CAKE Issue 17: The Cataract & Glaucoma Issue

The Marginal Gains

Dear Readers,

of Outsourcing Thinking in Ophthalmology to AI

Ah, I tried to get OpenAI to write this column for me, but I hated what it wrote for me. It’s not me. It’s not my voice. And it’s not a voice that I like to read either. It’s the same when I ask it to write on a topic like corneal cross-linking. It produces something that’s perfectly coherent (albeit quite stuck-up and wordy). When you ask it to reference what it wrote — it does so! Amazing! It’s also a disaster. The references it produces have recognizable author names, appropriate journals and dates, and perfectly sensible titles.

It’s unfortunate that when you check them against what’s in PubMed, they’re also complete works of fiction. Further, the confidently and coherently written copy isn’t quite right. If you know a topic well, you can see the mistakes and correct them ... but if you don’t, obviously you can’t. If someone is lazy enough to get AI to write copy for them, then they are probably also too lazy to spend the quality time that’s absolutely needed to fact-check it. This is a big problem.

If content like this gets published — which is especially dangerous in medicine — then the inaccuracy propagates and gets incorporated into the next model. Misinformation gets reinforced, rather than refuted.

I don’t know if AI’s going to have to think concepts through from first principles or refer back to known-correct datasets in order to make what it says accurate. But I worry that there’s enough falsehoods floating about in the ether in everything that’s newsworthy, we don’t need AI adding to it across everything else. Perhaps it won’t turn out all that bad. Instead of curing cancer and solving climate change, I can imagine that some of the best minds in the world will be working on fixing these issues. I hope.

So am I on an AI downer? Not at all. When its scope is limited to being, let’s say, a super-nomogram to predict refractive surgery outcomes, or what effect an excimer laser ablation pattern has on the shape and biomechanics of a cornea — all good. While I do wonder whether after crunching all of the numbers, the extra quarter-diopter improvement in refraction over what’s currently (incredibly good) state-of-the-art will be appreciated by most cataract or refractive surgery patients, there’s certainly lower hanging fruit waiting to be picked with a greater potential impact.

Combine AI with OCT aqueous outflow imaging and find out where’s the best location to place a MIGS stent. Optimize care by comprehensively understanding and modeling the risk of a patient’s glaucoma progressing on a certain medication, and recommend a timely switch or surgical intervention.

However, I don’t see AI here as being a paradigm shift in the same way as GPT-3 and deep generative neural networks seem to be for text copy and image generation — which look like they’re about to put many of the people who work in the creative industries out of a job. I do see AI speeding up the process of marginal

improvements across the board, be it the optics of multifocal IOLs or the deployment of phaco energy patterns in different parts of the lens based on pre-surgical imaging or values from a sensor in a phaco tip. Because, unlike the creatives, doctors are harder to replace. Too few have been trained over the years, and the demand on their services has never been higher.

I believe the biggest role AI has to play in ophthalmology over the next decade or two is to optimize for efficiency — be it an individualized anti-VEGF regimen for patients with AMD based on retina OCT scans that maximizes treatment effect and minimizes the number of clinic visits they need to retain their vision, or arranging the order of patients in a surgical list based on predicted operating times to maximize patient throughput in an OR.

We’ll all be working with AI sooner than we think, and it’s going to be interesting to see how enthusiastically (or not) we will be in terms of taking instructions from it.

So what did ChatGPT write when I asked it to finish this article with the instruction: “Please write a 100-word conclusion to this article?”

In conclusion, the author expresses concern about the potential inaccuracies of AI-generated content, particularly in the field of medicine. They argue that if someone is too lazy to fact-check AI-generated content, it can lead to inaccuracies being propagated and reinforced. However, the author also acknowledges the potential benefits of AI in fields such as ophthalmology, where it can be used to optimize care and efficiency. They predict that AI will play a significant role in the field over the next decade and express curiosity about how doctors will respond to taking instructions from it.

Awful, isn’t it?

Cheers, Mark Hillen, PhD Director of Communications ELZA Institute, Zurich, Switzerland Editor-At-Large | CAKE

Advisory Board Members

boris.malyugin@gmail.com

Society Friends

chelvin@gmail.com

george.beiko@sympatico.ca

jodmehta@gmail.com

wtrattler@gmail.com

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

Dr. Boris Malyugin S. Fyodorov Eye Microsurgery Institution Moscow, Russia

Dr. Chelvin Sng Chelvin Sng Eye Centre, Mount Elizabeth Novena Hospital, Singapore

Prof. Jodhbir S. Mehta Singapore Eye Research Institute (SERI); Singapore National Eye Centre (SNEC) Singapore

Dr. George H.H. Beiko University of Toronto; McMaster University, Ontario, Canada

Dr. William B. Trattler Center For Excellence In Eye Care Miami, Florida, USA

Arunodaya Charitable Trust (ACT)

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Eyeing a More Cost-Effective Option?

Study highlights ISBCS’s efficacy for cataract treatment

by Andrew Sweeney

One of the most significant public health crises faced today in the developing world is aging population. This means that state pension budgets are increasingly occupying higher shares of GDP, and public health systems are straining under the pressure of having to look after more people with more morbidities.

This problem can be observed across the medical industries of dozens of countries and is particularly acute in ophthalmology due to exploding rates of cataracts.

Cataract and old age

Cataract is associated with old age and is accepted as a natural part of the aging process. Indeed, according to the World Health Organization (WHO), cataract is one of the main diseases causing preventable blindness around the world, with an estimated number of 65.2 million people in need of treatment as of this moment.1

With the ever-increasing number of elderlies in the world, that number is only going to rise and rise until already strained healthcare systems could face new collapse.

At present, phacoemulsification cataract surgery with an intraocular lens (IOL) implantation is one of the most commonly performed types of surgery worldwide, thanks in no small part to its low rate of complications (1.2%) and high success rates (93%).2,3 The technique is also costeffective and can be performed in many healthcare facilities, but with the rising costs of healthcare —

and with an estimated 6.9 billion US dollars needed to cover the gap of costs for unaddressed cataract globally — clinicians are still under pressure.

Thus, there is an acute need for ophthalmologists to identify techniques that can provide significant cost savings and increased efficiency.1

The search for a more efficient solution

One technique that could provide significant cost savings and improved efficiency is immediate sequential

bilateral cataract surgery (ISBCS), which in layman’s terms refers to operating on both eyes on the same day in two separate procedures. This is opposed to the more conventional delayed sequential bilateral cataract surgery (DSBCS), which can involve gaps of days to months between procedures. As a result, the latter technique can cause a number of issues related to clinical efficiency and can delay the patient reaching their best possible outcome.

One might think that these issues would make ISBCS the preferred technique in most clinical settings. However, a number of countries’

healthcare systems and national guidelines recommend against it due to a perceived higher risk of complications. This is despite ISCBS being reported by a number of leading clinicians as offering faster visual rehabilitation with no visual imbalance (anisometropia) between first eye surgery and second eye surgery, avoidance of additional day-care admission, less use of home care, a reduction in hospital visits, and a reduction in overall costs.4,5

If ISBCS could be proven as safe and effective, without undue risk of complication to the patient, it could offer significant advantages to hospitals looking to save costs and improve their overall performance. That’s the consideration posed in one study, An Update on Immediate Sequential Bilateral Cataract Surgery, authored by two stalwarts of ophthalmology: Dr. Lindsay S. Spekreijse and Prof. Dr. Rudy M.M.A. Nuijts, a former president of the European Society of Cataract and Refractive Surgeons.6

The authors of the study focused on one of the most common reasons cited for not performing ISBCS, namely post-operative endophthalmitis. While pointing out that according to one review, “there is likely no significant difference in endophthalmitis rates between ISBCS and DSBCS,” they conceded that there was a low incidence of bilateral endophthalmitis overall, and that none of the included studies in the review was large enough to

References

detect a bilateral case. This would need to be rectified for a fuller picture of ISBCS.6

The experts speak and Swedish results

To overcome this issue, they examined additional large nonrandomized studies and randomized registry studies, and they were able to find more information that backed up ISBCS as a safe and effective procedure.

In one Swedish review,7 endophthalmitis incidences were recorded in 1,457, 172 cataract extractions, of which 92, 238 were performed according to the ISBCS procedure. Independent risk factors for developing endophthalmitis were found to be less frequent in the ISBCS group, and only one case of bilateral endophthalmitis occurred in this group.

The other area the study focused on was ‘refractive surprise’ as “the level of success for cataract surgery is mostly determined by postoperative refractive outcomes.” According to the study, in Europe currently accepted deviations from target refraction lie within 1.0 and 0.5 D, and success rates reach 93 and 72.7%, respectively. The authors pointed out that in bilateral cataract surgery, the refractive outcomes of the first eye can be used to further optimize the prediction accuracy of the second eye, which does offer an advantage over ISBCS.7

1. World report on vision. World Health Organization; 2019. Available at: https://www. who.int/docs/default-source/documents/publications/world-vision-report-accessible. pdf. Accessed on February 8, 2023.

