CAKE Issue 24 - The Cornea Issue

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The CORNEA Issue November 2024 cakemagazine.org

From Trauma to Recovery Dr. Farhan Irshad shares tales, techniques and therapies for corneal repair and regeneration p20

Letter to Readers

When the Biome’s Your Friend…

And your dry eyes mend, that’s amore!

Dear Readers,

Z

urich is a tech hub, with over 4% of the city’s workforce employed by Google. A plethora of tech titans surround them, including Microsoft NVIDIA Adobe, and Apple.

All of this adds up to a lot of people—mostly myopes—staring at screens all day, primarily working on artificial intelligence (AI), and often not blinking enough to keep their ocular surface lubricated.

I feel for them, man. Like all office workers, I spend most of my day in front of a computer, and I also have a pickled onion-like ocular surface—blinking infrequently and waking up with vague stinging sensations in my eyes in the morning.

The thing is… treating my form of dry eye should be straightforward. I know I should use lubricating drops regularly, but I don’t. I have a microwavable warming eye mask that Teifi James sent me about a decade ago that I could use—it must be somewhere in my flat, I assume. I own a cloth flannel, and my hot water tap delivers hot water, so I could use that as a compress. I even have access to an IPL machine and a red light facemask at work, which really works.

I think I’ve used it twice. Unlike many of your patients, I’ve read DEWS II. Yet like many of them, I absolutely struggle with eye self-care. So what’s behind this modern-day malaise, and what can be done to fix it?

requirements create too much friction for the everyday lazybones.

The same goes for saline-diluted insulin preparations—which seem to work wonders in corneal epithelial defect healing studies, but require too much effort for daily use.

A once-daily pinprick of your own blood applied to the inside of your lower eyelid can do a good job of improving dry eye markers, but it’s not a realistic prescription option. It brings a new dimension of friction to patients: Pain and bleeding.

I know of companies harvesting growth factors from mesenchymal stem cell culture soups, which have shown promising results in studies of severe corneal defects. While this might seem like overkill for dry eye, it could be exactly what’s needed. Perhaps an ideal solution would be something that can help repair the ocular surface and be kept in a plastic bottle in a handbag for a year, used as needed. Maybe therein lies the answer.

The malaise is ‘friction’. You know how teenagers complain when asked to do... well, literally anything? Every decision made and each step in a process tires the prefrontal cortex. Anything that eases that—reducing friction—makes a difference. It’s why we pay about a third more for pizza ordered on an app rather than by speaking to an actual person on the phone. Short of giving patients reminders to do something, there’s unlikely to be an “app for dry eye.”

Are stem cells the answer? Last weekend, I was at Oktoberfest in Munich (this is simply a boast—it was fantastic!), but the weekend before, I was in Zurich for the ELZA Refractive Surgery Course. At dinner, I sat next to François Majo, a refractive surgeon with a first-author paper on ocular surface stem cells published in Nature. And where is he these days?

The microbiome. Like stem cells, the right (beneficial) bacteria can also produce peptides that modify cell behavior. It makes sense.

There are so many etiologies and treatment options for dry eye, yet no easy answers for now. And in any event, many people don’t even realize they have dry eye. Often, they simply think they are ‘tired’.

Well, perhaps the future won’t feature Ozempic for the dry eye, but instead something like Yakult?

For the Zürcher tech workers—earning big salaries but with meibomian glands filled with toothpaste instead of oil—I see a potential market for a “dry eye spa.” Imagine pumping the gunk out of their glands, and getting the oil flowing again. Ah, blinking is nice once again.

It’s not a one-and-done solution; they’ll be back next month— and that’s a nice subscription model right there.

But what about an Ozempic-like drop for dry eye? One that’s pro-re-nata that treats inflammation, doesn’t sting on application, and lasts much longer than typical lubricants?

Autologous serum is effective, but its preparation and storage

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CAKE MAGAZINE | November 2024

Cheers, Mark Hillen, PhD

Director of Communications ELZA Institute, Zurich, Switzerland Editor-At-Large | CAKE

In This Issue...

Matt Young CEO & Publisher

Cataract

Anterior Segment

05

12

08

Gloria D. Gamat Chief Editor

Vision in Motion Navigating the high-speed impact of corneal higher-order aberrations after cataract surgery A Deep Dive into Cataract Care Experts share insights into challenging aspects of cataract management at ESCRS 2024

16 18

Mapet Poso Editor Matt Herman Associate Editor Maricel Salvador Graphic Designer Writers April Ingram Chow Ee-Tan Diana Truong Hazlin Hassan John Butcher Olawale Salami Tan Sher Lynn

Hannah Nguyen COO Travis Plage CFO Ruchi Ranga Society Relations & Conference Manager International Business Development Brandon Winkeler Robert Anderson Sven Mehlitz Published by

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At the Nexus of Eye Research Scientists and ophthalmologists in Australia, the UK and Canada are pushing the limits of corneal regeneration Fueling FLigHT ViaLase’s novel incision-free glaucoma solution, on spotlight at ESCRS 2024 Ophtec’s Artiplus Shows Promising One-Year Clinical Results Solving the Donor Crisis Innovative solutions are paving the way for more accessible and effective corneal treatments

Cover Story

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From Trauma to Recovery Dr. Farshan Irshad shares tales, techniques and therapies for corneal repair and regeneration

Kudos

Enlightenment

24

33 36 38

27 30

SIFI’s Ultimate Vision Mastering Sight with Wavefront Engineering and Innovative Ocular Surface Management Doctor of Many Hats With surgery, research and mentorship, Dr. Clara Chan is on a mission to revolutionize corneal care The All-New Pentacam Cornea OCT Offers Synergy for the Future of Corneal Assessment

Cash, Corneas and Controversy How for-profit entities are changing the game in eye banking Artiplus A new path for young presbyopes An Ode to a Visionary ESCRS 2024 Heritage Lecture puts a spotlight on phacoemulsification and Dr. Charles Kelman’s pioneering journey that transformed cataract surgery

Conference Highlights

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6001 Beach Road, #09-09 Golden Mile Tower, Singapore 199589 Tel: +65 8186 7677 Email: enquiry@mediamice.com www.mediaMICE.com

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Little Eyes, Big Insights Experts at WCPOS V 2024 address the challenges of pediatric vision in demyelinating and neuromuscular conditions Bridging the Gap in Education ESCRS 2024 Orbis Symposium addresses the challenge of equalizing cataract surgery training opportunities

We are looking for eye docs who can contribute articles to CAKE magazine. Interested? Let's talk!

Send us an email at editor@mediamice.com.

To place an advertisement, advertorial, symposium highlight, video, email blast, or other promotion in CAKE magazine, contact sales@mediamice.com.

Advisory Board Members

Dr. Harvey S. Uy

University of the Philippines; Peregrine Eye and Laser Institute, Manila, Philippines harveyuy@gmail.com

Prof. Burkhard Dick

University Eye Hospital Bochum Bochum, Germany burkhard.Dick@kk-bochum.de

Dr. Francis Mah

Scripps Clinic Medical Group La Jolla, California, USA Mah.Francis@scrippshealth.org

Prof. Dr. Sorcha Ní Dhubhghaill Brussels University Hospital (UZ Brussel) Brussels, Belgium nidhubhs@gmail.com

Society Friends

Arunodaya Charitable Trust (ACT)

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CAKE MAGAZINE | November 2024

Dr. William B. Trattler

Center For Excellence In Eye Care Miami, Florida, USA wtrattler@gmail.com

Dr. Cathleen McCabe The Eye Associates Sarasota, Florida, USA

cmccabe13@hotmail.com

CORNEAL HOAs

Navigating the high-speed impact of corneal higher-order aberrations after cataract surgery

by Hazlin Hassan

A new study sheds light on the intricate relationship between corneal higher-order aberrations and dynamic visual acuity post-cataract surgery. With findings suggesting that specific aberrations can significantly affect vision at higher speeds, this study offers valuable insights for refractive surgeons and their patients.

W

hile lower-order aberrations (LOA) are correctable, higherorder aberrations (HOA) are more challenging to address. LOAs, such as myopia, hyperopia and regular astigmatism, account for nearly 90% of the total aberrations in human eyes and can be corrected with spectacles or contact lenses.1 On the other hand, HOAs, such as

coma and spherical aberrations, cannot be corrected with conventional methods.2 As patient expectations rise, so does the need to correct HOAs to achieve better outcomes and quality of vision after cataract surgery, especially given increasingly demanding lifestyles and needs.

ataract

Correlation between HOAs and DVA velocities A study titled The impact of Corneal Higher-Order Aberrations on Dynamic Visual Acuity (DVA) on Post-Cataract Surgery explores the influence of corneal HOAs on DVA after cataract surgery.3 A total of 27 patients with 45 eyes following cataract surgery were included in the study. The postoperative monocular objectmoving DVA at the velocity of 20, 40 and 80 degrees per second (dps) were examined at 1 month. The total corneal HOAs were measured with Scheimpflug-based corneal topography. The correlation between postoperative DVA and HOAs was analyzed.3 Results showed that there was a significant difference among DVA at different velocities (P < 0.001). The 20 dps DVA was significantly better than 40 (P < 0.001) and 80 (P < 0.001) dps DVA. No significant difference was observed between 40 and 80 dps

CAKE MAGAZINE | November 2024

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ataract

CORNEAL HOAs

DVA (P = 0.420). The vertical coma and the root mean square (RMS) of coma (RMScoma) were statistically correlated with 80 dps DVA (P < 0.05). The vertical trefoil, RMStrefoil, and total RMSHOA were statistically correlated with 40 and 80 dps DVA (P < 0.05). The spherical aberration was not significantly associated with postoperative DVA (P > 0.05 for all velocities). The multivariate linear regression model revealed that age was a significant influential factor for 20 dps DVA (P = 0.002), and RMStrefoil (4 mm) and age were significantly associated with 40 and 80 dps DVA (P ≤ 0.01).3 In conclusion, the research demonstrated that larger corneal HOAs, especially coma and trefoil aberrations, were significantly associated with worse high-speed DVA, but not spherical aberration post-cataract surgery.

“This study resonates deeply with my practice as a refractive surgeon,” commented Dr. Noor Aniah Azmi, medical director and consultant refractive surgeon at the Ikonik Eye Specialist and General Health Centre, Malaysia.

Optimizing patient outcomes post-cataract surgery In today's world, patient expectations have evolved beyond merely achieving a 20/20 vision. They seek a level of ‘perfection’ that enhances their comfort and performance in daily activities, added Dr. Noor Aniah

“This research opens the door to more sophisticated post-operative evaluations, allowing us to better understand and address our patient's ocular issues. It helps me comprehend how these factors impact their daily activities, such as driving at night,” she explained.

“This research opens the door to more sophisticated post-operative evaluations, allowing us to better understand and address our patient's ocular issues. It helps me comprehend how these factors impact their daily activities, such as driving at night.”

– Dr. Noor Aniah Azmi

The results of the study highlighted the potential challenges that patients with higher levels of these aberrations may face in dynamic situations—such as driving at night— which could profoundly impact their quality of life.

That said, there are limitations.

“Ideally, we all want to give our patients the best possible care by addressing HOAs to improve their visual outcomes. However, some practical challenges make this difficult, such as measuring HOAs, which can be complex and often require advanced technology that isn’t available in every practice. Even with the necessary tools, interpreting the results can be tricky,” explained Dr. Noor Aniah.

She added that treatment options for HOAs remain limited and may not be suitable for every patient.

“Hence, while we aim for excellence in patient care, we must also balance the ideal with the realities of clinical practice. It would be interesting to correlate these findings with patientreported outcomes,” she said.

Insights into HOA-related postoperative visual challenges Assoc. Prof. Dato’ Dr. Khairidzan Mohd Kamal, director of Cornea, External Disease, and Refractive Surgery at the International Islamic University Malaysia (IIUM) Eye Specialist Clinic, said the study may provide insights into postoperative visual challenges—such as those for specific corneal HOAs (coma and trefoil) and reductions of DVA at fast motion speeds (40°/s and 80°/s). It may help in improving patients’ visual quality.

He pointed out that one notable finding of the study was that bigger corneal HOAs, particularly coma and trefoil aberrations, significantly worsen DVA at faster rates following cataract surgery. Age was also a significant factor in DVA, indicating that older patients may have more severe HOA-related visual abnormalities.

According to the study, some aberrations contribute more than others to visual function at high speeds, suggesting that specific therapies may be necessary.

“Collectively, these results highlight how important corneal HOAs and patient age are to visual outcomes following cataract surgery, particularly for tasks requiring

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CAKE MAGAZINE | November 2024

dynamic vision,” explained Assoc.

Prof. Dato’ Dr. Khairidzan.

requirements when organizing procedures,” he said.

“The implications for patients undergoing cataract surgery are multifaceted. Surgeons are more equipped to comprehend postoperative visual complaints from patients, especially those pertaining to motion when they are aware of the influence of corneal HOAs on DVA,” he added.

Patients who have corneal abnormalities may experience visual disturbances that make it difficult for them to engage in dynamic vision-intensive activities, like driving or sports.

They may have a higher quality of life if these anomalies are corrected, he emphasized.

To maintain adequate visual function, older patients may require additional therapies or closer monitoring, as age is a key factor.

Surgeons can improve postoperative visual results and increase patient satisfaction by carefully selecting appropriate IOLs and possibly correcting HOAs during surgery.

Additionally, patients’ expectations can also be set. “By helping patients understand how corneal HOAs may impact their dynamic vision, postoperative expectations are more realistically set, improving the doctorpatient bond,” he continued.

“Collectively, these results highlight how important corneal HOAs and patient age are to visual outcomes following cataract surgery, particularly for tasks requiring dynamic vision.”

– Assoc. Prof. Dato’ Dr. Khairidzan Mohd Kamal

Moreover, Assoc. Prof. Dato’ Dr. Khairidzan added that this study highlights the need for greater investigation into intraocular lenses (IOLs) and surgical methods that better manage corneal HOAs. “These ramifications emphasize the importance of considering lifestyle needs alongside physical

A call for further investigation

Contributors After completing medical school in Egypt in 2010, Dr. Noor Aniah Azmi pursued a Master of Ophthalmology in Malaysia in 2018, followed by a post-graduate diploma in Cataract and Refractive Surgery in the United Kingdom in 2022. The mother of four is active on social media, where she shares the daily challenges of managing both professional and family responsibilities, aiming to empower women. draniah@ikonik.com.my

Additional research is necessary, Assoc. Prof. Dato’ Dr. Khairidzan explained, for the following reasons: Although corneal HOAs are the main subject of the study, intraocular HOAs are also very important for total visual quality.

Future studies that take these into account might offer a more complete picture of postoperative vision.

One drawback of DVA testing is the absence of pupil diameter measurements. Although difficult to do, using this data could improve the precision of results pertaining to HOA profiles.

The limited sample size of the study and the lack of previous, comparable studies raise concerns about statistical bias. More extensive and varied sample sizes will be needed in future research to verify these results and guarantee wider use.

“These areas highlight the need for more research to address the limitations of the current study and investigate the variety of factors impacting DVA following cataract surgery,” he concluded.

References 1. Lombardo M, Lombardo, G. Wave aberration of human eyes and new descriptors of image optical quality and visual performance. J Cataract Refract Surg. 2010;36(2):313-31.

Assoc. Prof. Dato’ Dr. Khairidzan Mohd Kamal currently serves as an associate professor at the Department of Ophthalmology, International Islamic University Malaysia (IIUM). He is also the director of Cornea, External Disease, and Refractive Surgery Services at IIUM Eye Specialist Clinic. Assoc. Prof. Dato’ Dr. Khairidzan received his MBBS from the University of Queensland and obtained his Master of Surgery (Ophthalmology) from the National University of Malaysia. He spent a year as an adjunct clinical instructor and international fellow in Cornea, External Disease, and Refractive Surgery at UCLA. Assoc. Prof. Dato’ Dr. Khairidzan has published several articles in scientific journals and made over 300 scientific presentations.

He contributed his expertise to the Malaysia Dry Eye Advisory Board and directly supervised a number of PhD and Masters candidates in external disease and refractive surgery research.

Additionally, he received the AsiaPacific Association of Cataract and Refractive Surgeons Certified Educator Award in 2018, and was appointed a council member of the International Society of Refractive Surgery in 2021. khairidzan@gmail.com

2. Maloney RK, Bogan SJ, Waring GO. Determination of corneal image-forming properties from corneal topography. Am J Ophthalmol. 1993;115(1):31-41.

3. Wu T, Wang Y, Li Y, Li Y, Jiang X, Li X. The impact of corneal higher-order aberrations on dynamic visual acuity post cataract surgery. Front Neurosci. 2024;18:1321423.

CAKE MAGAZINE | November 2024

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ataract

IOLs

A Deep Dive D into Cataract

Care

Experts share insights into challenging aspects of cataract management at ESCRS 2024

by Olawale Salami

Phakic intraocular lenses (IOLs) are gaining traction among patients in their late 40s seeking to address presbyopia while preserving their natural lenses. The symposium not only explored the benefits of these lenses but also tackled key issues like managing dislocated IOLs and the debate over postoperative antibiotics. Experts shared insights that highlighted the complexities and innovations in contemporary cataract care.

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CAKE MAGAZINE | November 2024

uring a late afternoon Journal of Cataract and Refractive Surgery (JCRS) symposium at the recently concluded 42th Congress of the European Society of Cataract & Refractive Surgeons (ESCRS 2024), held on September 6 to 10 in Barcelona, Spain, the elite of the eye care world gathered with chairs Prof. Thomas Kohnen (Germany) and Dr. Liliana Werner (USA) to discuss some of the most pressing—and trending—topics in the anterior segment.

The rise of phakic IOLs Phakic intraocular lenses (IOLs) are on the rise, and the first section of the symposium addressed various current issues related to implanting phakic presbyopia-correcting IOLs in pre-cataract patients aged 45 to 50.

