Green Light

If proposal is approved, Europe could see better access to, and exchange and use of, health data.

The European Health Data Space (EHDS) will benefit European patients and healthcare professionals, according to Mor Dickman MD, PhD.

The EHDS was proposed by the European Commission in 2022 as part of the European Data Strategy, and it aims to facilitate the exchange of healthcare data within the European Union. “It is part of the Commission’s efforts to tap into the potential of health data to get the best social benefit from it,” Professor Dickman said. He observed this opportunity marks an exciting moment where technology and science finally come together.

The Commission, the Parliament, and the Council tried to find common ground during trilogue negotiations over the last three years. Despite some interoperability, data protection, and safety concerns, a provisional agreement addressing these challenges

was reached on 15 March 2024. The new EHDS regulation will enable the exchange and access of health data across the EU and make certain anonymized data available for research and innovation.

For instance, the EHDS will allow a doctor in the Netherlands to access the medical records of a Spanish citizen who fell ill while on vacation in Amsterdam. German patients will also be able to buy medicines prescribed by their regular doctor in a Polish pharmacy. This initiative will also benefit the research community and policymakers: Certain anonymized health data will be made available to scientists for research and innovation to improve treatments and patient care and for policymakers to improve informed decision-making.

Especially in ophthalmology, it might be a life-changing moment.

“With ESCRS, we already have

registries containing data from 5 million records around Europe, and it is one of the biggest IT projects in ophthalmology,” Prof Dickman explained. “We recognize the importance of digital health, and we are committed to making it interoperable and harmonized for our community and the patients. The EHDS brings additional legal clarity, which is welcomed.”

Ophthalmology heavily relies on imaging and technology, making EHDS a landmark event. “For us specialists, such a framework makes our lives and work easier: we can make better diagnoses, prescribe better treatments, and have a lower administrative burden,” Prof Dickman said. A lesson learned from the COVID-19 pandemic is the importance of having this data available in the interest of public health.

Also, patients would have access to their data everywhere within the EU

8 EUROTIMES | MAY 2024 ESCRS ANALYSIS

and free of charge. Finally, researchers in ophthalmology would have access to standardized and harmonized data, which can help R&D develop at an extraordinary pace. This is particularly important for rare diseases. “There are 30 million patients with rare diseases across Europe, and healthcare is really fragmented in this field,” he remarked. “So having a harmonized system is very beneficial.”

Issues and concerns

However, several issues have raised concerns in the past few months. In a statement coordinated by Digital Europe signed by 35 stakeholders, including the ESCRS, there was deep concern about some security aspects of this data possibly being overlooked due to the urgency of approving the regulation before the EU elections. The stakeholders highlighted the lack of clarity and coherence in the definitions and their scope. They advocated for consistency with existing EU data protection legislation, such as the GDPR. They also called against international health data transfer restrictions going beyond the existing EU legal framework to incentivize the free circulation of data within EHDS.

Concerns about data privacy have been the biggest mountain to climb. Led by the European Commission’s health division (DG Sante), the EHDS original text offered no option for patients to opt out of the system. “We need to establish a secure and trustworthy environment for handling this highly confidential data,” Prof Dickman said. “It is crucial to ensure that the data does not get into the wrong hands while simultaneously making it accessible to researchers to gain insights and find cures for diseases.”

Stakeholders were worried about the possibility that this information could lead to forms of discrimination for patients according to their health condition. In the agreed proposal, the EHDS prohibits the usage of health data for advertising or assessing insurance requests, as well as job offers or lending conditions.

The crucial point was the extent to which patients should opt out of the use of their data.

“Finally, it was agreed that EU countries would allow all patients to opt out of the system’s secondary use, except for public interest research,” Prof Dickman remarked. “It means patients will be able to opt out of their anonymized or pseudonymized data being used by private companies.”

Each EU member state would also establish national health data access services and monitor data safety, enforcing sanctions in the event of violations.

“Like everything in society, it is a question of balancing the different interests,” he concluded. “I think part of creating trust in this big change process is really ensuring that all stakeholders are involved.”

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ESCRS to Release Guidelines for Cataract and Refractive Surgery

Comprehensive approach to the safest and most effective modern surgery.

The ESCRS will soon release comprehensive cataract and refractive surgery guidelines. A workshop held during the ESCRS Winter Meeting in Frankfurt focusing on the cataract side featured co-chairs Filomena Ribeiro MD, PhD (Lisbon); Oliver Findl MD (Vienna); Sorcha Ní Dhubhghaill MD, PhD (Brussels); Alexander Day MD, PhD (London); and Anders Behndig MD, PhD (Umeå, Sweden).

The purpose of the ESCRS Cataract and Refractive Surgery Guidelines is to address the value of diagnostic and therapeutic steps for various stakeholders in the patient pathway. The guidelines will provide explicit, evidence-based recommendations and insights that healthcare providers should follow to deliver high-quality care. The clinical recommendations are crucial for supporting clinical decision-making and promoting better care, transparency, and reduced unwanted practice variation.

The goal of the guidelines is to highlight both the diagnostic and therapeutic steps in cataract treatment.

the true effect of an intervention lies close to the observed effect—to very low strength, where the true effect is likely substantially different from the observed effect.

Joukje Wanten PhD, Maastricht University, Netherlands, discussed the methodology being used to create the guidelines.

“The goal of the guidelines is to highlight both the diagnostic and therapeutic steps in cataract treatment,” she said. “This includes screening and patient selection, preoperative assessment, perioperative procedures, postoperative care, and complications. It is intended for all stakeholders working in the cataract field. We want to provide explicit and evidence-based recommendations and insights that healthcare providers should follow to deliver optimal care.”

The session began by reviewing the key steps to designing the guidelines, like the use of PICO questions, a standard approach when considering evidence-based treatments. The “P” stands for patient, population, or problem; the “I” for intervention; the “C” for comparison or control; and the “O” for outcome or objective. This line of questioning ensures key outcomes are defined in the guidelines. Next comes a systematic literature search. After appraising the literature, the evidence can be graded and recommendations considered.

Grading the evidence is a key step in creating the guidelines. Evidence is rated from high strength—very confident

“We assessed all available randomised clinical trials and systematic reviews to define the strength of the evidence available,” reported Victoria Kauer PhD, Hanusch Hospital, Vienna. “From the evidence, we can generate recommendations. All the recommendations are based on the lowest grade suggested by the evidence.”

The ESCRS cataract guidelines working group is applying this approach to every aspect of modern cataract surgery. For example, after applying the process to immediate sequential bilateral cataract surgery (ISBCS), the analysis determined ISBCS provides comparable clinical outcomes to conventional delayed sequential bilateral cataract surgery (DSBCS). Moreover, ISBCS offered the advantage of faster patient rehabilitation, avoiding the suboptimal visual function associated with DSBCS. Relative contraindications would include if there were an increase of peri- or postoperative complications or if complications occur in the first eye surgery.

Other examples of questions the workgroup considered include the value of femtosecond laser cataract surgery, optimal treatments for corneal astigmatism, and the most effective approaches to reduce postoperative inflammation.

The full cataract guidelines are expected to be announced at the 2024 ESCRS Congress in Barcelona, 6–10 September, with guidelines for refractive surgery to follow later.

10 EUROTIMES | MAY 2024
ESCRS EDUCATION

VJCRS celebrates 40 years of videos

The Video Journal of Cataract, Refractive, & Glaucoma Surgery has hit a major milestone, celebrating its 40th anniversary. The first issue of 2024 is titled “It’s All About Science” and includes nine new videos ranging from Dr Ruth Lapid-Gortzak’s presentation on a novel thermomechanical adjustable IOL to Dr Kansas Veena’s exploration of a model for green cataract surgery.

This brings the journal back to its roots, when the VJCRGS launched in the early 1980s with the singular mission of providing the highest quality of video education for ophthalmic surgeons. Online at vjcrgs.com, the journal is now a free member benefit of virtually every cataract society in the world, including the ESCRS.

Founded by Robert Osher MD in the US, the VJCRGS was the first video journal in medicine, established in the day of videotape, before the internet existed. Each quarterly issue offers at least an hour of the highest quality education for the anterior segment surgeon. The journal is free to all practising ophthalmologists and teaching institutions.

11 2024 MAY | EUROTIMES https://vjcrgs.com/
G L AUCOMA TREAT M E N T U NDER PRESSUR E mmHg 12 EUROTIMES | MAY 2024

New techniques and technologies add to surgeons’ difficult decisions.

urrent therapies for the management of open-angle glaucoma specifically aim at controlling IOP to avoid optic nerve damage. Topical treatments are still first-line but come with a plethora of side effects. Even newcomers like rho-kinase inhibitors may

On the other hand, the interventional approach has shown good outcomes through the years, with trabeculectomy still widely used and SLT and MIGS candidates for first-line IOP management in the early stages of the disease. However, minimally invasive procedures are still far from being perfect, with a narrow margin for IOP control, high costs, and some post-

Glaucoma is still a manageable but not curable condition, said Luis Abegão Pinto MD, PhD. Despite the many different treatment options available, it all boils down to a single goal: lowering IOP to the value ophthalmologists think will stop meaningful progression.

“Even if we are far less conservative than 10 years ago, with far more options on our hands, we are basically still monitoring intraocular pressure,” he said.

There are a lot of good treatments that can prevent damage caused by glaucoma. As Anthony Khawaja MD, PhD pointed out, there are situations like lens extraction for primary angle-closure glaucoma where the problem can be fixed enough to consider the patient “truly

“Because the damage is irreparable, we want to treat this condition before the damage to the optic nerve gets substantial,” he said. “We cannot regenerate the optic nerve.”

Things are moving slowly and steadily, with the threshold for surgical procedures becoming lower as the technology advances, Dr Pinto said. From medical glaucoma, the industry is moving more into the interventional approach, as new devices—and procedures such as SLT and DSLT—are becoming easier and faster, “but not more effective,” he warned. Some of these are still far from fully tested and might not prove capable of bringing some added value or

So how should glaucoma treatment be improved in the near term? Proactively perfecting prevention and early treatment can indeed be one of the most effective strategies, but it comes with a catch. Dr Khawaja noted it could be tricky to rely on people to realise there is something wrong with their intraocular pressure, go to the eye doctor for a check-up, and eventually get treated. Glaucoma is asymptomatic. Screening could be a valuable solution, he said, but unfortunately, glaucoma is not prevalent enough to justify screening on a wide scale.

13 2024 MAY | EUROTIMES

AI and genomics

However, recent developments in genetics and artificial intelligence could be a game-changer. “Genetics and genomics can help us identify the subset of the population at high risk, and AI can help refine the test to be more affordable and accurate,” Dr Khawaja said. “With these, we are in a new position to really screen to prevent late presentation.” Working with the European Glaucoma Society, Dr Khawaja established a task force for screening in the UK.