2. Lundström M, Dickman M, Henry Y, et al. Changing practice patterns in European cataract surgery as reflected in the European Registry of Quality Outcomes for Cataract and Refractive Surgery 2008 to 2017. J Cataract Refract Surg. 2021;47(3):373-378.

3. Lundstrom M, Dickman M, Henry Y, et al. Risk factors for refractive error after cataract surgery: Analysis of 282 811 cataract extractions reported to the European Registry of Quality Outcomes for cataract and refractive surgery. J Cataract Refract Surg. 2018;44(4):447-452.

4. American Academy of Ophthalmology. Cataract in the Adult Eye. Preferred Practice Patterns, 2016. Available at: https://www.aao.org/preferred-practice-pattern/cataract-inadult-eye-ppp-2021-in-press. Accessed on February 8, 2023.

5. Grzybowski A, Wasinska-Borowiec W, Claoue C. Pros and cons of immediately sequential bilateral cataract surgery (ISBCS). Saudi J Ophthalmol. 2016;30(4):244-249.

6. Spekreijse LS, Nuits RMMA. An update on immediate sequential bilateral cataract surgery. Curr Opin Ophthalmol. 2023;34(1):21-26.

7. Dickman

However, they referred to a review on ISBCS that found moderate (one randomized controlled trial) and low-certainty (three nonrandomized studies) evidence that there was no difference in the percentage of eyes that did not achieve refraction within 1.0 D of target one to three months after surgery. No information on differences in relevant parameters (e.g. IOL calculation formulas or axial lengths) between groups was provided either. Although it was suggested that refractive adjustments during the interval between the first and second eye surgery may have accounted for better outcomes in DSBCS, no data were provided on whether these adjustments were performed or not.6

In their concluding remarks, Dr. Spekreijse and Prof. Dr. Nuts stated that, “ISBCS is an effective and cost-effective alternative to DSBCS, provided that patients are selected carefully and safety guidelines are taken into account.”

Although, it appears, based on the results of their research, that fears about the significantly increased risk of complications compared to DSCBS are present, it’s certainly a more efficient and cost-effective procedure.

If it leads to increased patient outcomes, and it should improve quality of life considerably — thanks to reduced overall treatment time, then everyone is a winner.

MM, Spekreijse LS, Winkens B, et al. Immediate sequential bilateral surgery versus delayed sequential bilateral surgery for cataracts. Cochrane Database Syst Rev. 2022;4(4):CD013270.

What’s Cracking in IOL Calculations?

News, increments and purchases

New measurement techniques and devices are constantly being updated for intraocular lenses. And it’s pretty cool, really — for example, now that artificial intelligence is getting involved, the techniques are getting a bit sexier… if you’re into that kind of thing.

by Sam McCommon

It makes sense that if you intend to remove a person’s lens from their eye and insert an artificial lens, you’d want to be careful with your measurements. Even in carpentry, the maxim is “measure twice, cut once.” A piece of lumber is significantly less sensitive than an eye and won’t complain if it’s cut wrong, so take that wisdom’s necessity and multiply it umpteen times.

So, let’s take a look at what’s new in

intraocular lens (IOL) calculations and where they’re headed. After, we’ll look at big news surrounding a specific IOL and what to expect from it.

IOL calculations: What’s new?

Let’s set some expectations here before we dive in. The changes we’re seeing are positive, but not earth-shattering. As Dr. Boris Malyugin put it: “These changes are more incremental than absolute.

So the results that we have are slightly better than before, but not dramatically. Irrespective of the innovative tools we have, the clinical results are improving, but improving incrementally.”

Baby steps are a good thing — they show that things were on the right track before, and they’re continuing that way. They also mean that surgeons don’t have to go back and unlearn and relearn everything they’ve learned before. Small tweaks

are much easier to work in than radical retooling.

IOL calculations have improved very much over the last few years, though, said Dr. Malyugin. What’s more, we have renewed formulas that are already in use, such as the Barrett Universal II, with constantly improving quality. For him, this measurement represents the gold standard that other formulas can be compared to.

Dr. Malyugin sees two trends developing. One is the increasing viability and reliability of calculations that rely to some degree on artificial intelligence (AI) calculations, like HillRBF and Kane formulas.

The second trend is an improvement in toric calculations, since toric lenses are growing in popularity. “I believe the most groundbreaking improvement was the publication about the posterior astigmatism playing a role. We should account for it in formulations such as the Barrett Toric Calculator.”*

Tech trends and gray zones

Being able to make adjustments during surgery is a pretty neat development, Dr. Malyugin told us. “There are technologies like digital markers that help position the lens in a specific direction. There are also intraoperative aberrometers, that can help to adjust the actual power of the lens if needed,” he said.

The extreme biometric outliers still need some work, though. “I think there will still be a gray zone where we have highly myopic eyes or highly hyperopic eyes, or eyes with previous refractive surgery or different refractive procedures.”

He continued: “We are very much improving in the area where we have more normal eyes, but those extremes will always be the place we need to go further and have further improvement.”

So, what’s working currently with less common eyes? Dr. Malyugin pointed out that the Haigis formula was working well for very short eyes, for example. While surgeons can rely on standard formulas for normal biometric parameters, more specific

formulas will be needed for extreme parameters.

Ray tracing is under development and looks promising, but isn’t quite here yet. It should take into account individual geometrical patterns of each lens implanted, leading to individualized implants and refractive powers. This takes a lot of technical information, of course, which is why Dr. Malyugin expects manufacturers to come up with ray tracing formulas, which will not be universal for each lens.

Biometric machines are constantly improving, as well. Dr. Malyugin pointed to the Zeiss (Jena, Germany) IOLMaster 700® and its improved ability to read the anterior ocular surface, greatly improving biometric readings.

Digital transfer of information between IOL machines can help reduce human error as well. It can be shared from one machine to another, ending up right in the operating microscope so there’s no need for adjustment.

Of course, keep your eye on AI developments. A combination of exponential growth in AI power and availability and more widely available data can lead to improved measurements in many ways we don’t yet understand, but can still anticipate. This will be especially helpful when improving formulas for specific ethnicities, as there are ocular anatomical characteristics distinct to different ethnic groups.

AcuFocus small aperture IOL: Big news

Since we’re talking about IOL developments, let’s look specifically at an IOL that just hit the market in the US. In July 2022, the AcuFocus (Irvine, California, USA) IC-8 Apthera® became the first small aperture, presbyopia-correcting lens available in the country, and it was first implanted in 2023. The goal is to give a broad range of vision from near to far without any blurry zones. This appears to be a step forward from trade-offs associated with extended depth-of-focus (EDOF) lenses or others that aim to specifically improve one depth of vision.

The Apthera is also the first non-toric IOL designed for cataract patients with up to 1.5 diopters of corneal astigmatism. It’s been available in Europe since 2015, and is well-suited to patients with corneal aberrations, keratoconus, or previous cataract or refractive surgery.

Big moves have just taken place, business-wise: Bausch + Lomb just acquired the AcuFocus company as of January 18, 2023, adding a huge business boost to the company and the lens itself.

Watch this space, as doctors are likely to hear a lot more about this lens in the near future.

Reference

* Yang S, Byun YS, Kim HS, Chung SH. Comparative Accuracy of Barrett Toric Calculator With and Without Posterior Corneal Astigmatism Measurements and the Kane Toric Formula. Am J Ophthalmol. 2021;231:48-57.

Contributing Doctor

Dr. Boris Malyugin is a professor of ophthalmology and the deputy director general (R&D, Edu) of the S. Fyodorov Eye Microsurgery Institution in Moscow, Russia. He is also the president of the Russian Ophthalmology Society (RSO).

Dr. Malyugin is a world-renowned authority and expert in the field of anterior segment surgery. He has established himself at the forefront of advanced cataract surgery by pioneering numerous techniques and technologies. He is well known for his development of the Malyugin Ring, for use in small pupil cataract surgery. Dr. Malyugin has received multiple international awards and was invited to participate with named and keynote lectures and live surgery sessions during several national and international meetings. He is a member of the ESCRS Program Committee, Academia Ophthalmologica Internationalis (member since 2012), International Intraocular Implant Club (member since 2009), as well as the ICO and AAO Advisory Committees.

boris.malyugin@gmail.com

commonly encountered in the same patients, with up to 50% of glaucoma patients suffering the disease at the same time, especially among women. Finding the right treatment that alleviates the symptoms of DED in this large group of people won’t alleviate their high rates of intraocular pressure (IOP), but it will significantly boost their quality of life. Luckily for the nearly 40 million people with both conditions around the world, there are a number of promising developments on the cards.*

To understand more about these developments, we spoke with Dr. William Trattler, a refractive, corneal and cataract eye surgeon based at the Center For Excellence In Eye Care in Miami, Florida (proof that not only old fogies appreciate the Sunshine State).