Dr. Erik Mertens (Belgium) began the session with a presentation on the advantages of presbyopia-correcting phakic IOLs (PIOLs) for patients in this age group. He highlighted the key benefits of these lenses, emphasizing their role in preserving the crystalline lens and the residual accommodation it provides.

For Dr. Mertens, nothing trumps maintaining the body’s natural structures. “Phakic IOLs allow us to keep the natural lens intact while utilizing any remaining accommodation—a major win,” he stated.

with defocus curve predictability at 60% ±0.5 D—compared to 78% for the EVO monofocal,” he reported. In terms of safety, he noted that “32% of patients experienced a loss of one or more lines of CDVA, compared to just 14% with monofocal IOLs.”

Safety was also a key focus of Dr. Mertens’ talk, as he assured the audience about the low risks associated with these lenses.

“Retinal detachment rates don’t seem to increase after phakic IOL implantation. In a study of 2,000 eyes, the rate was only about 1.2%.

And with endophthalmitis, we’re looking at an incredibly low incidence of 0.016% in a report of 18,000 eyes,” Dr. Mertens shared.

In conclusion, he said, “Phakic IOLs represent a promising solution for patients under 50 or those with long axial length. However, real-world studies and cost-effectiveness analyses are still needed for longterm safety and efficacy.”

A unique selling point of these IOLs is their reversibility, which Dr. Mertens emphasized on behalf of all phakic enthusiasts. “Unlike in-the-bag IOLs, PIOLs are easier to remove if needed,” he said.

He also discussed their effectiveness for both myopia and hyperopia. “In hyperopic patients, there are more indications for lens exchange, but with phakic IOLs, the safety and efficacy remain strong,” he noted.

The phakic IOL face-off Next, Dr. Joaquín Fernández joined the conversation, offering insights for patients aged 45 to 50 on whether presbyopia-correcting phakic IOLs (PIOLs) or posterior chamber IOLs are the better option. His takeaway?

It’s all about finding the right balance between accommodation and quality of vision.

“For patients in this age group, we can perform refractive lens exchange or ICL,” Dr. Fernández explained.

“Two key considerations are the amplitude of accommodation and the quality of vision.”

For these younger presbyopes, he emphasized the importance of contrast sensitivity testing— especially when visual acuity is 20/20 or better. “In this category, we expect high-quality vision and good accommodation,” he stated.

Dr. Fernández highlighted the performance of the EVO VIVA IOL in patients over age 50. “In this group, we observed a one-line drop in CDVA,

Finishing up the topic, Dr. Michael Amon (Austria) explored the advantages of a supplementary IOL in the sulcus for this patient group.

“In patients aged 45 to 50 with a clear lens and reduced accommodation, we can opt for a duet procedure using a monofocal bag IOL with an addon IOL, clear lens extraction with a bag IOL, or a phakic IOL if there’s no posterior vitreous detachment,” he explained

“Phakic IOLs represent a promising solution for patients under 50 or those with long axial length.

However, realworld studies and cost-effectiveness analyses are still needed for longterm safety and efficacy.”

– Dr. Joaquín Fernández

Dr. Amon’s talk focused on the ‘duet’ procedure, which offers an adjustable option with primary addon implantation. “The duet procedure allows fine-tuning of the results, delivering optical quality comparable to a single IOL while providing better and more stable centration,” he continued. But, as with any duet, there’s a risk of hitting a sour note.

“Posterior vitreous detachment is a risk that should be monitored,” he added.

As for the available options, Dr. Amon pointed out, “There are currently three additive IOLs on the market: The Cristalens Reverso (Lannion, France), Rayner Sulcoflex (Worthing, UK), and Medicontur 1stQ (Zsámbék, Hungary). Made of hydrophilic acrylic, these lenses are designed for high biocompatibility due to contact with the uvea. Published data shows these lenses are safe and well-tolerated,” he emphasized.

Dislocated IOLs: To refix or replace?

Next, the challenging issue of managing dislocated IOLs took over the spotlight.

Dr. Shin Yamane (Japan), the inventor of the Yamane technique, addressed a dilemma that all eye surgeons know too well: What’s the best approach for dealing with a dislocated IOL? Should you refix it or opt for a full replacement?

“The management of a dislocated IOL involves either the removal and fixation of a new IOL (IOL exchange) or refixing the old IOL,” Dr. Yamane said.

He pointed out the perks of an IOL exchange in this context.

“Less surgical time, better control of refraction, and, of course, the advantage of a shiny new IOL,” he quipped.

But it’s not all rainbows and sunshine.

Refixation can get tricky, he noted, especially when dealing with issues like deformed haptics or the formation of Soemmering’s rings.

Dr. Yamane presented a series of cases demonstrating both refixation and exchange techniques, sharing his insights on when each method might be the best choice. “For rigid IOLs, large incisions are needed,” he noted, highlighting one of the challenges of IOL exchange.

He also shared a video of the famous Yamane technique, emphasizing its precision. “The Yamane technique allows the achievement of constant outcomes.” He stressed the importance of the needle insertion angle to avoid tilting the IOL. Dr. Yamane summed it all up simply by highlighting a special technique.

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IOLs

“Refixation is useful in limited situations. However, for removal, the Fukuoka technique—using Fukuoka forceps—is often the preferred option,” he said.

Refixation versus explantation Dr. Cathleen McCabe (USA) then shifted to the pros and cons of refixation versus explantation.

Dislocated IOLs, while rare, have causes as varied as pseudophakic exfoliation, prior eye surgeries, and good old-fashioned eye rubbing. “The incidence of IOL dislocation is 0.08%, but males are five times more likely to develop it—perhaps they just rub their eyes more,” she joked. Trauma, capsular phimosis, and complicated cataract surgeries are also culprits, with the highest risk in patients under 40.

But when it happens, what’s the best course of action—refixate or explant?

“Why would you scleral-fixate the IOL and not just take it out,” Dr. McCabe asked. She highlighted that studies comparing scleral-fixated and retropupillary iris-claw IOLs show similar outcomes and complications.

There are, however, situations where refixation is preferable. “If you want to retain a premium IOL, avoid conjunctival trauma, or skip an anterior vitrectomy, refixation is your friend,” Dr. McCabe advised.

She demonstrated two common scleral fixation techniques: The belt loop and polypropylene flanged methods. “The belt loop technique works well for most lenses and often spares patients from the risks of anterior vitrectomy,” she noted. Potential complications?

“Endophthalmitis, decentration, and flange erosion—but nothing’s perfect!”

In short, while there’s no one-sizefits-all answer, refixation often proves the more eye-saving option Dr. Luis Izquierdo Jr. (Peru) then presented the Artisan Aphakia IOL (Ophtec; Groningen, Netherlands) as a go-to solution for these cases.

“Explantation and Artisan IOL implantation are key for lens and IOL subluxation, whether spontaneous

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or post-trauma,” he said, highlighting the Artisan model’s versatility. “The Artisan 205 Aphakia IOL is a onesize-fits-all solution, known for its predictable, stable, and reliable outcomes.”

“The Artisan 205 Aphakia IOL is a one-size-fits-all solution, known for its predictable, stable, and reliable outcomes.”

– Dr. Luis Izquierdo Jr.

To support his claims, Dr. Izquierdo shared videos showcasing the Artisan IOL in action across different indications. “In my experience, this aphakic retro pupillary lens is atraumatic, easy to implant with excellent centration, and remarkably safe for the corneal endothelium,” he concluded, calling for long-term studies to further validate these promising results.

Postoperative antibiotics: To drop or not to drop?

Dr. Andrzej Grzybowski (Poland) was the first to discuss the hotly debated question that wrapped up the proceedings: Do we still need antibiotic eye drops after cataract surgery? He’s firmly in the proantibiotics camp.

“The incidence of postoperative endophthalmitis ranges from 0.08% to 0.68%,” Dr. Grzybowski pointed out. “That’s a risk many surgeons are unwilling to take.” With most surgeons sticking to post-op antibiotics, the fear of this rare but severe infection looms large.

But can we predict who’s at risk?

Dr. Grzybowski highlighted a study of over 15,000 surgeries. “A leaking wound on day one post-op was the single biggest relative risk for endophthalmitis,” he said. Capsule breaks and vitreous in the anterior chamber also send alarm bells ringing.

As for prevention, Dr. Grzybowski didn’t hold back on practical tips.

CAKE MAGAZINE | November 2024

“Preoperative irrigation and avoiding topical antibiotics, along with a solid surgical technique and proper wound sealing, are key. And don’t forget the intracameral antibiotics!”

And when it comes to those post-op drops? “Use them, but limit it to three to five days. High concentration, no tapering,” he advised. In short, while the debate rages on, Dr. Grzybowski isn’t taking chances.

However, Dr. Anders Behndig (Sweden) presented a contrasting viewpoint.

“I strongly support the use of intracameral antibiotics, not postoperative eye drops,” he said, before sharing some striking [unpublished] data from Sweden that showed the introduction of intracameral antibiotics resulted in a more than five-fold decrease in endophthalmitis rates.

For those still clinging to their antibiotic drops, Dr. Behndig had more to say. “Few studies have shown a reduction in endophthalmitis with post-op antibiotics compared to placebo,” he pointed out.

But the real kicker came when he crunched the numbers. “Seven million cataract surgeries are performed annually in Europe, using 35,000 liters of levofloxacin eye drops, equivalent to 175 kg of the drug. And for what? We’re talking about preventing 1,400 cases of endophthalmitis—assuming we also use intracameral antibiotics.”

To wrap it up, Dr. Behndig delivered his final punchline: “We’re using 125 grams of levofloxacin to prevent one case of endophthalmitis possibly.

And we don’t even know if it truly works!”

Editor’s Note Reporting for this story took place at the 42nd Congress of the European Society of Cataract and Refractive Surgery (ESCRS 2024), held from September 6 to 10 in Barcelona, Spain. A version of this article was first published on cakemagazine.org.

Industry Update

ZEISS Showcases New Revolutionary Surgical Solutions at AAO 2024

Z

EISS Medical Technology will showcase digital enhancements and revolutionary surgical solutions at the American Academy of Ophthalmology (AAO) conference from October 19 to 21 in Chicago, Illinois, USA. These innovations across cataract, corneal refractive, retina, and glaucoma workflows, offer new, enhanced paths to patient management and treatment, using a digitally connected environment to help advance the clinical workflow to support a higher level of personalized care.

“ZEISS continues to expand its digital leadership in ophthalmology, offering new, pioneering ophthalmic offerings and clinical tools that create an enhanced digital workflow experience for both patients and surgeons,” said Euan S. Thomson, head of the Digital Business Unit for ZEISS Medical Technology.

“With the foundation of our Health Data Platform as part of the ZEISS Medical Ecosystem, our datadriven healthcare solutions unlock enormous value for surgeons, helping them deliver more efficient and personalized care throughout a patient’s journey.”

Extending the ZEISS digital portfolio, the company will introduce ZEISS VisioGen, a cutting-edge AI-driven solution designed to enhance refractive patient communication and streamline clinic operations, expanding the value to ophthalmologists and clinics by helping them grow their business through improved patient engagement.

“ZEISS VisioGen is an extremely useful tool for the busy refractive practice. It can save time and prevent grammatical errors in responding to questions from potential patients. The response time is quick and useful. Responses can also be effectively tailored to the specifics of your individual practice,” said Dr. Luke Rebenitsch, ClearSight, Oklahoma City (OK, USA).

ZEISS will also showcase the recently FDA-approved VISUMAX® 800 with SMILE® pro software from ZEISS for surgically treating nearsightedness, with or without astigmatism. The updated ZEISS femtosecond laser provides US refractive surgeons with faster treatment, greater flexibility, and significant workflow enhancements as compared to the previous generation VisuMax. The VISUMAX 800 creates the lenticule in less than 10 seconds by using a higher laser pulse repetition rate of 2 MHz. A shorter procedure time may reduce stress for both surgeons and their patients.

Recently FDA-cleared and now broadly available in the US, ZEISS will demonstrate the ZEISS MICOR 700, the first hand-held lens removal device with ultrasoundfree operation, reinventing lens extraction by providing a sustainable solution with a low initial investment to help surgeons expand their intraocular working space. Designed to create a gentler patient experience, the ZEISS MICOR 700 offers a revolutionary approach to lens removal, including patented crystalline lens extraction technology, a blunt and rounded tip design, and a single-use “plug & play” system with a minimal operating room (OR) footprint.

ZEISS will also showcase its expanded portfolio of high-end microscopes with the ZEISS ARTEVO® 850 3D heads-up ophthalmic microscope setting the pace in digital visualization with true color imaging, and increased depth of field by nearly 60 percent.

Additionally, the ZEISS ARTEVO 850 with CALLISTO eye® features a redesigned intuitive user interface that centralizes all controls on a single touchscreen. The second latest addition to ZEISS’s portfolio of optical surgical microscopes, the new ARTEVO® 750, elevates the surgical workflow by introducing advanced optical visualization technology, including new RGB LED illumination with adjustable

light color temperature, as well as data overlays provided in the eyepiece with a 40 percent increase in resolution.4 The two devices are CE-marked and FDA-cleared and commercially available in all major markets.

At AAO, ZEISS will also highlight cutting-edge imaging technology and 3D visualization as part of the ZEISS Retina Workflow. The CIRRUS® 6000 from ZEISS introduces an expanded Reference Database, triple that of its previous database, with greater diversity and three different disc sizes for more individualized patient care. With an acquisition speed of 100,000 A scans per second, the device provides instantaneous dense data cubes and sub-10-second-widefield OCT Angiography capability, together with automated 9 slab standard report presentation to complement the review process.

Setting the pace in digital visualization, the ZEISS ARTEVO 850 includes customizable digital color settings depending on the surgical procedure’s needs and intraoperative OCT allowing for real-time monitoring of the surgical process and decision-making.

The newest addition to the ZEISS Retina Workflow, the DORC EVA NEXUS™ surgical system and instrumentation bring added value and synergy to the OR. The DORC vitreoretinal portfolio includes the EVA NEXUS™ phacovitrectomy system featuring the unique VTi pump, offering FLOW and VACUUM fluidics, EVA AVETA™ trocar cannula system with Push-Fit HI-FLOW™ infusion connection, TDC (twodimensional cutting) vitrectomy with cut speeds of up to 20,000 CPM 5, EVA INICIO™ microinjection system, and an extensive range of posterior instruments including 27G ULTRA for no-compromise, small-gauge surgery, as well as a wide range of highly purified posterior surgical liquids and tamponades.

For more information, visit www. zeiss.com/med.

CAKE MAGAZINE | November 2024

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ARTIFICIAL CORNEAS

At the Nexus of Eye Research

Scientists and ophthalmologists in Australia, the UK and Canada are pushing the limits of corneal regeneration

by John Butcher

Researchers in Australia have developed a method to amplify endothelial cells in the lab, potentially transforming corneal transplant procedures and addressing the global shortage of donor corneas. Meanwhile, collaborative efforts in the UK and Canada are exploring collagen-based artificial corneas, offering insights into corneal regeneration.

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revolutionary technique developed by Australian scientists could allow a single cornea donation to facilitate multiple transplants, significantly expanding the pool of available tissue. This development not only addresses the critical shortage of corneal donors but also offers new hope to millions affected by corneal blindness.

Across the globe, researchers at Cardiff University and Montreal University are exploring the potential of collagen-based artificial corneas, aiming to improve healing and understanding of corneal structures.

This breakthrough research may open new avenues for treating corneal disease and enhancing regenerative medicine.

From lab to life: Hope in tackling donor shortage Researchers in Australia have found a way to amplify endothelial cells in

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the laboratory that will help solve the global shortage of cornea donors.

The development means around 50 transplants could be possible from a single cornea donation, offering hope to cure blindness in many more patients than is currently possible.

It is a potential ‘game changer’ in corneal transplants, which could see 40 to 50 transplants from a single donation, shared Prof. Mark Daniell, head of corneal research at the Centre for Eye Research Australia in Melbourne, Australia.

Prof. Daniell, who is also a senior consultant at the Royal Victorian Eye and Ear Hospital in Melbourne, initiated the study more than a decade ago with researchers at the hospital. They first discovered that endothelial cells could be grown in the laboratory, something they do not do in the human body.

CAKE MAGAZINE | November 2024

Prof. Daniell then met with engineers from the University of Melbourne, who developed folding ‘scaffolding’ on which the cells could be grown before being inserted into the eye.

Made from the same substance as edible capsules, it pops open once inside the eye, said Prof. Daniell, and is completely biodegradable, dissolving without causing any inflammation.

“With this scaffold, we now have a method for culturing the cells outside the body, expanding the pool of donors, and introducing them into the eye,” explained Prof. Daniell.

“It’s a type of surgery that you don’t need to be a super expert in corneal surgery to do,” he added. “You just need to be able to do the usual corneal surgical techniques.

So far, the research has been tested in multiple sheep and is going through regulatory approval for human trials.

The future of tissue engineering According to Prof. Daniell, the impact on patients could be immense, with around 12 million people blind from corneal disease worldwide and only 100,000 transplants performed currently each year.

He added that the greater availability of transplant tissue should particularly impact developing countries, where a lack of infrastructure creates a severe shortage of access to donated corneas.

A company called BIENCO was established through collaboration among the Centre for Eye Research Australia, the University of Melbourne, the University of Sydney, the University of Wollongong and Queensland University of Technology.

Bienco will focus on developing complete corneas.

“The idea is that we will have the capability to replace any part of the cornea that we want, and we can do that at the order of the surgeon,” shared Prof. Daniell.

Prof. Daniell is also working on further research that could completely eradicate the need for

donors by using a person’s own tissue from another part of the body to grow endothelial cells.

“Theoretically, we’ve now done it in the lab: You can take skin cells and induce them to become pluripotent stem cells.

