CAKE Magazine Issue 03: The ebook version (The 'Haute Couture' Issue, ESCRS 2019 Edition) by Media MICE

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IN THIS ISSUE...

Cataract

Silver Bullet or Double-edged Sword? Going ‘dropless’ with post-cataract surgery

Matt Young

CEO & Publisher

Robert Anderson Media Director

Hannah Nguyen

Production & Circulation Manager

Gloria D. Gamat Chief Editor

Brooke Herron Associate Editor

Mark Hillen

Editor-At-Large

Ruchi Mahajan Ranga Project Manager

Travis Plage

Director of Finance

Alex Young

Publications & Digital Manager

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Out of the OR: Democratizing corneal crosslinking by bringing it to the slit lamp

Optimizing Antibiotic Use Under the Constant Threat of Developing Resistance

MIGS Rising: Uncovering the benefits of a new cuttingedge instrument

Cover Story

Graphic Designers

Winson Chua Kelsey Roode

SIGHT COUTURE: Top 10 Trends in Anterior Segment for Fall 2019

Writers

April Ingram Gerardo Sison Hazlin Hassan Khor Hui Min Joanna Lee Olawale Salami Tan Sher Lynn Published by

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Asia-Pacific Academy of Ophthalmology

Ophthalmology Innovation Summit

Kudos 34

BARBARA MASKET: On Seeing ‘Art to Eye’

Keeping Children’s Eyes Healthy in A Digital World, One Book at A Time

Enlightenment 36 42 What Europe Can Learn from India

Investments in Ophthalmology: What’s new, hot and trending in 2019?

When Fashion Meets Vision

A Lowdown on the Latest in Anterior Segment ‘Trends’

Conference Highlights 47

Age-related Eye Diseases and Latest Innovations in Ophthalmology

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CAKE MAGAZINE Letter to Readers

A Sartorial Vision “I blame Kylie Minogue.” I do a double-take. “What?”, I asked, blinking.

here I was, amongst a group of refractive surgeons. One is holding court, attributing some of the blame for the downturn in laser-assisted in situ keratomileusis (LASIK) numbers over the last decade to the five-foot Australian pop minstrel. There was a bit of a low commotion in the group after he said that, but he went on: “She wore glasses in her pop videos, looked good, and this was making Millennials think that glasses look cool”. I do have a pair of glasses, but not because I’m not cool (I should be so lucky!), but because I’m very mildly hyperopic. I also can say, hand on my heart, that I never, ever wear them. Less “Can’t get you out of my head”, more “Can’t find them to put on my head”. Let’s step back in time and look at what the fashion has been in terms of cataract and refractive surgery. If we ignore the cosmetic aspect (which is subject to the whims of popular culture), then the drive is to have tailored solutions to people’s vision disorders. The elective refractive surgery market exists for a reason — there’s still a big demand for it. To be fair, there’s never been a better time to undergo refractive surgery. Thanks to improvements in ocular biometry and laser technology, procedures like LASIK, photorefractive keratectomy (PRK), and small incision lenticule extraction (SMILE) have never been safer or more effective. And while the laser is the tailor’s scissors (which have got faster, sharper and safer over time), it’s the measuring tape of the diagnostic instruments that have enabled the final fit to be as good as it is, with far fewer wardrobe malfunctions than ever before. But if laser surgery is the leather jacket, then allogenic inlays are sports-casual blazers. (Which goes best with jeans?) Again, these refractive corneal implants are being tailored to each patient’s eye, be it by blade or by laser. Whether this approach comes to dominate the market is beyond my predictive abilities. But what I do notice is that multiple groups are working on this approach, and dare I say it: It’s currently in fashion. But let’s look at intraocular lenses (IOLs). Ridley’s first patient had a refractive surprise of 20 D, but the work of Fyodorov and others in the 1960s and 1970s brought about the combination of ocular biometers and IOL power calculations that enabled surgeons to pick an IOL that aimed for emmetropia. Today’s off-the-peg cataract surgery involved the implantation of a monofocal lens — usually to

give the patient clear distance vision. And if you’re of an age where cataract surgery is required, you’re not considering glasses because Kylie rocks a pair like no other: You need them to read, to shower, to drive . . . as does everybody else with them. Plus, everyone else your age is wearing them, too! But now we have multifocal and extended depth of focus (EDOF) IOLs. They’re not the best choice for everyone, and they tend to give two or three distances with sharp vision, with gaps in between, but for some, this (relatively) off-the-peg can be a great premium option (more Versace than Levi’s), dramatically reducing or even eliminating the need to wear glasses. But even here, better tailoring can occur. It’s clear that a comprehensive understanding of a patient’s visual needs is key to selecting the right multifocal IOL for them, but this takes a lot of “chair time” and requires the patient to remember all of their use cases. Forgetting that they like to embroider in low light next to the coal fire might be trivial to them, but it can make a big difference to which distances are required by the patient most, and therefore the IOL selected for implantation. So, I like the concept of the spectacle-mounted infrared distance sensing devices that record what the patient does and spits out suggestion list of IOLs that would serve the patient best. I like the idea of glasses that can be programmed to simulate any given multifocal IOLs that patients can wear to test-drive their post-surgical vision — this is like trying on an outfit in a changing room before deciding to buy it. But really, what’s to stop people from having tailored IOLs? As far as I’m aware, 3D printing isn’t at a point where an IOL can be custom-printed in the office for each patient. But I don’t think it’s too far beyond the capabilities of IOL manufacturers today to custom program a lathe to produce a unique IOL for each patient based on their biometry and use-case scenarios. The ultimate arbiter of visual quality is the retina, and there’s very little that can be done to enhance the quality of vision there (in a healthy retina, at least). But in terms of the light-refracting structures in front of it, it’s incredible how much power surgeons have to fine-tune and sculpt vision. This power is only going to get better and better. So, I may not be cool (with or without spectacles) – but what’s happening in cataract and refractive surgery certainly is.

Dr. Mark Hillen Director of Communications ELZA Institute, Zurich, Switzerland Editor-At-Large CAKE Magazine

September/October 2019

CAKE MAGAZINE Advisory Board Members Dr. Jodhbir Singh Mehta, B.Sc. (Hons.), M.B.B.S., PhD, FRCOphth, FRCS(Ed), FAMS Dr. Mehta is head of Cornea External Disease and senior consultant in the Refractive Service at Singapore National Eye Centre (SNEC), deputy executive director at Singapore Eye Research Institute (SERI), as well as a professor at Duke-National University of Singapore. With a main interest in corneal transplantation, he completed a corneal external disease and refractive fellowship at Moorfields Eye Hospital in London and at SNEC. He has co-authored nearly 20 textbooks and 333 citations, and holds 16 patents, six of which have been licensed. A seasoned committee organizer, Dr. Mehta will be part of the World Corneal Organizing Committee in 2020, as well as the Asia-Pacific Association of Cataract and Refractive Surgeons (APACRS), Singapore, in the same year. He has won several awards from the American Academy of Ophthalmology (AAO) and the Association for Research in Vision and Ophthalmology (ARVO), among others, the latest of which was from the American Society of Cataract and Refractive Surgeon (ASCRS) in 2018. Dr. Mehta is also a favorite keynote speaker and presenter in several international conferences. [Email: jodmehta@gmail.com]

Dr. William B. Trattler, M.D. Dr. Trattler 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, suture-less 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 board certified 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. [Email: wtrattler@gmail.com]

Dr. Chelvin Cheryl Agnes Sng, B.A., MBBChir, M.A., MRCSEd, MMed Dr. Sng is a consultant at the National University Hospital (NUH) and assistant professor at National University of Singapore (NUS). She is also an honorary consultant at Moorfields Eye Hospital, London, and adjunct clinic investigator at 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 “The Ophthalmology Examinations Review”, Dr. Sng has also written several book chapters and publications in various international journals. She has received international grants and awards for her research accomplishments from the American Academy of Ophthalmology and the Australian and New Zealand Glaucoma Interest Group. Proficient in conventional glaucoma surgery and trained in complex cataract surgery, Dr. Sng co-invented a new glaucoma drainage device, which was patented in 2015. She has been invited as a reviewer for several international ophthalmic publications, and as a speaker in various international lectures and conventions. When not working, Dr. Sng can be found volunteering in medical missions in India and across Southeast Asia. [Email: chelvin@gmail.com]

Dr. Harvey Siy Uy, M.D. Dr. Uy currently serves as associate clinical professor at the University of the Philippines-Philippine General Hospital, consultant for Retina and Uveitis Services at St. Luke’s Medical Center, as well as medical director at Peregrine Eye and Laser Institute in the Philippines. Previously, he was a clinical fellow in Medical and Surgical Retina at St. Luke’s Medical Center, Philippines, and in Ocular Immunology and Uveitis at the Massachusetts Eye and Ear Infirmary at Harvard Medical School. In 2015, he co-invented the Modular Intraocular Lens Designs, Tools and Methods, which was patented with the United States Patent Office. Dr. Uy is a recipient of numerous awards and honors, including the Immunology Award, presented by the Ocular Immunology Service from the Massachusetts Eye and Ear Infirmary, Harvard Medical School (1998), and the Senior Achievement Award from the Asia-Pacific Academy of Ophthalmology (2017). He has also published more than 32 international peer-reviewed journals and 30 book chapters, and is a prominent speaker, presenting in various national and international conferences. [Email: harveyuy@yahoo.com]

September/October 2019

Cataract ATARACT Eye Drop Therapy

Going dropless after cataract surgery? Let’s jump in! by Olawale Salami

ataract surgery is among the most common surgical procedures performed globally. Advances in technology and improvements in techniques, such as the clear corneal incision, small incision surgery and the use of a femtosecond laser, have made this procedure safe with excellent outcomes in an overwhelming majority of cases. Cataract surgeons are always careful to prevent postoperative inflammation and microbial proliferation through the use of steroids, nonsteroidal antiinflammatory drugs (NSAIDs), and antibiotics. Cystoid macular edema (CME) and postoperative infectious endophthalmitis are caused by uncontrolled inflammation and microbial proliferation, respectively, which can lead to suboptimal or even devastating outcomes. Therefore, every effective measure should be taken to prevent these complications.

The standard of care after cataract surgery

throughout the perioperative period has been the mainstay in inflammation control and infection prevention after cataract surgery. Despite the advances in other aspects of cataract surgery, this has remained unchanged as the standard of care over many years. However, there are some major drawbacks to topical therapy, including ocular surface toxicity, high expenses, unpredictable effective dose delivery and concerns associated with instilling eye drops, especially among inexperienced and poorly compliant patients, or those who need multiple drug administrations. As a result, dropless cataract surgery has become an interesting concept in recent years. Recently, the introduction of triamcinolone acetonide-moxifloxacin (Tri-Moxi), which contains 15 mg/mL of triamcinolone acetonide and 1 mg/mL of moxifloxacin, has made dropless surgery a new option.

A promising substitute for standard eye drop therapy

Traditionally, eye drop therapy

Dr. Saman Nassiri and colleagues at the Loma Linda Eye institute, California, USA, conducted a retrospective longitudinal study in which they

September/October 2019

compared outcomes of patients who underwent cataract surgery using Tri-Moxi injection along with a postoperative nonsteroidal antiinflammatory drug versus standard eye drop therapy. Results of this study were published in the June 2019 edition of the Journal of Cataract and Refractive Surgery (JCRS) in a paper titled “Comparative analysis of intravitreal triamcinolone acetonide-moxifloxacin versus standard perioperative eye drops in cataract surgery”.* Currently, there is a paucity of clinical data available in the literature about the effectiveness of this new compound drug in cataract surgery. The authors hypothesized that the intravitreal Tri-Moxi injection can effectively control infection and inflammation after cataract surgery and be at least comparable to standard eye drop therapy. Dr. Nassiri and co-authors reviewed electronic medical records of patients who underwent cataract surgery using Tri-Moxi injection, along with a postoperative nonsteroidal anti-inflammatory drug drop (Group 1). Group 1 was compared with patients who received a standard eye drop (Group 2) in terms of intraocular inflammation and corneal edema severity, and the rate of high intraocular pressure (IOP), postoperatively. Overall, a total of 1,195 consecutive eyes (Group 1 [681 eyes], Group 2 [514 eyes]) of 919 patients were included in the study. The study authors showed that postoperative intraocular inflammation decreased at a faster pace in the Tri-Moxi group versus the standard eye drop group. Hence, the degree of intraocular inflammation was lower in the Tri-Moxi group compared with the standard group at week 1 and month 1 after surgery, respectively.

According to Dr. Nassiri and colleagues, “Intravitreal injection of triamcinolone acetonide-moxifloxacin during cataract surgery was non-inferior to standard eye drop therapy in the control of inflammation and corneal edema after cataract surgery”. The rate of postoperative high IOP was comparable between intravitreal Tri-Moxi and standard eye drop regimens. It, therefore, represents a promising substitute for standard eye drop therapy, especially for patients who have poor compliance with eye drop usage.

Improving patient’s compliance postoperatively Prof. Jod Mehta, who heads the Corneal and External Eye Disease Service and is a senior consultant refractive surgeon at the Singapore National Eye Centre, commented on the publication by Nassiri and colleagues. “There have been good strides in reducing the risk of postoperative infection over the last decade,” he shared. “Rates have certainly dropped in most countries through various interventions. The majority of patients still require the use of topical medications after surgery to control inflammation and reduce the risk of infection. Topical drops are effective in reducing these side effects. However, they are dependent on patients’ compliance on use. IOP control immediately postop is not a major concern for most patients in routine cases.” In addition, he explained: “People are moving away from topical steroids to NSAIDS postoperatively due to possible issues in IOP control. In Asia, an added advantage of NSAID is the low risk of cytomegalovirus (CMV reactivation. As far a combination therapy goes, antibiotic plus steroid, as in this paper, has an appeal since it reduces the postop topical regime. However, as a single shot delivery, and assuming normal clearance from the vitreous, it is unlikely to have therapeutic effect after a few days. Hence, the antimicrobial pharmacokinetics is unclear.” Commenting further on intravitreal pharmacokinetics,

INDUSTRY UPDATE

Prof. Mehta explained that most patients present with acute endophthalmitis three to five days after surgery. “Even though the rates of infection in this study were similar to both groups, the pharmacokinetics will also be affected by the syneresis of the vitreous cavity, in that individual patient. The main issue of intraocular delivery of steroid is the risk of raised IOP, and method to reverse it if the drug is administered directly into the posterior segment. It is noteworthy that there was no difference between the two groups in this paper, but certain population groups are more prone to steroid-induced raised IOP.” More importantly, Prof. Mehta emphasized: “Subconjunctival or extra-ocular delivery devices may be more preferred choices of delivery of such drugs as long as intraocular therapeutic concentrations can be reached. Depot injections, as used in this paper, or innovative, new drug delivery systems appear to be the way forward to improve patient’s compliance postoperatively.” *Nassiri S, Hwang FS, Kim J, LeClair B, Yoon E, Pham M, Rauser ME. Comparative analysis of intravitreal triamcinolone acetonide-moxifloxacin versus standard perioperative eyedrops in cataract surgery. J Cataract Refract Surg. 2019:45(6):760-765.