For Dr. Trattler, helping his patients who already have issues with cataract or glaucoma — and then on top of that have other conditions like DED or blepharitis, both of which can be painful and debilitating in their own right — is not just about pain relief. Treating these conditions speedily and effectively often means that the treatment of the “the big two” becomes much more effective as well.

for the Price of 2 1

Glaucoma ain’t the only sign of aging

Given that the theme of this edition of CAKE magazine is focused on two of the most common conditions that ophthalmologists come across — namely, cataract and glaucoma — we want to start this article with a warning: You will get old.

Yes, eventually you will become old… a coffin dodger, a Florida enthusiast, and the type of person that enjoys

by Andrew Sweeney

shouting at children to “get off their lawn.” You can forestall this fate as much as you want — but eventually, it will hit you like your shock at your first social security check. So get ready for the twilight and the ocular conditions that often come along with it: cataracts, glaucoma, dry eye disease (DED) and presbyopia.

While glaucoma doesn’t directly cause DED, both conditions are

“The most common conditions I see at my clinic are blepharitis and DED, and both of these conditions do the same thing. They impact the health of the ocular surface and the tear film, so when they’re not normal, they’re going to impact preoperative measurements and the patient’s postoperative vision as well, that’s why it’s so important to treat them,” Dr. Trattler said.

Azura and Tarsus … not resort towns in Greece

Dr. Trattler has consistently been at the forefront of utilizing highquality new treatments for DED, blepharitis and other conditions. And at the moment, there are two products he’s keen to see deployed in the near future. The first is the AZR-BL-007 (surely shaken, not stirred…) by Azura Ophthalmics (Tel Aviv, Israel), which uses keratolytics to treat ocular surface conditions. The second is Tarsus, specifically the TP-03, again manufactured by an eponymous company but this time

based in Irvine, California — and if approved, would be the first US Food and Drug Administration (FDA)approved treatment for Demodex blepharitis.

“Azura is developing a therapy that’s going to hopefully get the oil glands to function better. It’s based on keratolytics treatment for dry skin warts, etc., and oil glands of the eyelid produce relatively the same substance. So what Azura does is get the meibomian glands to work better, which is ideal for blepharitis and is really exciting,” Dr. Trattler continued.

forward to it getting approved by the FDA,” he added.

Aging eyes? Glaucoma isn’t the only thing to consider…

As people get older (yes, I’m afraid we’re driving this point home), they also become more vulnerable to conditions like presbyopia, which is bad enough when a patient has relatively normal vision, but can seriously decrease quality of life when they also have conditions like cataract and glaucoma. Eye drops to treat this condition were something of a holy grail in ophthalmology for some time, and now they are becoming a practical reality. This development is something that Dr. Trattler welcomes on behalf of his patients.

“One thing that is interesting with presbyopia eye drops is that they may cause pupillary miosis. In some cases, having a smaller pupil might be the answer because sometimes there’s little astigmatism and a smaller refractive error. In that situation, if you make their pupil even smaller, that actually might improve their vision,” Dr. Trattler said.

have presbyopia in addition to other problems like cataracts or glaucoma, all of which require their own treatment regimen.

“As these presbyopia eye drops last for four to six hours, they might really help these patients. We’ll need to see how they work out once they become approved and available across the country. Right now there’s no evidence of their losing efficacy,” concluded Dr. Trattler.

Reference

* Williams RD. Dry Eye and Glaucoma: Double Trouble. Glaucoma Research Foundation Posted on September 15, 2019; Last reviewed on March 16, 2022. Available at https://glaucoma.org/dry-eyes-and-glaucomadouble-trouble/. Accessed on January 19, 2023.

Contributing Doctor

“Tarsus is similarly very interesting. The company is developing a medication called TP-03, which is targeted at the Demodex that lives on the eyelashes, it’s going to wipe it out. That will result in a dramatic improvement in blepharitis, and the product has already undergone phase three studies. I’m looking

Dr. Trattler pointed to a number of presbyopia-specific eye drops that should be available to clinicians in the near future, including the CSF-1 by Orasis Pharmaceuticals (Herzliya, Israel) and BRIMOCHOL PF by Visus Therapeutics (Seattle, Washington). He said that the appeal of these products is how easily they can be used by patients, especially those in demographic groups that are traditionally less compliant. Perfect for the young at heart who

Dr. William B. Trattler , MD, is a refractive, corneal and cataract eye surgeon at the Center For Excellence In Eye Care in Miami, Florida, USA. He performs a wide variety of cataract and refractive surgeries — including PRK, all-laser LASIK, no injection sutureless cataract surgery, as well as laser cataract surgery. He has been an investigator for next-generation technologies (like the Tetraflex accommodating intraocular lens) and procedures like corneal collagen crosslinking (CXL). His involvement in the FDA-approval study for CXL led to its approval in 2016. In addition to his private practice, Dr. Trattler is on the Volunteer Faculty at the Florida International University Wertheim College of Medicine, as well as the University of Miami’s Bascom Palmer Eye Institute. He is boardcertified by the American Board of Ophthalmology and has been an author of several articles and abstracts. In 2016, Dr. Trattler received the Catalyst Award in Advancing Diversity in Leadership from the Ophthalmic World Leaders (OWL), an association of interdisciplinary ophthalmic professionals dedicated to driving innovation and patient care by advancing diversity in leadership.

wtrattler@gmail.com

“The most common conditions I see at my clinic are blepharitis and DED. They impact the health of the ocular surface and the tear film, so when they’re not normal, they’re going to impact preoperative measurements and the patient’s postoperative vision as well, that’s why it’s so important to treat them.”

— Dr. William B. Trattler

MIGS

Making inroads in glaucoma specialization

by Sam McCommon

In the future, medical archaeologists and historians will look at the 2010s and 2020s as a wildly explosive era of ophthalmic evolution. The marriage of technology and medicine has produced all sorts of viable offspring, and the proliferation of new treatments and tools will continue to evolve. Those historians will probably look at the widening array of MIGS the way an entomologist studies highlyspecialized beetles in the jungle.

Nowadays, there are a lot of different microinvasive glaucoma surgery (MIGS) procedures, and plenty more in the pipeline. Since the term was first coined in 2009, many treatments have entered the market. These work in a myriad of ways, from being miniature versions of trabeculectomy to numerous anglebased treatment options to help fluid drain from the eye.

But what kind of a role can we expect MIGS to play in the future, and where are we now? Are we in the era of MIGS? Where do MIGS fit into glaucoma treatment regimens?

We reached out to two top glaucoma specialists to get their take on the big picture and some exciting new developments. These are Dr. Boris Malyugin, deputy director at S. Fyodorov Eye Microsurgery Institution in Moscow, and Dr. Chelvin Sng, a director and senior consultant ophthalmologist with numerous appointments in Singapore.

Let’s dive in.

How big is MIGS?

First, let’s get a look at the current state of MIGS — and how big a piece of the puzzle they are in current glaucoma treatments.

Dr. Malyugin weighed in here. As he explained, “At least for now, MIGS represent a small to moderate piece of the glaucoma treatment puzzle.” But it looks like things are set to expand soon, and for good reason.

Let’s step back though. There are some hurdles to clear. Quoth Dr. Malyugin: “The current situation is that there is a huge variety of different devices, and sometimes surgeons are being confused with respect to what device to choose properly. But I believe there is a good trend now

to classify MIGS devices, like with the trabecular stenting seen in iStent (Glaukos, San Clemente, California, USA). Similarly, there are devices that improve suprachoroidal outflow — some of which, like CyPass, did not stand the test of time.”

Classifying MIGS into different categories will certainly help surgeons get a hold on the rapidly developing field, he noted. There are more than a few ways to categorize: method of drainage, use for early or late-stage glaucoma, or placement in the eye, for example. Keep your eye on this space as types of MIGS become more clearly classified. There’s a lot of room for growth, especially since the field is developing so rapidly. “Maybe tomorrow there will be new technology, such as MIGS with devices that have sustainable release of intraocular medication. In the future, we will have much better longterm solutions than we have now,” shared Dr. Malyugin.

It’s not all roses, however, and there is plenty of more work to be done. “Glaucoma is generally about proper diagnostics and proper follow-up, and MIGS is kind of a one-step procedure,” he continued. “Obviously, it does not cover the lifespan of the glaucoma patient. The patient should be followed for a long, long time, and the treatment — as we know — should be adjusted according to the individual needs.”

Because glaucoma can only be treated and not cured, customized care is crucial. “MIGS is only one piece of this puzzle and we just need to integrate it into clinical practices properly,” said Dr. Malyugin.

Specific devices

So let’s look a bit closer. Dr. Malyugin mentioned treatments that work for early and late-stage glaucoma. For early glaucoma, there’s the iStent — a silicon tube that goes into the subconjunctival space. According to Dr. Malyugin, there are very optimistic results with respect to the Hydrus Microstent (Ivantis, Irvine, California, USA), which stents the Schlemm’s canal and remains there.