Once they’re induced, those stem cells can keep growing forever. You can then convert them back into corneal cells,” he explained.

Researchers are now at the stage of trying to prove that the grown cells function like normal corneal endothelial cells, he added.

“That holds great promise because it allows us to take some cells from a pinch of someone’s skin, and after some time in the lab, turn it back into a cornea. It could be possible to grow a cornea from just a bit of skin or some other basic tissue,” he said.

Contributors Dr. Philip Lewis, BSc, MSc, PhD, is a research fellow in the School of Optometry and Vision Science, Structural Biophysics Group, at Cardiff University. He has been part of the group for the last 20 years. His work has primarily been focused on the structural biology of the cornea in health and disease, the structural basis of corneal development in human and animal models, and the development of artificial corneas.

He is also the group's electron microscopist specializing in Cryo Transmission Electron Microscopy and the 3D Volume scanning technique of serial block face electron microscopy.

LewisPN@cardiff.ac.uk

New avenues in regenerative cell research Researchers at Cardiff University in the United Kingdom have been studying the ability of collagen cornea implants to activate healing in damaged eyes.

The research offers not just a promising development in curing blindness for many, but also a greater insight into the cornea that could aid further research.

“We aim to better understand the structure of the cornea and how diseases affect vision,” said Dr. Phil Lewis, a structural biophysics fellow at Cardiff University, who is involved in the research project.

The Cardiff team’s research is in collaboration with a group at Montreal University in Canada, led

by Dr. May Griffiths, a professor in the Department of Ophthalmology.

In 2010, her group developed an artificial cornea, tested in around 10 patients, which was made of labgrown recombinant collagen type 3, similar to the collagen that makes up the majority of the eye.

Those corneas, placed into the eye as a scaffolding structure, were intended to mimic the collagen in the cornea. It was found to encourage keratocytes, repair cells within the body and lay down new human

collagen—gradually replacing the introduced structure and repairing the eye.

Dr. Griffith’s group has since developed artificial versions of this collagen structure called synthetic peptides, which are cheaper and faster to produce than the original natural lab-grown material. She has also shifted from hard structures to ‘liquid corneas,’ said Dr. Lewis, which are like a gel that can be injected into a small wound.

Other agents, such as antiinflammatories, have been added to the artificial corneas, and it is important to understand their impact, added Dr. Lewis.

The Cardiff team hopes to understand how the collagen structures work, why they encourage regeneration and what is best in terms of biocompatibility and speed of repair.

“We are looking at what’s happening during regeneration,” said Dr. Lewis.

“We don’t want to create something new that doesn’t work, such as cornea with hazing,” he added.

As well as assessing the effectiveness of Dr. Griffith’s work

Prof. Mark Daniell is a senior consultant ophthalmic surgeon with a distinguished career in ophthalmic practice. He is head of the corneal service at the Royal Victorian Eye and Ear Hospital (RVEEH), overseeing a team of surgeons performing corneal transplantation. He is founding chair of the ANZ Corneal Society and medical director of the Lions Eye Bank. Previously he was head of ophthalmology at the Royal Melbourne Hospital.

Prof. Daniell is also leader of the Hygelix consortium and comedical director of BIENCO, a national collaboration developing a bioengineered cornea, funded by the Medical Research Future Fund.

In addition, he is head of surgical research at the Centre for Eye Research Australia and founder of the Keratoconus International Consortium. He was previously chairman of the Ophthalmic Research Institute of Australia (ORIA) for six years and continues to review grants for the National Health and Medical Research Council and ORIA. He has served on the RANZCO board for 10 years and is the organization’s immediate past president. Prof.

Daniell has achieved over $40m in competitive grant funding from MRFF, VMRAF, AISRF, ORIA, NHMRC, and University of Melbourne interdisciplinary grants.

He is the current beneficiary of the Frontiers of Health MRFF grants for tissue-engineered cornea projects. He has published 142 papers in peer-reviewed literature and has an H-index of 38. mdaniell@cera.org.au

and understanding how her artificial corneal structures function, the Cardiff team’s research also provides a better understanding of the cornea in general. This could open up new research areas, such as studies of regenerative tissue in other parts of the body—concluded Dr. Lewis.

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GLAUCOMA

Fueling FLigHT ViaLase’s novel incision-free glaucoma solution, on spotlight at ESCRS 2024

by Diana Truong

At the heart of every groundbreaking innovation lies a vision to solve the unsolved. Dr. Rick Lewis, Chief Medical Officer at ViaLase (Aliso Viejo, CA, USA), took to the stage at the ESCRS 2024 iNovation Day in Barcelona to share the company’s journey from pioneering femtosecond laser technology to a first-of-its-kind, incision-free interventional glaucoma solution.

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fter earning his PhD in Hungary, ViaLase CEO Tibor Juhász was fortunate to secure a research position at the University of Rochester (New York, USA) under the mentorship of Gérard Mourou—the world leader in ultrashort pulse laser technology at the time. Collaborating with Ron Kurtz, MD, their groundbreaking work demonstrated the femtosecond laser's ability to make precise incisions in ocular tissue with micron-level accuracy, without harming surrounding tissue. The femtosecond laser would go on to revolutionize laser refractive surgery, cataract surgery and corneal transplantation.

Fast forward to 2017, when ViaLase was founded with a laser-sharp focus on creating a non-invasive intervention for glaucoma. “The LenSx femtosecond laser cataract surgery was introduced almost 20 years ago,” noted Dr. Lewis. “But glaucoma has always been the goal of our founder.” Leveraging approximately two centuries of collective expertise in developing femtosecond lasers, the company’s leadership team set out to create a system that combined micronaccurate OCT imaging with the precision of a femtosecond laser.

“The goal here is to reduce the intraocular pressure using a micronaccurate femtosecond laser to noninvasively create a precise drainage channel in the trabecular meshwork,” Dr. Lewis explained.

Dr. Lewis made it clear that the choice of femtosecond laser technology wasn’t just a nod to history—it was a deliberate move to reconcile the unmet needs in glaucoma care. He highlighted that while topical medications are often the first line of defense, noncompliance is rampant—nearly half of patients stop using their drops within six months, leading to worsening disease conditions. Selective laser trabeculoplasty (SLT), though popular, has inconsistent efficacy, and its results diminish over time.

MIGS, though a minimally invasive glaucoma surgery, still involves cutting into the eye and is often only performed with cataract procedures.

Filtration surgeries are complicated, highly invasive, and have a high risk of failure, especially after five years.

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CAKE MAGAZINE | November 2024

The femtosecond laser, with its track record of safety, precision and predictability in anterior segment procedures, offers a promising alternative that is truly non-invasive and does not require opening the eye. It uses photodisruptive energy in such small amounts that it minimizes collateral damage to surrounding tissues. This well-established safety profile has made this technology a cornerstone of ophthalmic surgery, and ViaLase believes it’s time to bring that same reliability to glaucoma treatment.

Enter ViaLase’s latest innovation: the ViaLuxe Laser System, which delivers the first ever femtosecond laser image guided high-precision trabeculotomy (FLigHT). Unlike MIGS, which requires opening up the eye, FLigHT uses a femtosecond laser to create a precise drainage channel in the trabecular meshwork, offering a noninvasive solution that mitigates the potential risks associated with traditional incisional procedures. “Not only is it outpatient, but it’s not incisional,” Dr. Lewis noted.

Another significant advantage to FLigHT is its broad indication. The procedure is performed outside of cataract surgery—a common and limiting requirement for MIGS procedures—which expands patients’ access and may improve outcomes for a wider range of patients.

With its proprietary HD gonioscopic camera and micron-accurate OCT imaging technology, ViaLuxe offers advanced visualization capabilities so that surgeons can precisely target the trabecular meshwork.

This is a significant improvement over traditional gonioprism-based techniques, which can distort the surgeon’s view and make it difficult to accurately visualize the anatomy of the eye.

ViaLuxe also offers a highly customizable treatment approach.

Surgeons can target any of the four quadrants of the eye, allowing for individualized treatment based on the patient’s specific needs. This flexibility is particularly important as traditional angle-based procedures are often limited to the nasal quadrant.

The first-in-human study suggests promising results. “We looked at 18 eyes,” Dr. Lewis said. “These are single channel placements, 500 by 200 microns in the trabecular meshwork.” At 24 months posttreatment, the channels created by the laser remained patent, with no signs of closure or scarring. Notably, the surrounding trabecular meshwork and Schlemm’s canal remain undisturbed—a testament to the precision of the femtosecond laser.1 Clinical data from the study showed a durable mean IOP reduction of 34.6%, with 88% of treated eyes achieving IOP levels of 18 mmHg or lower. Moreover, 82% of patients experienced at least a 20% reduction in IOP, with more than half achieving a 25% drop or more. Equally significant is the absence of serious adverse events, reinforcing the procedure’s safety profile.2 With the recent CE Mark approval, ViaLase is gearing up for the next phase for its ViaLuxe system— a selective commercial rollout in key European markets.

As ViaLase prepares for the commercial debut of ViaLuxe, the excitement surrounding its technology is palpable. By combining

the precision of femtosecond lasers with advanced imaging, the company is on track to introduce a new standard in interventional glaucoma care. For patients and clinicians alike, this could mean fewer compromises and better outcomes—without the invasiveness typically associated with glaucoma surgery.

“We feel ViaLase’s femtosecond laser treatment is uniquely positioned to unlock one of the largest eye care markets,” Dr. Lewis emphasized. “It’s the first and only femtosecond laser treatment for glaucoma."

As Dr. Lewis concluded his talk, one thing was clear: The future of glaucoma care is brighter, more precise, and less invasive, thanks to the pioneering work of ViaLase.

Editor’s Note Reporting for this story took place at the 42nd Congress of the European Society of Cataract and Refractive Surgery (ESCRS 2024), held from 6-10 September in Barcelona, Spain.

A version of this article was first published on cakemagazine.org.

References 1. Mikula ER, Raksi F, Ahmed II, et al. Femtosecond laser trabeculotomy in perfused human cadaver anterior segments: A novel, noninvasive approach to glaucoma treatment. Transl Vis Sci Technol.

2022;11(3):28.

2. Nagy ZZ, Kranitz K, Ahmed II, et al. First-in-human safety study of femtosecond laser image-guided trabeculotomy for glaucoma treatment: 24-month outcomes. Ophthalmol Sci. 2023;3(4): 100313.

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IOL TECH

with a planned follow-up period of three years. Key inclusion criteria for participants included adult presbyopic patients requiring reading glasses of at least +1.0 D, a residual refractive cylinder of less than or equal to 0.75 D postoperatively, and a minimum anterior chamber depth of 2.80 mm or 3.00 mm based on age.

These criteria ensured that the trial focused on patients most likely to benefit from the Artiplus lens.

Ophtec’s Artiplus Shows Promising OneYear Clinical Results

by Diana Truong

At the invite-only Artiplus Experts Panel during ESCRS 2024 in Barcelona, Spain, the unveiling of one-year clinical trial outcomes for the Artiplus (Ophtec; Groningen, Netherlands) iris-fixated multifocal phakic intraocular lens sparked significant interest among the esteemed refractive surgeons in attendance.

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he Artiplus lens, designed for phakic patients with presbyopia, leverages the established safety and efficacy of Ophtec’s Artiflex platform, along with patented continuous transitional focus (CTF) technology.

This innovative solution aims to address the unique needs of phakic presbyopes, providing a clear alternative to conventional multifocal IOLs that often struggle with glare and halos—common issues for cataract patients. By targeting this specific population, Artiplus offers a tailored approach to vision correction, enhancing the quality of life for those seeking clarity at all distances.

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With a refractive design intended to maximize far vision while reducing visual distortions, the Artiplus lens is unique in its segment. Its development has been under rigorous evaluation in a multicenter international clinical trial, involving nine sites across Europe and South Korea. The study followed 42 patients (84 eyes), all of whom received bilateral implantation of the Artiplus IOL. As the trial progresses, the current one-year results offer a glimpse into what the future holds for this novel technology.

The study design The Artiplus lens trial was open-label, prospective and non-controlled,

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The primary outcomes measured included corrected and uncorrected visual acuity at near, intermediate and distance, residual spherical equivalent, defocus curve, contrast sensitivity, intraocular pressure and endothelial cell count. Subjective assessments, such as patient satisfaction and quality of vision, were also integral to evaluating the lens’s real-world impact.

Prof. Dr. José Luis Güell (Spain), the lead investigator of the study, presented the interim one-year results to an attentive audience at the event. As one of the leading experts in the field, Prof. Dr. Güell offered insights into the trial’s progress, focusing on visual acuity improvements and patient feedback.

A year in review The trial’s visual acuity results were notably encouraging. Patients in the trial started with a mean spherical equivalent error of -4.98 D ± 2.27 preoperatively, but after one year, this figure had significantly improved to -0.32 D ± 0.27. Such outcomes demonstrate the Artiplus lens’s effectiveness in delivering clear vision for both near and far distances.

Binocular uncorrected distance visual acuity (UDVA) also saw significant improvement, with mean preoperative scores at 0.85 ± 0.28 LogMAR, which improved to a mean of 0.06 ± 0.07 LogMAR at one year.

The results for binocular uncorrected intermediate and near vision were similarly strong, with 0.01 ± 0.10 LogMAR and 0.01 ± 0.07 LogMAR recorded at one year, respectively.

In his presentation, Prof. Dr. Güell emphasized these findings, noting, “The visual acuity results are extraordinary. The outcomes for uncorrected distance, uncorrected

intermediate and uncorrected near were certainly very good.

Additionally, the trial’s defocus curve—a crucial measure of how well patients can focus at varying distances—revealed an unprecedented ability to provide seamless vision across all distances, a feat that sets it apart from any other IOL on the market today. “What’s remarkable is how well these eyes adapt,” Prof. Dr. Güell commented, highlighting how the innovative technology and the patients’ residual accommodation play a pivotal role in this achievement.

This exceptional performance aligns perfectly with the newly published continuous full range of vision categorization by the ESCRS Functional Vision Working Group. The defocus curve not only exemplifies the capabilities of the Artiplus but also meets the evidence-based classification that defines multifocal IOLs improving visual acuity from intermediate to near vision below 0.05 LogMAR.1

Satisfaction and safety Beyond visual acuity, the trial also examined patient satisfaction, with results revealing high levels of contentment with the procedure.

Approximately 98% of participants reported being either “quite” or “very” satisfied with their uncorrected vision. Specifically, 100% of patients were satisfied with their distance and intermediate vision, while 90% expressed satisfaction with their near vision.

Feedback from participants underscored the lens’s ability to deliver on its promises. In particular, 92% of patients reported never or only occasionally noticing glare, while 93% said they experienced minimal halos. These figures suggest that the Artiplus lens is achieving its goal of minimizing the visual disturbances often associated with multifocal lenses.

The occurrence of adverse events was minimal, with most issues resolving without long-term impact.

A few cases of dry eye (2), increased intraocular pressure (2), and mild inflammatory deposits on the IOL (3) were noted, but these were asymptomatic or resolved without

complications. One case of optic neuritis was recorded, though it was classified as unrelated to the device and later resolved. Overall, these findings indicated a strong safety profile for the Artiplus lens, with minimal complications observed during the first year.

Endothelial cell count (ECC) loss is a crucial metric for evaluating the long-term safety of IOLs, and the data for Artiplus, which was built on the trusted Artiflex platform, reflects this commitment to safety with a mean ECC loss of just -0.30% at six months. Prof. Dr. Güell emphasized that numerous studies support the long-term safety of the Artiflex platform, showing that when guidelines are adhered to, concerns about endothelial cell loss are minimal. Moreover, comparisons with both posterior and iris-fixated phakic IOL studies reveal similar ECC loss profiles, reinforcing the reliability of Artiplus in preserving endothelial health.2,3,4,5

and patient experience. It has the potential to reshape the landscape of presbyopia correction by providing a superior alternative to clear lens extraction (CLE), which carries risks such as retinal detachment and early cataract formation. As more data emerges, this lens could redefine the standards for presbyopia treatment, offering a stable and effective solution for those looking to enhance their visual quality without compromising their long-term eye health.

In terms of regulatory progress, Artiplus has already secured approval in Argentina and South Korea, where the first commercial units have been sold. Ophtec is now awaiting the CE green light from a European notified body. With CE approval on the horizon, patients and surgeons alike anticipate the availability of Artiplus across European markets.

The road ahead As the Artiplus trial moves into its second year, the ophthalmology community remains keen to see how these outcomes will evolve over time. With the interim results already demonstrating a high degree of success in terms of visual acuity, patient satisfaction and safety, there is considerable optimism surrounding the lens’s potential for wider adoption.

The Artiplus lens, with its innovative approach to presbyopia correction in phakic patients, offers a glimpse into the future of eye care—one that prioritizes both functional vision

Editor’s Note Reporting for this story took place during the 42nd Congress of the European Society of Cataract and Refractive Surgery (ESCRS 2024), held from 6-10 September in Barcelona, Spain.

References 1. Ribeiro F, Dick BH, Kohnen T, et al. Evidence-based functional classification of simultaneous vision intraocular lenses: seeking a global consensus by the ESCRS Functional Vision Working Group. J Cataract Refract Surg. 2024;50(8):794-798.

2. Jonker SMR, Berendschot TTJM, Ronden AE, et al. Five-year endothelial cell loss after implantation with Artiflex myopia and Artiflex toric phakic intraocular lenses. Am J Ophthalmol. 2018;194:110119.

3. Monteiro T, Correia FF, Franqueira N, et al. Long-term efficacy and safety results after iris-fixated foldable phakic intraocular lens for myopia and astigmatism: 6-year follow-up. J Cataract Refract Surg. 2021;47(2):211-220.

4. Papa-Vettorazzi MR, Moura-Coelho N, Manero F, et al. Long-term efficacy and safety profiles of iris-fixated foldable anterior chamber phakic intraocular lens implantation in eyes with more than 10 years of follow-up. J Cataract Refract Surg. 2022;48(9):987-992.