About the Contributing Doctor Dr. Jod Mehta is head of Cornea External Disease and senior consultant in the Refractive Service at Singapore National Eye Centre (SNEC), deputy executive director at Singapore Eye Research Institute (SERI), as well as a professor at Duke-National University of Singapore. With a main interest in corneal transplantation, he completed a corneal external disease and refractive fellowship at Moorfields Eye Hospital in London and at SNEC. He has co-authored nearly 20 textbooks and 333 citations, and holds 16 patents, six of which have been licensed. He has won several awards from the American Academy of Ophthalmology (AAO) and the Association for Research in Vision and Ophthalmology (ARVO), among others, the latest of which was from the American Society of Cataract and Refractive Surgeon (ASCRS) in 2018. Dr. Mehta is also a favorite keynote speaker and presenter in several international conferences. [Email: jodmehta@gmail.com]

Ophtec and VSA Join Forces in Argentina

hanks to a partnership with VSA (or VSA Alta Complejidad), Ophtec’s products – like the Precizon™ IOL line and the Artisan® and Artiflex® line of iris fixated intraocular lenses – will now be commercialized in Argentina. Local Argentinean company VSA, imports and represents some of the most important ophthalmic brands in the world. Now Ophtec – The Netherlands-based privately held

medical device manufacturer with 35 years of experience in meeting ophthalmologists’ needs with unique and proprietary, high quality products – joins their ranks. Mauro Alvarez, the sales director at VSA says he’s proud to introduce this new alliance between VSA Alta Complejidad and Ophtec in Argentina. “It is undoubtedly a great opportunity to start working with such a prestigious

company as Ophtec, which over its 35 years has remained faithful to his own ideas, always developing avant-garde concepts and products for the most demanding ophthalmologists.” Ophtec Export Manager Teresa Filhó added: “Ophtec has a passion for vision and we look forward to continuing serving the Argentinian market and introducing out cataract lenses Precizon.”

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Cataract NTERIOR SEGMENT CXL

by Mark Hillen

n concept, corneal crosslinking (CXL) is simple. You saturate the corneal stroma with riboflavin (vitamin B2), irradiate the cornea with ultraviolet (UV)-A light, a photochemical reaction occurs, covalently binding the molecules of the cornea together (mostly collagen fibrils) – and just 30 minutes of illumination in the operating room (OR) later, presto... the cornea is strengthened. Just the ticket for treating corneal ectasias like keratoconus and ectasia after laser-assisted in situ keratomileusis (LASIK). It is such a successful technique that it has halved the numbers of corneal transplants performed in Europe in the decade since its introduction.1 As the technique was developed in Dresden and Zurich, it might be time to say “Wunderbar”, right?

If it sterilizes, why bother with the OR? A lot of work has been put into making CXL a faster and more effective treatment for corneal ectasias and

expanding its indications, but let’s park all of that there for the moment. CXL is a treatment that is performed in an OR, under a medical-grade (with an associated medical-grade cost) UV illumination lamp. If you’re following the long-standing standard of care, the Dresden Protocol2, the time it takes to debride the corneal epithelium (to expose the stroma to the riboflavin that you apply next), then add anything between 10 and 30 minutes of riboflavin instillation, plus 30 minutes of UV illumination, this can quite quickly add up to a lot of OR time. And even accelerated protocols easily take 30 minutes in total – the time needed to perform two cataract surgeries. But it is a sterile environment, and the epithelial cell scraping makes this a de facto surgical procedure. But ORs are costly, and they mostly all exist in developed infrastructure. If a patient in a remote part of a developing country has an ectasia, then the odds are against receiving CXL. But does CXL really need an OR?

Our friend, ROS When the body’s immune system

Strengthening corneas with CXL out of the OR? Slit lamp, here we come!

September/October 2019

fights infection, one of the ways it attacks pathogens is by phagocytes producing reactive oxygen species (ROS) adjacent to the pathogen. The ROS damages the invader species’ cell membranes and nucleic acids, killing them. Crosslinking with riboflavin and UV light also generates ROS. And those ROS leave the corneal sterile by the end of the process.3 At this point, it’s worth bearing in mind that the CXL photochemical reaction is limited to the corneal stroma – all the epithelial cells above it are scraped away. The fact that the stroma is saturated with UV light-absorbing riboflavin means that the endothelial cells – just a few layers below – are shielded from UV irradiation. It’s a simple, yet highly targeted intervention, and it means if any cells are killed during the process, it’s those of pathogens, not your patients’ corneas. So, if CXL renders a cornea sterile, it begs two questions: Why do you need a sterile OR to perform it, and why can’t this be used to treat corneal infections?

Ubiquity beats infection In response to the second question, CXL has been used to treat infectious keratitis for over a decade. The first clinical case series was performed in Zurich and published in 2008, and when CXL is used for this purpose, it’s called PACK-CXL (photoactivated chromophore for keratitis-corneal crosslinking). But again, PACK-CXL is normally performed in a sterile OR, which in some respects is counterintuitive. You’re bringing an infection into a sterile room, and sterilizing it in there with PACK-CXL. And this is a room that needs to be sterilized again before it can be used once more . . . So, irrespective of whether CXL is performed to treat ectasia or infectious keratitis, in principle at least, it doesn’t seem like you need to perform it in an OR. Why not perform it at the slit lamp? Pretty much every ophthalmologist has one, and they’re near ubiquitous wherever eye care is given (be it developing or developed countries). Just add a UV light source and you’re good to go, right?

Dancing past the stumbling blocks Before this could be viewed as a sensible approach, two issues, one practical, and one theoretical, must be settled. First, patients might feel comfortable resting their chin on a slit lamp for 10 or 15 minutes, but they aren’t going to feel that way after 30 minutes – the time taken to perform the Dresden protocol CXL. Second, you need to saturate the stroma with riboflavin. If you’re then going to have the patient sit up and be cross-linked, the question is, does gravity have an effect on the riboflavin present in the cornea? The second issue has a clear answer: there is no issue. There’s no significant settling or shift in riboflavin in the stroma even after one hour of sitting upright after saturation.4 Addressing the first issue sees us return to the first sentence of the second paragraph of this article: “A lot of work has been put into making CXL a faster and more effective treatment”. Much effort has been made to make CXL a faster procedure, in particular, in reducing the time needed to treat corneal ectasias. The classic Dresden protocol might require 3 mW/cm2 UV illumination for 30 minutes, but simple photochemical reactions are governed by something called the Bunsen-Roscoe law of reciprocity, which boils down to this: If all reagents in the reaction are in excess, you can increase the speed of the reaction in direct proportion to the amount of extra irradiation you supply the reaction. That 30 minutes of 3 mW/cm2 UV-A exposure turns into 15 minutes of 6 mW/cm2, and 10 minutes of 9 mW/cm2, although it can be pushed too far.5 The efficacy of the crosslinking reaction starts to drop off with too much illumination. The reason? The classic corneal crosslinking reaction consumes oxygen.6 Oxygen has to diffuse into the stroma for the crosslinking reaction to occur, and that is the rate-limiting step in the treatment of ectasias. Nevertheless, we’re down to 10 minutes, and that’s not an unreasonable amount of time to have a patient sit at the slit lamp.

Two distinct beasts What might surprise you is that this Bunsen-Roscoe limit doesn’t constrain PACK-CXL like it does CXL for ectasia. You treat for three minutes at 30 mW/cm2 and still get effective pathogen killing.7 This is particularly interesting in terms of PACK-CXL’s mechanism of action – perhaps there’s an anaerobic component involved – but it also means that you’re treating a patient in a very short period, well within the comfort zone of almost all adult patients you’ll see, and many older children, too. Whether the crosslinking has been for ectasia or infection, the immediate next step after illumination is complete (and the sterilizing effect is over) is to administer antibiotic prophylaxis. And the data is out there – in bacteria, it’s possible to accelerate the PACK-CXL photochemical reaction down to 150 seconds at 36 mW/cm2, and still maintain the same killing efficacy as the Dresden protocol’s 30 minutes at 3 mW/cm2 (overall fluence of 5.4 J/cm2).7 And there is room for further improvement, since in actual eyes, we know that even a fluence 15 J/cm2 illumination is still safe to use.8

PACKing some power to make a difference Whereas slit lamp CXL for treating ectasia is a big deal, as eliminating the need for an OR eliminates the (pretty significant) cost of the OR, and the ability to bring CXL to treat ectasia to developing countries (where ORs are scarce and concentrated mostly in major cities) – it’s actually PACK-CXL at the slit lamp that looks like it will have the greatest global impact. PACK-CXL is typically used as an adjunct to antimicrobial drugs. But a seminal paper by Jes Mortensen’s group in Sweden in 2012 really opened up the procedure’s possibilities. Mortensen was bold enough to ask his local ethics committee for approval of PACK-CXL as a primary procedure – no antimicrobials (even in follow-up). He had a case series of 16 eyes and 14 of them healed spontaneously after a single PACK-CXL procedure.9

Keep this in mind when you start to consider what a truly global burden infectious keratitis is. The World Health Organization (WHO) speaks of a ‘silent epidemic’, and this disease is one of the leading causes of visual impairment worldwide, especially in developing countries.10 Combine this with the phenomenon of antimicrobial resistance – the antibiotics and anti-fungal agents we have today are becoming less and less effective. New drugs aren’t coming through the pipeline; and we’re looking at a future where we just can’t treat certain infections if they’re resistant to the drug arsenal we have.11 This means that anything that can treat infection without requiring antibiotics is so incredibly important.

An irresistible broad-spectrum approach I’m based in Switzerland: A beautiful country with a temperate climate. When a patient comes to the ELZA Institute for PACK-CXL, over 9 times out of 10, it’s bacterial in origin. But in developing countries, especially those with a humid climate, that’s not the case. Often, these patients have fungal, or worse, mixed (e.g. bacterial/fungal) infections. If you consider that infectious keratitis is something that can rapidly spread and needs urgent treatment, and that it’s difficult to tell which type of pathogen

September/October 2019

Cataract NTERIOR SEGMENT CXL is present at the time of presentation, this means that making the wrong treatment decision here (in other words, prescribing an ineffective drug) wastes precious time. Whereas one might prescribe a broad-spectrum antibiotic until the cultures come back, PACK-CXL might be considered not a broad-spectrum antibiotic against bacteria, but a broad-spectrum antimicrobial therapy against bacteria and fungi. And the happy side-effects of PACK-CXL is that it will stiffen the cornea and at the same time increase its resistance to digestion by pathogens (and reduce the size of the eventual scar, too).

Effectively managing patients who never return But perhaps the biggest advantage of PACK-CXL – and especially PACK-CXL at the slit lamp – is cost effectivity. In medicine, there are two main costs: costs relating to the doctor, and costs relating to the therapy. Most antibiotics are relatively inexpensive. By far, the biggest cost is the doctor. In many developing countries, doctors are simply too expensive to treat a case of infectious keratitis where they tell the patient, ‘come and see me three times next week’12. Patients will not come back; they simply cannot afford to do so. If PACK-CXL – performed at the slit-lamp to bring the procedure to as many people as possible at the lowestpossible cost – can act as a one-shot treatment for a significant proportion of patients, then many of those who never return for follow-up are more likely to have had their infectious keratitis successfully treated. Multiply this by the number of people who aren’t visually impaired for the rest of their life, who can lead economically productive and more fulfilling lives, then the impact of PACK-CXL to help deal with this ‘silent epidemic’ can be quite profound.

tertiary centers, where a slit lamp and a slit-lamp mountable crosslinking device are available), and it can give the doctor peace of mind, knowing that if a patient does not return for follow-up appointments, it’s more likely that the procedure has been effective.

The bottom line So, by taking crosslinking portable and out of the OR and on to the slit lamp, you’re able to reduce costs for both you and your patients, and bring effective treatments for both ectasia and keratitis to a far greater population, democratizing CXL for patients, irrespective of whether they live in Berlin, Brunei, or Bulawayo. References Godefrooij DA, Gans R, Imhof SM, Wisse RP. Nationwide reduction

in the number of corneal transplantations for keratoconus following the implementation of cross-linking. Acta ophthalmologica. 2016;94(7):675-678. Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced

collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003;135(5):620-627. Randleman JB, Khandelwal SS, Hafezi F. Corneal Cross-Linking. Surv

Ophthalmol. 2015;60(6)509-523. Salmon B, Richoz O, Tabibian D, Kling S, Wuarin R, Hafezi F.

CXL at the Slit Lamp: No Clinically Relevant Changes in Corneal Riboflavin Distribution During Upright UV Irradiation. J Refract Surg. 2017;33(4):281. Hammer A, Richoz O, Mosquera S, Tabibian D, Hoogewoud F, Hafezi

F. Corneal biomechanical properties at different corneal collagen crosslinking (CXL) Irradiances. Invest Ophthalmol Vis Sci. 2014;55(5):28812884.

The evidence base

Biomechanical Effect of Corneal Collagen Cross-Linking (CXL) With

PACK-CXL was evaluated in a phase III, interventional, prospective, multi-center, randomized controlled clinical trial, where patients received either antimicrobials (alone) or PACKCXL (alone). If patients on the PACK-CXL arm worsened after a day, they received antimicrobials, and PACK-CXL was considered to be a treatment failure. What have we seen so far? PACK-CXL is associated with smaller ulcer sizes, although the time to re-epithelialization was five days longer than in antibiotic-treated eyes. You might initially think, “Yeah, so it takes longer to heal”. But really, the message is “It heals without antibiotics – after a single treatment!” – in 85% of patients. In those patients that dropped out, keratitis was treated with the addition of topical antimicrobial treatment (Hafezi et al., in preparation). Nobody is suggesting that PACK-CXL should be used alone in regular clinical practice just because it can (if effective antimicrobial agents are available). But in developed countries, PACK-CXL is attractive as it may reduce scar sizes, and work in antimicrobial drug-resistant infections. In developing countries, PACK-CXL is attractive as it can be used where antibiotics are unavailable (especially in

Richoz O, Hammer A, Tabibian D, Gatzioufas Z, Hafezi F. The

Riboflavin and UV-A is Oxygen Dependent. Transl Vis Sci Technol. 2013;2(7):6. 7

Richoz O, Kling S, Hoogewoud F, et al. Antibacterial Efficacy of Accelerated Photoactivated Chromophore for Keratitis-Corneal Collagen Cross-linking (PACK-CXL). J Refract Surg. 2014;30(12):850-854. Seiler TG, Fischinger I, Koller T, Zapp D, Frueh BE, Seiler T. Customized

Corneal Crosslinking: One Year Results. Am J Ophthalmol. 2016;166:14-21. 9

Makdoumi K, Mortensen J, Sorkhabi O, Malmvall BE, Crafoord S. UVA-riboflavin photochemical therapy of bacterial keratitis: a pilot study. Graefes Arch Clin Exp Ophthalmol. 2012;250(1):95-102.

Whitcher JP, Srinivasan M. Corneal ulceration in the developing world – a silent epidemic. Br J Ophthalmol. 1997;81(8):622-623.

WHO. Antimicrobial resistance: global report on surveillance 2016. http://www.who.int/drugresistance/documents/surveillancereport/en/. Published 2016. Accessed November 7, 2016.

Keay L, Edwards K, Brian G, Stapleton F. Surveillance of contact lens related microbial keratitis in Australia and New Zealand: multisource case-capture and cost-effectiveness. Ophthalmic Epidemiol. 2007;14(6):343-350.