Yet genetic testing also comes with a downside, Dr Pinto observed. It is not a viable option in continental Europe due to strict regulations preventing the downsides of early genetic testing. First, Dr Pinto outlined one problem not dissimilar to what the 1997 dystopian film Gattaca predicted—access to services and insurance. Imagine a patient will have a disease in 40 years, with no control over what happens: Would they be able to obtain a loan, a mortgage, or insurance if they have the genetics saying they surely will develop a health issue in the future? And what about countries with insurance-based healthcare? Would patients pay a premium just because they have a bad gene?

On the other hand, AI comes with fewer downsides in ophthalmology. Glaucoma specialists could really benefit from risk assessment algorithms, as AI could help the doctor decide, facilitate patient flow into the clinic, get broader access to information, and set a visiting routine for the patient. “It can redesign the circuits by using the same number of doctors and devices, but much more efficiently,” Dr Pinto said.

“As an esteemed senior and retired colleague once said, ‘In my whole career, I haven’t seen one full natural history of glaucoma,’” Dr Khawaja reported. Glaucoma works in the long term, so “how could I predict an outcome?” he asked. Data collection and AI could help accomplish that, giving the possibility to take advantage of automated processes and constant information on how a treatment could work for a specific patient, using real-world data that is far more realistic than the literature.

Dr Khawaja added the near future will not see some substantial change on the market but will be a great time for experimentation. He further remarked glaucoma needs surgery, and a good trabeculectomy can make the disease stable for a long time, but not without some risks. “Now we have less invasive surgeries—less risky but also less effective. We still have this drive for an effective and safe procedure, but we are not there yet.”

From his point of view, gene therapy and gene editing will not be a viable option within the next decade for glaucoma treatment, despite it being a disease caused in some cases by a mutation in the sole myocilin gene. “This is not going to be a thing in 2030, but it could be an exciting idea.”

That said, neuroprotection is paving the way for a promising future. Four clinical trials, still in the preclinical phase, are investigating nicotinamide and results are expected soon. Dr Khawaja noted it would be fascinating to have a well-tolerated tablet that could effectively help patients—despite not being a valuable replacement for IOP management.

Giving a supplement capable of helping the mitochondria of retinal neurons to scavenge out oxidants would not restore a patient’s vision at a youth level, Dr Pinto said, but at the end of the day, if the patient can see and maintain vision, it would be a win.

According to Dr Pinto, the future path for the management of glaucoma treatment should look at the reduction of daily eye drops for the patient. He pointed out a drug-free patient is free from the troubles of compliance and drop burden, but could feel anxious and unprotected, requiring close monitoring and home monitoring—something to address in the future because there is no available technology to make home monitoring practical and accessible.

The costs of innovation

What’s more, future innovations will have to deal with a conservative and cautious market. The current gold standards in both the medical and surgical fields are sufficiently effective and very low priced, making it difficult for brand new ideas to become immediately competitive.

“The barrier to innovation is that our current standard of care in terms of surgery (trabeculectomy) or medication (prostaglandin analogue) is already good enough to make sure whatever comes next needs to be better or cheaper,” Dr Pinto said. “The problem with all novelties is you do not have long-term data to evaluate them properly.”

“To borrow a definition from Professor Sir Peng Tee Khaw, we will have to reach the 10-10-10 target,” Dr Khawaja

14 COVER ARTICLE EUROTIMES | MAY 2024

suggested. “A surgical procedure that lasts 10 minutes and gets the pressure down to 10 millimetres of mercury for 10 years. Having a cheap and effective procedure that developing countries can also easily afford, in a cataract-like fashion, can make all the other approaches feel unnecessary. I think that what will be the real future game changer—a highly effective, easy, and safe procedure. I think we will achieve that one day.”

OUTSIDE THE BOX, INSIDE THE PIPELINE

Researchers are tackling glaucoma diagnosis and treatment from all sides.

Glaucoma requires chronic, lifelong management. To overcome the limitations of current options and release the burden on patients and physicians, researchers are looking at novel therapeutic approaches—sometimes thinking outside the box.

Several companies are placing their efforts in developing more effective and stable implants targeting aqueous outflow either through subconjunctival space, Schlemm’s canal, cilio-scleral or suprachoroidal space, as well as devices for the automatisation and enhancement of selective laser trabeculoplasty, aiming to provide a more durable and precise IOP reduction through time and targeting a wider population of patients. 1

At the same time, to enhance existing treatment strategies, companies are also looking for alternative and drop-free drug delivery systems, improving patient adherence and decreasing patient burden either through injectable and dissolvable implants or polymer-based nanocarriers delivering NGF directly to the posterior segment.2–3

Better monitoring and screening

a contact lens capable of both detecting IOP and administering drugs in an exquisite theranostic fashion.4–6 Genetic screening, gene therapy, and genome editing will play a key role in the future treatment of glaucoma. According to Tonti (Dell’Omo, et al.), existing therapeutic approaches could be optimised in synergy with epigenetic regulator targeting, leading to more patient-tailored treatment strategies.7 Although still only in its preclinical phase for different anterior segment conditions, gene therapy could become a game-changing tool in the glaucoma specialists’ armamentarium, shortly followed by CRISPR-Cas9 gene editing, both for neuroprotection and disease treatment.

The next out-of-thebox treatment in the pipeline could be stem cell therapy.

Anthony Khawaja MD, PhD is Professor of Ophthalmology and Honorary Consultant Ophthalmic Surgeon at the UCL Institute of Ophthalmology and Moorfields Eye Hospital, London, UK. anthony.khawaja@ucl.ac.uk

Luis Abegão Pinto MD, PhD, FEBOS-G is Head of the Glaucoma Clinic of the Department of Ophthalmology at the Centro Hospitalar Lisboa Norte, Portugal.

abegao.pinto@ulssm.min-saude.pt

Implementing home monitoring and telemedicine could be an invaluable support to treatment, allowing for rapid detection and progression assessment of an otherwise asymptomatic condition such as glaucoma. Keeping track of random IOP spikes is already a well-known challenge, and the demand for continuous monitoring is pressing companies to develop approaches to address this issue. A permanent implantable device called Eyemate and an IOP-detecting contact lens called Triggerfish already have the CE mark. On the other hand, South Korea’s Pohang University of Science and Technology is developing

The next out-of-the-box treatment in the pipeline could be stem cell therapy. In a recent study published in Proceedings of the National Academy of Sciences of the United States of America (PNAS), researchers of the Schepens Eye Research Institute of Mass Eye and Ear were able to collect stem cells from blood, turning them into retinal ganglion cells capable of migrating and surviving into the eye’s retina. 8 The study was performed in in vivo mice models, and the positive outcomes are highly promising.

For citation notes, see page 40.

15 2024 MAY | EUROTIMES
TIMOTHY NORRIS REPORTS

Analysing Laser Refractive Procedures

The ESCRS Eye Journal Club explores the continual evolution of diagnostic and laser technology—leaving conclusions of post-keratoplasty refractive surgery meta-analysis in doubt.

ROIBEÁRD O’HÉINEACHÁIN REPORTS

The ESCRS Eye Journal Club held a webinar hosted by Artemis Matsou MD and Alfredo Borgia MD, with guest experts Professor Sorcha Ní Dhubhghaill MD, PhD and Professor Riccardo Vinciguerra MD, to discuss the paper “Safety and efficacy of a laser refractive procedure in eyes with previous keratoplasty: systematic review and meta-analysis.”1

Dr Borgia summarised the study, noting the authors performed a comprehensive systematic review of the online peer-reviewed literature regarding patients undergoing LASIK and PRK after DALK or penetrating keratoplasty. Using the Cochrane, MEDLINE, and EMBASE electronic databases, they identified 631 articles published between 1992 and 2022, of which 31 fit the eligibility criteria. The studies involved a total of 732 eyes of 683 patients.

The meta-analysis showed that among LASIK-treated eyes, the UCVA was 20/20 or better in 8% of eyes and 20/40 or better in 50%. In addition, the mean spherical equivalent was reduced by 4.00 D after conventional LASIK and 3.30 D after customised LASIK. Cylinder was also significantly reduced—by 3.16 D after conventional LASIK and -2.66 D after customised LASIK.

Among PRK-treated eyes, UCVA was 20/20 or better in around 9% of cases and 20/40 or better in 40% of cases. Mean spherical equivalent was reduced by 3.00 D after conventional PRK and 2.74 D after customised PRK, and mean cylinder was reduced by -1.95 D after customised PRK and -2.78 D after conventional PRK.

The overall complication rate was 14.3% and the rate was 17% for PRK and 11% for LASIK. The most common complications were corneal haze for PRK epithelial ingrowth for LASIK. The rate of graft rejection was 2.4% and that of perforation was 1.2%. Around 6% of cases lost more than two lines of corrected distance visual acuity.

Opening the discussion, Dr Matsou noted that over the 30-year span in which the studies were conducted, there have been significant changes in the laser platforms, ablation profiles, and treatment zones. She asked the panellists if they would have conducted the meta-analysis differently.

“I think perhaps a more elegant approach would be to subdivide the studies based on technique. But even that is flawed, because each generation technique is improved,” Prof Ní Dhubhghaill said. “But I think that at least would give the surgeon more relevant information on the laser they have access to.”

Prof Vinciguerra concurred—although he noted the more one sub-stratifies, the smaller number of patients will be available for analysis, compromising the statistical power of the study. In his view, the first problem in the study was the primary outcome criteria.

“For this meta-analysis, the main outcome was uncorrected distance visual acuity. Who is aiming for a high uncorrected distance visual acuity after penetrating keratoplasty? No one,” he said. “Therefore, the primary aim reported is not even the primary aim of the surgeon.”

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CATARACT & REFRACTIVE

Panellists discussed the study’s outcome reliability, particularly when considering the high heterogeneity of primary outcomes and the implications of including studies with sequential laser procedures. They also took issue with the study authors’ conclusion that the laser refractive procedures were safe.

“When you were rolling the dice with a 5.8% chance of reduction in vision, a 1.5% chance of perforating the graft… My feeling is safe is not the optimal word, although if you’re quickly reading the abstract, you might get this impression,” Prof Ní Dhubhghaill said.

Prof Vinciguerra noted while the complication rate would be unacceptable if the goal was enabling patients to see without glasses or contact lenses, it would be more acceptable if the goal was enabling patients to see with correction, especially if the patient was not able to see in any way preoperatively.

“If we are doing these therapeutic laser procedures for a patient [unable] to see even with glasses, then what you have to show in terms of main outcome is higher order aberration, corrected distance visual acuity, and that’s it,” he said. “Then the amount of complication you are showing is acceptable.”

Concluding the webinar, Dr Matsou asked the panellists if they had any advice for young ophthalmic surgeons when dealing with post-keratoplasty patients.

“My tip would be to trust your instincts,” Prof Ní Dhubhghaill advised. “If you really feel that this patient expects

from you what is neither technically nor scientifically possible to guarantee, you really have to have the strength to say, ‘No, I’m going to advise you to do something else.’”