5. Papa-Vettorazzi MR, Güell JL, Cruz-Rodriguez JB, et al. Long-term efficacy and safety profiles after posterior chamber phakic intraocular lens implantation in eyes with more than 10 years of followup. J Cataract Refract Surg. 2022;48(7):813-818.

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CORNEAL TRANSPLANTS

Solving the Donor Crisis Innovative solutions are paving the way for more accessible and effective corneal treatments

by Diana Truong

Imagine a world where the waiting list for donor corneal tissue isn’t a looming number that haunts millions. Thanks to recent innovations, that reality might not be as far off as it once seemed. Here’s a glimpse into the exciting future that could reshape cornea transplantation forever.

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s Dr. Marjan Farid, director of Cornea, Cataract and Refractive Surgery at the University of California-Irvine (USA) Gavin Herbert Eye Institute, explained, “Corneal transplantation has come a long way over the past couple of decades.” The field has made great strides from penetrating keratoplasty—the full-thickness replacement of the cornea—toward more refined approaches. “Now, with the evolution of lamellar keratoplasty, we can transplant only the diseased part,” she added, referring to modern techniques like Descemet stripping endothelial keratoplasty (DSEK), Descemet membrane endothelial keratoplasty (DMEK), and deep anterior lamellar keratoplasty (DALK).

Yet even with these advancements, a critical challenge remains: A global shortage of donor tissue. With an estimated 12.7 million people waiting for a transplant, the demand far outweighs the supply. This reality has driven the exploration of

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novel transplantation methods— approaches that could alleviate the shortage and provide sustainable, scalable alternatives.1

Artificial corneas and bioengineered grafts Artificial corneal transplantation is not a new feat. Dr. Claes Dohlman (Sweden) first introduced Boston keratoprosthesis (KPro) back in 1965.

“It underwent multiple iterations and evolution to the current version we have today,” explained Dr. Farid. “But it carries with it a lot of risk including progression of glaucoma, infections, and corneal melts.”

CAKE MAGAZINE | November 2024

One promising development in artificial corneas is EndoArt® (EyeYon Medical; Ness Ziona, Israel), a 50-micron thick artificial endothelial prosthesis designed to block the influx of aqueous fluid from the anterior chamber. This flexible, easyto-store implant offers an alternative to traditional donor corneas. “This is working in higher-risk transplants,” reported Dr. Farid. “It has received approval in certain countries for highrisk eyes, and we’re looking forward to seeing it go into trials here in the US as well.”2 Another breakthrough is the CorNeat KPro (CorNeat Vision; Ra’anana, Israel), a synthetic cornea that bonds directly to the conjunctiva, eliminating the need for vascularized corneal tissue. It combines a polymethyl methacrylate (PMMA) optical core with an external biointegrating skirt, designed to support long-term stability and integration. While clinical trials are still ongoing, Dr. Farid pointed out that, “They’ve had some human surgeries, and while some have failed, others have succeeded.

We’re watching closely to see how it evolves.”3 On the horizon, there’s also work being done on bioengineered tissues. One particularly exciting development comes from Rafat et al., who conducted a clinical trial using double-crosslinked bioengineered porcine constructs (BPCDX) in patients with keratoconus. Implanted during a femtosecond laser-enabled intrastromal keratoplasty procedure, the BPCDX grafts led to significant improvements in visual acuity and a reduction in keratometry readings for the majority of the patients, with no cases of inflammation or rejection at 24 months.4

Natural corneal rings Traditionally, intrastromal corneal ring segments (ICRSs), made of PMMA, have long been used to treat keratoconus, but complications like extrusion pose ongoing challenges.

Building on ICRSs, corneal allogenic intrastromal ring segments (CAIRS), and corneal tissue addition keratoplasty (CTAK) reduced the risk of extrusion, but both require transplant-grade donor corneal tissue.

That’s where KeraNatural® (VisionGift; Boston, USA) steps in.

These rings are derived from donor corneas deemed unsuitable for full transplants and boast a shelf life of two years, making them a practical option for surgeons and patients alike.5

to treat multiple patients. Japan has already embraced this innovation by approving a corneal cell therapy called Vyznova® (Aurion Biotech; Seattle, USA), with additional therapies currently undergoing trials worldwide.8

Regenerative medicine and cell therapy

The challenges ahead

A new frontier in corneal decompensation is Descemet stripping only (DSO), where surgeons peel off the damaged Descemet membrane and rely on the patient’s own cells to regenerate.

“This works in eyes where the peripheral endothelial corneal cells are healthy,” explained Dr. Farid. “The thought is that those will migrate to the center, where we remove the diseased cells and repopulate in the central cornea.”

To enhance this process, rho-kinase inhibitors are utilized to promote faster corneal clearing. With clinical trial success rates reaching 90%, DSO offers significant promise for patients suffering from Fuchs endothelial corneal dystrophy (FECD).6 In addition to DSO, the development of cultured corneal endothelial cells (CECs) marks another groundbreaking advancement in corneal therapy. In a landmark study, researchers injected CECs derived from donor corneas into the eyes of patients with corneal decompensation. “I think cultured cells are the future for endothelial disease,” Dr. Farid predicted.7 These cells are cultured in the lab and injected into the anterior chamber, where they adhere to the back of the cornea and help to restore transparency. The results from trials were impressive, with significant improvements in vision and corneal thickness, and long-term follow-up studies have continued to show positive outcomes. “It amazingly clears the cornea, and it heals the endothelial disease,” remarked Dr. Farid. “These patients have almost very little to no risk of rejection.”7 A key advantage of CECs is their scalability; a single donor cornea can produce enough cultured cells

The novel approaches to corneal transplantation represent a seismic shift in how we treat corneal diseases. Yet, with innovation comes challenges.

“Expense is currently the top concern for both surgeons and patients,” Dr. Farid noted. The high costs and technical complexity associated with these cutting-edge procedures may be prohibitive, especially in low-resource settings.

And, while early data is promising, long-term outcomes for many of these techniques are still under investigation, leaving open questions about their sustainability and effectiveness over time.

Despite these hurdles, the future is undeniably bright. As techniques become more refined, costs could decrease and training could become more widespread, ensuring that more patients around the world can benefit from these life-changing procedures.

At the end of the day, the potential for more effective, accessible, and widely available corneal transplant options is not just a hope—it's an expectation.

Contributor Dr. Marjan Farid is a professor of Clinical Ophthalmology and director of Cornea, Refractive & Cataract Surgery at the Gavin Herbert Eye Institute, University of California-Irvine. Her clinical practice is divided between patient care, teaching, and research.

Her research interests focus on corneal surgery, specifically the use of the femtosecond laser for corneal transplantation. She is also the founder of the Severe Ocular Surface Disease Center at UCI which is recognized as a center of excellence as part of the Holland Foundation for Sight Restoration. She performs limbal stem cell transplants as well as artificial corneal transplantation for the treatment of patients with severe ocular surface disease.

She has served as chair of the Cornea Clinical Committee of ASCRS since 2021. Her work has been published in numerous peerreviewed journals, and she is the editor of two leading textbooks in her field and has authored multiple textbook chapters. Dr. Farid travels extensively to present her work as an invited professor at various ophthalmology institutes, as well as at multiple national and international meetings. mfarid@hs.uci.edu

References 1. Gain P, Jullienne R, He Z, et al. Global survey of corneal transplantation and eye banking. JAMA Ophthalmol. 2016;134(2):167-73.

2. Auffarth GU, Son HS, Koch M, et al. Implantation of an artificial endothelial layer for treatment of chronic corneal edema. Cornea. 2021;40(12):1633-1638.

3. Litvin G, Klein I, Litvin Y, et al. CorNeat Kpro: Ocular implantation study in rabbits. Cornea.

2021;40(9):1165-1174.

4. Rafat M, Jabbarvand M, Sharma N, Xeroudaki M, et al. Bioengineered corneal tissue for minimally invasive vision restoration in advanced keratoconus in two clinical cohorts. Nat Biotechnol.

2023;41(1):70-81.

5. Kramer EG, Boshnick EL. Scleral lenses in the treatment of post-LASIK ectasia and superficial neovascularization of intrastromal corneal ring segments. Cont Lens Anterior Eye. 2015;38(4):298303.

6. Colby K. Descemet stripping only for Fuchs endothelial corneal dystrophy: Will it become the gold standard? Cornea. 2022;41(3):269-271.

7. Kinoshita S, Koizumi N, Ueno M, et al. Injection of cultured cells with a ROCK inhibitor for bullous keratopathy. N Engl J Med. 2018;378:995-1003.

8. Ong HS, Ang M, Mehta JS. Evolution of therapies for the corneal endothelium: Past, present and future approaches. Br J Ophthalmol. 2021;105(4):454-467.

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From Trauma to Recovery Dr. Farhan Irshad shares tales, techniques and therapies for corneal repair and regeneration

by Diana Truong

Corneal trauma is one of the most common eye injuries, and its effects can be devastating, sometimes leaving permanent scars that cloud not only the patient’s eye but also their self-esteem. With modern treatments and innovative regenerative therapies, we’re now better equipped to heal these injuries. However, the journey from trauma to complete recovery is far from over.

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ye trauma accounts for approximately 3% of all emergency department visits, with corneal injuries representing the majority of these cases. The impact of such trauma can range from minor abrasions to severe injuries that threaten vision.

Traumatic incidents, often resulting from foreign bodies or abrasions, and exposure-related injuries, including chemical and thermal burns, can lead to long-lasting consequences. Each injury presents its own challenges, demanding immediate and appropriate responses to mitigate long-term damage.1 Dr. Farhan Irshad—a cornea specialist at the Eye Clinic of Austin in Texas, USA—shares healing mechanisms, explores current treatment options and highlights the latest developments in preserving the cornea.

More than meets the eye Corneal trauma can take many forms, each leaving its mark on the eye’s fragile architecture. From the sharp edge of a foreign body to the searing pain of chemical burns, corneal injuries disrupt not only its structural integrity but also its vital functions.

Common sources of corneal abrasion include everyday activities, such as woodworking or metal grinding, where high-speed projectiles can easily penetrate the eye. “For the majority of our patients… I would say it's foreign bodies,” noted Dr. Irshad. More severe injuries, like lacerations or perforations, often result from accidents involving power tools, with the nature of the projectile significantly influencing the damage.

The consequences of such injuries extend beyond physical harm, casting a shadow over one’s vision. Scarring from corneal trauma can impair light refraction, leading to diminished visual acuity and challenges in depth perception, which can dramatically alter a person's daily life and career.

penetration, the size of the corneal defect, and the location—whether central or peripheral—can certainly affect the outcome,” explained Dr. Irshad. An injury to the central cornea can have far more detrimental effects on vision compared to one located at the periphery.1

For instance, a 23-year-old patient came to Dr. Irshad with a deep corneal injury after a fish hook became embedded in his eye. This incident not only jeopardized his vision but also raised concerns about his ability to pursue his passions and livelihood.

For minor injuries, the corneal epithelium can regenerate relatively quickly, often within 24 to 48 hours.

However, larger defects require a more complex response, as cells ‘slide’ over the wound, and the basal layer must proliferate to restore normal thickness—a process that can take up to six weeks.2

The psychological impact of corneal injuries is profound and often overlooked. Beyond the physical pain and the potential for permanent vision loss, individuals may grapple with issues of self-esteem and body image, particularly when scarring affects the appearance of their eyes. “The scarring can affect cosmesis, which in turn affects someone's self-esteem and appearance,” Dr. Irshad pointed out.

“The depth of involvement of the traumatic injury, the severity of the penetration, the size of the corneal defect, and the location— whether central or peripheral— can certainly affect the outcome.”

These challenges can lead to feelings of depression and anxiety, significantly affecting one's quality of life. Recovery, therefore, must encompass more than just physical healing. It requires a holistic approach that addresses the emotional and psychological ramifications of living with the aftermath of corneal trauma.

Of natural healing and medical intervention When a corneal abrasion occurs, limbal stem cells play a crucial role, migrating to cover the defect with a single layer of epithelial cells. This process, however, is influenced by the size, depth and location of the injury.

“The depth of involvement of the traumatic injury, the severity of the

The cornea's unique structure, particularly its avascular nature, poses a challenge to this healing process.

“The cornea never really fully heals,” emphasized Dr. Irshad, highlighting the limitations of its regeneration capabilities.

Moreover, the presence of infections can severely hinder healing. A wound contaminated by a foreign body, such as a piece of glass, may complicate the recovery process, leading to prolonged healing and increased risk of scarring.

“Infections that result from trauma would obviously adversely affect outcomes,” Dr. Irshad explained.

Understanding the complexity of the corneal healing process highlights the importance of timely medical intervention and the potential need for surgical support in cases of severe trauma. With breakthroughs in medical science, we are better equipped to aid the cornea's recovery. However, the journey from trauma to regeneration remains a delicate balance of nature's healing mechanisms and medical expertise.

A multifaceted strategy for complex cases Treating corneal surface injuries has evolved to prioritize both

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healing and the prevention of further complications. The natural recovery process can be supported by treatments like antibiotics to prevent infection and medications for pain management, such as cycloplegic agents, which help to alleviate discomfort by relaxing the eye muscles.1 In more complex cases, however, treatment becomes multifaceted. For instance, corneal foreign bodies— like the fish hook case treated by Dr. Irshad—require immediate and careful removal to avoid long-term damage. “We ultimately removed the fish hook in the operating room and sutured the laceration closed,” he recalled.

Beyond these interventions, treatments such as amniotic membrane grafting and high doses of vitamin C are also utilized to enhance healing. According to Dr. Irshad, amniotic membrane grafting promotes rapid wound healing and provides a favorable environment for recovery, and vitamin C helps prompt collagen healing of the cornea.

While these treatments can be highly effective in halting further damage and promoting healing, they come with limitations. Suturing, for example, can save the eye, but carries risks of complications and involves operating room time. Amniotic membrane grafting can be costly and may not always be covered by insurance— making access a daunting hurdle for many patients.

And despite rapid intervention, complications such as scarring, limbal stem cell deficiency, or even secondary glaucoma can arise.1

"Just because you repair someone's cornea doesn't mean they will regain their vision.”

The initial treatment included antibiotics to prevent infection, but despite this early intervention, deeper issues can arise.

“Scarring was fairly deep into the stromal tissue… in the visual axis, causing irregular astigmatism and preventing him from being able to see,” explained Dr. Irshad.

This patient—left nearly legally blind—eventually required a corneal transplant to restore vision. The deep anterior lamellar keratoplasty (DALK) procedure saved the young man's eyesight.

Even with advances in corneal repair techniques, visual prognosis remains uncertain, particularly in cases involving deeper tissue damage. "Just because you repair someone's cornea doesn't mean they will regain their vision,” explained Dr. Irshad.

His fish hook patient’s vision improved to 20/60 post-DALK. Subsequent contact lens fitting brought it even closer to 20/30, showcasing the potential for recovery despite the initial severity of the injury. However, despite this significant improvement, the patient's vision remains slightly below average. While 20/30 vision is typically sufficient for most daily activities, it may still pose challenges for tasks requiring sharp, precise vision, such as reading small print or detailed work.

Moreover, traditional treatments like corneal transplants, though lifechanging, face challenges of donor shortages, the risks of rejection and prolonged recovery times. As the demand for corneal transplants far outweighs the availability of donor tissues globally, new approaches such as tissue engineering and regenerative therapies are being explored to address these limitations.

Promising therapies and techniques Emerging therapies and innovative techniques are sparking hope for more effective corneal surface repair treatments. At the forefront is stem cell therapy, a beacon for patients facing severe corneal epithelial injuries.

Stem cells, with their remarkable ability to self-renew and differentiate, are being harnessed to regenerate corneal epithelium. The integration of biological scaffolds—like amniotic membranes and hydrogels—provides the ideal environment for these cells to thrive. While these approaches show promise, they face challenges, particularly in retaining stem cells at the injury site, a hurdle that researchers are actively working to overcome.3 Tissue engineering has also made strides, with new scaffolds designed to improve stem cell retention and mimic the natural extracellular matrix of the cornea.

The progression has evolved from simple two-dimensional structures to more complex, customizable designs, such as 3D-printed hydrogels. This advancement allows

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for a more tailored approach to repair, enhancing the potential for successful outcomes in corneal injuries.3

complexity and perseverance.

Corneal injuries, once feared for their potential to leave lasting scars are now met with a range of treatments that blend the ingenuity of modern medicine with the body’s natural healing processes.

Contributor

1. Willmann D, Fu L & Melanson SW. Corneal Injury. StatPearls Publishing, Treasure Island. July 17, 2023. Available at: https://www.ncbi.nlm.nih.gov/books/NBK459283/. Accessed on: October 1, 2024.

Dr. Farhan A. Irshad, MD, FACS, is a board-certified ophthalmologist fellowshiptrained in cornea, anterior segment, and refractive surgery.

He specializes in laser cataract and clear lens exchange surgery, including light-adjustable lens, corneal transplantation, minimally invasive glaucoma surgery, LASIK and refractive surgery, implantable collamer lenses (ICLs), pterygiums and cancers of the anterior segment, and ocular surface reconstruction. Dr. Irshad double-majored in Biology and Finance at Washington University and then received his Doctorate of Medicine at the University of Tennessee Health Sciences Center. He completed his residency in ophthalmology, followed by a special fellowship, at Tulane School of Medicine. He is currently an associate clinical professor of ophthalmology at Tulane Medical Center and an affiliate faculty at Dell Medical School. He has served on the medical advisory board at Southern Eye Bank and the Medical Executive Committee. Currently, Dr. Irshad is a diplomate of the American Board of Ophthalmology, as well as a fellow of the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery. He is also a Fellow of the American College of Surgeons and participates in monthly Austin Ophthalmology Society meetings. He has several publications in peer-reviewed journals and recently published a chapter on microinvasive glaucoma surgery in Chandler and Grant’s Glaucoma textbook in 2021.