September/October 2019

CAKE MAGAZINE

Strutting down the Runway of

EURETINA 2019 in Paris

September/October 2019

Cataract NTERIOR SEGMENT Anti-infectives Optimizing

Antibiot Under the Constant Threat of Developing Resistance

by April Ingram

here’s a delicate balance to managing ocular infections; some would say it’s like walking on a tight rope, with one end aflame. The biggest feat is selecting the correct treatment to combat a specific infectious pathogen – at efficacious, yet nontoxic doses – while also not contributing to the very real threat of antimicrobial resistance.

Save the eye. Save the world. And don’t get burned. It’s all in a day’s work for ophthalmologists, whose superpower is less about defying death in this case than being super-antibiotic savvy. Bacterial resistance is a wellrecognized and ongoing problem across all infectious diseases. However, it presents a particular concern among ocular infection pathogens. Although antibiotic treatment can certainly improve outcomes for ocular infections, treatment selection can be complicated and the tolerable margin for treatment failure is very small. And due to the misuse and overuse of antibiotics, there is an increase of failure in previously efficacious treatments and a rise in antimicrobial resistance worldwide. Professor Donald Tan, partner and senior consultant ophthalmic surgeon at Eye & Retina Surgeons and a founding doctor of Singapore National Eye Centre (SNEC), is a corresponding author for the landmark Asia Cornea Society Infectious Keratitis Study (ACSIKS)*, which surveyed the demographics, risk

factors, microbiology and outcomes for infectious keratitis in Asia. Sharing his insight into optimizing antibiotic use in the face of resistance, Prof. Tan said that we [doctors] need to be more careful with antibiotics use. “When initially faced with an infectious eye, select a broad-spectrum antibiotic or series in order to cover a range of organisms, both bacterial and fungal,” he explained, adding that acting quickly is key. “It is important to quickly identify the organisms – decide as soon as possible which organism it is you are treating, then modify your approach depending on organism and resistance patterns.”

Geographical variations in treatment resistance ACSIKS captured clinical data from more than 6,600 eyes from several key academic and tertiary centers in countries including Singapore, India, China, Japan, Korea, Taiwan, Thailand, Philippines and Hong Kong. Investigators found that the demographics and risk factors, as well as the types of treatment resistance in infectious keratitis organisms, were quite variable across geographic areas. For example, wearing contact lenses was the greatest risk factor for infectious keratitis in Singapore (68.2%), Taiwan (43.3%) and Japan (25.6%); and the most commonly isolated organisms were

September/October 2019

Fusarium species and Pseudomonas aeruginosa, while a country like India, had very little contact lens-related infections. Prof. Tan explained that when selecting the right broad-spectrum treatment, it can be helpful to investigate what has been reported in the geographic data. However, he cautioned: “One of the problems in Asia is the generation of comparative data, as many localized studies from different parts of the world may not use comparable methodology and definitions, such as microbiology laboratory reports. Laboratory investigations can vary; the sensitivity and specificity are different, making it difficult to compare and draw conclusions.” Additionally, he said that there can be differences and variations in geographical data – and in some cases, this can help determine when to use common antibiotics: “In some less developed countries, such as India, China or the Philippines, there are more fungal infections. Singapore and Taiwan have high contact lens usage, and therefore more contact lens-related infections.” Resistance to current treatments is a result of either inappropriate dosing or suboptimal dosing, as bacterial flora can modify and develop resistance with incorrect usage. Prof. Tan provided an example: “In chronic ulcers or corneal

tic Use transplants, topical steroids are used heavily . . . and as we taper, many surgeons will also use antibiotics as part of their tapering method. Topical steroids are tapered because a sudden cessation may cause rebound inflammation to recur, but a common misuse is to taper the antibiotics in tandem, leading to suboptimal antibiotic dosing. In general, most antibiotics require dosing at least three or four times daily to maintain a minimal inhibitory concentration (MIC), and doses should not be tapered below this frequency, because a) the antibiotic will no longer be effective, and b) this clearly can lead to the development of resistance.”

Back to the balancing act The higher drug concentration in the tissues, the more effective it is at combating infectious microorganisms. Topical ocular antibiotics may quickly deliver high concentrations at the corneal surface; however these can be rapidly diminished by reflex tearing following instillation. Careful review of PK-PD studies, getting back to basics, and understanding the fundamental concepts of PK-PD is key, and this has to be titrated against potential toxicity from high dose treatment. Achieving the perfect balance all comes down to drug potency versus toxicity; meaning the amount of the drug or specific dose required to achieve the desired clinical response, compared to its potentially toxic effects on the cornea. The ideal antibiotic will have a high therapeutic index, which means a drug needs to have low toxicity so that it can be used at higher concentrations. So how do we get there? Pharmacokinetics (or PK) studies the time course of drug absorption, distribution, metabolism and excretion in the body – or how the body affects the drug. On the other hand, pharmacodynamics (or PD) studies what the drug does to the organism or body. PD can be time-dependant (where the time above minimum inhibitory concentration or MIC is most predictive of efficacy); concentration dependant (with concentration above MIC is more predictive of efficacy); or utilize an area under the curve/MIC ratio (where exposure above MIC is most predictive of efficacy). PK/PD parameters are used to optimize antimicrobial dosing and to produce the maximal effect with minimal toxicity. PK/PD is also used to determine breakpoints, which are the criteria used to determine the MIC of the isolate.

Usually the ‘susceptible’ breakpoint is the highest MIC at which the PK/PD efficacy target is achieved in a percentage of the population (often 90%) when standard dosing is used. “It boils down to MIC, which is a surrogate for resistance. In fluoroquinolones, you could have a low MIC level for a gramnegative organism (which means it is more effective at a lower dose – i.e. the organism is susceptible to the antibiotic), but a higher MIC level for Streptococcus (which means it is less effective and needs to have a higher concentration to kill the organisms – i.e. the organism may be relatively resistant to the organism), for example,” Prof. Tan said. “Even if an organism is relatively resistant (i.e. intermediate resistance), clinical treatment may still be effective by modifying treatment to ensure very high doses are achieved at the site of infection. So if you can achieve, say, 5x the MIC level, then the drug may still be clinically effective. This is why sometimes clinicians see a positive response to treatment with an antibiotic which is reported by the lab to have ‘intermediate resistance’,” he explained. Relative penetration of the antibiotic into tissues is also important to efficacy. Prof. Tan explained: “If the antibiotics don’t penetrate into the eye well, the actual clinical efficacy deteriorates. Ciprofloxacin is very good against Pseudomonas but it does not penetrate well, leaving a white deposit that precipitates on the eye surface. As opposed to newer drugs that are more soluble, and can therefore treat deeper infections, and even enter through the cornea into the anterior chamber to treat intraocular infections.” Therefore, he said doctors must determine if the antibiotic’s concentration level is reached in the target tissue. “When trying to prevent infection inside the eye – and to reduce the risk of endophthalmitis – there needs to be a post-op period when the drug concentration in the anterior

Can fluoroquinolones keep mean bugs at bay?

September/October 2019

Cataract NTERIOR SEGMENT Anti-infectives chamber is higher than MIC levels of most organisms,” Prof. Tan said. When selecting which antibiotic to use, Prof. Tan said it depends on relative penetration and concentration. “Antibiotics dosed at 1.5% are better than 0.5% in terms of concentration, but the relationship is not linear. In some cases, you see a good response, but the lab report says the organism is resistant,” he said. “Resistance doesn’t mean the drug is not working, it just means you are not getting above the MIC . . . but you can with higher concentrations – by increasing relative concentration by dosing every hour, you can manage to get above MIC level. MICs for some organisms are a bit lower with newer fluoroquinolones [such as gatifloxacin and moxifloxacin], but that is mitigated by the fact that you get 3x the concentration with levofloxacin.”

Are newer generation drugs always better? This is a common assumption, but it’s not always the case. As we go up in generations, there is more coverage of gram-positive organisms (e.g., fluoroquinolones like moxifloxacin and gatifloxacin were developed because they were effective against a larger range of organisms), but more frequent use of newer drugs can lead to resistance patterns, which can lessen efficacy. In some regions, older antibiotics like polymyxins are being used again for their high efficacy and low resistance patterns, and interestingly the ACSIKS data suggests that these older antibiotic are still very effective, and have lower resistance overall. It’s also important to consider potency and concentration, as Prof. Tan explained. “Even though higher generation fluoroquinolones were developed to enhance the efficacy against grampositive organisms, we still sometimes use ciprofloxacin today because

it’s potent against gram-negative organisms,” he said. “Another example is comparing moxifloxacin with levofloxacin. Moxifloxacin may cover one or two organisms better but it’s only available in lower concentrations; whereas levofloxacin has a 0.5% and a higher 1.5% dose . . . so, it may turn out that in practice, 1.5% levofloxacin is more effective because a higher concentration is more easily achievable at a lower dosing frequency.” Regarding high dose fluoroquinolones, Prof. Tan said that 1.5% levofloxacin is a paradigm shift. “It’s a high dose – and even when used at frequent dosing intervals, it’s the least toxic among higher dose fluoroquinolones, and it’s also preservative free, which is much better,” he said. “If you use 1.5% levofloxacin every hour, it’s very effective. The standard approach for very severe corneal infections is to use fortified antibiotic concentrations which are not commercially available, but will need to be compounded. These include fortified aminoglycosides

like gentamicin and tobramycin, vancomycin, cefazolin, among others, in very high concentrations, and at a high dosing frequency such as hourly application on a 24-hour basis for several days, until the infection begins to resolve. This approach often also results in high ocular surface toxicity with irritation, inflammation and ocular surface cell damage. This is also expensive to compound properly, and is only available at major centers with specialized compounding pharmacies, and the alternative would be preparing these concentrations in the clinic, which is less optimal. Now that we actually have a commercially available high concentration, broad spectrum antibiotic like 1.5% levofloxacin in an unpreserved formulation, this may change our approach significantly.” *Khor WB, Prajna VN, Garg P, et al; ACSIKS Group. The Asia Cornea Society Infectious Keratitis Study: A Prospective Multicenter Study of Infectious Keratitis in Asia. Am J Ophthalmol. 2018;195:161170.

About the Contributing Doctor Prof. Donald Tan is adjunct professor in ophthalmology and senior advisor of the Singapore National Eye Centre (SNEC), and the DukeNational University of Singapore Medical School Ophthalmology and Visual Sciences Academic Clinical Program; and medical director of the Singapore Eye Bank. Involved primarily in clinical and translational research in cornea, refractive surgery and myopia, he has published more than 350 peer-reviewed articles and contributed over 20 book chapters. He holds 13 patents in stem cell culture, myopia prevention, refractive corneal implants and surgical devices for endothelial keratoplasty, and has trained 28 corneal fellows from 14 countries. He is the recipient of more than 20 awards, which include the 2009 AAO and International Society of Refractive Surgery (ISRS) Casebeer Award, the Australia and New Zealand Corneal Society 2011 Doug Coster Award, the Canadian Society of Ophthalmology 2011 Bruce Jackson Award, the 2012 European EuCornea Medal, the 2013 Albrecht von Graefe Innovator’s Award, the 2015 ASCRS Binkhorst Medal Lecture, the 2015 CLAO Richard L. Lindstrom, MD Lecture, the 2017 Donders Netherlands Ophthalmology Society Medal, the 2017 APAO Jose Rizal Medal, the Fuchs Society Charles Tillet 2018 Lecture, and the Canadian Society of Ophthalmology 2019 Bruce Jackson Award. In 2007, Professor Tan formed the Asia Cornea Society (ACS) and continues today as the President. In 2012, Professor Tan became the first international President of the US-based Cornea Society. In 2018, he was voted as #1 on the top 50 Power List of global ophthalmologists by the UK-based Ophthalmologist journal. He currently serves as an International Trustee-at-Large for the Board of Trustees of the American Academy of Ophthalmology, and continues to train corneal specialists at SNEC, and conducts clinical and translational research in SERI, while juggling an active clinical practice. [Email: donald.tan.t.h@singhealth.com.sg]

September/October 2019

INDUSTRY UPDATE

‘Keep Sight’ Initiative Addresses Glaucoma in Underserved Populations

yecare biopharma company Allergan (Dublin, Ireland) has teamed up with two nonprofits, Sightsavers and the International Agency for the Prevention of Blindess (IAPB), to launch ‘Keep Sight’ – an initiative to prevent glaucoma-related vision loss in low- and middle-income countries. This program will focus on areas with the highest unmet need and will provide training for healthcare professionals to ensure early and accurate diagnosis, as well as appropriate treatment and long-term care. The program was officially unveiled at the recent World Health Assembly in Geneva, Switzerland – and a highvolume hospital in Nigeria will be the first to benefit. There, Keep Sight will provide training for 50 healthcare professionals, with the ultimate goal of screening 5,000 people, treating 500 patients and performing surgery on

70. By 2021, it is anticipated that the initiative will expand to screen 500,000 people in high-burden countries. “Seventy-five percent of sight loss can be cured or prevented, so it’s an area where donors can have a very real impact, and the partnership will enable us to establish new initiatives in Nigeria,” said Sightsavers CEO Caroline Harper. “Support from companies like Allergan is really important in our drive to help countries develop their health infrastructure.” By 2020, it’s expected that 80 million people will have glaucoma – the third leading cause of irreversible blindness. This figure will continue to rise unless effective screening and treatment measures are taken. According to Dr. Harper, the greatest global needs in eye health today exist in developing countries, where typical barriers include inadequate human resources, poor infrastructure, a lack of awareness and limited access to

medical treatments. “Glaucoma accounts for between 12 and 16% of blindness in highincome regions, central Asia, parts of Europe and Africa,” added Joanna Conlon, director of development and communications at IAPB. “Glaucoma in Africa is poised to be a significant public health burden in the coming decade. Keep Sight is the kind of solution we need today. IAPB is delighted to be working with Allergan to raise awareness of glaucoma, a ‘neglected’ eye condition.” Marc Princen, executive VP and president of international business for Allergan, says that for almost two decades Allergan has been committed to developing novel approaches to preserve visual function and prevent blindness caused by glaucoma. ‘”Keep Sight is an initiative that will make a real difference to people with glaucoma in these underserved populations,” he concluded.

September/October 2019

Cataract NTERIOR SEGMENT MIGS It’s the dawn of a new day – or era – in MIGS procedures.

MIGS Rising

Uncovering the benefits of a new cutting-edge instrument by Brooke Herron

o treat glaucoma, surgical intervention is often required to lower intraocular pressure (IOP) when therapies, like topical eye drops, do not produce the desired results. However, the standard surgeries for treating glaucoma, such as trabeculectomy and tube shunt implantation, are major and invasive procedures. And while they are effective, they can also result in serious complications.

Therefore, when it comes to ophthalmic surgical procedures, the less invasive, the less chance of sightthreatening adverse events. In recent years, micro-invasive glaucoma surgeries – or MIGS – are gaining popularity in the treatment of patients suffering from open-angle glaucoma (OAG). These procedures generally provide improved safety and mild-to-moderate IOP reduction and help fill the gap between topical medications and aggressive surgery. Below, we take a deeper look at one MIGS procedure: goniotomy using the Kahook Dual Blade (KDB) from New World Medical (Rancho Cucamonga, California, USA).