“My recommendation is if you have a patient like that, refer them to an expert with more experience in such cases, and if possible, come and see the treatment and how they did the surgery, and learn from it,” Prof Vinciguerra said.

For citation notes, see page 40.

Artemis Matsou MD, MRCP(UK), FEBO, PgDip CRS is Consultant Ophthalmologist and Cataract Lead at Queen Victoria Hospital, East Grinstead, United Kingdom. art.matsou@gmail.com

Alfredo Borgia MD, FEBO is based at Royal Liverpool and Broadgreen University Hospitals, Liverpool, United Kingdom. alfr.borgia@gmail.com

Riccardo Vinciguerra MD is based at the Humanitas San Pio X Hospital, Milan, Italy, as well as a research collaborator at Biochemical Engineering Group, University of Liverpool, United Kingdom. vinciguerra.riccardo@gmail.com

Sorcha Ní Dhubhghaill MBBCH, FEBOS-CR, PhD is Head of Department and Corneal and Cataract Specialist at UZ Brussels and Chair of Ophthalmology at the Vrije University of Brussels, Belgium. sorcha.ni.dhubhghaill@uzbrussel.be

17 2024 MAY | EUROTIMES
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Digitalising the OR—Experience and Perspectives

Benefits include saving time and improving outcomes.

Digitalising the OR saves time and may lead to more precise outcomes, effectively improving the refractive cataract surgery experience for both the surgeon and the patient, agreed presenters at a session at the 2024 ESCRS Winter Meeting in Frankfurt.

“Most of the time we spend on surgery is not on the surgery itself, but on the pre- and postoperative care,” Professor Dr Wolfgang J Mayer said. “Patient information, lens power calculation, and lens ordering are just some of the limitations preventing a smooth streamline of workflow in cataract surgery.”

“While doing a small literature search, I was surprised to find out how little is written about digitalisation,” Kjell Gunnar Gundersen MD, PhD, told the audience during his presentation. “There are definitely some obstacles or things to pass, especially being forced into some EHR systems, which are not very nice to integrate into the ophthalmological practice.”

Improving the set-up

Prof Dr Mayer contended that despite the barriers potentially preventing digital OR adoption, there is a sensible return in saving time.

“We have transformed our university clinic in Munich into a digital OR, fully digitalising a previously paper-based

40%

Since at least 40% of patients will profit from toric IOLs, measuring corneal astigmatism is crucial for the good outcomes of cataract surgery.

workflow and connecting every device from diagnostics to surgery,” he said. “So, we save up to six minutes per surgery in the OR, as well as four minutes per patient in the diagnostics, just by doing it completely digitally.”

In his practice, Dr Gundersen opted for a platform that can integrate different instruments from different providers. “I have all the preoperative biometry, transcriptions, and planning needed. During surgery, we have markings, cyclotorsion, rhexis, and positioning, and postoperatively, we can analyse our results and fine tune it for our next patients.”

Since at least 40% of patients will profit from toric IOLs, measuring corneal astigmatism is crucial for the good outcomes of cataract surgery.

“When we look at diagnostics, we have to look for solutions that can help us in making powerful measurements of corneal astigmatism, taking the exact data and value and comparing different formulas to get the right lens selected, and using an OCT for the posterior segment to avert possible macular or retinal conditions,” he added.

“This is the digital cataract procedure, where we can go ahead with our measurements and put our power calculation on any workstation—with no fear of transcription errors—because the data is provided directly from the network.”

There are many systems on the market for a tridimensional approach, focusing on improving depth perception and a more ergonomic surgical position, as well as an enhanced view for the entire surgical team.

Sharing personal experience

“In the examination room, we have access to information from biometry, optometry, digital photography, and OCT,” Dr Gundersen

18 CATARACT & REFRACTIVE EUROTIMES | MAY 2024

said. “When we have all this information, we can have a proper discussion with the patient to decide how to [proceed]. From [there], we go directly to the biometry room, which is the heart of cataract activity. We can use different biometries and plan surgery based on those examinations. We then export the information into the surgical room, ready for surgery.”

All the information is exported to workstations beside the surgical microscope, where the surgeon can access patient data, IOL information, and the video overlay of the toric axis on the screen. At the end of the procedure, the surgeon can fine-tune the axis based on the information on the video overlay.

Prof Dr Mayer reported that one of the first studies he did with the Callisto Eye System and Forum Viewer (Zeiss) compared the digital approach of toric lens alignment to the manual approach. He found it much safer and more efficient in correcting corneal astigmatism, also saving six minutes every time.

“During the implantation of a toric IOL we can see the steep axis of the cornea, which we have also calculated together during the power calculations with the EQ Workplace. And now, the Zeiss Callisto helps me track and align the toric lens, so it will always be on focus,” he explained, adding a digital workflow provides a complete solution, from software-based planning to surgery.

“We have all the data digitally and can provide this after a good and precise calculation within the software on any workstation in the OR, and maybe select another lens thanks to the real-time assessment—that is the most powerful tool we have with this kind of solution.”

“It is a nice way of transferring biometric data from the examination room to the surgical room, and thereby improving our results,” Dr Gundersen concluded. “At the end of surgery, a happy patient can walk out of the surgical room.”

19 2024 MAY | EUROTIMES
Wolfgang J Mayer FEBO is Deputy Director of the University Eye Hospital, Munich, Germany. wolfgang.j.mayer@med.lmu.de
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and trusted source for
education, and professional development
of cataract and refractive surgery. Learn more at ESCRS.org
Kjell Gunnar Gundersen MD, PhD is a practising ophthalmologist in Haugesund, Norway. KGg@Ifocus.no
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Dynamic Measures Needed for Quality of Vision

Functional visual acuity testing and straylight metering may better reflect real-world conditions.

More dynamic approaches beyond visual acuity and contrast sensitivity measurements are needed to more accurately determine quality of vision after cataract surgery, particularly when a presbyopia-correcting IOL has been implanted, according to Nino Hirnschall MD, PhD.

“Visual quality is about much more than visual acuity,” he said. “More dynamic approaches should be used in the future. Ideally, different near real-life situations should be simulated in our testing and the psychological aspect also needs to be taken into account.”

One of the key issues is postoperative refraction measurements—whether auto-refraction, subjective refraction, or derived from wavefront aberrometry—are not as accurate or reproducible as they should be.

Dr Hirnschall cited a study by Norrby (et al.) that showed preoperative estimation of postoperative intraocular lens

(IOL) position, postoperative refraction determination, and preoperative axial length (AL) measurement are the largest contributors to error in IOL power calculations (35%, 27%, and 17%, respectively).1

“That means one-third of the error derives from refraction itself, and the reason is the reproducibility or reliability of our measurements are not very good,” he said.

Postoperative evaluation after cataract surgery should ideally include functional vision testing that simulates real-life experiences and captures dynamic information about a patient’s quality of vision.

“Too often, we perform standardised testing of only a single parameter of vision, such as visual acuity or contrast sensitivity,” he said. “There is no dynamic information—we have letter guessing, and patients have time to guess the right letter. So, this is not a real-life measurement.”

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CATARACT & REFRACTIVE

Dr Hirnschall noted functional visual acuity (FVA) measurement is a more effective method to determine postoperative satisfaction in cataract patients. One such method developed in Japan shows different letters in a randomised fashion with different possible contrasts.

Visual quality is about much more than visual acuity.

“This is a continuous, dynamic measurement method that includes the worst and best visual acuity and the FVA, which is an average visual acuity within a specific time,” he said, adding average response time and blinks are also measured.

Another option is the Salzburg Reading Desk (SRD), a functional testing platform which allows multiple visual acuity, reading speed, and acuity tests on one device. While simulating a natural reading environment, the SRD calculates distance-corrected logMAR and reading speed at various illumination and contrast levels.

It is also important to bear in mind the deviation between forward scatter light and backward scatter light.

“Backward scatter is basically everything we see at the slit lamp, Scheimpflug imaging, and OCT imaging, but

this is not really what the patient sees,” Dr Hirnschall said. “Measuring forward light scatter with a straylight meter can be a useful additional tool, as it has a significant impact on positive dysphotopsia. This is not only a problem for multifocal and extended depth of focus (EDOF) IOls but also monofocal lenses.”

Several devices can measure positive dysphotopsias— glare, halos, and starbursts—and are particularly useful for assessing patients implanted with multifocal or EDOF lenses. Negative dysphotopsias are more difficult to quantify, and it is often best to ask the patient to make a drawing of what is obscuring their temporal field of vision.

Finally, Dr Hirnschall said the psychological component should not be overlooked.

“There are a wide variety of resilience tests and personality and lifestyle questionnaires which can help give an idea of how patients might respond to EDOF or multifocal lenses,” he said. “Patient motivation also plays an important role.”

Dr Hirnschall presented at the ESCRS Winter Meeting in Frankfurt.

For citation notes, see page 40.

Nino Hirnschall MD, PhD is a clinician and researcher at the Kepler University Clinic, Linz, Austria. nino.hirnschall@googlemail.com

21 2024 MAY | EUROTIMES

Time to Move Beyond Monofocal IOLs?

European surgeons appear hesitant to first offer other presbyopia-correcting options to patients.

Nowadays, monofocal IOLs are surgeons’ first choice regardless of the patient’s profile or the underlying clinical conditions; it is time to move forward and question this paradigm. Extended depth of focus (EDOF) or multifocal IOLs should be prioritised, as those are more likely to deliver higher rates of spectacle independence, according to Dominique Monnet MD, PhD.

“The reality is the monofocal IOL no longer fully meets the expectations of our patients. We are better off not considering monofocal IOLs as the first intention—but rather reserving their implantation for when we cannot do otherwise,” Dr Monnet said at the 2024 ESCRS Winter Meeting in Frankfurt.

Discussing the limitations of monofocal IOLs, Dr Monnet noted a recent survey of more than 455 French surgeons found 44% would select EDOF lenses for their own eyes compared to 40% who would prefer a monofocal lens.

“When we combine the results for EDOF and multifocal IOLs, we find that more than 60% of surgeons would prefer a presbyopia-correcting IOL (PC-IOL) implanted for their own cataract surgery,” he said. “And yet, we don’t give the same options to our patients.”

Enhanced patient expectations

Patient expectations are no longer the same in an era when cataract surgery has become a type of refractive surgery, noted Dr Monnet.

“First of all, we need to bear in mind that presbyopia is the primary cause of reduced quality of life in our patients,” he said. “Secondly, when we ask our patients their expectations just before cataract surgery, more than 83% of them say they are interested in no longer wearing glasses after cataract surgery.”

With options available to deliver higher rates of spectacle independence, the real paradox is the monofocal lens remains the most inserted implant in the world, far ahead of PC-IOLs, even in developed countries.

“This is clearly shown in the ESCRS Clinical Trends Survey where we see only a slight progression in the use of PCIOLs from 2016 to 2021,” he said. “We can deduce from the figures that monofocal lenses are still implanted in around 90% of cases.”