He contributes to Habitat for Humanity, volunteers on medical mission trips to Mexico with the World Cataract Foundation, and performs vision and glaucoma screenings in underserved communities. Married with three boys, Dr. Irshad’s passions include hiking, traveling, and racecar driving and instructing.

2. Barrientez B, Nicholas SE, Whelchel A, et al. Corneal injury: Clinical and molecular aspects. Exp Eye Res. 2019;186:107709.

firshad@eyeclinicofaustin.com

“We typically use an artificial cornea when someone's failed a regular corneal transplant three times.”

On the surgical front, keratoprosthesis offers a viable alternative for patients with recurring transplant failures. While this artificial cornea can be a lifesaver, it comes with a hefty price tag, often reserved for those who have exhausted other options.

“It’s much more expensive than suitable donor tissue,” Dr. Irshad shared. “We typically use an artificial cornea when someone's failed a regular corneal transplant three times,” he added, illustrating the challenge of balancing cost and accessibility in treatment options.

Redefining possibilities for patients As we stand on the brink of groundbreaking advancements in corneal repair and regeneration, it's clear that the journey from trauma to recovery is one of remarkable

Yet, as Dr. Irshad and his patient’s story reveal, even the most advanced therapies do not guarantee full restoration. The cornea, though resilient, bears the weight of each trauma, and healing is rarely straightforward.

What remains hopeful, however, is the progress being made in regenerative therapies and innovative surgical techniques. Stem cell research, tissue engineering and keratoprosthesis are no longer distant dreams—they represent tangible solutions that are slowly reshaping the future of ophthalmology.

With each new clinical trial and success story, we move closer to a time when corneal injuries, no matter the severity, can be treated with greater certainty and improved outcomes.

This progress comes with its own set of challenges.

Accessibility, affordability and the intricate balance of patient care must all be considered as we forge ahead. The work is far from over, but with each step, the window of hope opens wider, offering patients the chance not just to recover their vision but to reclaim their lives.

References

3. Wang M, Li Y, Wang H, et al. Corneal regeneration strategies: From stem cell therapy to tissue engineered stem cell scaffolds. Biomed Pharmacother. 2023;165:115206.

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IOL TECH

SIFI’s Ultimate Vision Mastering Sight with Wavefront Engineering and Innovative Ocular Surface Management

by Tan Sher Lynn and Gloria D. Gamat

calculations meeting the target within 0.5 D in 70-80% of cases.

“Because sometimes even the best biometer can make wrong measurements. And not all biometers are fully interchangeable. The best method in my opinion is the ESCRS IOL calculator because this has the most modern formula and the most accurate one,” he added.

Dr. Savini noted that these steps are crucial for improving the accuracy of IOL power calculations and enhancing overall patient satisfaction. “Focus on preoperative measurements, cross-check data from multiple devices, and refine the constants used in IOL formulas,” Dr. Savini concluded.

Comparative clinical evaluation: EVOLUX® vs.

TECNIS EyhanceTM IOLs

O

n Day 4 of the 42nd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS 2024), SIFI (Catania, Italy), in a special symposium, highlighted the company’s groundbreaking wavefront engineering technology that is designed to elevate intraocular lens (IOL) performance across all visual distances.

preoperative measurements and using more than one optical biometer to ensure precision. Constant optimization, another crucial factor, was discussed in detail.

Insights on advanced biometry and constant optimization

“For better outcomes, you should validate your measurements, use more than one optical biometer and to optimize your process – this is an ongoing effort that never stops. We have to make accurate calculations and be aware of the refractive outcomes… that we are not perfect, and that should be communicated to the patients,” explained Dr. Savini.

As the first speaker, Dr. Savini presented advanced biometry techniques, emphasizing the critical role of precision in achieving optimal outcomes with extended monofocal IOLs, such as the EVOLUX®. Also, he highlighted the necessity of validating

Dr. Savini also stressed the importance of using modern IOL calculation formulas like Barrett Universal II and EVO 2.0. However, despite technological advancements, achieving 100% accuracy remains elusive, with current IOL power

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In a comparative clinical evaluation, Prof. Oliver Findl (Austria) and his team at the Vienna Institute for Research in Ocular Surgery (VIROS) assessed the performance of the SIFI EVOLUX® IOL against the TECNIS EyhanceTM IOL (Johnson & Johnson Vision). This singlecenter, randomized, doublemasked, controlled trial included 35 participants (70 eyes), with each eye receiving either the EVOLUX® or TECNIS EyhanceTM lens. The study focused on visual outcomes, including near (40 cm), intermediate (66 cm) and distance (4 m) vision, as well as contrast sensitivity, glare and halo measurements.

The findings revealed that both IOLs delivered comparable distance and intermediate vision performance.

By the 3-month mark, contrast sensitivity and photic phenomena outcomes also showed minimal differences between the two lenses, further underscoring their similarity in performance.

Overall, the EVOLUX® IOL demonstrated very similar visual outcomes to the TECNIS EyhanceTM, making it a viable option for patients seeking enhanced vision postcataract surgery.

“The perceived vision at near was actually a little better for the SIFI eyes, but it was not statistically

significant. Over-all, the patients did not see any difference between the two eyes (EVOLUX® vs TECNIS EyhanceTM),” Prof. Findl noted.

EVOLUX® long term clinical outcomes show positive results in patients Dr. Kresimir Gabric’s eye clinic in Zagreb, Croatia (Eye Clinic Svjetlost Zagreb) has implanted more than 25,000 presbyopia-correcting since 1999 and has explored many IOL platforms. “In the last four years alone, we have implanted more than 8,000 premium IOLs,” Dr. Gabric shared. Dr. Gabric presented clinical long-term results on a large number of patients with the new EVOLUX® IOL platform. “Over 12 months ago we analyzed 230 eyes with a mean follow-up of 6 months,” shared Dr. Gabric.

In highlighting some of the most important points of the outcomes, Dr. Gabric presented data demonstrating that the EVOLUX® maintained contrast sensitivity, indicating that the lens not only showed good vision in normal lighting, but also maintained quality of vision in challenging lighting conditions.

“EVOLUX® is a great new addition to the IOL portfolio offering great uncorrected vision for distance and intermediate needs, with some usable near visual acuity,” added Dr. Gabric. Our experience with implantations and follow-ups shows great patient satisfaction and low patient reported issues with the lens. EVOLUX®, for us, represents

Prof. Giacomo Savini

a fundamental shift in standard of care,” he concluded.

WELL Fusion® System outperforms trifocal IOLs in presbyopia correction Prof. Emilio Pedrotti (Italy), discussed the performance of extended depth of focus (EDoF) IOLs versus trifocal IOLs in patients undergoing bilateral implantation.

“The idea to combine two different IOLs in both eyes in order to achieve a better extended depth of focus is not new. And when SIFI proposed this system – two IOLs that share the same platform, I was convinced,” Prof. Pedrotti shared.

According to Prof. Pedrotti, the WELL Fusion® System combines two EDoF non-diffractive IOLs (Mini WELL® and Mini WELL PROXA®). Patients with the WELL Fusion® System reported high visual acuity at all distances, from near to far, and exhibited continuous vision up to 33 cm. The WELL Fusion® System also provided an extended depth of focus of 4.5 D, allowing for complete presbyopia correction.

Notably, patients implanted with the WELL Fusion® System experienced higher satisfaction rates, with a significant reduction in glare and other photic phenomena compared to those with trifocal IOLs. Additionally, the WELL Fusion® System achieved higher spectacle independence, allowing patients to perform daily activities with minimal reliance on corrective eyewear.

Prof. Oliver Findl

“In conclusion, the WELL Fusion® System showed significantly better results in terms of quality of vision in both objective and subjective performances and with higher patient satisfaction.”

— Prof. Emilio Pedrotti

Overall, the WELL Fusion® System demonstrated superior performance in terms of visual outcomes and patient satisfaction, making it a highly effective option for presbyopia correction in cataract surgery.

“In conclusion, the WELL Fusion® System showed significantly better results in terms of quality of vision in both objective and subjective performances and with higher patient satisfaction,” Prof. Pedrotti summarized.

Optimizing ocular surface health for better cataract surgery outcomes In modern cataract surgery, taking care of the ocular surface is essential for ensuring positive outcomes.

According to Prof. Rita Mencucci from the University of Florence (Italy), comprehensive pre- and postoperative therapies, including NSAIDs, antiseptics, lubricants and steroids, play a pivotal role in patient recovery. However, complications such as dry eye disease (DED), inflammation and infection remain concerns, potentially leading to discomfort and reduced visual outcomes.

Cataract surgery-related dry eye stems from inflammation, hyperosmolarity and tear film instability, which disrupt ocular surface homeostasis. Prof. Mencucci highlighted that up to 50% of patients undergoing cataract surgery show signs of corneal damage and reduced tear stability. Addressing these issues through innovative treatments,

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IOL TECH

like dual polymer lubricating eye drops containing osmoprotectants, can improve tear film stability and alleviate dry eye symptoms.

“The end of the operative period is the beginning of the real nightmare, not just for the patient, but for the surgeon too. It is a postoperative discomfort,” emphasized Prof.

Mencucci.

Postoperative management also involves controlling inflammation and preventing infections. The use of antibiotics, especially intracameral cefuroxime and moxifloxacin, has proven effective in reducing endophthalmitis risk. Emerging treatments, such as ophthalmic gels based on xanthan gum, offer additional benefits by enhancing ocular hydration and wound healing.

Ophthalmic hydrogel formulations containing netilmicin/dexamethasone have demonstrated efficacy and safety in treating inflammation and preventing infection after cataract surgery. In addition, she shared a study that demonstrated that xanthan gum 0.2% + desonide sodium phosphate 0.025% eye drops were effective in reducing ocular surface disease symptoms and signs after cataract surgery.

“As a new solution, the inclusion of xanthan gum in ophthalmic solutions increases the satisfaction in both patient and surgeon,” concluded Prof.

Mencucci.

Posters and papers presented at ESCRS 2024 Dr. Victor Caparas and his team from The Medical City (Manila, Philippines), presented data at an ESCRS poster session on longterm visual outcomes following the implantation of EVOLUX® in twenty-three patients (46 eyes).

Their evaluation compared these long-term results to the immediate postoperative period.

Results showed that at both the early (90-105 days) and long-term (6-12 months) postoperative periods, bilateral implantation of the extended monofocal EVOLUX® IOL led to excellent distance vision, very good extended intermediate vision and very good near vision. The quality of

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Dr. Kresimir Gabric

Prof. Emilio Pedrotti

vision was notably high, as reflected by strong contrast sensitivity and a low incidence of photic phenomena.

Additionally, high scores on the (Quality of Vision) questionnaire confirmed strong patient acceptability and satisfaction.

Similarly, preliminary outcomes of EVOLUX® IOL patients presented

by Dr. Giovanni Romualdi and Prof.

Rita Mencucci in another poster at ESCRS 2024 shows good refractive accuracy and visual outcomes after cataract surgery.

Furthermore, data from an ESCRS 2024 poster presented by Dr. Savini and colleagues demonstrated that a new enhanced monofocal IOL (EVOLUX®) provides patients with improved DCIVA and DCNVA compared to the standard monofocal IOL with no loss of contrast sensitivity and no subjective visual disturbances.

In a cataract poster at ESCRS 2024, Dr. Camilla Pagnacco and colleagues from the University of Verona (Italy), presented data demonstrating the visual performance in terms of quality of vision and visual outcomes after bilateral implantation of extended monofocal IOL. Twenty patients (40 eyes) underwent bilateral implantation of EVOLUX®.

EVOLUX® IOLs demonstrated a good safety profile and excellent visual performance at all distances.

Patients had very good contrast sensitivity and high satisfaction in both objective and subjective evaluations of vision. Importantly, no patient needed YAG-laser capsulotomy.

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Prof. Rita Mencucci

In addition, Dr. Mercedes MoleroSenosiain and colleagues from Hospital Clínico San Carlos (Madrid, Spain), presented a poster at ESCRS 2024 reporting on the outcomes of a new ophthalmic solution containing sodium hyaluronate, osmoprotectants and xanthan gum in patients with dry eye disease (DED) after three months of treatment. The study demonstrated that this preservativefree solution significantly improved signs, symptoms, and quality of life in DED patients, with noticeable improvements observed as early as one month into treatment.

Editor’s Note Reporting for this story took place at the 42nd Congress of the European Society of Cataract and Refractive Surgery (ESCRS 2024), held from 6-10 September in Barcelona, Spain.

A version of this article was first published on cakemagazine.org.

WOMEN IN OPHTHALMOLOGY

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Doctor of Many Hats With surgery, research and mentorship, Dr. Clara Chan is on a mission to revolutionize corneal care

by Chow Ee-Tan

With a background in economics from Stanford University, Dr. Clara Chan made a pivotal shift to medicine, training under renowned mentors like Dr. David Rootman and Dr. Edward Holland. Today, Dr. Chan is a leading authority in corneal surgery in Canada, dedicated to enhancing treatment options and training the next generation of ophthalmologists.

W

earing many hats, Dr. Clara Chan is a corneal specialist, refractive surgeon, researcher, and academician who takes on multiple roles in Canada's ophthalmology fraternity. She serves as an associate professor of ophthalmology at the University of Toronto, where she teaches residents and fellows at two academic centers: Toronto Western Hospital and St. Michael’s Hospital.

In addition to performing corneal transplantation and cataract surgeries, ocular surface rehabilitation, and refractive surgeries, she also runs a private practice with an associate and conducts refractive cataract and laser vision correction surgeries at a private laser clinic.

From Silicon Valley to surgical suites It is not surprising then that Dr. Chan, a second-generation Chinese Canadian, has excelled since a young age. Her parents, both professionals in the healthcare industry, immigrated from Hong Kong to Toronto in the 1970s. After high school, Dr. Chan was admitted to Stanford University as an undergraduate, where she majored in economics and completed pre-med courses.

“During my college summers, I interned at an investment banking firm, Goldman Sachs, and a small start-up at the time called Google.

I was tempted to stay in Silicon Valley to work after graduation,” she recalled.

“However, my path ultimately led me to medical school, where I had the opportunity to spend a summer working in a cornea clinic and doing research with the world-renowned cornea surgeon Dr. David Rootman, who became one of my chief mentors,” Dr. Chan shared.

That experience solidified Dr. Chan’s ambition to pursue ophthalmology, particularly her interest in cornea, cataract, and refractive surgery—which was also sparked by working with Dr. Rootman. In 2001, she returned to Canada for medical school and completed her ophthalmology residency, followed by a cornea fellowship in the US. Eventually, she was recruited back to the University of Toronto, where she has been practicing for the last 15 years.

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WOMEN IN OPHTHALMOLOGY

Needless to say, Dr. Chan enjoys the ‘fast-paced, high-volume, highimpact clinics, as well as the fine microsurgery techniques’ involved in suturing a cornea transplant or performing cataract surgery.

“Striving for a clear cornea or a perfectly circular capsulorhexis appeals to my appreciation of symmetry and organization,” she shared. “I enjoy the ability to make a visual diagnosis, and I feel compelled to master the superb surgical skills and fine manual dexterity required in this field.”

Training under a luminary in cornea surgery During her residency, Dr. Chan dedicated her free time to the cornea clinics and operating rooms. When it came time to apply for fellowships, she felt fortunate to train with Dr. Edward Holland at the Cincinnati Eye Institute.

Dr. Holland is a world expert in cornea and ocular surface disease, having pioneered surgical techniques to manage the complex condition known as limbal stem cell deficiency.

Learning cornea surgeries and seeing a wide range of pathologies—as well as conducting research and networking with industry leaders— opened new doors for her.

Dr. Chan is passionate about research and has published over 140 papers and abstracts, which she has presented at conferences and meetings around the world.

“My husband, who is also a physician, jokes that doing research is my hobby,” shared Dr. Chan. “After spending the evening with my family and putting my nine-year-old son to bed, I often spend a few hours each night working on research projects, guiding trainees in manuscript preparations, taking conference calls

with industry reps, and preparing lectures.”

“I feel fortunate to work at a tertiary cornea center in a big multicultural city, where I see a high volume of complex cornea diseases and have access to a multitude of treatment modalities, both medical and surgical,” she continued. “I feel a sense of responsibility to make a greater impact through publications, teaching at meetings, and sharing our research findings—so that other ophthalmologists and their patients around the world can benefit from them,” she enthused.

Some of Dr. Chan’s research interests include cell-based therapies for corneal endothelial disease, enhancing corneal wound healing and improving ocular surface reconstruction outcomes for limbal stem cell deficiency, which can result from chemical injuries, genetic mutations like aniridia or chronic inflammatory conditions like StevensJohnson syndrome.

Breaking new ground Earlier this year, Dr. Chan became the first one in Canada to perform endothelial cell injection therapy as part of Aurion Biotech’s CLARA trial.

“This exciting technology has the potential to address the shortage of donor corneas worldwide, as 200 injections can be manufactured from just one donor cornea,” she explained. “Our group has also published on the use of dehydrated amniotic membrane, which can be stored at room temperature, as well as serum tears, other blood products, and insulin drops. These drops are nutrient and growth factor supportive modalities aimed at accelerating corneal surface healing and reducing ocular surface inflammation,” she added.

Subsequently, her group’s collaborations with transplant medicine specialists have led to a modified systemic immunosuppression regimen to help patients undergoing limbal stem cell transplants from deceased donors achieve outcomes similar to those receiving tissue from living matched donors.

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A commitment to peer support

and their surgical skills grow as they progress through their training.

As if her busy practice weren’t enough, Dr. Chan is also deeply involved with various ophthalmology associations and holds professional memberships both in Canada and internationally.