Dual blades for twice the precision An ab-interno Schlemm’s canal surgery, the KDB is used during goniotomy to enhance fluid outflow using the eye’s inherent drainage system. The single-use, ophthalmic knife removes the trabecular meshwork (TM) in a more complete fashion, with minimal residual TM leaflets and less collateral damage. During the procedure, the KDB’s distal tip pierces the TM and enters Schlemm’s canal. As the instrument is advanced along Schlemm’s canal, the TM is elevated on the KDB ramp and guided toward two parallel blades. Unlike a standard goniotomy knife that simply incises the TM (leaving contiguous anterior and posterior flaps), the KDB excises a strip of TM – which leaves a direct opening for aqueous to pass from the anterior chamber into Schlemm’s canal. Thus, goniotomy with KDB removes diseased tissue at the site of aqueous outflow obstruction, restoring the natural aqueous outflow pathway

September/October 2019

without the formation of a filtering bleb.1 Dr. Syril Dorairaj, a professor of ophthalmology and consultant in glaucoma and cataract surgery at Mayo Clinic, Jacksonville, USA, said the major benefit of the KDB is its precision. “The Kahook Dual Blade, by design, has the distinct advantage of a cleaner and more precise ab-interno trabeculectomy. The basic design of the device allows precise excision of the diseased trabecular meshwork, while minimizing damage to the surrounding tissues, thereby reducing complications and ensuring a faster recovery,” he explained. “There are published comparative data which shows that KDB reduced IOP significantly with fewer adverse events.” Additionally, the unique design of the blade allows surgeons to perform goniotomy as a stand-alone procedure, during cataract surgery, or on pseudophakic patients. And as with any procedure, patient selection is crucial for positive outcomes. “Published data shows that KDB has a distinct advantage in both open angle and closed angle glaucoma of varying severity,” said Dr. Dorairaj.

Cataract and glaucoma: when comorbidities collide Frequently, cataract and glaucoma coexist – and as the population ages, these comorbidities are expected to rise. As a result, the combination of phacoemulsification and MIGS is becoming increasingly used in glaucoma management. In 2018, a paper published in Advances in Therapy1 by Dr. Dorairaj and colleagues, described the 12-month efficacy and safety of goniotomy performed using the KDB

in combination with cataract surgery in eyes with medically treated OAG. During the prospective, interventional case series, 52 eyes (with medically treated OAG and visually significant cataract) underwent phacoemulsification combined with goniotomy using the KDB to reduce both IOP and use of IOP-lowering medications. From baseline to month 12, investigators found that mean IOP was reduced by 26.2% (16.8 ± 0.6 mmHg to 12.4 ± 0.3 mmHg (P < 0.001)), with mean IOP across time points ranging from 12.4–13.3 mmHg during follow-up. The mean number of topical IOP-lowering medications was reduced by 50.0% from baseline to month 12 (from 1.6 ± 0.2 to 0.8 ± 0.1 (P < 0.05)). Meanwhile, at month 12, 57.7% of eyes had IOP reduction ≥ 20% from baseline, and 63.5% were on ≥ 1 fewer IOP-lowering medications. The authors reported that in a subgroup analysis, 84.6% of eyes with lower mean baseline IOP were using ≥ 1 fewer medications at month 12, and 100% of eyes with higher mean baseline IOP had IOP reductions ≥ 20%. They found that the most common postoperative adverse events were pain/irritation (n = 4), opacification of the posterior lens capsule (n = 2) and IOP spike > 10 mmHg (n = 2). These events were not sight threatening and typically resolved spontaneously. This led the investigators to conclude that phacoemulsification with goniotomy using the KDB significantly lowers both IOP and dependence on IOP-lowering medications in eyes with OAG – and these results compare favorably with other MIGS procedures. Another study published in 2019

in Clinical Ophthalmology2, described the six-month rates of achieving target IOP (without requiring additional glaucoma surgery) after excisional goniotomy using the KDB combined with phacoemulsification (phaco-KDB) in patients with severe-stage glaucoma. This retrospective review included 42 eyes with severe glaucoma, including primary and secondary open-angle, as well as combined-mechanism glaucoma. The primary outcome was the proportion of patients achieving IOP ≤15 mmHg without additional glaucoma procedures, while secondary outcomes were mean change in IOP, reduction of glaucoma medications, additional glaucoma procedures needed and adverse events. The investigators reported that preoperative baseline mean IOP was 17.1±4.8 mmHg (mean ± SD) and number of medications was 2.4±1.3. At six months, they found that 64.3% (27/42) of eyes had achieved IOP ≤15 mmHg without additional glaucoma procedures, 45.2% (19/42) reached this target IOP on fewer medications, and 31.0% (13/42) on no medications. Overall, the mean IOP reduction was 2.1 ± 4.67 mmHg (P=0.022), and the mean medication reduction was 1.2 ± 1.4 (P≤0.001). Complications and the need for additional procedures were rare, with three eyes experiencing visually significant complications and requiring additional IOP-lowering procedures within six months of surgery. The authors concluded that patients with severe-stage open-angle glaucoma achieved significant IOP and medication reductions following phacoKDB – and notably, about two-thirds of eyes achieved an IOP of ≤15 mmHg at six months without additional glaucoma procedures. Overall, they found that “phaco-KDB may be an effective and safe alternative to more invasive filtering surgery in many patients with severe glaucoma”.

The Kahook Dual Blade is used during goniotomy to enhance ﬂuid outflow.

September/October 2019

Cataract NTERIOR SEGMENT MIGS Goniotomy with KDB: A beginner’s guide For doctors in the early stages of performing KDB goniotomy with phaco, Dr. Dorairaj has a few tips. According to him, one of the major guidelines is to perform a gonioscopic evaluation on all patients to understand the anatomy of the angle structures in the preoperative evaluation. Next, he said, is to practice direct gonioscopy to visualize the structures preoperatively, and to be comfortable with hand movements and also the patient’s head and eye movements. “Additionally, inform all patients on what to expect during surgery and postoperatively,” he continued. “Most cases of postoperative hyphemia will resolve in less than a week without any additional interventions.”

MIGS innovations in treating glaucoma, like the KDB, have not only translated to faster recovery times, but they’ve also opened doors for comprehensive ophthalmologists to treat mild to severe glaucoma surgically. “However, the outcomes of these surgeries are entirely dependent on the precision of the surgery. To ensure success, it is important to understand the anatomy of the angle and to perform a thorough postoperative exam by gonioscopy and imaging in cases of bad outcomes,” Dr. Dorairaj concluded, adding that the longterm safety and efficacy of these procedures remain to be validated.

About the Contributing Doctor

CMY

Dr. Syril Dorairaj is a professor of ophthalmology and consultant in glaucoma and cataract surgery at Mayo Clinic, Jacksonville, USA. He is one of the pioneers in minimally invasive glaucoma surgeries and has done extensive research on understanding the biomechanical aspects of glaucoma especially angle closure. A graduate of Bangalore Medical College, India, Dr. Dorairaj did his residency at the New York Eye and Ear Infirmary of Mount Sinai, New York, and glaucoma fellowships at the New York Eye and Infirmary and University of California, San Diego. He has presented over 100 instructional courses and over 300 lectures worldwide, and has been an invited speaker and chaired sessions at national and international conferences. He has co-authored over 200 peer-reviewed publications and abstracts, over 50 book chapters and editorials, and a book on glaucoma management. He has mentored over 25 fellows and residents. Dr. Dorairaj is a recipient of achievement awards from the American Academy of Ophthalmology and Asia-Pacific Academy of Ophthalmology. [Email: syrildorairaj@gmail.com]

References 1

Dorairaj SK, Seibold LK, Radcliffe NM, et al. 12-Month Outcomes of Goniotomy Performed Using the Kahook Dual Blade Combined with Cataract Surgery in Eyes with Medically Treated Glaucoma. Adv Ther. 2018;35(9):1460-1469.

Hirabayashi MT, King JT, Lee D, An JA. Outcome of phacoemulsification combined with excisional goniotomy using the Kahook Dual Blade in severe glaucoma patients at 6 months. Clin Ophthalmol. 2019;13:715-721.

September/October 2019

COVER STORY

The 35 Congress of Asia-PaciďŹ c Academy of Ophthalmology th

in conjunction with

The 25th Congress of Chinese Ophthalmological Society

Celebrating our Diamond Jubilee (1960~2020)

(852)3943-5827 secretariat@apaophth.org http://2020.apaophth.org/

HOSTS:

September/October 2019

When Choosing Presbyopic MIOLs Smooth Transition Matters

nnovative IOL designs – like multifocal intraocular lenses (MIOLs) – have emerged over the past decade to provide better outcomes in the correction of presbyopia for many patients. And now, technological progress is pushing the frontiers of research and development into IOLs that are better adapted to patients’ needs. Still, unwanted optical effects may occur depending on the patient’s eye anatomy. There are two key aspects of eye anatomy that affect patient outcomes: 1) the degree of misalignment between the pupil and the visual axis of the eye (angle κ); and 2) the misalignment between the optical axis of the cornea and the visual axis (angle α). In cases where physiological κ or α is relatively large, specific parameters of MIOL geometry can greatly impact the results of the visual acuity of the implanted IOL and subsequently, patient satisfaction. Therefore, care should be used to select an MIOL insensitive to decentration of the visual axis and MIOL center. For this reason, the Precizon Presbyopic NVA (Ophtec, Groningen, The Netherlands) has a geometry

that limits dependence on angle κ, with a central zone 1.4 mm in diameter in one direction, and 2.6 mm in diameter in the perpendicular direction (“butterfly” shaped). For angle κ with visual axis decentration up to 0.7 mm, the visual axis passes through the smooth central part of the lens regardless of MIOL orientation. And for large angle κ patients, the MIOL can be oriented so that the visual axis passes through the wider part of the central segment, which can then accommodate a decentration of up to 1.3 mm at the extreme. The innovative design of the Precizon Presbyopic NVA integrates a CTF (Continuous Transitional Focus)

Choose wisely: Patient selection is key for better outcomes.

optical system, with an anterior surface with multiple segments for far and near vision. The entire anterior and posterior lens surfaces are shaped by computer-guided patented Transitional Conic technology, which is capable of producing an aberration-neutral aspheric IOL with a plus power of 2.75D or an aspherical negative aberration lens of -0.11μm depending on the patient’s needs. Additionally, regular MIOLs cause positive dysphotopsia due to concentric rings, however CTF uses segments to avoid that problem, as they are designed to produce a lens more tolerant to halos and glares. Having conducted extensive research into presbyopic IOLs and with decades of clinical experience, Dr. Rahman Korkmaz from the Visus Oogkliniek in Rotterdam, The Netherlands, shared his experience with Precizon Presbyobic NVA IOLs. “I started with the first version of this IOL during the precommercial testing when it wasn’t in the market yet,” recalled Dr. Korkmaz. “I got a lot of insight into the best kinds of patients to use this IOL with. The design of the Precizon Presbyopic IOL is a disruptive design with segments instead of rings, which is a totally new approach. Therefore it is not in the same class with existing products.” “Positive aberrations are natural,” he emphasized. “And you might want to compensate for these with a negative aberration lens like the Natural Visual Acuity (NVA) model.” Furthermore, Dr. Korkmaz noted that “angle κ [angle kappa] and angle α [angle alpha] are important considerations in the use of MIOLs”.

“For surgeons, this [the NVA model] is an excellent lens to work with and is highly indicated in patients where we want to eliminate glare or halos,” he said. “The Precizon Presbyopic NVA IOL is designed to give cataract patients excellent far vision. I have used this lens in more than 40 patients bilaterally and most were patients with difficult eyes (high angle alphas and kappas) with excellent results.” According to Dr. Korkmaz, he would also suggest this lens for tall patients because reading distance with presbyopia is less. Furthermore, Dr. Korkmaz explained: “As the eye’s anatomical structure is very patient-dependent, I would like to recommend that in order to achieve the best possible outcome for the patient, an evaluation should be performed prior to implantation of any IOL to ensure it is the right one for the specific individual. For patients with larger than normal angle κ values, MIOLs with a wider central segment such as in Precizon Presbyopic NVA, should be considered to allow for accommodation of decentration that arises from the natural misalignment of the eye itself, and the implantation procedure.” “This IOL [Precizon Presbyopic NVA] does not have the traditional dips associated with trifocal lenses,” noted Dr. Korkmaz. “In particular, this lens provides a more fluid transition of focus from a nearby to a faraway object. This has been the experience reported by majority of my patients, who have attested to the smooth transition when they try to focus from far to a near object. This smooth transition has been a remarkable change in their quality of vision and overall quality of life,” he concluded.

About the Contributing Doctor Dr. Rahman Korkmaz studied biology

and medicine at the University of Leiden. He has supplemented his interest in ophthalmology with work experience and research. He received his training as an eye doctor at the AMC and the OLVG in Amsterdam, The Netherlands. There he was trained by top Dutch surgeons and ophthalmologists such as Jan Peter Witmer. His success and qualities have led him to immediately start training ophthalmology residents and to assist young ophthalmologists surgically after completing his specialization. In addition to Visus Oogkliniek, Dr. Korkmaz currently also works as an eye doctor within the OLVG hospitals in Amsterdam. He has been named in the global top 40 of cataracts, who participate in the further development and improvement of implant lenses. Thanks to his extensive knowledge and experience, he conducts research into developments and new techniques in the field of implant lenses. [Email: R.Korkmaz@olvg.nl]

September/October 2019

COVER STORY

SIGHT COUTURE

Top 10 Trends in Anterior Segment by Brooke Herron

for

Fall 2019

h, Paris. The city of love, fabulous food and wine, and haute couture. As the city gears up for the much-anticipated Paris Fashion Week in September, so do we at CAKE Magazine for our first-ever Top 10 list of anterior segment trends. While fashion might not be top-of-mind for many physicians – we haven’t necessarily seen any ophthalmologists strutting down a catwalk (yet!) – trends backed by research and data certainly are. That’s because these new(er) procedures, instruments and innovations have one end goal: improving patient outcomes. To learn what’s ‘hot’ (and also what’s ‘not’), we spoke with some of the most stylish ophthalmologists lighting up the anterior segment. Below, they reveal their opinions on what’s trending in refractive, glaucoma, and cataract surgery.

SMILE is Looking Dapper

According to Prof. Dr. Gerd Auffarth, chairman of the Department of Ophthalmology at the University of Heidelberg, Germany, a lot of changing trends can be seen in refractive surgery today. “Treating myopia, especially in younger patients, has become the standard in ophthalmology,” he said. For treating myopia, LASIK has ruled the refractive runway for quite a while. However, a new contender is causing quite a stir: SMILE or small incision lenticule extraction. SMILE is designed to treat refractive errors like myopia, hyperopia, presbyopia and astigmatism. And while LASIK uses an excimer laser to create a flap, SMILE uses the VisuMax femtosecond laser (Carl Zeiss Meditec, Jena, Germany) to create a corneal lenticule, which is then extracted through a small incision. Data shows SMILE has similar efficacy and safety to LASIK, with potential advantages in biomechanical stability and postoperative outcomes. So, this begs the question: Is SMILE the new ‘black’?