One of the ironies of recent IOL history is surgeons were encouraged to move away from spherical IOLs in favour of aspheric lenses, ostensibly to ameliorate the quality of vision and compensate for the spherical aberrations created by the cornea, Dr Monnet explained.

“Visual acuity and especially contrast sensitivity were better with aspheric lenses, particularly in mesopic conditions,” he said. “But we discovered that our patients lost depth of field, which was not a great surprise as we know there is an inverse relationship between the degree of asphericity in the optic and the depth of field.”

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CATARACT & REFRACTIVE
The principle is to move away from the habit of considering monofocal as first intention.

Industry solution

The industry solution was to develop an enhanced monofocal or monofocal-plus lens to induce some spherical aberration, thereby improving depth of field and intermediate vision.

“We consider our previous spherical lenses could probably be categorised today as a monofocal-plus lens, as they essentially achieved the same effect,” he said, adding the main limitation of the monofocal lens is it does not provide spectacle independence.

“It is not the best option for a patient who wants to become independent of glasses after cataract surgery. Even for uncorrected distance visual acuity, EDOF and multifocal IOLs perform better than monofocal IOLs.”

Although mini-monovision might be considered a viable option to compensate for presbyopia, Dr Monnet said the approach also has some limitations.

“There is still less spectacle independence compared to multifocal IOLs with monovision, and the loss of stereopsis is not always well tolerated by the patient,” he said.

Decision tree to orient choice

In his practice, Dr Monnet said he uses a decision tree for IOL selection based on patient motivation and clinical examination.

“The principle is to move away from the habit of considering monofocal as first intention,” he explained. “I classify my patients into three categories: very motivated, moderately motivated, or little or not motivated. After clinical examination, I implant either a multifocal or a multifocal toric IOL in a very motivated patient in the absence of any comorbidities. If there is a contraindication for the multifocal lens, I propose an EDOF lens for motivated patients. And if there is a contraindication for the EDOF, I propose a monofocal IOL.”

Dr Monnet concluded the enduring popularity of monofocal lenses could be ascribed to two factors: low cost and the absence of induced visual symptoms. However, lens solutions exist to correct presbyopia and should be offered if the patient fits the criteria.

“Compensation for presbyopia is based on a compromise between three factors: visual quality, depth of field, and photic phenomena, which must be adapted to the profile of our patients,” he said. “In the future, the monofocal lens could regain its interest with the advent of a functional accommodative lens.”

GLOBAL REACH

As a renowned authority in the field of cataract and refractive surgery, ESCRS facilitates global connections amongst ophthalmic professionals, fostering collaboration and the exchange of knowledge.

Our events span across continents, providing a platform for pioneering research, advanced surgical techniques, and continuous professional development.

Using the interactive map on our website, we invite you to explore our global presence by viewing upcoming events and academies.

Join us to network with esteemed experts, access the latest advancements, and contribute to the enhancement of eye care on a worldwide scale.

Dominique Monnet MD, PhD is an ophthalmologist at Cochin Hospital, Paris, France. dominique.monnet@cch.aphp.fr

escrs.org/meetings-and-events/global-reach/

23 2024 MAY | EUROTIMES

Evaluating the EDOF Effect

Expanding options for treating presbyopia.

Extended depth of focus (EDOF) IOLs have overcome some of the issues associated with multifocal IOLs while providing enhanced spectacle independence over a wider range of vision compared to classic monofocal lenses, according to Myriam Böhm MD.

“The EDOF lenses help to minimize optical phenomena such as halos and glare, which are common to diffractive bifocal or trifocal lenses or refractive IOLs with a higher near addition of +3.0 D,” she said. “However, EDOF lenses do not provide complete spectacle independence, and glasses may still be required for near vision for many patients.”

Historically, there were two options for presbyopia correction—monofocal or multifocal IOLs—with benefits and drawbacks for each category of IOL. Monofocal IOLs provide focus at one distance only with a loss of depth perception and compromised intermediate vision. Multifocal lenses offer multiple focal planes for a full range of vision but with an increased chance of visual disturbances and reduced contrast sensitivity, she said.

The development of EDOF lenses has been driven in recent years by a change in patient lifestyle and priorities, said Dr Böhm, with a lot more tasks now performed at intermediate distances (computers, phones, driving dashboards, etc.).

“There was a clear gap in the market EDOF lenses could address by providing improved intermediate vision, reduced visual disturbances, and better contrast sensitivity,” she said.

The EDOF lenses help to minimize optical phenomena such as halos and glare.

In essence, the EDOF lens delivers an elongated focal point for a continuous range of focus, avoiding images overlapping and therefore (theoretically) eliminating the halo effect, Dr Böhm said.

She explained there is no universal agreement on the definition of an EDOF lens, even though the American Academy of Ophthalmology issued a consensus statement in 2017 of criteria that could be used to evaluate an EDOF IOL’s performance under photopic, mesopic, and glare conditions. “However, there are no criteria on visual disturbances in the consensus statement,” she said.

The benefits of EDOF lenses include excellent distance visual acuity, improved visual acuity in the intermediate range between 60 cm and 100 cm, and functional near visual acuity. The drawbacks are that reading glasses are often required, with a potential decrease in contrast sensitivity and optical quality and photic phenomena that depend on the lens design implanted.

There are several sub-categories of EDOF lenses, including IOLs based on spherical aberrations (Sifi Mini Well Ready, Wichterle IOL), pinhole effect (Acu-Focus ICL, Xtrafocus Pinhole Implant), hybrid EDOF and multifocal designs (EDEN, Finevision Triumf Pod, Tecnis Synergy), multifocal and low-power addition lenses (Lentis Comfort, AT Lara), and those with a modified central optical profile (Eyehance Tecnis, AcrySof IQ Vivity, etc.). All of these approaches have their strengths and weaknesses, Dr Böhm said, and no one lens will satisfy the requirements of all patients.

Dr Böhm presented at the 2024 ESCRS Winter Meeting in Frankfurt.

Myriam Böhm MD is an ophthalmologist at Goethe University Frankfurt, Germany. myriam.boehm@kgu.de

24 CATARACT & REFRACTIVE EUROTIMES | MAY 2024

ICL Implantation for More Myopes

Safety and efficacy across a range of cases show low and high myopes benefit.

Implantable collamer posterior chamber phakic refractive lenses deliver impressive visual outcomes with a high degree of safety for myopic patients, according to a long-term retrospective study presented by Milad Modabber MD at the ESCRS Winter Meeting in Frankfurt.

“Our study demonstrates the safety and efficacy of implantable collamer lens (ICL) surgery for both low and high myopia,” Dr Modabber said. “Notably, ICL implantation was associated with significant improvements in best-corrected visual acuity (BCVA), particularly with increasing degrees of myopia.”

The retrospective study included a total of 1,332 eyes implanted with EVO or EVO+ ICLs (STAAR Surgical) between 2016 and 2023 for the correction of low, intermediate, and high degrees of myopia with or without astigmatism. All surgeries were uneventful, and 71% of the implanted ICLs were toric lenses to correct astigmatism greater than 1.0 D.

Discussing the results, Dr Modabber said the uncorrected distance visual acuity (UDVA) at the last follow-up appointment was very good for all patients, with a mean UDVA of 0.02 logMAR, 0.03 logMAR, and 0.05 logMAR for the low, intermediate, and high myopia groups respectively.

Significant reductions in manifest refraction spherical equivalent (MRSE) were observed in all myopia groups, with 97%, 96%, and 86% of eyes within 0.5 D of target refraction in the low, intermediate, and high myopic groups, respectively. The refractive outcomes were stable over the follow-up period. There was no change in corrected distance visual acuity (CDVA) at the last follow-up examination for 91%, 88%, and 86% of patients in the low, intermediate, and high myopic groups.

Efficacy and safety indices were favourable in all groups. There was no significant decrease in endothelial cell counts

during the six-month follow-up period. The intraocular pressure was also stable, with Dr Modabber surmising that a temporary and mild postoperative rise in IOP seen in some patients after one week may be due to retained viscoelastic material.

Around 6% of patients required a secondary intervention, with laser enhancement in 40 patients (3%), ICL size adjustment in 26 patients (2%), and toric IOL rotation in 15 patients (1%).

“We had very low numbers of laser vision correction enhancements. Almost all of them were in the high myopia group, either because of refractive unpredictability or because those patients with extreme degrees of myopia (greater than -18.0 D) had been maximally corrected with ICL and then enhanced further with laser,” Dr Modabber explained. Explantation was required in a single patient (0.15%).

Summing up, Dr Modabber said the visual performance of ICL has been shown to be on a par or superior to wavefront-guided LASIK in low to moderate myopia.

“I think this is another area of evidence that shows ICL should not be reserved only for high degrees of myopia, as the lens performs extremely well across all degrees of myopia. This is particularly relevant bearing in mind all the limitations in corneal refractive procedures in thin corneas, irregular corneal topography, or pre-existing dry eye syndrome,” he said. “As the safety and acceptability of ICL increases, I feel we [will] continue to work down the dioptre curve and implant ICLs in ever smaller prescriptions, as deemed appropriate for a given patient.”

25 2024 MAY | EUROTIMES
Milad Modabber MD, FRCSC is a cornea, cataract, and refractive surgeon at the Herzig Eye Institute, Toronto, Canada. mmodabber@herzig-eye.com

What Is Stopping Digital OR Adoption?

Ophthalmologists know the benefits—now it’s time to construct the right plan.

Adigital OR (DOR) can potentially do a lot to create a more straightforward and effective clinical practice. “So, why is it still struggling to become widely used in Europe, let alone around the world?” H Burkhard Dick MD, PhD, asked during his presentation at the 2024 ESCRS Winter Meeting in Frankfurt.

“We cannot consider the possibility of a digitalised future if we don’t address and consider every possible barrier keeping surgeons from improving and upgrading their professional lives.”

What are these potential benefits? The first to consider, Dr Dick said, is sustainability. “Because you have everything digital, something that improves efficiency thanks to the fast and easy access to the patient’s data, with less paper involved,” he said. “All the data is converged into one single screen, also avoiding safety concerns due to the use of potentially harmful USB flash drives.”

Making those updates leads to a better understanding of the data, allowing faster decision making that can have an immediate positive impact on the workflow while also increasing accuracy and precision and reducing avoidable errors, he explained.

The digital OR also offers immediate ergonomic benefits, as reflected in the 2023 ESCRS Clinical Trends Survey: 52% of surgeons reported an improvement in efficacy and workflow with a DOR, with 42% underlining the improvement of comfort during surgery.

“Down the road, we also have to consider the surgeon’s health: I know a lot of colleagues who suffer neck or shoulder problems, and it is well documented how much we are subject to pain and all kinds of diseases,” Dr Dick said. “Visualisation is purely digital in the DOR, so you can just sit up straight— there’s no need to rotate during surgery.”