She is the president of the Canadian Cornea, External Disease and Refractive Surgery Society, where one of her primary responsibilities is organizing the agendas for cornea and refractive meeting sessions at the annual meeting of the Canadian Ophthalmological Society.

“The most inspiring is seeing them return to their home countries to establish their own cornea practices, become leaders in the field locally and internationally and share their knowledge from the podium at conferences or have their names featured “I am also in publications,” she remarked. one of the

founding editors of Canadian Eyecare Today, the only peerto-peer journal distributed quarterly to all Canadian ophthalmologists and optometrists.”

Additionally, she is one of the Cornea Section editors for the Canadian Journal of Ophthalmology, which currently ranks as the 12th highest in impact factor among ophthalmology journals.

“I am also one of the founding editors of Canadian Eyecare Today, the only peer-to-peer journal distributed quarterly to all Canadian ophthalmologists and optometrists,” she continued. “With the American Academy of Ophthalmology, I sit on the committee that evaluates the annual surgical skills courses to ensure those selected remain relevant, up to date, and of high quality for the attendees. With the American Society of Cataract and Refractive Surgeons (ASCRS), I was the Cornea section editor for Eyeworld, the organization’s official magazine for almost 10 years, curating their cornea-related educational content for each edition.”

Connecting through mentorship Dr. Chan feels a profound sense of pride as she watches each of her cornea fellows graduate.

Over the years she has trained 38 ophthalmologists from around the world and finds it very rewarding to see their knowledge base expand

Dr. Chan often receives messages from her former fellows, reaching out for advice about a patient case, sharing a research idea or recounting surgical insights they gained during their time with her that have helped them tackle tough cases.

“Or sometimes they just message to say ‘hi’. That feeling of human connection—knowing that the fellows I have helped to train are now making a difference for thousands of their own patients—is just as energizing as the endorphin rush of seeing a 20/20-happy post-op cataract patient!” she quipped.

Life beyond the OR Dr. Chan thrives on the variety and diversity of her multiple roles, skillfully managing and organizing her weekly schedule with aplomb.

“Usually, I do three days of surgery a week—a day of transplants, a day of cataracts, and a day of either minor procedures like pterygiums and superficial keratectomies or refractive surgery,” she shared.

“Clinic days are packed with about 60 to 80 patients, and each week, I spend half a day in my role as the medical director of our provincial Eye Bank, which processes and distributes cornea and other ocular tissues, amniotic membrane, and research/training eyes.”

Despite her numerous commitments and responsibilities, Dr. Chan, a master of time management, prioritizes having a work-life balance.

She shared that she uses a Google Calendar, which is accessible to both her family and her administrative staff at all the sites where she works—to stay organized.

“We live near a great hiking trail, so I love going out for walks or enjoying dinners out with my husband and son,” she said. “We also plan our vacations a year in advance, and I really love exploring different cities with them and attending live sporting events. Once you have kids, it forces you to find that work-life balance.

They are relentless in demanding your attention, so you quickly learn to use any free time efficiently,” she concluded.

Contributor Dr. Clara C. Chan, MD, FRCSC, FACS, is an associate professor of ophthalmology at the University of Toronto and serves as the president of the Canadian Cornea Society. She teaches fellows as part of the Cornea fellowship program and is the medical director of the Eye Bank of Canada, Ontario Division. After her undergraduate studies at Stanford University, she completed medical school at Queen’s University, her ophthalmology residency at the University of Toronto, and her cornea fellowship at the Cincinnati Eye Institute with Dr. Edward Holland. Dr. Chan has published more than 145 peer-reviewed papers and received the American Academy of Ophthalmology Senior Achievement Award in 2024.

Additionally, she is the Cornea editor emeritus for the ASCRS EyeWorld magazine, the Cornea section editor for the Canadian Journal of Ophthalmology, and the founding editor of the Canadian Eye Care Today journal. Most recently, Dr. Chan was included in The 2023 Ophthalmologist Power List, which recognizes the top 100 most influential global figures in ophthalmology. clara.chan@uhn.ca

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CORNEAL IMAGING

The All-New Pentacam Cornea OCT Offers Synergy for the Future of Corneal Assessment

by Matt Herman

OCULUS' latest innovation, the Pentacam® Cornea OCT, made its highly anticipated debut at ESCRS 2024 in Barcelona—and some of the biggest names in ocular surgery believe it could forever alter the way that ophthalmologists approach corneal assessment.

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he OCULUS Pentacam saw its latest evolution step onto the world stage in eye care at the 42nd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS 2024) in the form of the Pentacam Cornea OCT. But does it deliver on its next-generation promises for corneal assessment in refractive surgery—and ophthalmic medicine in general?

Experts like Prof. Damien Gatinel (France), Dr. Pooja Khamar (India), Dr. Riccardo Vinciguerra (Italy) and Dr. Renato Ambrósio, Jr. (Brazil) think so—and they stepped up to the podium at an ESCRS 2024 Day 2 lunch symposium to explain why.

From the class-leading resolution (1.9 µm) and scanning radius (15mm) on its onboard OCT to simultaneous, fully integrated Scheimpflug imaging, these doctors believe that this next generation of Pentacam is a notable leap forward—and the implications for the way ophthalmologists practice medicine could be profound.

The power to perceive “Eyes cannot find what the mind does not seek, nor see without the power to perceive.” With this potent quotation, world-famous

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anterior segment surgeon Dr. Renato Ambrósio, Jr. outlined his vision on how the OCULUS Pentacam Cornea OCT enables ophthalmic surgeons to imagine—and attain—new heights in their practice.

According to Dr. Ambrósio, there has been a paradigm shift in the way ophthalmologists are approaching corneal procedures: the simultaneous integration of a vast array of data, including corneal biomechanics from OCULUS’ Corvis® ST, into preoperative corneal assessment.

“It’s important to note that with the evolution of imaging, we must now use biomechanical properties as well,” he said, citing a paper he co-authored with co-presenter Dr. Riccardo Vinciguerra (Italy).1 This paradigm shift has brought together a variety of tools to the surgeon for screening, diagnosing and treating patients with keratoconus and corneal ectasias.

For Dr. Ambrósio, the Pentacam Cornea OCT represents the culmination of combining these tools into one central hub to gain new insights and analyses on the cornea not previously possible—in other words, synergism.

CAKE MAGAZINE | November 2024

Dr. Renato Ambrósio, Jr.

“Synergism is when one plus one equals more than two. When you only have OCT [imaging], that’s a limiting factor. But we now also have [corneal] geometry because the Scheimpflug image is taken simultaneously with the OCT,” he said.

The result, for Dr. Ambrósio, is an unprecedented new way of looking at the cornea. “It’s very impressive and you have a lot of data,” he noted.

“This synergism is important because you have a huge scan of the cornea.

This leads to a high amount of data for things like power calculation.”

The possibilities for such a massive amount of high granular data have not yet been fully realized, but there are current applications, such as epithelial mapping, that are already causing a sea change in corneal assessment.

Dr. Ambrósio believes not only in the power of these measurements, but also in their quality— setting a new standard in corneal assessment.

“We found high repeatability and reproducibility,” he said, summarizing an in-house OCULUS study that he participated in. “A small standard deviation of sub three microns makes it state-of-the-art in precision for epithelial thickness mapping.

“Synergism is when one plus one equals more than two. When you only have OCT [imaging], that’s a limiting factor. But we now also have [corneal] geometry because the Scheimpflug image is taken simultaneously with the OCT.”

Digging deeper into layers Rising anterior segment star Dr. Pooja Khamar thinks that the future of corneal assessment for corneal surgery is in layers, and that the Pentacam Cornea OCT is uniquely positioned as the single device to get surgeons there.

Her presentation revolved around the Pentacam Cornea OCT’s ability to visualize — Dr. Renato Ambrósio, Jr. a cross-section of the cornea—and especially at the high resolution needed to analyze corneal structures like Bowman’s and Dua’s layers.

“Predictability of better postrefractive outcomes necessitates a

multi-pronged approach involving the whole of the cornea—layer by layer,” she said.

Although topography and biomechanics are crucial in planning, Dr. Khamar thinks that there’s another oft-overlooked piece of the puzzle—one that Pentacam Cornea OCT holds the key to. “Understanding epithelial patterns and the dynamics of epithelial remodeling is becoming an essential skill for every refractive surgeon,” she noted.

One example she gave of this involves analyzing Bowman’s layer with Pentacam Cornea OCT and the use of Bowman’s roughness index (BRI), a biomarker brought to the mainstream by research from Dr. Rohit Shetty that she had a hand in.

2,3 “Because of the resolution of the OCT, you can very beautifully look at the condition of the patient’s Bowman’s layer,” she said, giving examples of patients who underwent SMILE (ZEISS; Jena, Germany), KLEx procedures like SILK (Johnson & Johnson Vision; Irvine, USA) and SmartSight (Schwind eye-techsolutions; Kleinostheim, Germany).

Dua’s layer is another structure of interest, according to Dr. Khamar, and there’s one area in particular that it helps with, thanks to the resolution—and novel scanning geometry—of the Pentacam Cornea OCT. She highlighted this as she drew to the end of her presentation.

“Sometimes, it's very difficult to image Dua’s layer, because of the parallel [to the optical axis] structure of the rays of other OCTs,” she said.

“But we are now able to image this layer—and that has a very important role when it comes to acutely high drops in keratoconus. You can now also see that [with Pentacam Cornea OCT], which is something we would have missed otherwise”

The evolution of refractive diagnostics Influential cornea researcher Dr. Riccardo Vinciguerra echoed Dr. Khamar’s comments and went a step further with his turn on the podium.

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For Dr. Vinciguerra, the Pentacam Cornea OCT gives modern surgeons unprecedented access to what he believes is the new essential triangle of refractive diagnostics— Scheimpflug tomography, cornea OCT imaging and biomechanics.

“In 2013, biomechanics was research,” said Dr. Vinciguerra. But things have changed, and markers like stiffness parameters, the Corvis biomechanical index (CBI), and tomographic biomechanical index (TBI) are standard practice.

And now, according to Dr. Vinciguerra, corneal assessment is evolving again with the debut of Pentacam Cornea OCT and its full integration of this triangle. Dr. Vinciguerra’s talk revolved around two topics that point to a new necessity for including OCT—ectasia detection and fixing complications in refractive surgery.

For detecting keratoconus, Dr. Vinciguerra pointed to OCT as

a third essential component, in addition to tomography and biomechanical assessment. In the cycle of keratoconus, as he called it, Dr. Vinciguerra discussed the technology’s indispensability.

“It’s not possible to have a change in corneal curvature, thickness, epithelium and elevation without a previous trigger,” he said.

“Biomechanics must be the first to change, in addition to, potentially, tear film changes.”

OCT, he noted, is a fundamental confirmation of the diagnosis. Dr. Vinciguerra pointed out that it increases sensitivity by a significant degree—but there is one other key that pushes it over the edge. “We need OCT because it might improve the sensitivity of our device and thus the detection of keratoconus,” he began, pointing to a recent study on the role of advanced biomarkers on keratoconus diagnosis.4

“But what I believe is that, most of the time, it will also improve the specificity. It will tell you this looks like keratoconus, but the epithelium is thick in an area where it’s not steep, for example, so it’s not keratoconus.”

After presenting some cases corroborating these observations, he turned his attention to what he sees as the critical role of corneal epithelial mapping in the modern corneal assessment paradigm for refractive surgery planning and ectasia detection. “When do you need an epithelial map? Always,” he said.

“You need it in pre-op, particularly for trans PK. You need it all the time in PTK. You need it in normal post-op to evaluate remodeling regression, and if you have an abnormal post-op, you need it to fix,” he said.

Dr. Vinciguerra’s final case presentation was an illuminating one.

For those who question the need for Pentacam Cornea OCT’s ultrafine 1.9 µm resolution, he showed just why that might cost some patient’s vision—a hyperopic scar underneath a PRK flap. “In this case, it is really crucial to know how to treat the patient,” he said. And without the Pentacam Cornea OCT’s resolution necessary to detect this scar, this case would have gone completely differently.

“Tomography is always mandatory,” he said in conclusion. “Corneal biomechanics has been shown to help in many ways, and OCT with epithelial map is now a fundamental tool for screening, post-refractive surgery and fixing complications.”

Dr. Riccardo Vinciguerra

Dr. Pooja Khamar

References 1. Vinciguerra R, Ambrósio R Jr, Elsheikh A, et al. Detection of Keratoconus With a New Biomechanical Index. J Refract Surg. 2016;32(12):803-810.

2. Shroff R, Francis M, Pahuja N, Veeboy L, Shetty R, Sinha Roy A. Quantitative Evaluation of Microdistortions in Bowman's Layer and Corneal Deformation after Small Incision Lenticule Extraction. Transl Vis Sci Technol. 2016;5(5):12.

3. Shetty R, Francis M, Shroff R, et al. Corneal Biomechanical Changes and Tissue Remodeling After SMILE and LASIK. Invest Ophthalmol Vis Sci. 2017;58(13):5703-5712.

4. Kenia VP, Kenia RV, Maru S, Pirdankar OH. Role of corneal epithelial mapping, Corvis biomechanical index, and artificial intelligence-based tomographic biomechanical index in diagnosing spectrum of keratoconus. Oman J Ophthalmol. 2023;16(2):276-280.

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Tools, these doctors believe, whose natural synergy is realized for the first time on the OCULUS Pentacam Cornea OCT.

Editor’s Note Reporting for this story took place at the 42nd Congress of the European Society of Cataract and Refractive Surgery (ESCRS 2024), held from 6-10 September in Barcelona, Spain.

EYE BANKING

nlightenment

that people fear that could dissuade future donors if they were to hear about it, and I think that is a valid concern.”

Cash, Corneas and Controversy How for-profit entities are changing the game in eye banking

by April Ingram

In the previous issue of CAKE Magazine, we discussed the not-for-profit model of eye banking and corneal donation.

In this issue—to provide a balanced perspective, we will explore the other side of the coin: The for-profit model and its mission, including its history, while also dispelling a few myths along the way!

D

r. Samera Ahmad, a fellow in corneal and external diseases at the Bascom Palmer Eye Institute in Miami, Florida, holds a Master’s in Bioethics with a focus on eye banking—making her an expert on this topic and its ethical implications.

“Eye banking has changed significantly in the last several decades, and for-profit eye banking raises many challenging ethical questions. After all, any for-profit endeavor in a donation-based space is bound to provoke scrutiny,” noted Dr. Ahmad.

To gain a better understanding of some of the questions and concerns raised by corneal surgeons and eye bank leadership, Dr. Ahmad and colleagues from Emory University conducted an interview study involving 50 US-based corneal surgeons and 25 eye bank leaders.

The findings were published in the journal Cornea in 2020.* “We found that the majority of corneal surgeons interviewed held some ethical concerns with the emergence of for-profit eye banking,” Dr. Ahmad shared some of the study results. “One major concern was

“Eye banking has changed significantly in the last several decades, and for-profit eye banking raises many challenging ethical questions.

After all, any forprofit endeavor in a donation-based space is bound to provoke scrutiny.”

— Dr. Samera Ahmad

Interestingly, many participants also recognized the potential benefits of the for-profit model. “On the other hand, many feel that the research and development initiatives spurred by for-profit entities could justify their approach,” she noted.

The role of investment in eye banking To learn more about the for-profit model, we spoke with Mr. Bernie Iliakis, who has been involved in eye banking since 1995 and currently serves as the president and CEO of CorneaGen, a Seattle-based forprofit ocular tissue processor and distributor.

Mr. Iliakis discussed the role and impact of CorneaGen, providing some historical context about the for-profit model and its implications for surgeons, patients, donors and researchers.

“CorneaGen was established in 2016, bringing in more than $160 million in investor dollars to the cornea space—resources that would not have existed otherwise—all to fulfill the vision of transforming the lives of everyone impacted by corneal disease. Fundraising through a non-

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EYE BANKING

profit would not have come close to reaching this level of investment,” he explained.

As those of us in the research space know too well, funding is important to help translate benchside innovations into clinical advancements and bedside applications.

CorneaGen and Mr. Iliakis also recognize the benefits and advantages of funded innovation.

“We knew external capital investment would be critical to make innovation possible. Our primary investment has been Aurion Biotech, which is bringing endothelial cell therapy to market in Japan and is currently undergoing FDA clinical trials in the US. A for-profit can push new technologies forward, benefitting the entire industry,” continued Mr. Iliakis.

Mr. Iliakis highlighted some of the innovations that have come to fruition from investments in the for-profit eye banking model. “Our efforts have achieved incremental advances in corneal processing and tissue delivery, as well as significant, new FDA-approved devices like the EndoSerter®-PL, a preloaded graft insertion device for corneal transplant,” he said.

“Additionally, CorneaGen has announced the commercial availability of Corneal Tissue Addition for Keratoplasty (CTAK) in 2024—a solution for keratoconic eyes, maximizing the use of each corneal donation. Innovations like these not only optimize valuable time in the OR but also improve patient outcomes and expand the addressable market for corneal tissue,” Mr. Iliakis explained.

Meanwhile, Dr. Ahmad also recognizes the benefit of well-funded research but believes that non-profits could play a similar role—though the path may be more challenging.

the cornea donation and transplant environment, including surgery centers, hospitals, funeral homes, transport agencies and more.”

“Realistically, I think that non-profits could likely achieve a similar research mission, but it would require a strong ethos of collaboration among many eye banks to get there,” she noted.

“For-profits exist throughout the cornea donation and transplant environment, including surgery centers, hospitals, funeral homes, transport agencies and more.”

Demystifying for-profit eye banking For those of us who view for-profit tissue donation as a relatively new entity, Mr. Iliakis clarified that this is not the case.

“For-profits in tissue banking— including skin, bone, heart valve, ligament and more—have been in existence for 25 years. According to the American Association of Tissue Banks (AATB), 50% of tissue banks in the United States are for-profit and have directly contributed to advances in musculoskeletal surgery and tissue products. Therefore, this is not a new concept in organ and tissue donation,” he explained.