According to Dr. Gaurav Luthra, director of cataract & refractive surgery at Drishti Eye Institute, Dehradun, India, SMILE is currently the trend in refractive surgery. “With better understanding of the key strengths and the limitations of the procedure, and the confidence of numbers – with more than two million SMILE procedures performed worldwide – there is better acceptance of the procedure by refractive surgeons.” “There is now some competition between the SMILE procedure and classical Femto LASIK,” said Prof. Auffarth. “SMILE gets a lot of attention especially at international meetings – however, Femto LASIK is still performed in higher numbers than SMILE.” A 2016 study1 by Shen Z. et al., compared results from SMILE with Femto LASIK (FS-LASIK) for treating myopia in 1,076 eyes. At 6 months postop, there were no significant differences between the two groups with regard to the following: a loss of one or more lines in the best corrected spectacle visual acuity (BSCVA); uncorrected visual acuity (UCVA) of 20/20 or better; logMAR

SMeaprtcehm/ Ab pe r i/ lO2c0t o1 b9 e r 2 0 1 9

UCVA; postoperative refractive spherical equivalent or postoperative refraction within ±1.0 D of the target refraction. However, they did find that the FS-LASIK group suffered more severely from dry eye symptoms and lower corneal sensitivity at 6 months. The authors concluded that “both FS-LASIK and SMILE are safe, effective and predictable surgical options for treating myopia. However, dry eye symptoms and loss of corneal sensitivity may occur less frequently after SMILE than after FS-LASIK”. “With visual results of SMILE appearing at least on par, if not better than LASIK, the benefits of a flapless procedure including better corneal biomechanics (and lesser risk of ectasia) and minimizing flap complications will be too appealing to any surgeon, and ultimately the patient, to ignore,” said Dr. Luthra. “Moreover, with pure astigmatic corrections becoming commercially available and good outcomes reported in ongoing hypermetropia SMILE trials, the indications continue to expand.”

ith ESCRS in Paris, ‘Congress Couture’

is ‘haute’ this season. To look your most dapper during scientific sessions, CAKE Magazine has compiled four simple tips on the hottest trends hitting the ophthalmic conference catwalk.

All about Attitude This is less about being fashionable, and more about being ‘fierce.’ Whether speaking at a symposium or networking with peers, confidence is key – making this CAKE Magazine’s #1 ‘Congress Couture’ trend for 2019. Model: CAKE Magazine Production & Circulation Manager and Media MICE CFO & COO Hannah Nguyen

September/October 2019

COVER STORY

Hot On Its Heels: Topography-Guided Refractive Surgery

Dr. George Beiko, a cataract, anterior segment and refractive surgeon practicing in St. Catharines, Ontario, Canada, says: “My impression is that corneal lenticule directed and corneal surface procedures involving topography guided approaches seem to be the trends in refractive surgery.” Topography-guided laser refractive surgery corrects vision by altering the surface of the eye. The procedure has been found to be uniquely effective in eyes with corneal irregularities or in highly aberrated corneas, where wavefront aberrometry is often not possible2-3. Holland S. et al., published a review3 of topography-guided ablations in normal corneas and highly aberrated corneas and found that “topography-guided laser ablation is increasingly used with good efficacy and safety outcomes in highly aberrated corneas with irregular astigmatism.” These include eyes with refractive surgery complications including post-LASIK ectasia, decentered ablation, small optical zones, asymmetrical astigmatism, and postradial keratectomy astigmatism. “Topography-guided laser refractive surgery is proving to be effective and well-tolerated in the visual rehabilitation of highly aberrated eyes, with increasing predictability based on the recent research,” Holland concluded. “The expected future trend in refractive surgery procedures is likely to see a growth in SMILE procedures, phakic lenses with photorefractive keratectomy (PRK) and advanced surface ablation (ASA) holding fort, and LASIK numbers gradually declining, to remain limited to customized treatments not possible yet with SMILE,” added Dr. Luthra.

RLE is All the Rage

Another trend noted by Dr. Beiko and Prof. Auffarth is the refractive lens exchange (RLE), which rides the wave between refractive and cataract surgery. The procedure is identical to cataract surgery, except rather than a cloudy lens, a clear lens is replaced to correct presbyopia. “It seems that lens-based refractive surgery is also on the rise,” said Dr. Beiko. In fact, improved outcomes in cataract surgery have organically led to the use of lens surgery as a refractive modality. It offers distinct advantages over corneal refractive surgery in selected cases, while simultaneously eliminating the need for cataract surgery in the future. According to Alio et al., RLE is an elective intraocular surgery that needs to be minimally invasive and performed with precision and high accuracy. The authors said: “The indication of this surgery is the presence of high refractive error in the absence of cataract and requires an approach with the risk–benefit ratio in mind depending on the age, refractive condition and pre-operative condition,” adding that in general, RLE should be performed only in presbyopic eyes and the main challenge involved is to reach emmetropia.4 Prof. Auffarth has also taken notice of RLE, including presbyopic clear lens extraction, up to premium lens application in cataract patients. “The more sophisticated the implant, the more advanced and the more comprehensive the preoperative evaluation should be, as well as having high standards for the intraoperative procedures.” On the flip side, Dr. Beiko provided a word of caution regarding these procedures: “Surgical intervention for presbyopia with clear lens extraction needs to be critically reviewed. Long-term follow-up of uncomplicated lens extraction reveals optical quality to be inferior to the native lens, retinal detachment rates and in-the-bag lens dislocation both increase with time, opacification of intraocular lens optic may be an issue with some materials, and with only partial resolution of the presbyopia – all to be of grave concern.”

Tailored Suits If ‘the suit makes the man’, then it makes sense that it should actually fit the man. Cheekiness aside, the Media MICE fashion line was created in Hoi An, Vietnam . . . the tailored clothing promised land. This season, fine lines, colorful shirts and jacket linings are trending in ophthalmic Congress Couture. Model: Media MICE Director of Finance Travis Plage

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The Sophistication of Astigmatism Management

Cataract surgery is one of the most common procedures to treat preventable blindness around the world. So, what is trending in cataract today? According to Dr. Beiko, management of astigmatism is a very hot topic, specifically as it applies to the posterior corneal surface. More than 50% of patients undergoing cataract surgery have corneal astigmatism ≥0.75D, which may significantly limit visual outcomes if left uncorrected. Generally, with astigmatism, the main consideration is related to the anterior cornea. However, it’s been revealed that the posterior surface exhibits more toricity than the anterior surface – and ignoring posterior corneal astigmatism (PCA) could be a significant factor with regard to postoperative refractive astigmatism after toric intraocular lens (IOL) implantation.5 “Our understanding of the role of the posterior corneal surface is extensive, but our ability to measure it directly is limited,” explained Dr. Beiko. “Devices recently made available which measure the total keratometry and incorporate the Barrett formulas, which have been developed for this measurement, have been very effective in my hands.” The Barrett formula uses the Universal II formula to predict the required spherical equivalent IOL power; and the calculator derives the posterior corneal curvature based on a theoretical model proposed to explain the behavior of the posterior cornea.5 These lens power calculations, based on predicted, rather than measured posterior corneal curvature have yielded the best results thus far.6 “More surgeons now rely on these newer formulas, including Barrett and Hill-RBF methods, for more predictable outcomes,” said Dr. Luthra. A 2019 study6 by Skrzypecki et al. compared refractive predictions of the Barrett Toric Calculator, based on IOL Master 700 biometry (Carl Zeiss Meditec), with and without measurements of posterior corneal curvature. The authors found that astigmatism prediction errors, with and without measured posterior corneal curvature, were similar. “The updated Barrett Toric Calculator is the first formula to provide non-inferior and reliable predictions based on measurement of posterior corneal curvature,” the authors concluded. According to Dr. Luthra, the increased use of toric IOLs can be attributed to a better understanding of posterior corneal astigmatism, along with better calculators, that incorporate the same. “Most surgeons have lower thresholds for switching to a toric IOL than ever before,” he said, adding that image-guided cataract surgery, like with Zeiss Callisto and the Alcon Verion, has gained popularity with surgeons, especially for toric IOL planning and surgery.

OCT in the Spotlight

Dr. Beiko mentioned that another ‘hot’ topic is the integration of intraoperative optical coherence tomography (iOCT) into the microscope, which allows for enhanced visualization of the anterior segment. Intraoperative OCT aids in decision-making in various anterior segment surgeries and has the potential to decrease surgical time as well as postoperative complications.7 According to Titiyal et al., iOCT is also useful in assessing the posterior capsule during cataract surgery.7 The authors noted: “In cases with posterior polar cataract, it may help detect cases with a true posterior capsular defect, and this may allow the surgeon to exercise extra caution in such cases, thus reducing the incidence of complications.”

OCT, Upgraded in Style

In addition to iOCT, the use of OCT for pre- and postoperative patient management has been in style for a while. However, new upgrades are further enhancing its capabilities in anterior segment procedures. “For premium lens patients, OCT diagnostics for the macula is almost mandatory to rule out epiretinal membranes or other pathologies,” added Prof. Auffarth. “New machines, for example the Oculus Pentacam AXL or Pentacam AXL Wave (Wetzlar, Germany), and similar machines from different other companies, offer the possibility to assemble a lot of parameters on one machine – which is necessary for finding the right lens or excluding the patient due to some pathology.” “With the availability of reliable high-resolution epithelial thickness mapping on OCT, it has become a valuable tool for better evaluating, planning and following up patients with suspect corneas, as well as candidates for refractive surgery, including monitoring postoperative outcomes and surprises,” explained Dr. Luthra. “Epithelial thickness mapping is likely to become an indispensable aid to the cornea and refractive surgeon with time.” Dr. Luthra adds that now, surgeons also increasingly depend upon aberrometry devices like the iTrace to plan premium IOLs, and for dealing with dissatisfied cases. The iTrace (Tracey Technologies, Houston, Texas, USA) is a raytracing, wavefront and corneal topography combination device.

Fashionable Footwear

Any CAKE Magazine Congress Couture ‘haute’ list must include shoes – and this season, the ‘funkier’ the better. On the ophthalmic runway, shoes are certainly one area where you can show your own style, or quirkiness... just make sure they’re comfortable! Model: Media MICE CEO & Publisher Matt Young

September/October 2019

COVER STORY

The ‘Perfect’ Capsulotomy

One of the most important steps to ensure optimal visual outcomes in cataract surgery is the anterior capsulotomy. Recently, femtosecond lasers have allowed surgeons to create a perfectly sized and perfectly circular anterior capsulotomy. However, an increased rate of anterior capsule tears following femtosecond laser has been reported8, which remains an important concern.This has led to the development of alternative approaches. “In regard to femtosecond laser technology in the cataract segment, demand for a perfect circular capsulotomy has become much bigger, and alternative applications have been developed,” shared Prof. Auffarth. “Devices such as CAPSUlaser (Excel-Lens, Livermore, CA, USA) or Zepto (Mynosys Cellular Devices, Fremont, CA, USA) can create a capsulotomy like a femtosecond laser. However, in contrast to femtosecond laser, they cannot perform a fragmentation of the lens and also cannot create corneal incisions.” The CAPSULaser is a thermal laser, and unlike the femtosecond laser it acts in a continuous manner to create the capsulotomy – plus, it’s small and attaches to the underneath of an operating microscope, which doesn’t interfere with the operating flow. Meanwhile, Zepto is a singleuse device which consists of a suction ring containing a wire made of nitinol. The device is pushed into the eye through the phaco wound, then placed on the anterior capsule. Once it has been centered by the surgeon, suction is applied to attach the device to the capsule. A short electric charge is activated to cut the capsule.9

IOLs: In or Out?

Another trend under speculation are multifocal IOLs – with some opinions in favor, and other not. “Intraocular lenses which increase depth of focus have been disappointing in their outcomes, despite the initial promises,” said Dr. Beiko. So, will they stay or will they go? That is yet to be determined. A 2017 paper10 reported that “the patient’s satisfaction depends on careful and individualized selection based on the preexisting conditions, visual needs and realistic expectations, as well as on the knowledge of the different optical designs and visual performances of the multifocal IOLs, and the proper surgical technique and eventual complications management. The main reasons for patient dissatisfaction following a multifocal intraocular lens implantation are residual ametropia, posterior capsule opacification (PCO), dry eye, IOL decentration, inadequate pupil size, and wavefront abnormalities”. It’s also suggested that trifocal models are better for those patients who require a good intermediate vision. “Trifocal lenses are gaining increased popularity for managing near vision performance in cataract surgery, but they are far from being the mainstay in daily practice,” said Dr. Beiko. “Trifocal IOLs, which offer good acuity at near, intermediate and distance, with lesser complaints of glare and haloes, have taken over from the bifocals and to an extent from the extended depth of focus (EDOF) lenses in many practices,” added Dr. Luthra. “Trifocals are likely to gradually replace the bifocal IOLs completely as surgeon confidence grows.”

Stylish Accessories Completing the 2019 Congress Couture trends this season are accessories – and in Paris, especially, scarves are always in. ‘Haute’ right now are long, flowing scarves ... a dapper final addition for runway-ready conference style. Model: Media MICE Director of Media Rob Anderson

MIGS is a Runway Hit

When topical drops fail to manage intraocular pressure (IOP), and with the complications posed by more invasive surgeries to treat glaucoma, micro-invasive glaucoma surgery (or MIGS) has certainly been ‘in’ lately. Currently, there are numerous MIGS devices and procedures – and to list them all would require more space than this short runway. Dr. Beiko helped to narrow down the list to one: The ab externo approach and placement of the XEN GEL Implant (Allergan Inc., CA, USA). It decreases IOP by creating a permanent drainage shunt from the anterior chamber to the subconjunctival space through a scleral channel.11 “This technique offers the opportunity for some surgeons to perform it at the slit lamp, negating the necessity of going to the operating theatre,” said Dr. Beiko. A 2019 review12 by Chatzara et al., summarized the current knowledge on XEN implant for the treatment of glaucoma. They found that there was a significant reduction in IOP, as well as in the number of medications needed, both in patients treated with XEN implant alone or combined with cataract surgery. The authors concluded that “XEN implant devices have been developed as a surgical alternative for glaucomatous patients and are expected to play an important role in the management of glaucoma in the future”. “I believe that devices which increase flow through the trabecular meshwork remain the mainstay of modalities employed surgically to manage glaucoma,” Dr. Beiko concluded.

September/October 2019

Ocular Fads: Hot or Not?

While fads in fashion can result in embarrassing photos, ‘fads’ in ophthalmology can have more devastating consequences, like permanent ocular damage (sounds fun!). And ironically enough, some of these ocular ‘fads’ can have quite a bit to do with actual fashion – no metaphor needed! Prof. Auffarth said that one anterior segment procedure that may fall under this category is the elective changing of iris color by femto-laser or other laser applications – or keratopigmentation (KTP). “In the last three to four years, it came several times up as a lifestyle procedure and there has been some investment in new companies changing a dark or brown iris to a blue one,” he said. In 2018, Alio et al., published a study13 which reported complications observed in 234 eyes of 204 patients treated with KTP for both therapeutic and cosmetic reasons. Different KTP techniques and three generations of pigments (GP) were used. Of those, 50 eyes of 29 patients suffered complications (12.82%). They found that 49% of patients complained of light sensitivity, then color fading and change in color (19%). Neovascularization, visual field limitations and magnetic resonance imaging (MRI) complications constituted 7%, 4% and 2%, respectively. Although light sensitivity remained with the corneal-specific pigments, it gradually disappeared in most of the patients (81.81%) 6 months postoperatively. Organic complications were observed with the previous GP, but resolved with the latest and third GP. “It seems to be for some patients or some societies or professions as something very important – however, the complications can be quite dangerous. I think this is ‘fad’ in the category of anterior segment,” concluded Prof. Auffarth. Be sure to catch up with the CAKE team at the European Society of Corneal and Refractive Surgeons (ESCRS) annual meeting in Paris. We will be wearing our finest haute couture while we continue our search for all things ‘hot’ in ophthalmology.