There are also devices that help remove the trabecular meshwork,

such as Kahook Dual Blade (New World Medical, Rancho Cucamonga, California), the iTrack system (Nova Eye Medical, Adelaide, Australia) for ab-interno trabeculectomy, and Trabectome (NeoMedix, Tustin, California, USA), one of the first MIGS treatments.

“Glaucoma is generally about proper diagnostics and proper follow-up, and MIGS is kind of a one-step procedure.”

— Dr. Boris Malyugin

While there is increasing data that MIGS devices aren’t particularly effective at improving trabecular outflow, there is still an added benefit to having them, Dr. Malyugin noted.

Getting cataract surgeons involved

There’s room for cataract surgeons to get involved in MIGS devices, even if they don’t commonly use them now. This is largely down to skillset.

As Dr. Malyugin put it: “Cataract surgeons can dig in because these surgeons don’t usually deal with glaucoma patients very much. But cataract surgeons are skilled surgeons with a good level of dexterity who can accommodate these new devices into their surgical practice. For them, it’s natural and easy to use these MIGS devices during their procedure.”

There are certainly technical challenges involved with implanting some MIGS devices, which cataract surgeons appear readily suited for. “You have to know how to do intraoperative gonioscopy. You have to adjust the operation microscope. It should be tilted by at least 30 degrees to view the angle structure. And there are certain limitations in the movement that are the result of the gonioscopic lens positioned on the cornea,” he continued.

While these are technical skills to be mastered, Dr. Malyugin believes the average cataract surgeon with a good level of dexterity can tackle the skills and add them to their repertoire.

Three exciting MIGS developments

There are three intriguing MIGS devices we wanted to discuss with Singapore star Dr. Chelvin Sng, and she gave us the goods. These are the Paul Glaucoma Implant (Advanced Ophthalmic Innovations, Singapore), the MINIject (iSTAR, Wavre, Belgium), and PreserFlo (Santen, Osaka, Japan).

We’ll start in that order. The Paul Glaucoma Implant (PGI) was designed by Singapore’s Professor Paul Chew and is a novel, valveless glaucoma drainage device developed to reduce complications seen in some other drainage devices. Dr. Sng was a co-inventor of the PGI, so she knows what’s up.

Paul Glaucoma Implant

So what’s up with the PGI? What’s its future, how does it work, and how safe is it?

Dr. Sng sang a song for us. “The PGI has the potential to replace the Ahmed and Baerveldt tubes as the preferred tube implant,” she incanted. “A recent publication in the Journal of Glaucoma reporting the two-year outcomes of the PGI shows that it significantly reduces the IOP to the low teens, with a significant reduction in medications. My personal experience with the PGI is that its efficacy is similar to the Baerveldt with a higher safety profile than the Baerveldt, and now I use the PGI in more than 95% of my tube implant surgeries,” Dr. Sng continued.

Avoiding endothelial cell loss, hypotony, and tube erosions are potential concerns with existing glaucoma drainage devices. Steps to reduce those effects — which the PGI is designed to do — are valuable ones for the development of MIGS.

MINIject

The MINIject implant creates an alternate drainage pathway from the anterior chamber to the supraciliary space. This makes it a bit special in

the MIGS world and certainly helps it stand out.

We asked Dr. Sng what she liked about it, what about its placement made it different, who it is for, and what advice she’d give to fellow doctors.

“The MINIject drains aqueous from the anterior chamber to the supraciliary space,” she began. “Though this space is potentially able to lower IOP significantly, scarring also occurs here and, unlike the subconjunctival space, we are unable to modulate wound healing with antimetabolites.”

There’s a lot more to be done to fully understand this approach, according to Dr. Sng. As she put it, “I think we still have a lot to learn about the supraciliary space and how we can unlock its full potential

Contributing Doctors

Dr. Boris Malyugin is a professor of ophthalmology and is the deputy director general (R&D, Edu) of the S. Fyodorov Eye Microsurgery Institution in Moscow, Russia. He is also the president of the Russian Ophthalmology Society (RSO).

Dr. Malyugin is a world-renowned authority and expert in the field of anterior segment surgery. He has established himself at the forefront of advanced cataract surgery by pioneering numerous techniques and technologies. He is well known for his development of the Malyugin Ring, for use in small pupil cataract surgery. Dr. Malyugin has received multiple international awards and was invited to participate with named and keynote lectures and live surgery sessions during several national and international meetings. He is a member of the ESCRS Program Committee, Academia Ophthalmologica Internationalis (member since 2012), International Intraocular Implant Club (member since 2009), as well as the ICO and AAO Advisory Committees.

boris.malyugin@gmail.com

in glaucoma surgery. Compared to trabecular bypass procedures, supraciliary drainage is associated with a higher risk of complications, including hypotony. Hence, I would not offer this to patients with very mild glaucoma, especially as a phaco-plus procedure when the eye pressure is controlled with eye drops.”

So, is there room for it in the MIGS world? “It may have a role in refractory glaucoma in the context of failed subconjunctival drainage procedures, though this still awaits investigation,” said Dr. Sng.

Dr. Chelvin Sng , BA, MBBChir, MA(Cambridge), MRCSEd, FRCSEd, MMed, FAMS, is the medical director of Chelvin Sng Eye Centre at Mount Elizabeth Novena Hospital. She is also an adjunct associate professor at the National University of Singapore (NUS), a visiting consultant at the National University Hospital, Singapore, and an adjunct clinician investigator at the Singapore Eye Research Institute (SERI). A pioneer of minimally invasive glaucoma surgery (MIGS), Dr. Sng was the first surgeon in Asia to perform XEN, InnFocus Microshunt, and iStent Inject implantation. A co-author of an open-access book on “Minimally Invasive Glaucoma Surgery”, Dr. Sng has also written several book chapters and publications in various international journals. Proficient in conventional glaucoma surgery and trained in complex cataract surgery, Dr. Sng co-invented a new glaucoma drainage device (currently known as the “Paul Glaucoma Implant”), which was patented in 2015. Dr. Sng has received multiple international awards, including the Asia Pacific Glaucoma Society Young Investigator Award and the Asia Pacific Academy of Ophthalmology Achievement Award. When not working, Dr. Sng can be found volunteering in medical missions in India and across Southeast Asia.

chelvin@gmail.com

PreserFlo

The PreserFlo Ab-Externo Microshunt has been available in Europe since 2012, while FDA approval in the US is pending. It can be used on its own or in conjunction with cataract surgery, producing a bleb under the conjunctiva and Tenon’s capsule.

We were curious about what Dr. Sng liked about PreserFlo, how it could fit into a treatment regimen, and what else it works well with.

— Dr. Chelvin Sng

“I like the design of the PreserFlo implant, which has a fin that prevents peri-implant leak, or migration of the implant into the anterior chamber. It is very rare to encounter persistent hypotony after the surgery,” said Dr. Sng. “The sub-tenon placement of

the implant and its length ensures that the bleb is posterior, and patients are less likely to complain of bleb dysesthesia compared with trabeculectomy blebs.”

She continued: “I would offer the PreserFlo MicroShunt to patients

with moderate to severe medically uncontrolled glaucoma. I have paired this procedure with cataract surgery in patients with visually significant cataracts, though that may increase the risk of subconjunctival scarring.”

MIGS moves

So, as you can see, a lot is changing in the MIGS world — and fast. The upshot? More options for doctors and patients, and more room for development in the future. It makes sense to take almost an evolutionary lens to MIGS development since the proliferation is so fast and diverse. What’ll we call the MIGS Cambrian Explosion in the future, do you think?

“I think we still have a lot to learn about the supraciliary space and how we can unlock its full potential in glaucoma surgery. Compared to trabecular bypass procedures, supraciliary drainage is associated with a higher risk of complications, including hypotony. Hence, I would not offer this to patients with very mild glaucoma, especially as a phaco — when the eye pressure is well controlled with eye drops.”

A new crop of novel therapies in glaucoma and cataract takes root

by Matt Herman

The seeds of glaucoma and cataract research are coming to fruition. CAKE magazine talked to an international cast of doctors about what they are most excited about in the future.

Medical research can be a tough sell. As societal problems mount, splashy investments by governments in research seem increasingly like a luxury to a public weary of wasteful spending, corruption, and wealth inequality.

Private investors, too, are not exactly entranced by the idea of waiting long years for returns on their investment. Though flawed, the widely-cited ‘time lag’, or time it takes research to turn into medical intervention of 17 years1 is enough to give pause to even the most patient potential financiers. Even if a generous 12 years is knocked off of this figure, five years is still a long time to wait for a payday on an already risky proposition, especially in the world of meme stocks and cryptocurrency.

This isn’t to say that we are entering a Dark Ages for medical research. Pharma firms themselves have enthusiastically picked up the slack in funding where governments and private capital have turned skittish. After all, self-funded research means higher profits, especially in the United States.