“In fact, the first for-profit eye bank was the first to precut tissue for Descemet stripping automated endothelial keratoplasty (DSAEK) in 2004,” shared Mr. Iliakis. “With improved tissue quality and reduced waste, non-profits soon followed— making this for-profit innovation the standard of care for endothelial keratoplasty today.”

He further noted that the for-profit corneal tissue banking model isn’t some kind of underground secret society. “For-profits exist throughout

— Mr. Bernie Iliakis

Ethics versus financial dynamics As for Dr. Ahmad, she believes that the for-profit model is likely here to stay, but emphasized the importance of keeping ethical implications at the forefront.

“I don’t think for-profit eye banking is going anywhere,” she said. “But it is important to ask salient ethical questions as we move forward.

The for-profit business model itself doesn’t carry any ethical weight, but the conduct of an eye bank does.”

Ethics is central in the discussions surrounding for-profit entities, and Mr. Iliakis provided valuable insights into the ethics and financial dynamics of both non-profits and for-profits.

“Some may argue that it is unethical ‘to profit off the donation of tissue,’ claiming that this ‘commoditizes’ the donated gift. However, if you look at the public Schedule 990 of any non-profit eye bank, you’ll see profit margins in the 5% to 20% range. Some non-profits are sitting on reserves of $10 million to $100 million instead of using those funds to support innovation,” he explained.

The differences between the two models may not be as clear-cut as we originally thought. “These nonprofit organization reserves were

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built through ‘processing fees’ collected over years from ‘donated tissue.’ Essentially, the business model of the non-profit and for-profit eye bank is identical,” Mr. Iliakis continued.

“The processing fees allowed for the tissue are the same. The key difference is that for-profits pay taxes on any year-end profits, whereas nonprofits do not. Moreover, many nonprofit eye banks and associations are now directly investing in and taking ownership of for-profit ventures. The lines between these two models have blurred and contradictions abound,” he said.

Hypocrisy or competition?

Mr. Iliakis recalled that not long ago, a bill had quietly passed in the State of Kentucky that limited a surgeon’s ability to choose their provider of corneal tissue to non-profit eye banks only—thus, making it illegal for for-profit entities to participate in eye banking.

“This was a clear restriction on surgeons’ access to perform these life-changing corneal surgeries.

Fortunately, this bill was ruled unconstitutional by the Circuit Court and upheld unanimously by the Kentucky Court of Appeals,” he shared.

Despite the ruling, the lines between non-profit and for-profit remain drawn. “For-profit eye banks are not permitted to be members of the Eye Bank Association of America (EBAA). However, the EBAA has recently allowed for-profit companies to be members, so long as they do not perform eye banking functions.

This situation raises questions of hypocrisy and appears to be influenced by competitive concerns,” noted Mr. Iliakis.

In Dr. Ahmad’s study, one concern identified was that a for-profit model could hypothetically lead to a loss of donor trust and the potential exploitation of donor generosity.* These are similar sentiments that CorneaGen has heard before, but Mr. Iliakis said this is not the case.

“An argument has been made that for-profits deter donations, but this

Contributors Dr. Samera Ahmad, MD, is a corneal and external diseases fellow at the Bascom Palmer Eye Institute in Miami, Florida.

She graduated from residency and medical school at Emory University, where she also obtained a Master’s in Bioethics with a focus on eye banking. Her research work has largely focused on ethical considerations in eye banking, including changing business structures in US eye banking. She has spoken at multiple conferences on the ethics of eye banking, and as she begins her career as a corneal surgeon hopes to further develop the area of ophthalmology and corneal transplantation ethics. sxa3004@miami.edu

simply isn’t true,” he argued. “If you look at the musculoskeletal donation model over the past 25 years, there has been no shortage of tissue for transplant in the US. Also, there hasn’t been a waiting list for corneal transplants in the past two decades.”

“A for-profit model highly honors and respects the gift of donation, often with as much or greater investment and awareness in organ, tissue, or eye donation. In fact, donor registry rates and general eye donation continue to increase year after year, regardless of the presence of forprofit entities in the space.”

Transforming cornea care Despite the concerns and myths surrounding for-profit eye banking models, the benefits cannot be ignored.

“We [at CorneaGen] are proud of the work that we and other for-profit organizations have done to advance cornea care,” Mr. Iliakis enthused.

“Our significant innovations, such as cell therapy, are made possible only through a for-profit model, investor capital and industry partnerships that are bringing new solutions to life.”

Mr. Bernie Iliakis is the president and CEO of CorneaGen, responsible for all aspects of the tissue services organization. Throughout his career, he has been responsible for the distribution of more than 150,000 sight-restoring grafts to nearly 50 countries worldwide.

In 1995, Mr. Iliakis began his career in eye banking, when he joined SightLife as an eye bank technician. In 2003, he became the chief operating officer overseeing all operations, including clinical services and quality assurance. He transitioned to CorneaGen COO after its establishment in 2016. In early 2021, he was promoted to president of the organization. For 15 years, he served on the Medical Advisory Board for the Eye Bank Association of America (EBAA), which creates and revises the medical standards that govern eye banking. He was also an inspector on the Accreditation Board for 15 years, which determines the EBAA accreditation status of eye banks.

In 2016, Mr. Iliakis was honored by the EBAA with the Leonard Heise Award for his outstanding devotion to the field of eye banking. He received his master’s degree in Health Administration from the University of Washington and graduated cum laude with a Bachelor of Science in Zoology, also at the UW. Info@corneagen.com

References *Ahmad S, Vong G, Pentz RD, Dixon M, Davis KW, Khalifa YM. Ethics in Eye Banking: Understanding Professional Attitudes Toward Industry Changes. Cornea. 2020;39(10):12071214.

Editor’s Note To read the full non-profit take on eye banking in Part 1 of this article series, see page 16 of the previous CAKE Magazine Issue 23.

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IOL TECH

Artiplus

A New Path for Young Presbyopes

by Diana Truong

At the private Artiplus Expert Panel event during ESCRS 2024 in Barcelona, Spain, a select group of refractive surgeons gathered to explore Ophtec’s latest innovation—Artiplus.

The invitation-only event united leading voices in the field to discuss how this iris-fixated multifocal phakic intraocular lens (IOL) could transform presbyopia correction, continuing Ophtec’s legacy of advancing vision care.

journey through decades of IOL development. This journey began with the creation of the Worst claw iris-fixated lens by Prof. Dr. Jan Worst, Ophtec’s founder. Over time, it evolved into the Artisan, and later the Artiflex—a foldable version that offered more flexibility for surgical implantation.

Artiplus is the natural progression in this lineage, designed to address presbyopia in a growing demographic of patients. As Bos noted, “This is not only a new lens but a lens in a tradition.” Ophtec’s philosophy of patient-centric design is evident in Artiplus, delivering seamless vision correction across distances without compromising stability or comfort.

“This is not only a new lens but a lens in a tradition.”

— Remko Bos

Addressing a growing market With the global population aging, the demand for vision correction solutions is rising. By 2050, it’s projected that around 52% of the world’s population will be myopic, with an estimated 80% to 90% of young adults in Asia already affected.

Meanwhile, presbyopia now impacts 1.8 billion people globally.1,2,3

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phtec, a long-standing leader in the intraocular lens industry, is expanding its reach with Artiplus, building on its well-known Artiflex platform. Known for its expertise in phakic IOLs, Ophtec’s latest lens is designed to meet the growing demand for presbyopia and myopia correction, offering new advancements tailored to modern patient needs.

Tiago Guerreiro, and R&D manager Paolo Soleri. They were joined by prominent clinical experts such as Prof. Dr. José Luis Güell (Spain) and Dr. Julián Cezón (Spain), who shared insights from the Artiplus clinical trials. Surgeons Dr. Chan-Young Im (South Korea) and Prof. Dr. Ramin Khoramnia (Germany) contributed their perspectives, emphasizing the lens’s potential and performance.

The Artiplus Expert Panel featured key figures from Ophtec (Groningen, Netherlands), including marketing manager Remko Bos, product and business development manager

A clear philosophy

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At the heart of the Artiplus iris-fixated multifocal IOL lies a rich tradition of innovation, rooted in Ophtec’s

CAKE MAGAZINE | November 2024

Artiplus serves a specific and growing population: adults between the ages of 40 and 60, too young for cataract surgery but grappling with presbyopia.

“We call Artiplus the solution for young presbyopes,” noted Soleri.

Many in this age group are typically still in the prime of their lives— professionally, socially, and physically active—and are looking for a solution that restores their vision without the need for glasses or contact lenses.

Design and technology Artiplus stands out in the crowded field of premium lenses by offering

an innovative blend of advanced technology and patient-centered design, built on the trusted Artiflex platform with over 20 years of demonstrated safety and efficacy.

Its design focuses on delivering “natural vision” across a full range of distances.

Unlike traditional multifocal lenses, which often rely on fixed, annular rings for near and far vision, the Artiplus employs a purely refractive optic with segments that smoothly transitions between distances. Soleri noted, “We translated this into the CTF technology, a multi-segmented, purely refractive optic with far/near zones.”

This smooth focus adjustment also helps minimize common visual disturbances, such as glare and halos, which can be problematic with more traditional multifocal lenses.

“We didn’t introduce any diffractive rings or aberration corrections to the lens because we wanted to preserve the patient’s natural vision,” Soleri explained. “We believe this is especially important in younger, healthier eyes.”

Decentration tolerance is another key feature. Many multifocal lenses require perfect centration for optimal outcomes, but Artiplus is designed to perform well even when slightly decentered. “We didn’t want any abrupt changes in optical properties,” Soleri noted. The lens’s low add power of +2.5 diopters ensures strong intermediate vision while providing functional near vision without compromising performance.

Another major advantage is its irisfixated design, which places the lens far from the natural lens, reducing the risk of cataract development in younger, myopic patients.

“Anything that avoids lens surgery in young myopic patients is a major advantage,” emphasized Prof. Dr. Khoramnia.

Patient satisfaction While clinical data is important, the true measure of Artiplus’s effectiveness comes from patients.

In the ongoing clinical trial, 98% of participants reported being “quite to very satisfied” with their uncorrected vision post-operatively.

Satisfaction rates were highest for distance and intermediate vision, with 100% of patients expressing satisfaction, while 90% were pleased with their near vision.

One early adopter, a professional rugby player from Spain, epitomizes the lens’s success. “He’s a very happy patient,” noted Dr. Cezón, who added that the athlete continues to enjoy excellent vision nearly three years post-implantation

Built for the future The safety of Artiplus is supported by the strong track record of the Artiflex platform, which has demonstrated minimal loss of endothelial cells over time. "There are reports about the loss of only 1% of endothelial cells per year," shared Prof. Dr. Khoramnia from Heidelberg University, underlining that proper patient selection is key to maintaining this level of safety.

While all phakic IOLs carry some risk to the endothelium, the Artiplus’ irisfixated design places it further away from the natural lens, minimizing the potential for complications.

Prof. Dr. Khoramnia noted the importance of this design, especially in younger patients where posterior chamber phakic lenses can lead to an increased risk of early cataract formation.

Another option, clear lens exchange (CLE), though effective for presbyopia and other refractive errors, involves removing the natural lens and can heighten the risk of retinal detachment, especially in highly myopic individuals. Artiplus offers a safer, long-term alternative by preserving the natural lens and providing clear vision correction without the added risks of CLE. This makes Aritplus an appealing option for younger patients seeking early presbyopia correction, offering both stability and a lower complication profile.

From presbyopia to cataract Artiplus is specifically designed to bridge the gap between presbyopia correction and the eventual need for cataract surgery, allowing patients to enjoy a unique balance of clarity and long-term flexibility. Because Artiplus preserves the natural lens, unlike other solutions, it leaves future cataract surgery options open—an advantage over laser procedures that might limit these choices as patients age.

"If we mount it in a 45-year-old and 10 years later the patient develops a pathology, it’s quite easy to reverse whenever necessary," Prof. Dr. Khoramnia explained. This means patients can confidently address their presbyopia now, knowing the lens can be removed or replaced if needed, such as when cataract surgery becomes necessary.

As these patients eventually transition to cataract surgery, the familiarity with the procedure and continuity of care make Artiplus an attractive option for both patients and surgeons alike. Through this approach, Ophtec has crafted a lens that not only meets the demands of today’s presbyopic patients but also anticipates their future needs, offering clear vision now, without compromise, and into the years ahead.

Editor’s Note Reporting for this story took place during the 42nd Congress of the European Society of Cataract and Refractive Surgery (ESCRS 2024), held from 6-10 September in Barcelona, Spain.

References 1. Nouraeinejad A. More than fifty percent of the world population will be myopic by 2050. Beyoglu Eye. 2021;6(4):255-256.

2. Morgan IG, French AN, Ashby RS, et al. The epidemics of myopia: Aetiology and prevention. Prog Retin Eye Res. 2018;62:134-149.

3. Fricke TR, Tahhan N, Resnikoff S, et al. Global prevalence of presbyopia and vision impairment from uncorrected presbyopia: Systematic review, meta-analysis, and modelling. Ophthalmology.

2018;125(10):1492-1499.

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HERITAGE LECTURE AWARD

An Ode to a Visionary ESCRS 2024 Heritage Lecture puts a spotlight on phacoemulsification and Dr. Charles Kelman’s pioneering journey that transformed cataract surgery by Tan Sher Lynn Dr. Richard Packard, this year’s European Society of Cataract & Refractive Surgeons Congress (ESCRS 2024) Heritage Lecture Awardee, took us down memory lane, celebrating how eye surgeon and saxophonist Dr. Charles ‘Charlie’ Kelman introduced phacoemulsification to the world—a breakthrough that continues to benefit millions today.

T

he Heritage Lecture Award, one of the most anticipated events at ESCRS 2024, honors individuals who have made significant and lasting contributions to the field of ophthalmology. This year, this prestigious award went to Dr. Richard Packard (United Kingdom), who has played a significant role in shaping the society and its heritage projects, contributing to its growth over the years.

In his opening remarks, Dr. Packard humbly expressed gratitude for the honor, especially as it coincided with the 75th anniversary of the intraocular lens (IOL). The theme of his lecture focused on phacoemulsification—a revolutionary technique introduced by Charles Kelman in the 1960s.

Dr. Packard chose this topic to highlight the legacy of Dr. Kelman, who passed away 20 years ago.

He believed many younger ophthalmologists might not be fully familiar with his contributions to this groundbreaking technology.

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encounter with his father, he was encouraged to pursue medicine.

Despite his illustrious medical career, Dr. Kelman’s passion for music never faded. He even adopted the stage name Kerry Adams, and one of his songs, “Telephone Numbers,” resulted in a recording contract. However, his musical career eventually stalled, prompting him to refocus on medicine.

One day, he envisioned a revolutionary idea: Could a cataract be removed through a tiny incision, enabling patients to leave the hospital within a day or two instead of enduring a lengthy 10-day stay?

To turn this vision into reality, he dedicated years to experimenting with various methods—from encapsulating lenses in rubber bags to drilling and grinding them. It wasn’t until a breakthrough moment in his dentist’s office that led him to the concept of ultra-acceleration through ultrasonics.

This led to the creation of the first phacoemulsifier, a machine so heavy that it had to be suspended above the patient’s eye during surgery.

Despite the challenges, Dr. Kelman persisted, patenting his invention and conducting the first human phacoemulsification in 1967. Early procedures were difficult, often taking up to four hours, with complications occurring frequently.

Dr. Packard shared dramatic moments from those early surgeries. One assistant, Cheryl Jarvin, described the tension in the operating room when complications arose.

From musician to phacoemulsification pioneer Dr. Packard described Dr. Kelman as a man of many talents from a young age, originally dreaming of becoming a musician. However, after a dramatic

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Despite these difficulties, Dr. Kelman’s determination paid off.

By 1970, he was ready to teach the technique, holding rigorous weeklong courses in New York. These sessions introduced surgeons to phacoemulsification and the use of microscopes in surgery, a new skill for many at the time.

folding lenses to fit them into phaco incisions. “Some of the original phaco adopters were producing new designs to overcome issues with incision size needed with irissupported lenses, such as the J loop lens and the Sinskey/Kratz lens,” he said.

Dr. Richard Packard

From skepticism to the standard of care The spread of phacoemulsification across the globe was gradual, with early adopters like Dr. Eric Arnott (Dr. Packard’s mentor) bringing the technique to Europe in the early 1970s. However, strong resistance persisted, and complications from the procedure raised concerns among practitioners.

Dr. Packard reflected on this period of skepticism, recalling how patients with poor outcomes were often highlighted at conferences. An open mic session even allowed attendees to share their negative experiences.

However, Dr. Kelman persisted, capturing the media’s attention with his dual identity—as a saxophonist and a doctor. Although his practice grew, phacoemulsification did not gain widespread popularity. “The reason was that the iris clip or anterior chamber lenses used at the time required large incisions, leading people to question the need for phaco,” Dr. Packard explained.

By the late 1970s, there were an estimated 700 phaco machines in the USA, but most were not being used, as surgeons had concerns about complications.

Dr. Packard recalled that when he finished his Moorfield residency in 1978, phaco and intraocular lenses (IOLs) were not widely used.

However, things began to change— thanks to the development of foldable lenses.

Dr. Packard shared how he and his colleagues experimented with

In 1984, Thomas Mazzocco successfully produced the first folded silicone lens that could be injected through a cartridge— revolutionizing foldable lenses. “This, along with other foldable and small incision lenses that appeared in the 1980s, prompted many surgeons to shift from intracapsular cataract extraction (ICCE) and extracapsular cataract extraction (ECCE) to phaco,” he continued.