References

Shen Z, Shi K, Yu Y, Yu X, Lin Y, Yao K. Small Incision Lenticule Extraction (SMILE) versus Femtosecond Laser-Assisted In Situ Keratomileusis (FS-LASIK) for Myopia: A Systematic Review and Meta-Analysis. PLoS One. 2016;11(7):e0158176. 2 Pasquali T, Krueger R. Topography-guided laser refractive surgery. Curr Opin Ophthalmol. 2012;23(4):264-8. 3 Holland S, Lin DT, Tan JC. Topography-guided laser refractive surgery. Curr Opin Ophthalmol. 2013;24(4):302-9. 4 Alió JL, Grzybowski A, Romaniuk D. Refractive lens exchange in modern practice: when and when not to do it? Eye Vis (Lond). 2014;1:10. 5 Yogi MS, Ventura BV, Nakano EM. Posterior Astigmatism: Considerations for Cataract Refractive Surgery Planning.Vision Pan-America XVII. N. 1. Jan-Mar 2018. 6 Skrzypecki J, Sanghvi Patel M, Suh LH. Performance of the Barrett Toric Calculator with and without measurements of posterior corneal curvature. Eye (Lond). doi: 10.1038/s41433-0190489-9. [Epub ahead of print] 7 Titiyal JS, Kaur M, Falera R. Intraoperative optical coherence tomography in anterior segment surgeries. Indian J Ophthalmol. 2017;65(2):116-121. 8 Sharma B, Abell RG, Arora T, Antony T, Vajpayee RB. Techniques of anterior capsulotomy in cataract surgery. Indian J Ophthalmol. 2019;67(4):450-460. 9 Wygle˛dowska-Promieńska D, Jaworski M, Kozieł K, Packard R. The evolution of the anterior capsulotomy. Wideochir Inne Tech Maloinwazyjne. 2019;14(1):12-18. 10 Salerno LC, Tiveron Jr. MC, Alió JL. Multifocal intraocular lenses: Types, outcomes, complications and how to solve them. Taiwan J Ophthalmol. 2017;7(4):179-184. 11 De Gregorio A, Pedrotti E, Stevan G, Bertoncello A, Morselli S. XEN glaucoma treatment system in the management of refractory glaucomas: a short review on trial data and potential role in clinical practice. Clin Ophthalmol. 2018;12:773-782. 12 Chatzara A, Chronopoulou I, Theodossiadis G, Theodossiadis P, Chatziralli I. XEN Implant for Glaucoma Treatment: A Review of the Literature. Semin Ophthalmol. 2019;34(2):93-97. 13 Alio JL, Al-Shymali O, Amesty MA, Rodriguez AE. Keratopigmentation with micronised mineral pigments: complications and outcomes in a series of 234 eyes. Br J Ophthalmol. 2018;102(6):742-747. 1

About the Contributing Doctors George H.H. Beiko, BM, BCh, FRCS(C) is a medical graduate of Oxford University and completed his ophthalmology specialty training at Queens University in Canada. After completing his residency, he worked for one year at the St. John Ophthalmic Hospital in Jerusalem. He is currently a cataract, anterior segment and refractive surgeon practicing in St. Catharines, Ontario, Canada. His research interests include development of advanced cataract techniques and new intraocular implants. He has also done extensive work investigating multifocal, accommodating and aspheric IOLs. He is a founding member of the International Society for Intraocular Lens Safety and is an Associate Clinical Professor at McMaster University and a Lecturer at the University of Toronto. He has published over 30 peer-reviewed articles and authored twelve book chapters, and has given over 700 scientific presentations at meetings throughout the world. [Email: george.beiko@sympatico.ca] Gerd U. Auffarth, MD, PhD, FEBO of Heidelberg, Germany, is professor and chairman of the Department of Ophthalmology, University of Heidelberg, Germany. He is also a director of the International Vision Correction Research Centre (IVCRC) and the David J. Apple International Laboratory for Ocular Pathology, board member and secretary general of the German Society for Cataract and Refractive Surgery (DGII), honorary member of the Hungarian Society for IOL implantation, and board member of the European Society for Cataract and Refractive Surgeons (ESCRS). His surgical expertise includes cataract and refractive, as well as cornea and glaucoma surgery. He was the first surgeon worldwide to implant a toric, aspheric, multifocal IOLs. In 2018, he was ranked number two of the most influential individuals in ophthalmology worldwide. [Email: gerd.auffarth@med.uni-heidelberg.de] Dr. Gaurav Luthra is an alumnus of Maulana Azad Medical College, New Delhi, India. Presently, he is the director and chief of Cataract & Refractive Surgery at Drishti Eye Institute, Dehradun, Uttarakhand, since 1998. His areas of interest are refractive surgery, pediatric & challenging cataract surgery, premium IOLs and keratoconus. A past president of Intraocular Implant & Refractive Society of India (IIRSI), he is currently the chairman, Academics & Research, IIRSI and a Member, Scientific Committee, All India Ophthalmological Society (AIOS), besides being the Honorary General Secretary of UKSOS. Dr. Luthra is regularly invited as a faculty at most international meetings including ASCRS, ESCRS, American Academy, APAO, APACRS, and World Ophthalmology Congress. He has successfully performed over 120 live surgery workshops, demonstrating latest cataract and refractive surgical techniques around the world and has presented over 135 papers/lectures in international conferences and over 200 papers/courses in national conferences. [Email: luthrag@yahoo.com]

September/October 2019

CAKE MAGAZINE

Behind-the-Scenes of Media MICEâ&#x20AC;&#x2122;s Haute Couture Photoshoot

September/October 2019

UDOS Literature

Keeping Children’s Eyes Healthy in A Digital World, One Book at a Time by Tan Sher Lynn

Kudos to Assoc. Prof. Mo Dirani for his tireless crusade against myopia in children. His recent projects include a book series, called The Plano Adventures, which aims to educate children on the environmental risk factors that contribute to the development of myopia.

obile device dependency, gaming addiction, cyberbullying, and lack of outdoor activity are all common and growing problems in children worldwide. Often, these are the results of excessive device usage, which often leads to vision conditions, particularly myopia or nearsightedness. To address this issue, academic and global myopia authority Associate Professor Mohamed (Mo) Dirani collaborated with Singapore’s awardwinning creatives, Hwee Goh and David Liew, to produce an engaging book series for children, called “The Plano Adventures”. We talked to Prof. Mo to find out more about the books and get his take on myopia.

CAKE: What is The Plano Adventures about?

Prof. Mo: The Plano Adventures is a series of books that aims to educate children on the environmental risk factors that contribute to the development of myopia, including excessive near work and lack of outdoor activity. The five books in the series address global issues on the link between excessive device use and adverse health outcomes, with a focus on myopia (first two books), gaming addiction, cyberbullying and device dependency. The underlying call to action in each book in the series is for children to remember and adopt Professor Plano’s “Clear Vision Recipe”, which consists of recommendations on healthy device use and eye care habits, developed using the latest scientific literature.

CAKE: What inspired you to publish the series?

Prof. Mo: I knew that it was important to empower the next generation with the required knowledge to avoid the pitfalls of excessive device usage and establish healthy relationships with emerging technology. The challenge was finding a way to go about educating children

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in an engaging manner. Through this publication, we have truly managed to deliver science in a fun and engaging narrative that all children will enjoy.

CAKE: Please share your experience in producing the books. Prof. Mo: As an eye scientist focused on writing scientific manuscripts, it was a huge opportunity for me to collaborate with author and renowned children’s book writer Hwee Goh and celebrated illustrator David Liew to relay our scientific findings to the public and educate children on vision care and the perils of excessive device use in a creative and engaging way.. It was very special how the stories came together, from the initial pitch, to the draft storylines, sketches, scientific reviews and finally, the official publication by Marshall Cavendish, without whom this book series would not have been possible. We engage readers through each of our social media platforms, print and media publications, as well as live book readings. These have been very well received by both parents and children, and we are incredibly humbled to have their continued support ever since we embarked on this journey together.

CAKE: Will there be more Plano Adventure books in the pipeline? What are you currently working on?

Prof. Mo: Goh, Liew and I are developing The Plano Adventures sequel and picture books, and we have also developed a 24-week video series called The Plano Diaries at the request of many parents. The episodes are released every Friday and are available on the Plano App social media platforms. Each episode in the video series offers a deeper look into the backstory of each of the characters.

CAKE: Please tell us more about the Plano App.

Prof. Mo: My team at Plano Pte. Ltd. has developed the Plano App to address the rising issue of unhealthy smart device use in children and to assist parents in cultivating healthy eye care habits in children. The app provides various child safety functions, while using science-based features that help modify behavior in children to reduce myopia-related risk factors. We are also working on launching a major update to our in-app optometry referral platform, where the Plano App uses smart algorithms to remind parents when to take their children for comprehensive eye examinations according to recommended national guidelines. Parents can then easily locate and book their childrenâ&#x20AC;&#x2122;s next eye examination within the platform itself. Through this platform, we hope to make the process of getting children into eye care early and in a regular and timely manner, which is pivotal in addressing the growing issue of myopia in Singapore and around the world.

CAKE: After the books, whatâ&#x20AC;&#x2122;s next for Plano?

Prof. Mo: Beyond these current efforts, we are looking into partnering with major players in the publication and film industries to create a film adaptation of the series. We also hope to get The Plano Adventures integrated into the school curriculum across the globe to ensure that children as young as five years old can have the knowledge at hand to better understand the role of smart devices in their life.

September/October 2019

UDOS Literature

Professor Plano’s ‘Clear Vision Recipe’ [and the research findings that support it!] 1. Scoops of Good Distance – We should use smart devices at a distance of at least 30 cm from our eyes. Bababekova Y, Rosenfield M, Hue JE, Huang RR. Font size and viewing distance of handheld smart phones. Optom Vis Sci. 2011;88(7):795-797.

CAKE: What is your take on myopia? How do you foresee the condition in the future? Prof. Mo: Myopia is one of the most common health problems, affecting an estimated two billion people worldwide. The number of people with myopia is expected to increase to five billion by 2050, which will be half of the world’s population. Studies have attributed the increasing prevalence of myopia to the rising trend of smart device use in children. The unfortunate reality is that 90 percent of all cases develop during childhood years. Unless we address this immediately, we will be seeing our clinics and hospitals filled with patients with sight-threatening high myopia. Our collective efforts are necessary in alleviating this public health and economic crisis. When it comes to myopia, early detection and ongoing management is important. The sooner we educate children on how to develop responsible device use and increase outdoor activity, the better the chances of reducing the risk of device dependency and myopia.

2. Dashes of Eye Breaks – We are recommended to take eye breaks after 30 minutes of using smart devices. Huang L, Kawasaki H, Liu Y, Wang Z. The prevalence of myopia and the factors associated with it among university students in Nanjing: A cross-sectional study. Medicine (Baltimore). 2019;98(10):e14777. 3. Heaps of Time Outdoors – We should spend at least two to three hours every day outdoors. i. Foreman J, Dirani M. Keeping an eye on smart device use. Singapore, 2018. https://www.plano.co/vision-smart/ ii. Huang L, Kawasaki H, Liu Y, Wang Z. The prevalence of myopia and the factors associated with it among university students in Nanjing: A cross-sectional study. Medicine (Baltimore) 2019;98(10):e14777. iii. Dirani M, Tong L, Gazzard G, et. al. Outdoor activity and myopia in Singapore teenage children. Br J Ophthalmol. 2009;93(8):997-1000. iv. Xiong S, Sankaridurg P, Naduvilath T, et al. Time spent in outdoor activities in relation to myopia prevention and control: a meta-analysis and systematic review. Acta Ophthalmol. 2017;95(6):551-566. v. Deng L, Pang Y. Effect of Outdoor Activities in Myopia Control: Meta-analysis of Clinical Studies. Optom Vis Sci. 2019;96(4):276-282.

CAKE: What advice would you give to parents to help them reduce and manage myopia-related risk factors in their children?

Prof. Mo: Parents should be empowered to manage the time their children spend on smart devices better and help modify their children’s behavior to reduce myopiarelated risk factors. By modifying particular risk factors, such as the amount of time their children spend on devices and the lack of outdoor activity, they can help slow down the progression of myopia or even in some cases, delay the onset of myopia, which reduces the chances of developing sight-threatening high myopia. We have published a report for parents and teachers on how to manage smart device use and myopia in children, which is available to download for free from our website, www.plano.co.

Editor’s Note: The Plano Series is currently sold in all major bookstores in the United Kingdom, the United States, Australia and Singapore. It is also available for online orders in Singapore on The Plano Shop (www.plano.co/ plano-shop/), and worldwide on websites for Amazon, Book Depository, and Marshall Cavendish.

4. MyPower – We should remember and adopt the recommendations every day.

About the Contributing Doctor Associate Professor Mohamed (Mo) Dirani is the founding managing director of Plano Pte. Ltd., adjunct associate professor at the Duke-NUS Medical School, and honorary principal investigator at the Singapore Eye Research Institute (SERI) and the Centre for Eye Research Australia (CERA). He completed his PhD at the age of 26 in 2006, during which he established the world’s largest twin study to investigate the genetic and environmental risk factors of myopia. In 2008, Prof. Mo undertook a post-doctoral appointment at the National University of Singapore (NUS), in which he coled a study that produced one of the first and most cited scientific papers that provided novel insights into the protective nature of outdoor activity in the development of myopia. Since completing his PhD, Prof. Mo has published over 120 peer-reviewed manuscripts in prestigious medical journals, has been an invited speaker across the globe as an expert in myopia, published several government-commissioned reports, and has received several competitive scholarships, fellowships, and scientific awards. [Email: mo.dirani@plano.co]

September/October 2019

TARUN ENTERPRISES

8/8, Strachy Road, Allahabad - 211001, U.P. , INDIA Phone : 91 8176080204 e-mail : info@optitecheyecare.com +91 9335154556 URL - www.optitecheyecare.com

INDUSTRY UPDATE

Cooking with Geuder CAKE Magazine recently chatted with Hamadi El- Ayari, the vice president of sales and marketing for Geuder AG in Heidelberg, Germany, to learn more about the company’s latest foray . . . out of eyeballs and into cookbook publishing. Called “You Eat with Your Eyes First”, the Geuder Ophthalmic Cookbook 2019 features recipes from doctors and industry professionals from around the world.

CAKE: What is the idea behind the cookbook?

Mr. El-Ayari: Basically, the idea was born a while ago. As a whole, the ophthalmic society and industry is small – and after a while you’ve developed both personal relationships and friendships with many eye specialists. At that point, you start talking about things other than business and ophthalmology. And food is something we all have in common. We all have to eat, we all travel, and we all have had opportunities to try different regional cuisines. So, the step from eating and talking together – to making a cookbook together – wasn’t that far.

CAKE: Who provided recipes for the cookbook?