Feedback from your patients and staff is also very useful for this task, helping you to improve and optimise.

How to get involved in DOR today:

How to get involved in DOR today:

To build a functional DOR, Dr Dick outlined a simple but necessary roadmap to overcome the many barriers, including the first, costs.

Benefits of a Digital Operating Room

Sustainability

“I would first determine which process must be streamlined, with a little help from the outside to improve and decide the next steps,” he said. “It is important to educate yourself, opting for a gradual approach, starting from budgeting basic digital tools such as a health record system, digital maps processing, and scheduling software to improve data management and patient coordination. You should also address your infrastructure and find an IT capable of protecting you from potential cyberattacks—especially during surgical procedures.”

He added a connectivity plan can be of the essence to avoid frustration.

“My recommendation is to be as cost effective as possible, gradually adjusting your set-up. Feedback from your patients and staff is also very useful for this task, helping you to improve and optimise. Even if the learning curve [remains] a psychological barrier, you should not fear the challenges that come with keeping up to date with the latest technologies.”

H Burkhard Dick MD, PhD is Professor of Ophthalmology and Chairman, Ruhr University Eye Hospital Bochum, Bochum, Germany. burkhard.dick@kk-bochum.de

26 EUROTIMES | MAY 2024 DIGITAL OPHTHALMOLOGY
TIMOTHY NORRIS REPORTS
à
digital patient records
fast
no
measurements
Efficacy à
and easy access to patient data Safety à
manual transfer of preop
Improvements
Accuracy & Precision à reduction of errors Workflow à faster decision making
Surgeon health à proper postural alignment
informed of relevant regulations and standards governing DOR Protect patient data Consider their scalability and compatibility with your existing infrastructure Identify areas where digital technologies can be integrated Gain insights and guidance Stay informed about latest technologies
Benefits of a Digital Operating Room Stay
Educate Yourself Collaborate with Experts Assess Current Infrastructure Invest in Digital Tools and Devices Implement Health Information Systems Cybersecurity Measures Compliance with Regulations Streamline data management

Integration for Better Digitalisation

Software integration in ophthalmology remains a critical point in the search for a digital optimisation of the operation theatre. Despite the high standard quality hardware for imaging, diagnostics, and surgery, ophthalmology still must deal with multiple underlying problems and technical issues.

It is a problem Bruce Allan MD said must be addressed as soon as possible. “We are not so happy,” he said during his presentation at the 2024 ESCRS Winter Meeting in Frankfurt. “Good data standards are already implemented in cardiology and radiology—but if we are talking of another image-rich specialty like ophthalmology, we are way behind.”

This lack of proper software integration can become frustrating and time consuming for a technology-savvy surgeon. Finding essential information, even writing down an operating note, can be a challenge. “We spend ages going through a forest of lenses before getting the right one,” he said. “Wouldn’t it be great if it was possible to take the lens box and just scan the barcode to find all the details already in the system?”

It is all here

A key to unlocking this issue can be in the right choice of electronic healthcare record (EHR) system. As Dr Allan observed during his “unconference” talk, to promote seamless communication, EHR systems and ophthalmic imaging devices need to conform to the same three data standards: SNOMED (Systematized Nomenclature of Medicine), FHIR (Fast Healthcare Interoperability Resources), and DICOM (Digital Imaging and Communications in Medicine).

“DICOM is the widely accepted common language for dealing with image data and metadata,” he noted. Even so, cross-device communication is still hindered by incomplete DICOM adoption in ophthalmology. “It is frustrating we cannot get our devices to speak to our electronic records,” Dr Allan said. “We have our EHR systems, we have some ‘sexy’ hardware, but they are not joined up. As of today, we are haphazardly entering this data on our own in a time-consuming manner.”

Dr Allan suggested proprietary software and the presence of airtight ecosystems as one of the main culprits in the lack of integration. “Whilst companies have done a great job with the hardware, lack of compliance with common data standards leaves users trapped in their ecosystem,” he said, noting if surgeons would like to use devices from different companies, they may not be compatible. “When companies say a device is DICOM compliant, they often mean it is only partially compliant.”

By simply implementing some data standards, Dr Allan believes the industry could see beautiful things happen. “With a bit of integration, we could go automatically from our biometry to the ESCRS calculator and straight into our EHR systems.”

Apply pressure

The goal of software integration cannot be achieved by just waiting for companies to solve it by themselves. Rather, Dr Allan argued there is a need for an active engagement of stakeholders and industry to implement a common standard. “We also need to lobby the regulators because they are not enforcing DICOM adoption. We need their help,” he said. “We also need to educate—let people know why this is important for us as surgeons.”

Bruce Allan MD, FRCS is a consultant ophthalmic surgeon at Moorfields Eye Hospital and Professor of Anterior Segment and Refractive Surgery at University College London, UK. bruce.allan@ucl.ac.uk

27 2024 MAY | EUROTIMES
Lack of data standards holding back progress in clinical ophthalmology. TIMOTHY NORRIS REPORTS

Knowing Iris Repair: PostTherapeutic PK for Corneal Ulcer

Challenging path lies ahead for corneal ulcer patients seeking visual rehabilitation after this common indication.

Corneal ulcers are a common presentation in both the developed and the developing world. It can be very devastating, resulting in the loss of the eye. Intense medical management is required, often indicating a therapeutic penetrating keratoplasty (TPK). Done in an acutely infected and inflamed setting, a TPK aims to remove the bulk of infection.

Preventing infection in the new graft needs intense medications postoperatively. Recovery from TPK depends on the extent of initial infection, pathogenic organism, type and extent of surgery, postoperative medications, antibiotic sensitivity, systemic and ocular conditions, etc. Surgery can sometimes be unpredictable, and an increased risk of expulsion of lens and vitreous exists, especially if the infection involved a large extent of the cornea, necessitating large-diameter host trephination. Any breach into the posterior segment can result in the introduction of the pathogenic organism into the vitreous cavity with resultant endophthalmitis. Even if surgery is completed successfully, reinfection of the graft can necessitate a repeat therapeutic keratoplasty.

The prognosis is not always bleak, however. A therapeutic graft can often clear infection and save the eye. In fact, the primary aim of a successful TPK is only infection clearance and not visual rehabilitation. Therefore, following successful recovery from a TPK, the patient often has an oedematous and failed graft—usually vascularised because of intense postoperative inflammation, lack of steroids, and sometimes inadvertent retention of loose sutures. Fibrin and exudates in the anterior chamber (AC) are common postoperatively, and these may resolve, leaving extensive peripheral anterior synechiae (PAS) in their wake, which can result in angle closure glaucoma.

The path forward for these patients includes secondary surgery for visual rehabilitation. Surgery can be complex and involve combined surgeries, even multiple surgeries, with most cases requiring anterior segment reconstruction. Anterior segment OCT is helpful preoperatively to understand the AC characteristics since the opaque graft may not allow visualisation of AC details through the slit lamp.

Many problems need to be tackled:

Neovascularisation

This is a risk factor for graft rejection and should be treated preoperatively. Topical anti-inflammatories such as steroids help in the regression of new vessels. Various techniques have been described, such as fine needle diathermy, where a needle is passed through the area of neovascularisation and cauterised. Localised collagen shrinkage is, however, a disadvantage.

Mitomycin intravascular chemoembolization (MICE) for regression of new vessels has recently gained traction—although difficult cannulisation, inability to treat very small vessels, and use of MMC are some disadvantages. Topical, intrastromal, sub-Tenon, and (if required) intracameral anti-VEGF injections and argon green laser photocoagulation are other tried methods, but cost, limited efficacy, and difficulty are disadvantages.

Cataract

Co-existing cataract needs to be extracted, but visibility is often very low. Trypan blue and the endoilluminator may be used for improving visualisation. Muscle memory also plays a major role during manoeuvres with suboptimal view. A hydrophobic IOL is preferred to avoid opacification from the air tamponade used in endothelial keratoplasty.

Secondary IOL implantation

This may be required if the crystalline lens or an IOL were expelled during the therapeutic keratoplasty or if a PCR occurred during cataract extraction. Sulcus placement is done with optic capture when anterior capsular support is good and a glued IOL, Yamane, or iris fixation if capsular support is insufficient. At Dr Agarwal’s Eye Hospital, the preference is

CORNEA 28 EUROTIMES | MAY 2024
Figure: A) Corneal ulcer; B) Oedematous, failed graft post therapeutic keratoplasty; C) Clear cornea and successful visual rehabilitation after cataract extraction, IOL implantation, pupilloplasty, and pre-Descemet’s endothelial keratoplasty.

a glued IOL due to good stability provided by the haptic tuck within intrascleral Scharioth tunnels.

Peripheral anterior synechiae

PAS can be a cause not just for angle closure glaucoma but also for future graft rejection and must be released, which may be done simply with viscoelastic or may involve a combination of sharp and blunt dissection. Fibrotic, atrophic, and often friable iris can lead to stromal or pupillary tears. Different combinations of iris repair—such as single-pass four-throw pupilloplasty, iridodialysis repair, and iridodiathermy—may be utilized, although bleeding and increased postoperative inflammation may occur. The final reconstructed iris may continue to have tears or appear distorted because of poor iris tissue availability. Though not of cosmetic concern in darker irides, this may be concerning in lighter irides. In addition, stray light or photophobia from central iris defects may cause visual symptoms such as photophobia, glare, or starbursts. Simple solutions are tinted glasses, coloured cosmetic lenses, or even iris prosthetic devices.

Iris fibrosis dissection

Fibrotic membranes over the iris are common and may result in a distorted pupil and inability to move the iris sufficiently for pupilloplasty. Such membranes can be removed with dissection using a 23-gauge needle to create a plane, followed by the combined use of microscissors or vitrector.

Pupil

Pupilloplasty corrects pupillary distortion by making the pupil small and the iris diaphragm taut to help prevent PAS reforming. Making the aperture small enough for a pinhole effect can also help tackle irregular astigmatism from a penetrating keratoplasty by cutting off peripheral light rays and decreasing the effect of higher-order aberrations. Iridodiathermy, as previously described, flattens the iris and allows better air fill for endothelial keratoplasty.

Ahmed glaucoma valve (AGV)

In case intraocular pressure is increased, an AGV may be required. If being combined with endothelial keratoplasty, the valve plate is first sutured before creating a 5x5 mm scleral flap, followed by

other steps such as cataract surgery, iridoplasty, etc. The tube is then trimmed and inserted in the posterior chamber behind the iris and in front of the IOL for visibility just beyond the pupillary border. The endothelial keratoplasty is finally performed, and, if required, a temporary tube ligation suture applied.