The result is that, despite waning enthusiasm, pharmaceuticals, with eye care included, are still in a golden age of discovery. New drugs, devices, and treatments are rolling off the line with consistency, and the coming year and beyond a promise to be better than ever — especially for cataract and glaucoma, two of the leading causes of blindness worldwide.

The harvest in novel therapies for these critical diseases is bountiful, indeed. So we caught up with top anterior segment MDs from around the world to see the cream of the crop rise to the top.

ROCK: What’s growing on?

Of all the novel innovations, devices, treatments, and tricks coming out, there was one in particular that generated the most buzz out of the doctors we interviewed — ROCK inhibitors (RKIs). So named because they inhibit pathways associated with Rho kinases (ROCKs), these drugs have the potential to be used in everything from hypertension to erectile dysfunction.

“The ROCK inhibitors currently available are ripasudil and netarsudil,” summarized Dr. Chelvin Sng, glaucoma expert and founder and medical director of the Chelvin Sng Eye Centre in Singapore. “Both increase trabecular outflow, and netarsudil also reduces aqueous production,” she explained.

Intraocular pressure (IOP)-lowering agents like RKIs are not new for glaucoma. But it is the mechanism of action of this novel treatment that has doctors talking. There are many drugs that ultimately lower IOP and ocular hypertension, but none do so by actually relaxing the trabecular meshwork as ripasudil and netarsudil do. This is accomplished due to the downstream effects of Rho kinase inhibition, and the hype over this novel approach to IOP reduction is turning heads, including Dr. Harvey Uy’s, Medical Director at Peregrine Eye and Laser Institute in the Phillippines.

“[RKIs are] intriguing drugs because [they are the first] new class of therapeutic agents in more than a decade,” Dr. Uy shared. “[They are] also the first to work directly on the trabecular meshwork, which is believed to be the site of pathology for many cases of glaucoma,” he continued. This direct effect on the trabecular meshwork sans invasive methods is the calling card of RKIs driving the hype train.

Netardusil is the darling of the RKI ball, as it goes a step further by reducing aqueous humor outflow, further amplifying its IOP-reducing superpowers. This is because it includes a norepinephrine transporter (NET) inhibitor, giving the drug an edge over its competitors.

All in all, the ball is just getting rolling for netardusil and ripasudil, and their advantages are clear for Dr. Uy and Dr. Sng. One great advantage over existing treatments for Dr. Sng is the lack of systemic side effects. Though conjunctival hyperemia can occur within two hours of use, it subsides after this window without the systemic risks in other IOP-lowering agents.

The list goes on. “The efficacy of netardusil is similar to that of timolol,” Dr. Sng continued. “[And] studies have shown that the efficacy

of rhopressa [ripasudil] is similar in patients with lower pressures as those with moderately elevated pressures,” she concluded.

And there’s more to be excited about beyond raw efficacy. Compliance with glaucoma eye drops can be marred by the need for frequent application. This ends with RKIs. “The oncea-day dosing offers much-desired convenience,” Dr. Uy added. This once-a-day dosage is unprecedented with IOP-reducing agents. Many popular medications like timolol require at least two doses a day,2 meaning more failure points for patients struggling to keep up with their treatment regime.

Dr. Sng sees even further patient compliance potential when RKIs are combined with other drugs. “There are also fixed combination eye drops containing ROCK inhibitors and FP agonist prostaglandin analogs, which would improve patient adherence,” added Dr. Sng.

Whatever the advantages of RKIs have already proven to be, there are likely still many more to be found, both inside and outside of ophthalmology. But regardless of what is coming down the line for these therapies, Dr. Sng agrees that they have arrived in a big way in glaucoma. “ROCK Inhibitors are a mainstay, as they are a useful addition in our armamentarium of glaucoma eye drops,” she confirmed.

Sowing the seeds of digital tech

The world at large is half-drunk on artificial intelligence (AI). Tools like ChatGPT are sparking fevered discussions around the planet about the future of work and of humanity and its relationship to machine intelligence. So frenzied is the din surrounding this breakout technology that a recent gaffe by Google’s Bard AI during a live demonstration instantly vaporized nearly $100 billion of the tech giant’s market capitalization.

Fortunately for eye care, the dawn of the era of intelligent machines has taken on a more reserved air. AI’s prowess in analyzing images has paid dividends in everything from diabetic retinopathy to glaucoma to wet agerelated macular degeneration (AMD).

Tools like AI retinal fluid monitoring are starting to see widespread clinical use around the world.

“There’s a variety of different applications for AI — it is very good at analyzing images, and we have a lot of visual information in ophthalmology,” explained worldrenowned cataract and refractive expert Dr. Boris Malyugin, deputy director of S. Fyodorov Eye Microsurgery Federal State Institute in Moscow, Russia. “We love images and we rely on them. That’s why AI is a good tool for ophthalmologists — because we have a lot of optical and visual information.”

And one space where this optical and visual information comes together is in the increasingly complex web of biometric data and imaging involved in IOL power calculations. For Dr. Malyugin, the need is glaring. “What we are doing [with AI in IOL

power calculations] is improving our refractive results, and this will benefit our patients,” he remarked. But the benefits are there for doctors, too. “We know that one of the major sources of litigation is incorrect IOL power.”

To this end, there are promising new formulae incorporating AI and machine learning algorithms in them. These include, among others, Hill RBF 2.0, Kane, PEARL-DGS, and the Ladas Super Formula 2.0. Though the function of these proprietary formulae remains largely opaque, the results they are clocking are starting to turn heads.

One major contribution that the predictive power of AI is making to minimize postoperative refraction prediction error is in one of the major bugaboos of modern IOL implantation — effective lens position (ELP) predictions. An influx of postoperative data has led to the ability to train AI to predict postoperative anterior chamber depth (ACD) with unprecedented accuracy. A 2021 study3 showed that

with ACD and ELP values predicted with machine learning methods, the mean absolute error (MAE) in refraction prediction was significantly lower than with the original formulae.

This is great news for ray tracing IOP calculation methods, another novel technology on the verge of a breakout. Extremely accurate in ways that traditional formulae are not (like corneal aberrations), but ultrasensitive to errors in things like ELP, ray tracing might just be on the verge of a breakthrough on the heels of the AI revolution.

Dr. Malyugin thinks there are other reasons ray tracing is about to get its long-awaited day in the sun. “[Ray tracing] must take into account the individual geometric parameters of each lens, like anterior and posterior surface curvature,” he explained. “Some manufacturers will come up with their own ray tracing formulas because they have specific information that will not be universal for each lens that we have in our machines,” predicted Dr. Malyugin.

Despite the obstacles, the future of more accurate, more capable IOL power calculation is upon us — thanks to the advances brought about by AI and ray tracing. But while the massive leaps forward like RKIs and machine learning are grabbing headlines in the vision space, doctors are also looking at a host of smallerscale innovations poised to make power moves.

Fresh picks: Medication miscellanea

Dr. George Beiko, associate clinical professor at McMaster University and a lecturer at the University of Toronto, Canada, has his eye on one important niche in glaucoma. “I am looking forward to an expansion of preservative-free glaucoma medications,” Dr. Beiko wrote.

He sees the current landscape of glaucoma management meds as not meeting the demands of the modern patient. “As glaucoma therapy is chronic and tends to be lifelong, toxicity from preservatives is an eventuality,” he continued. Benzalkonium chloride (BAK) is by far the most common preservative used in eye drops, and is known to be toxic to many ocular structures, and in

particular the ocular surface.4

“Patients frequently come in with irritated eyes. However, stopping their current treatment may not be a desirable option since their glaucoma may be controlled,” shared Dr. Beikos. Replacing highly toxic and outdated preservatives like BAK, which has been in use since the 1940s,4 should be a priority after around 80 years of the same noxious substance.

“Preservative-free options make the treatment bearable,” added Dr. Beiko. And for sufferers of a lifelong, chronic disease like glaucoma, bearable should just be the bare minimum.

Outside of RKI’s, Dr. Chelvin Sng is keeping tabs on another gamechanging pharmaceutical innovation this year. “I am most excited about sustained release drug delivery devices,” Dr. Sng said.

The harvest of potential drug implants that deliver critical glaucoma management drugs is abundant, indeed. Punctal plugs are one promising direction, with the Evolute by Mati Therapeutics leading the way after it completed a phase II trial this year. Contact lenses that deliver drugs like timolol and latanoprost are also in the early stages of development. Both have shown promise, but also come with a plethora of issues. Punctal plugs become dislodged. Both run the risk of bacterial infection. But research and more tinkering might just unlock the significant latent potential.

Intracameral inserts seem to be the most promising contender in the near future. Glaukos’ iDose TR travoprost delivery system is coming off of extremely promising Phase III clinical trial results, while the OTX-TIC from Ocular Therapeutix (USA), ENV515 from Aerie Pharmaceuticals (USA), and Alcon (SUI) and Latanoprost FE SR from PolyActiva (AU) look to join the FDA-approved DURYSTA bimatoprost implant from Allergan (IRL).