Mr. El-Ayari: Mainly, eye specialists from around the globe contributed one or two of their favorite dishes, including starters, main courses, and desserts. There was no committee to decide and select authors – rather, we asked people within our network, which turned out to be a rather colorful mix. We have some Geuder employees who contributed, as well as a scrub nurse; a professor of ophthalmic bioengineering focusing on Eye and Vision Science Research at the University of Liverpool; renowned surgeons like Theo Seiler of Switzerland, Thomas Kohnen of Frankfurt, Gerd Auffarth of Heidelberg and his wife. We also have surgeons contributing from Mexico, Peru, Australia, Pakistan, Austria, Italy, France, and more. The CEO of the European Vitreoretinal Service Company (EVRSC) and the Media MICE COO and CEO have also submitted recipes. Many contributors have a dual citizenship and provided recipes from one of their two countries. We hope this cookbook will provide the reader with both recipes and inspiration, while showcasing culinary highlights from around the world. Be surprised and inspired as “You eat with your eyes first”!

CAKE: Where can our readers get a copy?

Mr. El-Ayari: We’ll have a limited supply with us at ESCRS. We will also have a PDF or eBook available for download on our website. (As my 16-year-old daughter would say: “It’s 2019, we don’t carve such things into stone anymore!”)

CAKE: Is there anything else you’d like to add?

Mr. El-Ayari: Geuder is not liable for associated risks, such as (but not limited to) weight gain, dirty kitchens, burned food, or discovering new hidden cooking talents. For more information about Geuder, or to get an online cookbook, visit: www.geuder.de.

September/October 2019

UDOS Women in Ophthalmology

BARBARA MASKET On Seeing ‘Art to Eye’ How an architectural designer devised an innovative ophthalmological apparatus to fulfill an unmet need... by Tan Sher Lynn

Mrs. Barbara Masket – architect and designer – deserves kudos for her ingenious contribution to ophthalmology. The wife of ophthalmologist and Advanced Vision Care founder, Dr. Samuel Masket, Mrs. Masket invented the MASK-it Eye Patch, a revolutionary monocular device that makes eye examinations more comfortable and hygienic for the patients.

arbara Masket has always been an artist at heart. At seven years-old, she started taking oil painting lessons from a famous local art collector and teacher. Later on, she took up stone sculpting and calligraphy, and eventually graduated with a master’s in architecture. “I had been practicing architectural design for about 20 years when it became obvious that my husband needed help to run his ophthalmology office in a pinch,” shared Mrs. Masket. “That lasted longer than the weekend I expected to help out, straightening things out at the office. So, I stayed on as a senior office administrator at his office, Advanced Vision Care, from 2003 until 2018.” As administrator, Mrs. Masket was responsible for interviewing and hiring new staff. “I also became the ‘patient proxy’ and was the subject for the visual field test numerous times. The reusable ‘pirate patch’ is typically used to cover one eye during the visual field test. It is cleaned with alcohol before each use – but that does not eliminate the risk of infections. Instead, it incurs additional cost and time. I complained about the lack of cleanliness of using the pirate patch, and my husband suggested that I should invent something better. That was how the seed was planted – it was in 2013,” said Mrs. Masket.

The birth of the MASK-it eye patch Mrs. Masket put on her thinking cap and drew upon her artistic skills and background in design to come up with a solution. “I cut and glued for about a year before I went looking for someone to create my product. Finally, I found a small company in Los Angeles who made them for me,” she said. “I tested the eye patch in my husband’s office and the patients and staff loved it.” At this point, she still did not have a name for her product yet. “I continuously described it as a ‘mask’ for the eye, and my husband

September/October 2019

pointed out that that’s what it should be called. Thus, the “MASK-it” was born. It’s the name of my product, at the same time, it describes its function,” she explained. The MASK-it Eye Patch overcomes the problems and shortcomings of existing monocular devices. “Devices for blocking a patient’s eye during monocular eye examinations have commonly been rigid, paddle-shaped, handheld instruments or pirate patches. Hand-held instruments are cumbersome and difficult for children and elderly patients to use throughout the duration of a procedure,” Mrs. Masket explained. In addition, she said that type of occluding device presents the risk of transferring diseases because it is reused and may come into contact with eye secretions of various patients. “Meanwhile, the pirate patch offers very little adjustment and has hygiene issues. Normally, this type of patch is used in conjunction with a tissue placed between the patch and the patient’s eye,” she explained. “That tissue remains in compressive contact with the patient’s eyelid while the test is being performed. After removing the pirate patch, we need to spend time waiting for the patient’s second eye to readjust. In addition, patients who take prostaglandin analogs (PGA) medication for the treatment of glaucoma tend to have long or bushy eyelashes and have found the standard pirate patches very uncomfortable during testing,” added Mrs. Masket. The MASK-it Eye Patch, on the other hand, sits perfectly around the patient’s eye as it replicates the contour of an eye-shield. A partial slit bisecting the larger portion allows the patch to be

shaped into a cone of variable depths, which fits all orbital configurations without compressing the lids or lashes, allowing both comfort and convenience. It is not limited to one particular test, nor is it limited to a single use, but may be reused on the same patient, for the second eye.

On support system and overcoming challenges From the beginning and until today, Mrs. Masket’s husband, Dr. Samuel Masket, has been her biggest supporter. “He suggested that I pitch my product to large companies to produce and sell them for me. He introduced me to two large manufacturers of ophthalmic equipment, and one of them loved it and took it on,” shared Mrs. Masket. “However, as a European company with concerns about CE marking, they felt that it should be a fully medical product. So, they altered the materials, thereby reducing the quality and versatility of the device.” After two years on the market, she said it became clear that the paper and adhesive they used no longer worked as expected. “Moreover, they did not market it as an individual product, and sales were poor,” added Mrs. Market. “We negotiated the return of the product back to me, whereby I corrected and improved upon their changes to the patches and began marketing and selling them on my own.” Mrs. Masket also displayed her upgraded MASK-it Eye Patch at the American Society of Cataract and Refractive Surgery (ASCRS), American Academy of Ophthalmology (AAO), as well as at the Joint Commission on Allied Health Personnel in Ophthalmology (JCAHPO) events.

“I call it disruptive technology,” said Mrs. Masket. “I have found that, in general, younger ophthalmologists and younger staffers are more open to change. The older, more established inhabitants of this world are more hesitant. However, most ophthalmologists have never taken, nor given, the visual field test. They merely want good results. When I point out that my patch gives a better quality test for the second eye and does not induce dark adaptation, they pay attention,” she noted. Mrs. Masket was never in it for the money. “I was never looking for a quick million,” she said. “What I wanted is to invent something that would improve an existing procedure by making it more pleasant for the patient. The field of ophthalmology is so positive and yet so frightening. Most people know nothing about their eyes, but when something seems wrong, they become so afraid of going blind.” For most patients, going through that first step to check their eye is not a pleasant experience. “The visual field test is very stressful for most patient because it might mean glaucoma. So, messing with the wet pirate patch and tissues and lashes in your eyes is not pleasant, and it adds to the anxiety. While my staff is preparing patients for this test, sometimes they tell them my story. It’s sort of funny because my name and the product’s name sound so similar, and it puts them at ease.” Mrs. Masket’s product is so simple and obvious, that it might look frivolous. “But my patent attorney told me that most inventions of this type come from the staff who knows what’s needed in an office,” she said. “I believe that someday, the use of MASK-it will be as common as using eye drops in the ophthalmology office. Someday, it will hit critical mass.”

About the Contributor Barbara Masket is the owner of Masket Design, LLC, in Los Angeles, California, USA. She was the senior office administrator at Advanced Vision Care, an ophthalmology clinic established by her husband, Dr. Samuel Masket. She was also a successful architectural designer in the Los Angeles area. She holds a Bachelor of Education from the American University, Washington, D.C., and a master’s in architecture from the Southern California Institute of Architecture. [Email: maskitpatch@gmail.com]

September/October 2019

NLIGHTENMENT East Meets West

by Brooke Herron

ith more than 1 billion people, India has the second largest population in the world. In a region where access to healthcare services can be limited in most rural and underserved areas, more people means more potential patients. This is especially true for cataract, which is the most significant cause of blindness and is responsible for 50% to 80% of bilateral blindness in India.1 It is well known that India experienced a severe cataract backlog in the past, but through government and non-government organization (NGO)-sponsored programs, that number has decreased tremendously. Through the sheer volume of surgeries performed, Indian ophthalmologists have refined their surgical technique for efficacy and efficiency, with an emphasis on safety.

To learn more, CAKE Magazine caught up with Prof. Dr. S. Natarajan, the All Indian Ophthalmological Society (AIOS) president, and head and consultant of Vitreo-Retinal Surgery at Aditya Jyot Eye Hospital in Mumbai, India, at the 2019 Annual Meeting of the American Society for Retina Specialists (ASRS) in Chicago. There, he discussed India’s past and present – and how European ophthalmologists can learn from their Indian counterparts.

A look back: India’s cataract backlog In the 1970s, increasing rates of treatable blindness due to cataract caught the Indian government’s attention. And in 1976, the National Programme for Control of Blindness September/October 2019

and Visual Impairment (NPCB&VI) was launched. At that time, the NPCB&VI was 100% government-sponsored, with the goal of reducing the prevalence of blindness to 0.3% by 2020. “They did a lot of camps to identify cataract in the small places like schools,” said Dr. Natarajan, adding that now the camps are done in hospitals. “This started in the early 1960s and then it picked up in the 1970s. In the ‘60s, they were doing intracapsular cataract extraction (ICCE).” During this time, Dr. Natarajan said they increased the number of cataract surgeons to help handle the backlog. Government incentives also created an initiative for surgeons to take up the cause. “For example, if you registered with the government or the National Programme for the Control

European doctors can come to India “ and learn how to refine the technique, then

”

implement that into their practice at home.

- Prof. Dr. S. Natarajan, Head and consultant of Vitreo-Retinal Surgery, Aditya Jyot Eye Hospital, Mumbai, India in the 1980s, and the cataract surgical output increased to 3.9 million per year by 2003.1 Fast forward to 2016-2017, over 6.48 million of cataract surgeries have been performed in India.2

A lesson in refining techniques for efficiency

of Blindness, and you are doing the surgery for free, they would reimburse the surgeon 750 rupees or about $100 for the cataract surgery,” he explained. “This encouraged the other surgeons to do it. It doesn’t cover the whole thing, but instead of a total loss you have something to cover the surgery. And when bigger hospitals did it, and because of the sheer numbers, they could manage the expenses.” Further, he said that every state and region [in India] has a premier institute of ophthalmology. “Their main thing is to prevent blindness for the needless blind, like cataract and glaucoma – and cataract is the primary one.” To show the increase in cataract surgeries in India, there were roughly 1.2 million cataract surgeries per year

Dr. Natarajan said that in all the government hospitals today, everyone is an expert in cataract. “Every day, everywhere, cataract surgery is being done.” So, how did the rate of cataract surgeries increase from 1.2 to 6.48 million annually over the last few decades? By refining their technique to make surgeries more efficient. “I went to Brazil last month, and they were admiring the amount of cataract surgery done in India,” he shared. “I think they would like to do something like that.” Dr. Natarajan explained that there is a system in place for European ophthalmologists who would like to come to India to train and become quicker and more efficient in cataract surgery. Ophthalmologists from outside of India need to be licensed and registered through the proper Indian channels. “They can come to India and learn how to refine the technique, then implement that into their practice at home,” he said. “The main goal should be ‘patient first’ – it should be refining the technique in every case, so the patient benefits from the best surgery with the best surgical skills,” said Dr. Natarajan, noting that approximately 1,000 cataract surgeries are performed daily in the bigger hospitals in India. In the camps, about 100 are completed per day – all to combat the backlog. “I don’t think

that would be required for a European doctor,” he continued, adding that there is something to be gained from the volume of patients – and that comes in the form of unusual pathologies. “I think the variety of patients available, apart from cataract, make for the different pathologies. Maybe in their country, they would normally see one per day, but in India they could see 10 to 20 of those cases per day,” he said. “I always recommend that they should go and see some other operating rooms to see what each one is doing and pick up what they like, what’s good for their country and follow that.”

Opportunities for training and innovation India is also a hotbed for ophthalmic innovation, notably in instrumentation and intraocular lenses (IOLs) – and much of it is driven by low cost. Dr. Natarajan said the cheapest IOL in India currently runs about USD $2 – the low cost is tied to government and NGO subsidies, along with the sheer volume of patients which allows for lower prices. The IOL market is growing in India – and that’s because the demand is there. “About two-thirds of India’s population will have cataract in the next 30 years – so that’s the market. They’re thinking cataract is going to happen, and everyone is working on the maximum capacity to do the surgery,” he said. Of course, premium IOLs are available in India as well, at a cost that Dr. Natarajan believes is lower than in developed countries. According to Dr. Natarajan, in addition to IOLs, European doctors can take advantage of India’s lower cost instruments and other technologies.

September/October 2019

NLIGHTENMENT East Meets West “I think the microsurgical instruments – in India, they make the best and they’re cheaper – maybe 1/10 the cost of what’s available in Europe,” he shared, adding that this could be a great advantage for European surgeons. Of the different Indian companies focusing on microsurgical equipment, several stand out to Dr. Natarajan, including Kholsa and Epsilon (both located in Mumbai) and Appasamy Associates (Chennai), which also manufactures and distributes ophthalmic equipment, microscopes, lasers, pharmaceuticals and IOLs. Lenses coming out of India would also be advantageous to European physicians from a cost-versus-quality perspective. For example, Biotech Healthcare Group (Gujarat) has developed OPTIFLEX TRIO, a diffractive-

refractive trifocal IOL used for presbyopia correction; while Care Group (Gujarat) has a single-piece posterior chamber phakic IOL, called IPCL V2.0 (Implantable Phakic Contact Lens). On the imaging end of things, Bangalore-based Remedio is gaining popularity, with products like the C3 Field Analyser, the world’s first clinically validated portable visual field perimeter device, where the test is performed in a wearable headset format is administered using a smart phone. Meanwhile, there are opportunities for companies from the West to enter India as well. “Even now, more than 50% of IOLs are from the West. In India, you have to think of the mass – the numbers – that will help show a profit, even if the devices are more expensive.”

Prof. Dr. S. Natarajan with CAKE Magazine Publisher, Matt Young, at the at the ASRS Annual Meeting in Chicago

References 1

Murthy G, Gupta S, John N, Vashist P. Current status of cataract blindness and Vision 2020: The right to sight initiative in India. Indian J Ophthalmol. 2008;56(6):489-494.

Maharana PK, Chhablani JK, Das TP, et al. All India Ophthalmological Society members survey results: Cataract surgery antibiotic prophylaxis current practice pattern 2017. Indian J Ophthalmol. 2018;66:820-824.