“Phaco has brought us to a point of sutureless microincisions, viscoelastics, capsulorhexis, phaco machines with power modulation and advanced fluidics, as well as techniques like phaco chop, stop and chop, and prechop.”

— Dr. Richard Packard

“During the 1980s, several key advancements in cataract surgery emerged, including scan biometry and YAG lasers, eliminating guesswork and the need for frequent adjustments,” Dr. Packard explained.

He also noted that in 1989, the four quadrant nucleofractis technique

by John Shepherd (commonly called ‘divide and conquer’ today) brought many surgeons to phaco.

“Phaco and Dr. Kelman were finally being recognized. He received the National Medal of Technology from President HW Bush in June 1992,” he recounted. “Dr. Kelman was overwhelmed, as he felt that his dream of minimally invasive cataract surgery had now come to fruition.”

Throughout the 1990s, a variety of foldable lenses made from different materials became available. As these foldable IOLs gained popularity, phacoemulsification became the standard of care for cataract surgery in the mid-1990s.

A journey of innovation Phacoemulsification techniques also continued to evolve, with new methods emerging such as Dr. Nagahara’s 'Phaco chop' in 1993, Dr. Akahoshi’s ‘Phaco prechop’ in 1994, and the ‘vertical chopping’ in 1998.

In the 2000s, lasers began assisting with various parts of the cataract surgery process. Advances in phaco fluidics and power delivery have continued to enhance the safety and efficiency of the procedure.

“Much has happened to phaco over the 60 years since Dr. Charles Kelman sought faster recovery from cataract surgery. In 2003, the AAO, which had once criticized Charlie, finally honored him as an AAO Laureate,’ Dr. Packard remarked.

“Phaco has brought us to a point of sutureless micro-incisions, viscoelastics, capsulorhexis, phaco machines with power modulation and advanced fluidics, as well as techniques like phaco chop, stop and chop, and prechop,” he added.

“We now have increasingly accurate biometry, square-edge foldable lenses capable of correcting astigmatism and presbyopia, and laser assistance for parts of the surgery. Thank you, Charlie, for all you have given us and our patients,” Dr. Packard said, concluding his speech.

Editor’s Note Reporting for this story took place at the 42nd Congress of the European Society of Cataract and Refractive Surgery (ESCRS 2024), held from September 6 to 10 in Barcelona, Spain. A version of this article was first published on cakemagazine.org.

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Conference Highlights

WCPOS V 2024

Little Eyes, Big Insights Experts at WCPOS V 2024 address the challenges of pediatric vision in demyelinating and neuromuscular conditions

by Tan Sher Lynn

Demyelinating and neuromuscular diseases can significantly affect children’s vision and eye function. Early recognition and treatment are essential for effectively managing these challenges. Experts discussed the visual difficulties associated with these disorders and shared insights on treatment strategies to preserve and restore sight in children.

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t the recently concluded 5th World Congress of Pediatric Ophthalmology & Strabismus (WCPOS V 2024), held in Kuala Lumpur, Malaysia, experts shared insights into demyelinating and neuromuscular diseases in children.

Dr. Ng Sui Yin emphasized critical symptoms and diagnostic methods, while Dr. Prem S. Subramanian talked about multiple sclerosis treatments. Additionally, Dr. Virender Sachdeva explored cranial nerve palsies, and Dr. Ellen Mitchell discussed myasthenia gravis, highlighting the need for early detection and tailored therapeutic approaches across these complex conditions.

Dr. Ng Sui Yin (Malaysia) shared that symptoms commonly linked to ON include numbness, ataxia, limb weakness, and constitutional symptoms such as prolonged vomiting, hiccups, or new-onset seizures.

Optic neuritis with encephalomyelitis

She then discussed the clinical presentation of ADEM, which includes encephalopathy and polyfocal deficit. Typically, children with ADEM have a history of viral infection or recent immunization days or weeks before presentation.

Meanwhile, CIS is defined as white matter disease suggestive of inflammatory demyelination with symptoms lasting more than 24 hours but not meeting the criteria for a diagnosis of ADEM, neuromyelitis

Optic neuritis (ON) can be a crucial indicator of underlying demyelinating conditions. According to the Pediatric Optic Neuritis Group, 50% of optic neuritis cases are either postinfectious or post-immunization, while the other 50% are associated with underlying neuroinflammatory disorders.

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“There are five categories associated with ON with encephalitis: Acute disseminated encephalomyelitis (ADEM), clinically isolated syndrome (CIS), multiple sclerosis (MS), pediatric neuromyelitis optica spectrum disorder (pNMOSD) with AQP4-IgG positivity, and myelin oligodendrocyte glycoprotein antibody disease (MOGAD),” Dr. Ng said.

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optica, or multiple sclerosis, and cannot be explained by other etiology. In the case of MS, the presence of oligoclonal bands in the spinal fluid is a good marker. On the other hand, pNMOSD and MOGAD are rare conditions.

Dr. Ng concluded that the diagnostic workup for children with ON includes magnetic resonance imaging (MRI) of the brain and orbits with contrast, MRI of the spine with contrast (especially for patients with recurrent disease or other neurological symptoms), serology testing for neuromyelitis optica and myelin oligodendrocyte glycoprotein (MOG) antibodies, and cerebrospinal fluid (CSF) analysis for patients with a high suspicion of multiple sclerosis.

Treatment guidelines for pediatric demyelinating disorders Pediatric demyelinating disorders are a group of conditions affecting children, in which the protective covering of nerve fibers, called myelin, is damaged, impairing nerve function.

According to Dr. Prem S. Subramanian (USA), multiple sclerosis (MS)—a common pediatric demyelinating disorder that involves the formation of plaques in the central nervous system—is generally milder than adult cases, accounting for 3% to 5% of all MS cases.

He added that the acute treatment of pediatric MS often involves the use of intravenous corticosteroids given at 20 to 30 mg/kg/day for three to five days.

“Patients are typically given oral taper especially if they have incomplete resolution of symptoms. Plasma exchange (PLEX) is only used in refractory cases that are not improving, and steroids are repeated for relapse,” he said.

Meanwhile, chronic treatment varies by disease. “Fingolimod is the only FDA-approved medication for children with MS and is considered superior to weekly interferon-beta,” he continued.

In pediatric MOG-antibodyassociated diseases (MOGAD), acute treatments include intravenous methylprednisolone, PLEX, and intravenous immunoglobulin (IVIG).

Meanwhile, chronic treatment involves long-term oral steroids, rituximab, mycophenolate mofetil, and IVIG. Dr. Subramanian emphasized that the goal is to promote recovery of function and prevent relapse.

Pediatric cranial nerve palsies Cranial nerve palsies encompass a spectrum of conditions, including supra-nuclear control disorders, nuclear lesions, nerve palsies, orbital lesions, and myopathies.

Dr. Virender Sachdeva (India) emphasized that the definitive treatment is surgery, and it is advisable to monitor for recovery over a period of six months to one year. Prognosis can vary from fair to poor, with better outcomes observed in cases of congenital palsy and inflammatory causes. In contrast, he noted that recovery from trauma or compressive causes is usually poor.

“In pediatric cases, diagnosis is more difficult because detailed history may not be available and medical examination may not be possible. Children may not be cooperative. We may need to rely on saccadic velocities, and MRI may be mandated,” he said. Dr. Sachdeva added that neuroimaging will be indicated if there is an incidence of trauma, associated headaches and neurological signs, associated disc edema, associated acquired nystagmus, worsening of observation, or no signs of spontaneous recovery.

In conclusion, Dr. Sachdeva highlighted that cranial nerve palsies are not uncommon. “They can be congenital or acquired. We should try to localize and look for accompanying signs to help us pick up myopathy. We should rule out primary myopathies. Neuroimaging and ancillary testing are important, and early interventions can help to prevent amblyopia,” he stressed.

muscle weakness and a negative evaluation for more common causes.

Some clinical symptoms of LEMS, such as ptosis, overlap with those of other myasthenic syndromes, most commonly MG, which can lead to misdiagnosis or delayed diagnosis,’ she said.

Pediatric neuromuscular junction disorders

Shedding light on ocular myasthenia gravis (OMG), Dr. Venkateshwar Rao (India) noted that OMG occurs in 10% to 35% of all childhood MG cases and has a higher prevalence among Asians. He noted that the most common manifestation is ptosis, which occurs in 90% of cases. Diplopia and strabismus are present in 45%, while complete ophthalmoparesis occurs in 24%.

Additionally, 40% to 50% of cases may progress to generalized myasthenia gravis.

Myasthenia gravis (MG) is an autoimmune disorder affecting the neuromuscular junction (NMJ).

According to Dr. Ellen Mitchell (USA), it is the most common NMJ disorder in children and most often presents with symptoms such as variable ptosis and strabismus.

“Pediatric myasthenia gravis comes in three forms: Congenital myasthenic syndromes, transient neonatal myasthenia, and juvenile myasthenia gravis,” Dr. Mitchell reminded the audience.

She emphasized that congenital myasthenic syndromes can present in infancy, and a genetic diagnosis is necessary to tailor treatment. On the other hand, transient neonatal myasthenia gravis occurs in 5% to 30% of infants born to mothers with MG and presents after birth with symptoms, such as a weak cry, poor sucking, respiratory distress, and generalized hypotonia.

Meanwhile, juvenile myasthenia gravis is characterized by fluctuating fatigue of skeletal muscles in patients aged 0 to 18 years. Symptoms include fatigable ptosis, variable strabismus, and general weakness.

“These infants may experience flaccid paralysis and require close monitoring for respiratory compromise. They typically respond well to treatments like neostigmine and plasma exchange.

Once autoantibodies are cleared, symptoms usually resolve,” she explained.

Furthermore, Dr. Mitchell also discussed Lambert-Eaton myasthenic syndrome (LEMS).

“The diagnosis of LEMS should be considered in children with unexplained progressive proximal

Pediatric ocular myasthenia

Dr. Rao shared that clinical signs of OMG include fatigability on sustained upgaze and Cogan lid twitch. Diagnostic tests such as the ice test (with 80% sensitivity), the rest test, the edrophonium (Tensilon) test, the neostigmine test, and various laboratory tests are useful in determining the condition.

In treating OMG, anticholinesterase drugs are the primary option.

Most patients also require immunosuppressive therapy, as early immunosuppression helps to prevent progression.

“All patients with MG and thymoma should undergo thymectomy.

Strabismus surgery can be performed for stable deviations, and full spontaneous remission occurs in the majority of these patients,” concluded Dr. Rao.

Editor’s Note Reporting for this article occurred during the 5th World Congress of Paediatric Ophthalmology & Strabismus (WCPOS V 2024), held from July 11 to 13 in Kuala Lumpur, Malaysia. A version of this article was first published on cakemagazine.org.

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Conference Highlights

ESCRS 2024

Bridging the Gap in Education ESCRS 2024 Orbis Symposium addresses the challenge of equalizing cataract surgery training opportunities

by Diana Truong

During an Orbis Symposium at the 42nd Congress of the European Society of Cataract and Refractive Surgery (ESCRS 2024), experts from around the world tackled the issue of cataract surgery training access in low- and middle-income countries.

fierce competition, with too many trainees vying for the few cataract surgeries scheduled in both teaching and non-teaching hospitals.

This gap in training echoes in countries like Bolivia, where Giro revealed that over a third of cataract surgeries result in poor outcomes, largely due to complications arising from insufficient training. She reported that a staggering 82% of these cases are linked to a lack of qualified ophthalmologists, inadequate resources in training centers, and limited access to highquality education.

What’s more, the traditional "see one, do one, teach one" model of training—once a cornerstone of surgical education—simply isn’t effective in today’s context anymore.

As both Ferris and Dr. Garcia pointed out, this outdated approach fails to meet the demands of modern cataract surgery training.

Digital learning platforms Cybersight, Orbis’s digital learning platform, is revolutionizing access to high-quality surgical education by connecting trainees with over 100 international mentors, online courses, live surgical demonstrations, and even a cuttingedge artificial intelligence (AI) platform for clinical decision-making support. “It’s superb for education, and all courses are translated into 12 languages,” noted Ferris.

Cybersight’s distance learning capabilities have already made a significant impact. In one study, a group of 21 ophthalmic residents participated in a five-week distance cataract wet-lab course delivered via Cybersight. The results were remarkable.1

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ith a focus on digital learning platforms, remote mentoring, and simulation training, speakers highlighted how these solutions are transforming access to education and improving surgical outcomes. As the demand for skilled ophthalmologists grows, these initiatives promise to enhance competency and ultimately help save sight worldwide.

The session featured insights from John Ferris (Orbis International,

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United Kingdom), Dr. William Dean (Orbis International, United Kingdom), Anna Barba i Giro (Eyes of the World, Spain), and Dr. Oliver Garcia Yanez (Oftalmo University, Mexico).

The hurdles In low- and middle-income countries, the challenges surrounding cataract surgery training are both urgent and multifaceted. In sub-Saharan Africa, for example, aspiring surgeons face

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Over the course of the training, residents' average competency scores increased by 6.95 points.

Additionally, the post-training surgeries performed by the residents yielded impressive visual outcomes: 92% of patients achieved visual acuity of 20/60 or better, meeting the World Health Organization’s standard for quality.1 This demonstrates that structured, distance-based wet lab training in phacoemulsification can significantly

enhance surgical skills, helping to bridge the gap in cataract surgery competency in regions where inperson training opportunities are scarce.

Remote surgical mentoring Remote surgical mentoring not only transcends geographical boundaries but also brings real-time expertise directly into the operating room. In one study, senior ophthalmology residents in Trujillo, Peru, were paired with a seasoned mentor from Vanderbilt Eye Institute in Tennessee.

The setup was simple but powerful: Live phacoemulsification surgeries were performed in Peru, with the mentor watching in real-time via audio-visual equipment and Zoom conferencing.2 Despite the nearly 4,000 miles separating them, the mentor and surgeon maintained constant voice contact throughout the procedures.

With minimal audio and video latency—226 milliseconds for video and 232 milliseconds for audio—the mentor could guide each step of the operation, offering instant feedback and support. The precision of the video feed, with a resolution of 1280 x 720 pixels, ensured that the mentor could clearly observe every detail of the surgery.2 Over four sessions, seven surgeons performed a total of 12 operations under this mentorship model.

Remarkably, 10 of these surgeries achieved postoperative vision of better than 6/18, demonstrating the effectiveness of this remote training approach.2

Virtual reality training Orbis, known for its cutting-edge eye health innovations, has developed a virtual reality (VR) tool specifically designed to teach manual smallincision cataract surgery (MSICS).

This immersive experience is aimed at students and ophthalmic residents who have little to no experience with MSICS, helping them progress from novices to advanced beginners.

“Practicing in virtual reality gives surgeons the muscle memory and confidence they need to perform their duty efficiently,” Ferris asserted.

The Orbis MSICS VR Experience

offers a low-cost, portable, and scalable educational tool, making it accessible even in regions with limited resources. It forms part of a larger surgical training curriculum, enabling self-directed learning at the trainee's own pace. With a detailed 28-step process, the tool provides comprehensive insight into MSICS, breaking down each step of the technique, highlighting the expected outcomes, and preparing users for potential complications.

Simulation training An innovative approach that allows ophthalmology trainees to practice critical procedures in a controlled, risk-free environment, simulation training accelerates their learning curve and improves surgical outcomes.

The OLIMPICS trial recruited 50 first- and second-year ophthalmology trainees from five different training institutions, giving them access to high-quality simulation training specifically focused on small-incision cataract surgery (SICS).3 The results were transformative.

Confidence scores among the trainees doubled, empowering them to take on more surgeries with skill and assurance. In the year following their training, these young surgeons performed an average of 21.5 SICS procedures as primary surgeons, compared to just 8.5 before their simulation training.3 They also assisted in more cases—24.6 on average compared to 10.9. Perhaps most importantly, patient safety saw a significant improvement, with complication rates reduced by 72%, and posterior capsular tear (PCT) rates dropping from 26.2% to 7.4% in the first year.3

But that’s not all. The personalized teaching methodology at OU goes beyond mere technical training.

Learning at OU “happens in a collaborative and supportive environment, and mentors provide tailored guidance and individual support,” noted Dr. Garcia, ensuring that each student’s unique learning needs are met and building their confidence from the ground up.

Having trained ophthalmologists from 140 different countries, the impact of OU’s comprehensive approach is profound. With a unique program that blends simulation, mentoring, and psychological preparation, one graduate of OU performed an impressive 250 cataract surgeries in just one year.

Multiplying hope In a world where one skilled ophthalmologist can potentially perform hundreds, even thousands of surgeries in a single year, the true challenge lies not in the scarcity of talent but in our collective approach to training and accessibility. By focusing on preparing more people, we don’t just multiply the number of surgeries—we multiply the hope, the potential, and the possibility for countless individuals.

References 1. Geary A, Wen Q, Adrianzen R, et al. Impact of distance cataract surgical wet laboratory training on cataract surgical competency of ophthalmology residents. BMC Med Educ.

2021;21(1):219.

2. Geary A, Benavent S, Amador De La Cruz E, et al. Distance surgical mentorship for ophthalmologists in northern Peru.

MedEdPublish (2016). 2019;8:45.

3. Dean WH, Gichuhi S, Buchan JC, et al.

Intense simulation-based surgical education for manual small-incision cataract surgery.

JAMA Ophthalmol. 2021;139 (1):9-15.

Blended training Oftalmo University (OU) is a learning space that redefines how ophthalmologists, particularly in low- and middle-income countries, acquire cataract surgery skills.

Leveraging cutting-edge simulation tools, OU provides trainees with state-of-the-art technology that mimics real-life surgical scenarios, enabling them to refine their motor skills in a risk-free environment.

Editor’s Note Reporting for this story took place at the 42nd Congress of the European Society of Cataract and Refractive Surgery (ESCRS 2024), held from September 6 to 10 in Barcelona, Spain. A version of this article was first published on cakemagazine.org.

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