Whatever modality is still standing when the dust settles, Dr. Sng sees a host of benefits for those who need it most. “[Sustained drug delivery devices] can potentially improve our patients’ quality of life by reducing or eliminating glaucoma medications,” she stated.

A bountiful harvest for cataract and glaucoma

All in all, the future is ablaze with possibilities in ophthalmology. Impending breakthroughs in AI implementation loom large across the field, and cataract and glaucoma are well-positioned to take immediate advantage. And despite the pandemic hangover and a waning appetite

Contributing Doctors

Dr. Harvey S. Uy , MD, is a clinical associate professor of ophthalmology at the University of the Philippines, and medical director at the Peregrine Eye and Laser Institute in Makati, Philippines. He completed his fellowships at St. Luke’s Medical Center (Philippines) and the Massachusetts Eye and Ear Infirmary (USA). Dr. Uy is a pioneer in femtosecond cataract surgery, accommodation restoration by lens softening, modular intraocular lenses and intravitreal drugs. He has published over 30 peerreviewed articles and is on the editorial board of the American Journal of Ophthalmology Case Reports. He is a former president of the Philippine Academy of Ophthalmology (PAO) and current council member of the APVRS.

harveyuy@gmail.com

Dr. George H.H. Beiko , BM, BCh, FRCSC is a medical graduate of Oxford University and completed his ophthalmology specialty training at Queens University. He is an associate clinical professor at McMaster University and a lecturer at the University of Toronto. Dr. Beiko has published over 30 peer-reviewed articles and authored 16 book chapters. He has been awarded 4 best papers of session at the ASCRS annual meeting, Winning Video in Cataract Implant Surgery in the ASCRS Film Festival, 5 video awards in team competitions, Best Poster Award at AAO, Best Paper of Session (Cataract) at APAO-AAO Joint Meeting and the Best Original Paper in Cataract

for government-funded research in novel medicines, industry is more than happy to pick up the slack with lucrative drugs like RKIs and qualityof-life boosting innovations like sustained drug delivery devices. The ground for innovation in cataract and glaucoma is more fertile than ever, and patients with these potentially debilitating disorders are already starting to reap the benefits.

References

1. Balas EA, Boren SA. Managing Clinical Knowledge for Health Care Improvement. Yearb Med inform. 2000;(1):65-70.

2. Timolol (Ophthalmic Route) Mayo Clinic. Available at: https://www.mayoclinic.org/ drugs-supplements/timolol-ophthalmic-route/ proper-use/drg-20071111. Accessed on February 11, 2023.

3. Li T, Stein J, Nallasamy N. AI-powered effective lens position prediction improves the accuracy of existing lens formulas. Br J Ophthalmol. 2022;106(9):1222-1226.

Surgery at AAO. He is on the review panel or editorial board of over 30 ophthalmology journals. His honors include being elected to membership in the IIIC, named one of the “Premier Surgeons” of North America and made an Officer of the Most Venerable Order of the Hospital of St. John of Jerusalem, by Her Majesty The Queen of England. He was honored on 3 occasions with the Gold Medal by the IIIRS, an Achievement award and a Senior Achievement award by the AAO, an Achievement Award by the APAO, the Presidential Award of the ISRS and the Boberg-Ans Award of the Danish Ophthalmological Society.

george.beiko@sympatico.ca

Dr. Chelvin Sng , BA, MBBChir, MA(Cambridge), MRCSEd, FRCSEd, MMed, FAMS, is the medical director of Chelvin Sng Eye Centre at Mount Elizabeth Novena Hospital. She is also an adjunct associate professor at the National University of Singapore (NUS), a visiting consultant at the National University Hospital, Singapore, and an adjunct clinician investigator at the Singapore Eye Research Institute (SERI). A pioneer of minimally invasive glaucoma surgery (MIGS), Dr. Sng was the first surgeon in Asia to perform XEN, InnFocus Microshunt, and iStent Inject implantation. A coauthor of an open-access book on “Minimally Invasive Glaucoma Surgery”, Dr. Sng has also written several book chapters and publications in various international journals. Proficient in conventional glaucoma surgery and trained in complex cataract surgery, Dr. Sng co-invented a new glaucoma

drainage device (currently known as the “Paul Glaucoma Implant”), which was patented in 2015. Dr. Sng has received multiple international awards, including the Asia Pacific Glaucoma Society Young Investigator Award and the Asia Pacific Academy of Ophthalmology Achievement Award. When not working, Dr. Sng can be found volunteering in medical missions in India and across Southeast Asia.

chelvin@gmail.com

Dr. Boris Malyugin is a professor of ophthalmology and is the deputy director general (R&D, Edu) of the S. Fyodorov Eye Microsurgery Institution in Moscow, Russia. He is also the president of the Russian Ophthalmology Society (RSO). Dr. Malyugin is a world-renowned authority and expert in the field of anterior segment surgery. He has established himself at the forefront of advanced cataract surgery by pioneering numerous techniques and technologies. He is well known for his development of the Malyugin Ring, for use in small pupil cataract surgery. Dr. Malyugin has received multiple international awards and was invited to participate with named and keynote lectures and live surgery sessions during several national and international meetings. He is a member of the ESCRS Program Committee, Academia Ophthalmologica Internationalis (member since 2012), International Intraocular Implant Club (member since 2009), as well as the ICO and AAO Advisory Committees.

boris.malyugin@gmail.com

What a long, it’s been… awesome trip

It’s hard to believe that the last in-person APAO congress was in 2019 — now that we’re finally back on the congress floor, let’s take a look back at the last time APAO and Media MICE got the chance to catch up…

Keeping an Eye on Gender Equality

Finally… we’re seeing a promising future for women in glaucoma

by Andrew Sweeney

According to the global management consultancy group McKinsey & Company, business in 2023 will be characterized by an increased drive towards diversity efforts, particularly aimed at women. Spending on initiatives related to these efforts has reached $7.5 billion over the last two years and that figure is expected to double by 2025.

It’s big business, to put it bluntly — and not just in the corporate world. Medicine is nearly as much of a business as consulting and finance, and efforts to include more women at the senior level of ophthalmology, especially in developing countries where they

are significantly less represented, will be a feature of the next 12 months. 1

That being the case, it’s important that we understand the current representation of women in ophthalmology generally, and in some

of its sub-specialties specifically, like glaucoma. For this question, we’re fortunate to have a study to examine this, namely Gender Shift Among Academic Glaucoma Specialists in the Past 30 Years, published in 2020 by a group of researchers based at the University of California, Irvine.2 Their paper makes for simultaneously heartening and disheartening reading about the position of women specializing in glaucoma.

For example, the study found that there is a high representation of women specializing in glaucoma at 40% of the surveyed population in the study, and there were more women

than men among those glaucoma specialists who were board-certified within the past five years across the United States. However, it also highlighted an association between gender and academic rank, with the majority of professors in the field being male. Therefore, there’s been great progress but more needs to be done.

Ophthalmologists, remarkable human beings

Studies are crucial to understanding the broader picture, but it’s equally important to get a picture “from the trenches.” So we spoke with Dr. Ruth D. Williams, a glaucoma specialist and president of the Wheaton Eye Clinic located near Chicago, Illinois. Recognized by the American Academy of Ophthalmology with the Senior Achievement Award and a recipient of the prestigious Chicagobased “Top Doctors” award, Dr. Williams is passionate about her work as an ophthalmologist generally, and the field of glaucoma specifically.

“One of the best aspects of being an ophthalmologist and glaucoma specialist is that I get to spend time with such remarkable humans, both male and female. We continue to be shaped by the people we spend a lot of time with, and we spend a lot of time with our colleagues. I’m a better person and a better clinician through the influence of my peers,” shared Dr. Williams.

“I have more in common with my glaucoma specialist friends in another state than with my next-door neighbor, who might not understand why I have to plan three months ahead to get together. It’s an exciting time to be in this field as I predict that the biggest advancements in understanding and treating neurodegenerative diseases will happen in the glaucoma space,” she said.

AGS provides a platform for women

Dr. Williams was happy to share that more women are present in the ophthalmology profession, while noting that there’s still room for progress. She said that she had noticed a slight drop in the number of women joining the field generally, however, she said that this could

be attributed to more of the women who do join entering more specific sub-specialties. She believes that adopting a more proactive approach to attracting women to ocular health may resolve this issue.

specificity of its work. Of course, her greatest passion lies in her chosen field.

“Glaucoma is the best specialty. More than just about any specialty, it has very well-defined goals as our patients highly value their vision and most of what we do enhances quality of life. This is why ophthalmologists tend to be optimistic, energetic and happy people,” continued Dr. Williams.