Endothelial keratoplasty

Our hospital prefers a pre-Descemet’s endothelial keratoplasty (PDEK) for these cases because of the unique advantages this provides. Such eyes are complex, and Descemet’s membrane endothelial keratoplasty is difficult because of difficulties in graft unfolding and centring and a higher risk of detachment. The air pump-assisted technique allows PDEK to be performed with ease since graft decentration and extreme edge folds can be easily corrected. Infusion of pressurised air also decreases the risk of graft detachment. In addition, a PDEK graft is easily amenable to other manoeuvres such as trans-graft suturing. Complete clarity can be recovered in the old TPK graft stroma with excellent visual results, especially in well centred and large grafts. Decentred TPK grafts or those with large amounts of irregular astigmatism may benefit from a repeat penetrating keratoplasty or a PDEK combined with pinhole pupilloplasty. Graft rejections have an increased risk, and therefore close follow-up, medication compliance, pre-/intraoperative treatment of neovascularisation and inflammation, and surgical correction of PAS are important. If the graft does reject, repeat endothelial keratoplasty is possible, though extensive corneal or iris neovascularisation may necessitate a Boston keratoprosthesis. Glaucoma should be watched for in these patients and managed according to its type and aggressiveness.

To conclude, treatment and visual rehabilitation for corneal ulcer can be a long path to travel, both for the ophthalmologist and the patient. But the results of these surgeries can be miraculous and very gratifying—gifting vision once again to patients who were blind in the eye.

29 2024 MAY | EUROTIMES
YOUNG OPHTHALMOLOGISTS ESCRS Contact: YO@ESCRS.org YO.ESCRS.org ESCRS Young Ophthalmologist Ad_178x75mm.indd 1 11/15/21 4:49 PM
Soosan Jacob MS, FRCS, DNB is Director and Chief of Dr Agarwal’s Refractive and Cornea Foundation at Dr Agarwal’s Eye Hospital, Chennai, India, and can be reached at dr_soosanj@hotmail.com.

Applying Artificial Intelligence to Glaucoma

AI screening tools could improve early diagnosis.

The development of artificial intelligence (AI)-based technologies for glaucoma is an active area of research, with results that show promise for enabling disease detection, management, and multiple other applications, according to Felipe A Medeiros MD, PhD.

Suggesting an AI-based screening tool could help overcome the existing problem of delayed diagnosis, Dr Medeiros noted a system for glaucoma screening using fundus photographs has been hampered by the limitations of subjective interpretation that render human-graded photographs a poor reference standard for model training.

To overcome that obstacle, Dr Medeiros and colleagues implemented an approach known as machine-to-machine learning (M2M) to train a deep learning (DL) model that predicted retinal nerve fibre layer (RNFL) thickness from fundus photographs. Initial testing found the mean predicted RNFL thickness determined with the DL algorithm was almost identical to OCT-measured values. Applying the DL algorithm to a data set of fundus photographs from an African cohort undergoing glaucoma screening as part of the Tema Eye Survey showed RNFL thickness was much thinner in eyes diagnosed with glaucoma compared to normal eyes.

“One might ask, what is the point of using fundus photographs for screening if we could use OCT?” Dr Medeiros said. “OCT is a great diagnostic tool, but widespread availability is an issue. Using AI, we can empower interpretation of fundus photographs to do the same thing as OCT.”

Using AI, we can empower interpretation of fundus photographs to do the same thing as OCT.

He even envisioned that just as there are machines for free blood pressure measurement in community settings, AI-enabled fundus photography devices for glaucoma screening might as well.

Helping the clinician

Dr Medeiros also identified multiple ways to leverage AI to enable patient care in daily practice. Researchers have applied AI to improve OCT assessment quality, for example, by identifying and correcting segmentation errors. In this area, a

DL model he developed with colleagues was shown to detect segmentation errors just as well as experts from a highly qualified reading centre. Taking a step forward, they also showed the model could be trained to detect glaucoma simply from a raw B-scan—without requiring segmentation.

“Girard and colleagues also have shown that 3D models of the optic nerve could be used to train an AI algorithm to diagnose glaucoma damage on OCT,” Dr Medeiros said.1

Additional AI use includes applications to predict and identify progression. After citing work by Pasquale and colleagues—who applied machine learning to data from participants in the Ocular Hypertension Treatment Study to identify patterns of visual field loss that predicted rapid progression2—Dr Medeiros reported he and his colleagues have also been working in this area, developing an AI model to predict progression based on analysis of a sequence of OCT images.

“We found the model performed very well and matched the performance of glaucoma experts, suggesting it can be used to raise general clinicians’ skills to an expert level,” Dr Medeiros said.

Looking ahead, he suggested there will eventually be AI-based tools capable of performing a comprehensive assessment of all clinical information to provide personalised treatment recommendations to patients.

Dr Medeiros spoke at AAO 2023 in San Francisco, US.

For citation notes, see page 40.

Felipe A Medeiros MD, PhD is Professor of Ophthalmology and Vice-Chair of Research, Bascom Palmer Eye Institute, University of Miami School of Medicine, Miami, Florida, US. fmedeiros@med.miami.edu

30 GLAUCOMA EUROTIMES | MAY 2024
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escrs.org/education/educational-resources

Anti-Complement Therapy Debate

Is the reduction of geographic atrophy provided by new anti-complement worth the risks?

The development of two new drugs for dry AMD—pegcetacoplan (Syfovre™, Apellis Pharmaceuticals) and avacincaptad pegol (ACP; Izervay/Zimura, IVERIC)— could represent a new era in the management of the previously untreatable retinal disease. However, whether the 20% reduction in lesion growth and limited functional benefit the complement inhibitors provided in clinical trials merit their monthly injection was up for debate.

Supporting the proposal was Jordi Monés MD, PhD, who argued the reductions in lesion growth reported in the clinical trials with the newly approved complement inhibitors are not truly representative of what the agents can achieve with appropriate patient selection.

“Whenever I am going to treat a patient with anti-complement therapy, I am not aiming for a 20% reduction in lesion growth,” he said. “I am aiming for 30% to 40% because I will be selecting those patients that will get the most benefit.”

Preservation of RPE and photoreceptors

In the OAKS and DERBY trials, geographic atrophy (GA) patients receiving pegcetacoplan had significant 22% and 18% mean reductions in lesion progression at 24 months compared to those receiving sham injections.1 At 36 months, in the GALE extension of those trials, pegcetacoplan-treated eyes had a 35% slower lesion growth rate than sham-treated

eyes.2 They also had a 42% slower subfoveal lesion growth, amounting to preservation of 2.40 mm2 retinal tissue containing 12,000 retinal pigment epithelium (RPE) cells, each supporting 30 photoreceptors.

I am aiming for 30% to 40% because I will be selecting those patients that will get the most benefit.

In both trials, Professor Monés said there was no significant difference in best-corrected visual acuity between the sham and the pegcetacoplan groups at 24 months. However, at 18 months of treatment, microperimetry showed a trend starting towards a lower mean sensitivity threshold and a lower number of scotomatous points around the atrophic lesions in the pegcetacoplan-treated eyes than in the sham-treated eyes. More recently, a post hoc analysis of both trials showed the risk of progression to severe visual loss was diminished by approximately half over 24 months of treatment with pegcetacoplan, compared to sham treatment.

RETINA 32 EUROTIMES | MAY 2024

The safety of pegcetacoplan in the OAKS and DERBY trials was good and acceptable, Prof Monés said. However, since the drug’s approval in February 2023, there have been 10 cases of severe and occlusive retinal vasculitis—including 3 cases with irreversible severe visual loss. But he pointed out that, as there have been around 100,000 vials of the anti-complement agent distributed, the incidence of the complication per injection has been only 0.01%.

He noted he bases his decision to treat geographic atrophy cases largely on their rate of progression—using a 0.20 mm2 per year growth rate as the cut-off point to start considering anti-complement therapy and a more than 0.35 mm2 per year growth rate as an almost universal indication. Other considerations include the proximity of the lesions to the fovea, the drusen phenotype, the photoreceptor/RPE ratio, macular vascularisation, and ocular comorbidities in the fellow eye.

No functional benefit, new exudative AMD Michaella Goldstein MD questioned the value of the treatment, given the limited functional benefit seen so far in clinical trials and the treatment-emergent adverse events.

“In the OAKS and DERBY trials, the total area of geographic atrophy was slightly less in the treatment group compared to sham, but is this difference clinically relevant?” she asked. “Patients lost, on average, between eight to nine letters regardless of whether they were treated every month, every other month, or not at all. Furthermore, there was no difference in monocular reading speed, functional reading independent score, and no difference in the NEI visual function questionnaire.”

New exudative AMD is the most concerning complication reported in the clinical trials with the approved complement inhibitors, she added. In the OAKS study, new nAMD occurred in 24 (11%) pegcetacoplan-treated eyes over 24 months but only 4 (2%) sham-treated eyes. Similarly, in the DERBY study, 27 (13%) eyes receiving monthly pegcetacoplan developed exudative AMD compared to 9 eyes (4%) in the sham group.

Another adverse event associated with complement inhibitor injections is intraocular inflammation, of which there was a combined total of 25 cases in the OAKS and DERBY studies, she pointed out. Most patients (20/77%) resumed pegcetacoplan treatment without further recurrence at their last visit, but six (23%) had to continue anti-inflammatory treatment. In addition, since pegcetacoplan’s launch, there have been 17 cases of panuveitis, 7 cases of retinal vasculitis, and 7 cases of occlusive vasculitis in eyes receiving the treatment.

“It is difficult to convince a patient to receive monthly injections for an unknown period when, despite repeated fixed dosing, the treatment shows no functional benefit or efficacy but carries increased risk for undesired complications,” Dr Goldstein said.

The US FDA approved pegcetacoplan early in 2023 for geographic atrophy. However, earlier this year, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use issued a negative report, advising against marketing authorisation for pegcetacoplan. Apellis Pharmaceuticals said it would address relevant issues and asked the EMA to reconsider the application.

Prof Monés and Dr Goldstein spoke during the EURETINA Educational Debate Webinar.

For citation notes, see page 40.

Jordi Monés MD, PhD is the director of Institut de la Màcula and director of the Barcelona Macula Foundation, both of Barcelona, Spain, and an adjunct professor at John A Moran Eye Center, University of Utah, US. jmones@institutmacula.com

Michaella Goldstein MD is head of the Retina Vascular Unit, Division of Ophthalmology, Tel Aviv Medical Center, Faculty of Medicine, Tel Aviv University, Israel. michaellagoldstein@gmail.com

iLEARN

ESCRS iLearn is an online learning platform, free for ESCRS members.

Visit elearning.escrs.org to access over 30 hours of interactive, assessed, and accredited e-learning content, including surgical videos, diagrams, animations, quizzes, and forums.

33 2024 MAY | EUROTIMES

Extending the Long-Acting Debate

Is monitoring between anti-VEGF agent injections still needed? Experts discuss.

Robust results and long, 16-week injection intervals achieved with new long-acting anti-VEGF agents— such as faricimab (Vabysmo®, Roche) and high-dose aflibercept (Eylea HD, Regeneron)—in the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular oedema raise the prospect of a reduced need for monitoring between injections. Whether that would accord with best practice was the topic of a debate at a EURETINA webinar.