“What we do brings tangible quality of life to our patients, and our work is meaningful and definable. We have choices that can include a lovely mix of surgery, clinic, research, writing, speaking, leadership, activities, business and finance. There is flexibility in ophthalmology and glaucoma,” she said.

— Dr. Ruth D.

The American Glaucoma Society (AGS) is one of the country’s major ophthalmologic institutions, and Dr. Williams reports that it has achieved a great deal in propelling women to the front stage. The society has over 400 members, including some of American ophthalmology’s leading figures, many of them female trailblazers in their own right. For Dr. Williams, the AGS’s support is as much practical as it is inspirational.

“AGS has done a fabulous job in getting women on the podium and thanks to the society’s leadership, it’s been simple to recommend one’s friends for panels, speakers and awards. Diversifying leadership positions often naturally diversifies everything else,” shared Dr. Williams.

“Diversity, of course, means a lot of things and gender is just one of them. Most of us are good communicators, good speakers, and talented leaders — we’ve had to be — and our organizations will be better if women are included in leadership,” she added.

Dr. Williams’ positivity about the future of her profession is infectious, and she’s keen to encourage other women to join. She points to the transformative power of ophthalmology: How it can astound patients with the beneficial effects clinicians can provide, and the

“We are the luckiest people in the world,” she concluded.

References

1. Diversity, Equity and Inclusion Lighthouses 2023. McKinsey & Company. Published on Jan. 23, 2023. Available at https://www. mckinsey.com/featured-insights/diversityand-inclusion/diversity-equity-and-inclusionlighthouses-2023. Accessed on Jan. 20, 2023.

2. Mohammadi SO, Afzali K, Gharaei N, Khodadoustan P, Lin K. Gender shift among academic glaucoma specialists in the past 30 years. Invest Ophthalmol Vis Sci. 2020;61(7):5111.

Contributing Doctor

Dr. Ruth D. Williams is a specialist in the diagnosis and management of glaucoma. She received a BS in biology from Wheaton College and her MD from Rush Medical College in Chicago. Following an internship at West Suburban Hospital Medical Center in Oak Park, Illinois, Dr. Williams completed her residency in ophthalmology at California Pacific Medical Center and a fellowship in glaucoma at the University of California in San Francisco. She is the president of Wheaton Eye Clinic, residentelect of the American Academy of Ophthalmology, and a national spokesperson on ophthalmic issues.

ruthwilliams@wheatoneye.com

“Diversity, of course, means a lot of things and gender is just one of them. Most of us are good communicators, good speakers, and talented leaders — we’ve had to be — and our organizations will be better if women are included in leadership.”

Williams

Best Ring Forward

How one doctor’s vision becomes a sight-saving reality in cataract surgery

by Joanna Lee

As the saying goes: “Dreams don’t work unless you do.” This holds true for Dr. Suven Bhattacharjee, the inventor of the B-HEX® Pupil Expander 1 (formerly known as the Bhattacharjee ring). Seeing his innovation reach a developed stage — expanding from India into various corners of the world — has been worth every sweat and teardrop in bringing his dream to life.

The B-HEX Pupil Expander is a hair-thin, disposable 6.5 mm flexible hexagonal device with notches at corners and flanges at sides, which offers eye surgeons easy insertion through small incisions and good control at the site of action with its well-thought design.

Expanding from one man’s vision

Dr. Bhattacharjee is the founder and director of Med Invent Devices, the company that markets the innovative pupil expander device. It took him five years to develop the product from scratch, and even longer to patent it while facing multiple roadblocks, including a life-threatening health crisis, before his eureka moment.

Without giant financial backings, team support, or sophisticated labs — and being told his invention wouldn’t work — with hard work and dedication, the fruit of his labor has resulted in the B-HEX being registered with the US FDA for use in the United States, while also emerging as the preferred pupil expansion device in India.

According to a 2020 online survey in India, 42% of responders favored the B-HEX as their preferred pupil expansion device, while 41% choose iris hooks, and 8% went for the Malyugin ring.

“This result was a pleasant surprise,” shared Dr. Bhattacharjee. “Expanders are closed rings and require a single incision for insertion, whereas hooks require at least four incisions. Expanders also cost more than hooks. In India, the B-HEX costs four times that of iris hooks, which have been popular for years because cost is an important determinant,” he explained.

With no marketing budget or any sales representatives, the success of B-HEX is remarkable, largely due to its ease of use. “No wet labs or hands-on demos were given to any surgeons. They just watched videos and were good to go,” Dr. Bhattacharjee said.

The B-HEX has also been used in vitreoretinal surgery and manual small incision cataract surgery (SICS).

Spurring surge in device’s usage

Dr. Bhattacharjee attributes the expansion of B-HEX’s popularity to the overwhelming response from surgeons around India.

“We owe a debt of gratitude to them,” he said. “The B-HEX has been used across the length and breadth of India from individual practices to large corporate hospitals. We haven’t been able to make inroads into government hospitals probably because of complicated purchase systems.”

“We receive messages from experienced as well as rookie surgeons expressing gratitude for how the B-HEX has made complicated surgery easier, safer, and affordable,” he expressed.

The B-HEX had also been mentioned by a number of key opinion leaders on

several occasions during conferences and meetings. Dr. Bhattacharjee said it has been meaningful for him. For instance, Dr. David Chang demonstrated the use of the B-HEX during his surgery at the “Spotlight on Cataract Complications” session during the AAO 2021 meeting. A video on the AAO website by Prof. Dr. Deepak Edward and Dr. Michael Henry from the University of Illinois in Chicago showed the B-HEX being used in a challenging phaco surgery with a glaucoma tube shunt. Dr. Bhattacharjee also shared words from Prof. Dr. J. S. Titiyal, head of ophthalmology at the All India Institute of Medical Sciences: “The B-HEX is simple, user friendly, and with marvelous results.”

There are also YouTube videos highlighting the advantages of using the B-HEX, as posted by Dr. Pradip Mohanta, Dr. Deepak Megur, Dr. Sourabh Patwardhan, and Dr. Soosan Jacob from India, as well as Dr. Neto Rosatelli from Brazil.

The rising popularity that the B-HEX now enjoys is a far cry from the early days when Dr. Bhattacharjee’s research papers and patent applications had been rejected several times.

Limitations play into growth strategy

After the device’s test and launch in India, which saw its growth in popularity, it appears it was time to scale up fast and make the B-HEX available in all countries.

“Since Med Invent Devices has a limited reach, we have been strategically adding value to the B-HEX to make it attractive for acquisition by an MNC. Towards this, we already have globally granted patents and trademarks, clinical validation, US FDA registration,

and user testimonials indicative of superiority over competition,” Dr. Bhattacharjee shared.

He believes that acquisition by or collaboration with an MNC will make the B-HEX available to a global user base worldwide and translate into more rapid growth in its market share.

When asked why they didn’t go for distribution contracts outside of India, he said: “These would require long-term commitments on supply and pricing, which would be a deterrent in the process of acquisition.”

“The B-HEX was registered with the US FDA to make it legally usable and so that it could be showcased in the US. We deliberately did not register in other countries as that is best done by the acquirer,” Dr. Bhattacharjee explained.

Despite these limitations, in the Asia Pacific they have sold the B-HEX directly to surgeons in Japan, China, Korea, Nepal, Bangladesh, Indonesia, Malaysia, Thailand, and the Philippines, as well as to surgeons in the USA, Canada, Brazil, Germany, Italy, Oman, Slovenia, Azerbaijan, and Rwanda, among others.

“It is worth mentioning that in all countries outside India, the surgeons went out of their way, used physician privileges, incurred high import duties, and did the paperwork just to use the B-HEX. They did all this despite the fact that other devices were easily available with local distributors,” he noted.

Soon, the B-HEX will be available in more countries in Europe and around the world, as Dr. Bhattacharjee and his company are at different stages of talks with a few MNCs through investment bankers.

Challenges of gaining acceptance in the West

“It is a challenge to convince some surgeons that the first mover’s product is not necessarily the best product,” he said. “They get used to certain devices and do not like moving out of their comfort zone.”

However, he shared that evidence for the B-HEX’s effectiveness

recorded in peer-reviewed scientific publications2,3,4,5 and videos by early adopters and key opinion leaders are removing that initial barrier to acceptance.

For example, Dr. Bhattacharjee said the surgeons are used to an injector for some pupil expanders. “However, the injector is only a means to circumvent the problem of snagging of the corneal incision when these biplanar rings are inserted into the eye or removed from the eye. It only overcomes a design disadvantage in the ring and is actually counterproductive for a pupil device,” he added.

“The injector tube occupies precious incision space, calling for larger incisions. Moreover, it is not helpful to have the control away from the site of action for pupil devices,” Dr. Bhattacharjee explained.

On the other hand, the B-HEX’s disruptive planar patented design allows it to glide through much smaller corneal incisions with the B-HEX 23G forceps.

Of future foresights and immense satisfaction

Dr. Bhattacharjee envisions the B-HEX in the future as a “necessary inventory in every ophthalmic operating room” because surgery in an eye with a non-dilating pupil or intraoperative miosis, such as intraoperative floppy iris syndrome (IFIS), can lead to vision-threatening complications.

“When IFIS strikes suddenly and the pupil becomes small during surgery, the surgeon prefers a simple device which is easily manipulated, passes through small incisions, and does not come in the way of other instruments. The B-HEX is the only device that checks all these boxes,” he said.

Above all, the joy of creating something that is “societally useful” has been described as phenomenal for Dr. Bhattacharjee. “That we have been able to make surgery easier for our colleagues, safer for our patients, and affordable for healthcare systems is immensely satisfying.”

“As a product, the B-HEX is fully

developed. But in terms of reaching market potential, it is in its infancy. If morning shows the day, the B-HEX has clearly indicated the future. The right partner will catalyze its growth and help achieve market dominance,” concluded Dr. Bhattacharjee.

References

1. Bhattacharjee S. Pupil-expansion ring implantation through a 0.9 mm incision. J Cataract Refract Surg. 2014;40(7):10611067.

2. Chakraborty D, Mohanta A, Bhaumik A. B-HEX pupil expander in vitreoretinal surgery – A case series. Indian J Ophthalmol. 2020;68(6):1188-1191.

3. Sarosh R, Rashid O. B-Hex, an ace up the sleeve for small pupil phacoemulsification. Rom J Ophthalmol. 2022;66(1):61-68.

4. Bhattacharjee, Suven. B-HEX Pupil Expander: Pupil expansion redefined. Indian J Ophthalmol. 2017;65(12):1407-1410.

5. Salviat, Flore & Febbraro, Jean Luc & Zuber, Kevin & Yavchitz, Amélie & Moran, Sarah & Gatinel, Damien. (2022). Evaluation of a uniplanar pupil expansion ring in small-pupil cataract surgery: a feasibility study. Int Ophthalmol. 2022;42(2):489-496.

Contributing Doctor

Dr. Suven Bhattacharjee is an eye surgeon, innovator, and entrepreneur. He is a consultant at the Nayan Eye Centre, Kolkata, India. He is also the founder and CEO of Med Invent Devices, a startup with many awards to its credit. He holds international patents for his invention, the ‘B-HEX Pupil Expander’, which has redefined pupil expansion in cataract surgery. The B-HEX has made complicated small pupil cataract surgery safer with more predictable outcomes. He was adjudged Top Innovator & Gold Medalist at the DST - Lockheed Martin - India Innovation Growth Program 2016. He has received Technology Commercialization training at the Stanford Graduate School of Business. He has received the AIOS Dr. P. Siva Reddy International Award, Col Rangachari Award for overall best paper, Sante Vision Award for best Cataract Paper, ASCRS best paper of session, AIOS International Hero Award, CS Reshmi Gold medal for best video and APACRS Video award. suven@medinventdevices.com

Big things to talk about

by Andrew Sweeney

The 38th Asia-Pacific Academy of Ophthalmology Congress is one of the last events to get back into the usual swing of things, having been forced online since the beginning of the pandemic.

Remember COVID-19? It’s beginning to feel like it was a lifetime ago … but let’s be real — it wasn’t — and it’s only recently that our lives have started to return to a “2019 normal.” This is something you’ve probably noticed if you’ve been following Media MICE’s coverage of various ophthalmology and optometry events. Plenty of places have opened up to normality once again — but for others, it’s taken a little more time.

The Asia-Pacific Academy of Ophthalmology (APAO) Congress is coming back in full force this year and

will be held in the Malaysian capital of Kuala Lumpur from February 23-26. And of course, the Media MICE team will be attending in-person — and looking as funky as ever. Not only does this event represent the final confirmation of normality returning (being one of the last “big” shows to return to real life), but it’s also notable for its bumper program.

This quarter’s edition of CAKE magazine focuses on glaucoma and cataract, and both conditions feature prominently in the program overview at APAO 2023, with two sessions dedicated to glaucoma surgery on the first day alone.

There are “hot topic” formats covering both separate diseases, various debates on major issues in cataract surgery and treatment, and a number of other symposia focused on more niche considerations. We’re particularly looking forward to Managing the Little Things That Mess Up Otherwise Perfect Surgery about cataract surgery on February 25, and Epidemiology, Risk Factor, Lifestyle, and Genetic, which focuses on glaucoma on the same day.

Learning from the best

To learn more about what to expect at APAO 2023, as well as what the

organization is working on to help treat patients with glaucoma and cataract, we spoke with APAO 2023 Congress President Dr. Kenneth Fong. He is also a former president of the Malaysian Society of Ophthalmology and one of AsiaPacific’s leading ophthalmologists. One of the main concerns he has for ocular healthcare in the region is the disparity between rural and urban patients, and he hopes this year’s conference can help address that, inspired perhaps by the host country’s initiatives.

“There is an oversupply of ophthalmologists in the urban areas in all Asia-Pacific countries, and governments all have the same issues of trying to provide adequate cataract surgery coverage to rural areas. In Malaysia, our Ministry of Health provides a well-equipped mobile cataract service for rural areas in East Malaysia, while regular cataract surgery camps are carried out by the government and voluntary groups,” said Dr. Fong.

“Malaysia is a middle-income country and shares many of the same issues as most Asia-Pacific countries. We are fortunate to have a free national healthcare service that offers good ophthalmology care generally, while the vibrant private sector offers costeffective subspecialty care for local and international patients,” he added.

Dr. Fong was also keen to point out that a number of important developments are taking place in the treatment of glaucoma, too. The historical trend has been that access to glaucoma treatment was lacking, both in ophthalmology and optometry, and especially in developing nations like Cambodia and Laos. It’s a regionally specific problem too: There has been a trend of using medications for allergies that can cause serious side effects, including glaucoma.

Many reasons to be optimistic

However, while Dr. Fong reported that issues persist and that there are barriers to treatment in some places, overall the situation regarding glaucoma treatment in Asia-Pacific has improved, public awareness campaigns are increasingly full-throated and effective, and

urbanizing populations mean more people have access to treatment. New technologies like telehealth are assisting rural populations, too.

caused by a pandemic. There’s much to look forward to and Dr. Fong is particularly optimistic about the APAO’s work in 2023 and beyond.

“The APAO has carried out many outreach projects for teaching and training in Myanmar, Laos, Cambodia, and Indonesia. I was part of the APAO Gateway Project subcommittee for several years, and we worked hard to fund and support such projects. But unfortunately, the COVID-19 pandemic stopped all this valuable work and we will have to start from scratch again in 2023,” shared Dr. Fong.

“Major conferences, like the APAO main congress and our satellite meetings, serve to share the current best practices from our members from all over. We also have many travel grants to support ophthalmologists from developing countries to attend. It’s an exciting time to be president and the conference should be fascinating,” he concluded.

— Dr. Ken Fong

“Many Asian patients buy over-the-counter topical steroid medications for eye allergies without undergoing a check-up with an ophthalmologist, and this often leads to severe steroid-induced glaucoma. More enforcement could be done to improve this situation and arrest this problem. Glaucoma specialists remain in short supply in the region, and good surgical care for both pediatric and adult glaucoma cases remains limited to tertiary eye care centers,” Dr. Fong shared.

“The main issue for glaucoma now is early detection, and we have very good national glaucoma awareness programs in most Asia-Pacific countries. Also, topical glaucoma medications are high quality and readily available too,” he continued.

APAO 2023 will be a great event for its attendees and the longer-term picture looks exciting as well with the organization’s continued outreach programs. These cover a number of conditions like cataract and glaucoma, with clearer prospects and without (presumably) the disruption

Contributing Doctor

Congress President of APAO 2023

Dr. Kenneth Fong is recognized as an ophthalmologist in the United Kingdom, Australia and Malaysia. He graduated with a medical degree from the University of Cambridge in 1998 and trained to be an eye surgeon in London. Dr. Fong then spent two more years training in the U.K. and at the Royal Perth Hospital in Australia to subspecialize in retina. After 18 years of working in the U.K. and Australia, he returned to Malaysia in 2009 to serve as associate professor, consultant ophthalmologist and retinal surgeon at the University of Malaya in Kuala Lumpur. He is currently the managing director of OasisEye Specialists in Kuala Lumpur. As of 2023, Dr. Fong is the immediate past president of the Malaysian Society of Ophthalmology (MSO), the congress president of APAO 2023, and serves as a council member for the Asia Pacific Vitreoretina Society (APVRS).

kcsfong@gmail.com

“There is an oversupply of ophthalmologists in the urban areas in all Asia-Pacific countries, and governments all have the same issues of trying to provide adequate cataract surgery coverage to rural areas. In Malaysia, our Ministry of Health provides a well-equipped mobile cataract service for rural areas in East Malaysia, while regular cataract surgery camps are carried out by the government and voluntary groups.”