Starting the debate, Anat Loewenstein MD, PhD posited long-acting anti-VEGF agents actually increase the need for monitoring to achieve optimal anatomic and visual outcomes and longer treatment intervals. She added home optical coherence tomography (OCT) monitoring can provide maximum vigilance for the physician and minimum inconvenience for the patient.

“Treat and extend provides only limited personalised care,” she said. “Long-acting treatments create an even bigger challenge to find the right treatment interval, patients have different reactivation patterns, and their response to treatment and fluid reactivation is sometimes missed.”

Studies involving treatment-naïve and treatment-experienced nAMD patients have shown significant heterogeneity in their fluid volume trajectories between treatments while monitored with home OCT devices over three and six months. Such findings not only support the need for regular monitoring but also advocate for wider adoption of home OCT in patients receiving intravitreal anti-VEGF treatment for macular disease, she said.

Professor Loewenstein noted that experience with home OCT in more than a thousand eyes in clinical settings demonstrated a 90% rate of good quality images, a more than 90% agreement rate with human graders, and a longitudinal performance of almost six scans per week on average.

“Early results show a significant impact of home OCT monitoring data on physician decision making,” she added. “The remote monitoring paradigms are almost here, and we can’t wait to give them to our patients.”

Gemmy Cheung took the opposing view, pointing out that long experience with treat and extend protocols and the results of large clinical trials with long-acting agents show monitoring between injections is generally unnecessary.

“We know that by using the principle of loading and titrating, we can personalise very accurately and predictably treatment for the majority of our patients, even with ranibizumab,” she said.

Keys to treat and extend

The first key to a successful treat and extend protocol is to not be too ambitious in extending patients’ treatment intervals. The second key is to avoid over-rechallenging with a longer treatment interval. After two failed attempts to extend the treatment interval, it is best to maintain the eye at the unextended interval. Dr Cheung noted the pooled results of the TENAYA and LUCERNE study showed both BCVA and anatomical results were very stable among eyes on 16-week treatment intervals but fluctuated more among those on 8-week treatment intervals.

“What these data tell us is it is not the long duration patients that get into trouble,” she said. “Whether we are using short-term or long-term agents, it is always those who are stuck at 8-week intervals that have the most disease activity.”

This debate took place during a 2024 EURETINA webinar.

Anat Loewenstein MD, PhD is director of the Department Ophthalmology, Tel Aviv Medical Center, and Incumbent Sidney A Fox Chair of Ophthalmology, Tel Aviv University, Tel Aviv, Israel. anatl@tlvmc.gov.il

Gemmy Cheung MBBS, FRCOphth, FAMS, MCI is Arthur Lim Professor of Ophthalmology, Duke NUS Medical School; Head of the Retina Department, Singapore National Eye Centre; and head of the retina research group, Singapore Eye Research Institute. gemmy.cheung.c.m@singhealth.com.sg

RETINA 34 EUROTIMES | MAY 2024

ESCRS Educational Forum is supported by multiple industry partners to provide independent didactic education on selected therapeutic areas. The platform combines presentations from ESCRS Winter and Annual Congresses, selected EuroTimes articles, videos, and webinars to provide an in-depth overview on current clinical outlooks.

Education Forum

escrs.org/education/forum/

ESCRS HERITAGE PROGRAMME

Visionaries past and present.

The first in a series of video discussions about the early days of cataract and refractive surgery took place in front of a live audience during the ESCRS Winter Meeting in Frankfurt, Germany. The event marked the 75th anniversary of Harold Ridley’s bold move, implanting the first IOL.

The panel consisted of Richard Packard MD, FRCS, FRCOphth, Professor Thomas Neuhann MD, Professor Hans Reinhard Koch MD, PhD, and Sean Henahan, Editor-in-Chief of EuroTimes

The discussion began with a recap of Harold Ridley’s first IOL implantation. Dr Packard recounted how Dr Ridley first got the idea to do such a novel surgery.

“The actual idea of implanting a lens was something Ridley had thought about 10 or 15 years earlier. He discussed it with his father and his mentor, and both told him he was crazy. But some of his experiences during the war working with injuries in young men with bits of Perspex (PMMA) in their eyes stuck in his memory,” he said. “Somebody suggested he could put a new lens back in the eye, and that was the trigger he required for the cure for aphakia. This is what led us to IOLs.”

The first IOL was implanted without phacoemulsification, without viscoelastic—even without a microscope. It was a dangerous and controversial procedure. Dr Ridley encountered harsh resistance from the ophthalmology establishment that lasted for decades. The theme of an innovative new surgical approach developed by young surgeons encountering massive resistance continues in the 75 years since Ridley’s first operation.

Professor Koch recounted the epic struggle of Dr Michael Ulrich Dardenne to introduce phacoemulsification in Germany.

“Ulrich went to New York to see Charlie Kelman perform cataract surgery using phaco. He was convinced and

wanted to do it in Germany. Upon returning home, he was told no; it was too dangerous and too complicated. We don’t want this in Germany,” Prof Koch noted. “Then Ulrich decided to talk to the health insurance companies, a no-go for the professors of ophthalmology. Ulrich told the companies if they support phaco, they will earn a lot of money, with reduced hospital stays and a reduced need for cataract glasses. The companies agreed on a contract with Ulrich. The professors in Germany were horrified and decided he should be expelled from the German Ophthalmological Society.”

Professor Neuhann described his introduction to phacoemulsification, first by way of Dr Kelman and then under the tutelage of Dr Richard Kratz. After seeing Dr Kratz perform a successful procedure, he despaired that he would ever be able to do such a complex procedure.

“At the time, I thought I should go back into cardiology—that this was

not something I could learn; I don’t have the hands,” he said. “I went back to Germany and sat up late at night in the OR with the phaco machine, practising on cadaver eyes. I was having no luck. But then one moment, it worked, the lens was out, the Shearing lens slipped in, I thought, ‘I’ve done it, it worked!’ I don’t know what I did differently, but from then on, it worked.”

Prof Neuhann also recalled how he came to develop the continuous, curvilinear capsulorhexis simultaneously with Dr Howard Gimbel, which is still the standard today.

The discussion also included fascinating descriptions of cataract surgery before phaco and IOLs were available. The guests shared more on the development of phaco, foldable IOLs, and the ultimate combination of phaco and IOL surgery.

The complete video and transcript will be made available at escrs.org

36 NEWSMAKER EUROTIMES | MAY 2024

Need a quick introduction or refresher about a surgical procedure? Have a tip to share about a technique or approach you use that makes surgery easier?

The ESCRS 100 is the place to go. It’s a library of short (roughly 100 seconds), high-quality instructional videos about all fields of cataract and refractive surgery.

More than a dozen videos have already been created, and additional videos are being uploaded each month. Current videos include the following topics:

• DALK: How to get to DM

• LASIK: Lifting the flap

• Reading a topo

MAKE EVERY SECOND COUNT

37 2023 MONTH | EUROTIMES
HTTPS://WWW.ESCRS.ORG/EDUCATION/EDUCATIONAL-RESOURCES/ESCRS-100/
—PUT THE ESCRS 100 VIDEO SERIES ON YOUR LIST OF MUST-WATCH EDUCATIONAL RESOURCES ! ESCRS 100

New sinusoidal trifocal launched in Frankfurt

VSY Biotechnology launched the Enova Maestro sinusoidal trifocal toric preloaded intraocular lens (IOL) at the 2024 ESCRS Winter Meeting in Frankfurt. Composed of 100% glistening-free hydrophobic acrylic material, the lens is designed to provide vision across far, intermediate, and near distances under all lighting conditions. The Enova Maestro features Sinusoidal Vision Technology (SVT), an optical design using soft ridges instead of the sharp-edged overlapping diffraction patterns of conventional trifocal lenses to reduce halos and glare.

https://www.vsybiotechnology.com

PureSee IOL availability expanded across EMEA

Johnson & Johnson MedTech announced the availability of the TECNIS PureSee IOL in the Europe, Middle East, and Africa (EMEA) region. The lens has a purely refractive aspheric optic, designed to provide high-quality distance and intermediate vision and some degree of functional near vision, with a low-light performance similar to a monofocal IOL. In addition, the IOL’s refractive design provides high tolerance to refractive error.

https://www.jnj.com/medtech

First clinical retinal surgery with new robotic system

AcuSurgical announced the completion of its first clinical case of retinal surgery with the Luca™ robotic surgery platform at Ghent University Hospital in Belgium by Fanny Nerinckx MD. The robotic system is designed to augment surgical precision by enhancing the surgeon’s dexterity.

https://acusurgical.com

Gene therapy for LHON effective at four years

GenSight Biologics reported the REFLECT phase 3 clinical trial results show significant improvements in vision maintained at four years in eyes with Leber’s hereditary optic neuropathy (LHON) following a single intravitreal injection of Lumevoq (GS010; lenadogene nolparvovec). At one year and four years after a single intravitreal administration of the gene therapy, all eyes had a visual acuity improvement of more than 15 letters. The treatment also had a favourable safety profile.

https://www.gensight-biologics.com

New factory for Oertli

Oertli Instruments AG announced the opening of its ultra-modern Lean Factory. With an area of 11,000 m2 and an investment of about CHF 30 million, the Lean Factory incorporates a spacious and modern warehouse and logistics system over the entire ground floor and expanded first-floor production areas to greatly increase manufacturing capacity. Moreover, Oertli has invested in many sustainable features in its construction, including a photovoltaic system that reduces the factory’s CO2 emissions by 10%, a heating and cooling system regulated by waste heat, and water-cooled roof panels.

https://www.oertli-instruments.com

RNA-Interfering drug fails to meet endpoint

Sylentis, a subsidiary of Spain-based PharmaMar, announced its phase 3 clinical trial of SYL10111_V (RNAi-based tivanisiran) for the treatment of dry eye disease (DED) associated with Sjögren’s syndrome did not meet its primary endpoint, namely changes in fluorescein staining and DED symptoms. The randomised, double-masked, placebo-controlled study involved 203 patients across hospitals in the United States and Spain. Tivanisiran, also known as SYL1001, is a small interfering RNA that inhibits the synthesis of transient receptor potential V1 (TRPV1), a protein involved in dry eye pathophysiology.

https://sylentis.com

38 INDUSTRY NEWS
EUROTIMES | MAY 2024

LESS POSTOPERATIVE INFLAMMATION WITH FORTIFIED BALANCED SALT SOLUTION IN DIABETIC CATARACT PATIENTS

Fortified balanced salt solution (fSS) can alleviate postoperative inflammation better than Ringer’s lactate solution in diabetic patients undergoing cataract surgery, according to the findings of a randomised prospective masked controlled trial. The study showed that in 40 patients with regular cataracts, postoperative anterior chamber (AC) cells and flare measured with anterior segment OCT were not significantly different between 20 patients receiving Ringer’s solution and 20 receiving fSS on the first and seventh postoperative days. However, in 40 cataract patients with diabetes mellitus (DM), AC cells and flare were higher in 20 eyes in the Ringer’s group than in 20 eyes in the fSS group on postoperative day one. In addition, compared with those in the Ringer’s solution group, patients in the fSS group had increased transepithelial electrical resistance (TEER) and zonula occludens-1 immunofluorescence values, suggesting better blood-aqueous barrier protection. Eyes of diabetic patients in the fSS group also had lower levels of adhesion of THP-1 monocytic leukaemia cells, indicating a lower inflammatory response to the surgery than in the eyes in the Ringer’s group. M Ma, et al. “Effects of a fortified balanced salt solution and Ringer’s lactate solution on anterior chamber inflammation after phacoemulsification in diabetes,” 50(4): 352–359.

MIGS GENERALLY SAFE FOR ENDOTHELIUM, BUT PROBLEMS WITH CYPASS

Postoperative endothelial cell loss is not significantly greater in eyes with open-angle glaucoma that receive the iStent minimally invasive glaucoma surgery (MIGS) implant in conjunction with phacoemulsification than it is in eyes that undergo phacoemulsification alone, according to a post hoc five-year analysis of prospective randomised single-masked pivotal trials. However, in eyes with the Hydrus and the CyPass MIGS implants, the analysis showed significantly greater postoperative endothelial cell loss than in eyes with phacoemulsification alone. Over 60 months of follow-up, mean endothelial cell density in eyes with the iStent implant was indistinguishable from that of control eyes. In eyes with the Hydrus implant, the increase in endothelial cell loss over control values occurred primarily in the first three postoperative months. In eyes with the now-discontinued CyPass implant, endothelial cell loss accelerated after two years, and some eyes developed complications related to endothelial cell loss.

I Ahmed, et al. “Corneal endothelial safety profile in minimally invasive glaucoma surgery,” 50(4): 369–377.

LOSS OF ENDOTHELIAL DENSITY WITH ICL MORE RELATED TO SURGICAL TRAUMA THAN LENS

Endothelial cell density (ECD) loss in myopic eyes implanted with the implantable collamer lens V4c is similar to other ICL models, according to the findings of a meta-analysis of 18 studies. The analysis showed the average postoperative loss in endothelial cell density was 1.32% after 3 months, 1.75% after 2 months, and 3.84% after 21.25 months. ECD loss was most pronounced during the first 3 postoperative months, suggesting it results primarily from acute surgical trauma rather than the lens, the authors concluded.

FBM Kisiel, et al. “Endothelial cell loss post-implantable collamer lens V4c: meta-analysis,” 50(4): 420–423.

39 JCRS HIGHLIGHTS
2024 MAY | EUROTIMES
leading community and trusted source for SCIENCE, EDUCATION & PROFESSIONAL DEVELOPMENT in the fields of cataract and refractive surgery. learn more at escrs.org
The

Cited in this Issue

Outside the Box, Inside the Pipeline

Page 15

1. Chan L, Moster MR, Bicket AK, et al. “New Devices in Glaucoma,” Ophthalmol Ther, 2023; 12: 2381–2395. https://doi. org/10.1007/s40123-023-00780-3

2. Sarkisian SR, Ang RE, Lee AM, Berdahl JP, Heersink SB, Burden JH, Doan LV, Stephens KG, Applegate D, Kothe AC, Usner DW, Katz LJ, Navratil T. “Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: 12-Month Results of a Randomized, Double-Masked Trial,” Ophthalmol Ther, 2024 Apr; 13(4): 995–1014. doi: 10.1007/ s40123-024-00898-y. Epub 2024 Feb 12.

3. Colucci P, Giannaccini M, Baggiani M, Kennedy BN, Dente L, Raffa V, Gabellini C. “Neuroprotective Nanoparticles Targeting the Retina: A Polymeric Platform for Ocular Drug Delivery Applications,” Pharmaceutics, 2023; 15(4): 1096. https:// doi.org/10.3390/pharmaceutics15041096

4. Szurman P, Gillmann K, Seuthe AM, Dick HB, Hoffmann EM, Mermoud A, Mackert MJ, Weinreb RN, Rao HL, Mansouri K; EYEMATE-SC Study Group. “EYEMATE-SC Trial: Twelve-Month Safety, Performance, and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure,” Ophthalmology, 2023 Mar; 130(3): 304–312. doi: 10.1016/j.ophtha.2022.09.021. Epub 2022 Oct 3.

5. Dunbar GE, Shen BY, Aref AA. “The Sensimed Triggerfish contact lens sensor: efficacy, safety, and patient perspectives,” Clin Ophthalmol, 2017 May 8; 11: 875–882. doi: 10.2147/OPTH.S109708.

6. Kim TY, Mok JW, Hong SH, et al. “Wireless theranostic smart contact lens for monitoring and control of intraocular pressure in glaucoma,” Nat Commun, 2022; 13: 6801. https:// doi.org/10.1038/s41467-022-34597-8

7. Tonti E, Dell’Omo R, Filippelli M, Spadea L, Salati C, Gagliano C, Musa M, Zeppieri M. “Exploring Epigenetic Modifications as Potential Biomarkers and Therapeutic Targets in Glaucoma,” Int J Mol Sci, 2024 Feb 29; 25(5): 2822. doi: 10.3390/ijms25052822.

8. Soucy JR, Todd L, Kriukov E, Phay M, Malechka VV, Rivera JD, Reh TA, Baranov P. “Controlling donor and newborn neuron migration and maturation in the eye through microenvironment engineering,” Proc Natl Acad Sci, 2023 Nov 14; 120(46): e2302089120. doi: 10.1073/pnas.2302089120.

Analysing Laser Refractive Procedures

Page 16

1. H Alsubhi, et al. “Safety and efficacy of a laser refractive procedure in eyes with previous keratoplasty: systematic review and meta-analysis,” J Cataract Refract Surg, 2023 Dec 1; 49(12): 1275–1282.

Dynamic Measures Needed for Quality of Vision

Page 20

1. Norrby S. “Sources of error in intraocular lens power calculation,” J Cataract Refract Surg, 2008 Mar; 34(3): 368–376. doi: 10.1016/j.jcrs.2007.10.031.

Applying Artificial Intelligence to Glaucoma

Page 30

1. Girard M, et al. “Discriminating between Papilledema and Optic Disc Drusen Using 3D Structural Analysis of the Optic Nerve Head,” Neurology, 2023 Jan 10; 100(2): e192–e202.

2. Yousefi S, Pasquale L, et al. “Machine-Identified Patterns of Visual Field Loss and an Association with Rapid Progression in the Ocular Hypertension Treatment Study,” Ophthalmology, 129(12): 1402–1411.

Anti-Complement Therapy Debate

Page 32

1. Apellis Pharmaceuticals, Inc. “A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration,” ClinicalTrials.gov, 20 Feb 2024. classic.clinicaltrials.gov/ct2/show/NCT06161584

2. Apellis Pharmaceuticals, Inc. “An Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects with Geographic Atrophy Secondary to AMD (GALE),” ClinicalTrials.gov, 30 Aug 2023. classic.clinicaltrials.gov/ct2/show/NCT04770545

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.

40 CITATION INDEX
EUROTIMES | MAY 2024

Upcoming Events

May 5–9

2024 ARVO Annual Meeting

Seattle, United States

24 May

May 24–26

2024 EuCornea Annual Congress

Paris, France

June 1–4

2024 European Glaucoma Society Congress

Dublin, Ireland

June 5–8

2024 Retina International World Congress

Dublin, Ireland

September 6–10

2024 ESCRS Congress

Barcelona, Spain

November 28–29

UKISCRS

75th Anniversary of the IOL

London, United Kingdom

41
2024 MAY | EUROTIMES
1 Jun 6 Sep

STOP! Glaucoma Disease Progression

iStent ® technologies have been proven to stabilize visual fields loss and glaucoma disease progression with a favourable risk-benefit ratio1

+3 YEARS FOLLOW-UP

15 STUDIES ON ISTENT TECHNOLOGIES

1,115 EYES

26.6 % MEAN IOP REDUCTION WAS SUFFICIENT TO ACHIEVE THIS FUNCTIONAL EFFECT

-0.024 DBS/YEAR MEAN RATE OF PROGRESSION SIMILAR TO THAT REPORTED IN NONGLAUCOMATOUS EYES

INTERVENE EARLIER WITH ISTENT INJECT ® W TO PRESERVE PATIENTS’ FUNCTIONAL VISION AND QUALITY OF LIFE

1. Gillmann K, Hombeak DM. BMJ Open Ophth 2024;9:e001575.doi:10.1136/bmjophth-2023-001575.

iStent inject® W IMPORTANT SAFETY INFORMATION

INDICATION FOR USE: The iStent inject ® W, is intended to reduce intraocular pressure safely and effectively in patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The iStent inject ® W, can deliver two (2) stents on a single pass, through a single incision. The implant is designed to stent open a passage through the trabecular meshwork to allow for an increase in the facility of outflow and a subsequent reduction in intraocular pressure. The device is safe and effective when implanted in combination with cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and conventional glaucoma surgery. CONTRAINDICATIONS: The iStent inject ® W System is contraindicated under the following circumstances or conditions:

• In eyes with primary angle closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations.

• In patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.

WARNINGS/PRECAUTIONS:

• For prescription use only.

• This device has not been studied in patients with uveitic glaucoma.

• Do not use the device if the Tyvek® lid has been opened or the packaging appears damaged. In such cases, the sterility of the device may be compromised.

• Due to the sharpness of certain injector components (i.e. the insertion sleeve and trocar), care should be exercised to grasp the injector body. Dispose of device in a sharps container.

• iStent inject ® W is MR-Conditional; see MRI Information below.

• Physician training is required prior to use of the iStent inject ® W System.

• Do not re-use the stent(s) or injector, as this may result in infection and/or intraocular inflammation, as well as occurrence of potential postoperative adverse events as shown below under “Potential Complications.”

• There are no known compatibility issues with the iStent inject ® W and other intraoperative devices. (e.g., viscoelastics) or glaucoma medications.

• Unused product & packaging may be disposed of in accordance with facility procedures. Implanted medical devices and contaminated products must be disposed of as medical waste.

• The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. If intraocular pressure is not adequately maintained after surgery, the surgeon should consider an appropriate treatment regimen to reduce intraocular pressure.

• Patients should be informed that placement of the stents, without concomitant cataract surgery in phakic patients, can enhance the formation or progression of cataract. ADVERSE EVENTS: Please refer to Directions For Use for additional adverse event information. CAUTION: Please reference the Directions For Use labelling for a complete list of contraindications, warnings and adverse events.

© 2024 Glaukos Corporation. Glaukos, iStent®, iStent inject ® and iStent inject ® W are registered trademarks of Glaukos Corporation. PM-EU-0294
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