About the Contributing Doctor

INDUSTRY UPDATE

Prof. Dr. S. Natarajan is the All Indian Ophthalmological Society (AIOS) president, and head and consultant of Vitreo-Retinal Surgery at Aditya Jyot Eye Hospital in Mumbai, India. He is a multi-award-winning ophthalmologist who has performed over 27,000 exclusive vitreo-retinal surgeries in the past 33 years, and trained 64 vitreo-retinal surgeons across the globe. He is a visiting professor in the Marmoindes University (Argentina), University of Lugano (Switzerland), Balaji Medical College (Chennai, India), and Saveetha Medical University (Chennai, India). [Email: prof.drsn@adityajyoteyehospital.org]

FDA Approves Delivery Design Optimization Changes for Ophtec’s RingJect

ecently, Ophtec USA (Boca Raton, Florida) received FDA approval for delivery design optimization changes to RingJect™, a single-use injector preloaded with the Ophtec Capsular Tension Ring (CTR), originally designed for use in complicated cataract surgery. The RingJect delivers the Ophtec CTR which is a uniplanar 270 ring, made entirely of ultravioletlight-absorbing PMMA with one manipulation eyelet at each end of the ring. Its patented compression molding technology makes for a durable,

flexible device to stabilize the capsular bag in the presence of weakened or compromised zonules during cataract surgery. Ophtec USA Vice President and General Manager Abraham Farhan expressed gratitude for the FDA approval, and added: “Our surgeons and patients will continue to benefit from our legacy Capsular Tension Ring. We are very excited about the RingJect, as it saves time in surgery and reduces surgical preparation time.” Today, surgeons use RingJect in premium IOL surgeries for better IOL

September/October 2019

centration and stabilization “Ophtec has a passion for vision and we look forward to provide the same preloaded sterile Capsular Tension Ring that has offered surgeon’s a high level of safety for complicated cataract cases and which has shown its added value in premium IOL cases with years of successful clinical outcomes,” added Tiago Guerreiro, Ophtec’s global marketing director. For more information, visit www.ophtec.com.

New F-Sonic Phaco Tips The F-Sonic Phaco Tip allows cataract surgeons to get the best out of every step of phacoemulsification: • Constant aspiration flow • Increased irrigation flow • Chamber stability even under high vacuum conditions • Effective emulsification of the nucleus • Double flared design • Limited tissue damage due to reduction of thermal impact • Effective phaco time reduction also in small incision size (MICS)

“

With the Medicel F-Sonic Phaco Tip I am able to administer as little phacoemulsification power as possible, even on hard cataracts – which also helps to minimize energy damage in general.

Dr. J. K. Shah, Shah Eye Clinic Andheri West, Mumbai, India

„

Medicel AG Dornierstrasse 11, 9423 Altenrhein / Switzerland T +41 71 727 10 50, info@medicel.com

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The newly developed Medicel F-Sonic Phaco Tip allows a significant modification in my surgical procedure, as I am able to work efficiently quick, using high vacuum levels without having to give up well-established safety aspects. Dr. Christian Scheib, ViDia Kliniken Karlsruhe, Germany

„

www.medicel.com

NLIGHTENMENT Business

by Khor Hui Min

phthalmology is an exciting field to invest in, especially with the unfolding of new developments and opportunities in 2019 and beyond. With the help of Michael Lachman, founder and president of EyeQ Research, we’ve rounded up some investment trends and opportunities to look out for this year.

Gene therapy: What’s new? Ophthalmic technology stocks have gotten off to a strong start in 2019, driven primarily by strategic developments for gene therapy companies. Most of the gains for the ophthalmology sector resulted from the announced acquisitions of Spark Therapeutics and Nightstar Therapeutics by Roche and Biogen, respectively. MeiraGTx’s shares also moved higher following an announced partnership with an investment from Janssen Pharmaceuticals (J&J). Of course, it’s hard to predict the next big acquisition or partnership in the ophthalmic gene therapy space. Companies that plan to announce early stage clinical trial results in ophthalmic gene therapy programs this year include AGTC, MeiraGTx and REGENXBIO.

Alcon strikes out on its own A major ophthalmic investing event in April was the spin-out of Alcon from Novartis, enabling a pure-play investment in this ophthalmic market leader for the first time in nearly a decade. The Alcon investment thesis is based on revenue growth driven by multiple product lines, including premium IOLs, vitreoretinal systems, contact lenses and over-the-counter

(OTC) dry eye products. This year, Alcon plans to submit to the Food and Drug Administration (FDA) for approval in the U.S. of three new intraocular lens (IOL) systems, including the PanOptix trifocal (Alcon, Geneva, Switzerland) IOL and a new extended depth of focus (EDOF) IOL. In addition to developing new products internally, Alcon has also been active in acquiring new technologies, including recent acquisitions of Tear Film Innovations, TrueVision Systems and PowerVision. The Alcon investment thesis is also driven by margin improvement through a favorable product mix, productivity and efficiency, and leverage of existing infrastructure. Of course, these positive investment characteristics come at a price, and Alcon already trades at a premium to its peers.

STAAR takes the limelight Another ophthalmic device company with possible important milestones this year is STAAR Surgical. The company could benefit from U.S. approval of its EVO Visian ICL, which has performed well in Asian markets. STAAR plans to submit for CE mark approval of its EDOF IOL to address presbyopia by the middle of this year.

September/October 2019

Aerie is making major moves One of the highest profile ophthalmic product launches this year was the US launch of Aerie Pharmaceuticals’ Rocklatan for glaucoma and ocular hypertension. The stock peaked in July last year upon the announcement of early FDA acceptance of the company’s new drug application (NDA) submission. Aerie’s stock regained some lost ground in anticipation of FDA approval in earlier this year, but gave back those gains following approval. Investors hope that sales of this product will drive a rebound in the stock. Aerie continues to make progress toward regulatory approval in Japan of netarsudil ophthalmic solution (Rhopressa in the U.S.), having initiated a Phase 2 clinical trial in March. Aerie’s stock performance over the past year illustrates the fact that it is sometimes more rewarding to own stocks heading into events, such as product approval decisions and clinical data announcements, since they can sell off following achievement of such milestones. With that in mind, it is useful to keep an eye on anticipated upcoming FDA approval decision dates.

Kala Pharmaceuticals was expecting an FDA approval decision in August for its dry eye product candidate, KPI-121 0.25%, and expected to announce topline results from its STRIDE 3 trial in Q4. Clearside Biomedical anticipates an FDA approval decision in October for XIPERE for uveitis.

More to look out for Additional news related to late-stage ophthalmic development programs could come from Molecular Partners, which, in collaboration with its development partner Allergan, has key milestones this year in its agerelated macular degeneration (AMD)

and diabetic macular edema (DME) programs involving Abicipar (DARPin therapy). Allergan plans a biologics license application (BLA) filing for neovascular AMD in H1-2019, and initiation of a Phase 3 trial in DME in H2-2019. Separately, in H2-2019, Aldeyra Therapeutics plans to announce Phase 3 results for Reproxalap for noninfectious anterior uveitis, and possible initiation of the first part of a Phase 3 trial involving ADX-2191 for proliferative vitreoretinopathy. This year looks to be a year of many interesting developments and opportunities in ophthalmology, and investors can potentially make good gains from smart investments.

About the Contributor Michael Lachman is the founder and president of EyeQ Research, a consulting partner for strategic transactions in eye care. EyeQ Research provides consulting services to innovators and investors in eye care, including financial modeling and business valuation, proprietary market research, due diligence, and strategic advisory. Previously, Lachman was a managing director and equity research analyst with ThinkEquity Partners, healthcare analyst with SAC Capital Advisors, and a medical device analyst with Hambrecht & Quist, where he received a number one ranking in medical industry stock picking in the Wall Street Journal All-Star Analyst Survey. Lachman worked for five years in business development for Johnson & Johnson, and for seven years in marketing and R&D with Baxter. [Email: michael@lachmanconsulting.com]

INDUSTRY UPDATE

Alcon Launches Advancements to the CENTURION Vision System

elegates at ASCRS 2019 San Diego were among the first to see the latest advances to the CENTURION Vision System (Alcon Inc., Geneva Switzerland): the ACTIVE SENTRY Handpiece and INTREPID Hybrid Tip, both of which are designed to improve safety, consistency, and control during cataract surgery. The ACTIVE SENTRY Handpiece is the first (and only) phaco handpiece with a built-in fluidics pressure sensor that detects pressure in real time and communicates with the CENTURION Vision System. As fluctuations occur in the anterior chamber, the handpiece alerts Active Fluidics™ Technology, which triggers immediate adjustments. This helps stabilize the anterior chamber and ensure consistency. An update to the INTREPID BALANCED Tip, the INTREPID Hybrid Tip has a rounded polymer edge to reduce the risk of capsular tears and improve patient safety in the OR. Its

cutting performance is suitable for cataract densities up to 3+, and its fluidics performance and configuration is identical to the INTREPID BALANCED Tip. To highlight the potential clinical benefits of these new products, several doctors presented data on both upgrades during ASCRS. In one session, Dr. Kevin M. Miller presented findings from a study which demonstrated that the CENTURION Vision System with ACTIVE SENTRY upgrades produced the lowest occlusion break surge volumes when compared to two previous generation units. According to data presented by Drs. Nick Mamalis, Liliana Werner and Caleb L. Shumway, the INTREPID Hybrid Tip might be an effective means to help mitigate complications like posterior capsular rupture – which could occur during phacoemulsification. This might be useful for both experienced surgeons and those in training.

“The results showed that the INTREPID Hybrid Tip may help surgeons during cataract surgery by adding another layer of protection for the patient,” said Dr. Mamalis, from the John Moran Eye Center in Salt Lake City, Utah. “As surgeons, we know there is always the risk for potential posterior capsule tears, so the Hybrid Tip is a welcomed advancement to help us perform and deliver optimal results for our patients.” Jim Filippo, vice president and general manager for US Surgical, Alcon, said that that they’re constantly looking to develop new innovations that will offer a differentiated and measurable benefit to both surgeons and patients. “We are excited to launch these important innovations to our leading phaco system, as part of our continuous efforts to improve cataract surgery and help deliver consistent and controlled outcomes.”

September/October 2019

NLIGHTENMENT Fashion

by Tan Sher Lynn

Dr. Arun C. Gulani, dubbed “the Da Vinci of Eye Surgery”, talks about how he threads ophthalmology and fashion together. . . r. Gulani is an ophthalmologist specializing in advanced KeratoLenticulo-Refractive (i.e. the full spectrum cornea and lens-based surgeries), which includes all versions of LASIK, premium cataract surgeries and corneal surgeries, to provide patients with spectacle independence. Originally from India, he completed his postgraduate in ophthalmology and earned the coveted gold medal. While still a junior resident ophthalmologist, he

wrote the first textbook on Color Doppler for eye tumors, which attracted the attention of renowned eye surgeons and universities from all over the world. And at the young age of 25, he was invited to receive the Becton Dickinson Career achievement award in Philadelphia, where most of the competing candidates were in retirement age. “Having received numerous invitations from the U.S., I proceeded with refractive surgery while it was still in its infancy, and was even called ‘Buccaneer Surgery’,” he said. According to Dr. Gulani, he was naturally attracted to ophthalmology when he was exposed to it during surgical rotations in medical school. “Not only was it a combination of surgical artistry at its highest form, it also

September/October 2019

provided for my desire for innovation, along with near-immediate gratification from patient’s visual outcomes,” he said. In 2003, he founded the Gulani Vision Institute at the Southpoint area of Jacksonville, Florida, based on his philosophy of a “High-Tech” and “High-Touch” approach to patient care. The institute soon grew into a globally acclaimed ophthalmology center, receiving patients and students from all over world.

An eye for fashion Impeccably dressed, even in the slightest details, Dr. Gulani’s love for high fashion is evident in his practice. To him, it is important to be well-dressed as it reflects his pride in his work and his desire to impart elegance wherever he can. “Fashion is my parallel passion, just like eyes are. In my practice, my penchant for colors, symmetry, beauty and elegance is always the driving factor to bring out the best in each and every person as I custom-treat each and every eye to fulfill my patients’ best vision potential,” he shared.

In 2017, Dr. Gulani launched his fashion line – Gulani Fashion. “My fashion line is as unique as my practice is. In fact, my tagline for Gulani Fashion is “For Those Who Have Arrived” – for people who aspire to look their very best. Once again, just like my eye surgeries, I don’t offer choices. I will decide what is best for my clients based on each person’s unique characteristics – their background, desires, body type and what I feel should be the colors and cuts that would suit them best, for both men and women. Then, I celebrate their looks just like how I celebrate their vision,” he said. In fact, his artistic sense can be felt and seen in his everyday life. For instance, he uses colors in full range from suits to scrubs to the lighting in his surgery suite and colors of medical instruments. “One surreal observation is that somehow (without knowing it), I always seem to be wearing the color that coincides with the color of the theme of the conference at which I am speaking,” he noted.

A fulfilling life Dr. Gulani believes that each one of us is born with our internal GPS, and it is this GPS which he has allowed to unfold throughout his life, creating beautiful, unique outcomes that the world is able to regale in today. Even though he has received numerous national and international awards and recognition, to him, his best achievement is his family and the fact that he was able to help so many patients around the world. “My proudest achievements are my family and the blessing that I have gathered from so many patients from all over the world for nearly three decades, and from having mentored so many to achieve the best of their potential. My passion for eyes and fashion has never allowed me to feel that I am working at all, and when my patients celebrate their outcomes with me there is nothing higher or greater that I can look forward to,” he said. When he is not busy with fixing

Fashion is my parallel passion, just like eyes are. In my practice, my penchant for colors, symmetry, beauty and elegance is always the driving factor to bring out the best in each and every person as I customtreat each and every eye to fulfill my patients’ best vision potential.

eyes or designing clothes, Dr. Gulani loves to spend time with his family, and indulge in his other passions, namely modeling, sports, travel, Porsche-racing, as well as eating ice-cream and candies. As a sought-after mentor and speaker, he constantly encourages eye surgeons to stop talking about technology and in-the-box thinking, but to rise beyond and accept the artistry of eye surgery in delivering vision beyond 20/20 in every patient. “It is a constant pleasure to share my work with colleagues worldwide, and despite how exciting our progress in the eye care industry may be, I am dedicated to change the mindset of eye

care providers to believe that no patient should be wearing glasses or contact lenses, as they are a mark of disability whose time of extinction has already passed,” he said. “They say imitation is the best form of flattery and I must say I am gratified to see lately, doctors dressing up, allowing pictures with patients and even using my ‘thumbs up’ sign tradition, which I introduced nearly three decades ago,” he quipped. Editor’s Note: This story was first published in PIE Magazine Issue 11 (EURETINA 2019 Paris issue), Media MICE’s magazine on the posterior segment of the eye.

About the Contributing Doctor Dr. Arun C. Gulani is a world-renowned LASIK cataract, and corneal surgeon and performs the entire spectrum of advanced vision surgeries to reduce dependence on glasses and contacts, customising vision correction surgery to meet each patient’s unique goals. He has extensive experience in a wide variety of eye surgery techniques and technology. He was formerly the Chief of Cornea and Assistant Professor of Ophthalmology in the University of Florida’s School of Medicine before founding the Gulani Vision Institute in 2003, where he receives a global clientele and acts as a consultant to eye surgeons and the eye care industry as well. With an eye of an artist, his passion is to make people see and with his no-hype, oneon-one personalized care, he has turned Jacksonville, Florida into a vision destination for the world. [Email: gulanivision@gulani.com]

September/October 2019

INDUSTRY UPDATE

Zeiss Unveils First Digital Microscope: ARTEVO 800

arl Zeiss Meditec (Jena, Germany) introduced a new era in visualization at ASCRS 2019 with the unveiling of ARTEVO 800 – the first digital microscope in ophthalmic surgery. The microscope was developed in partnership with more than 300 surgeons for use by surgeons – a critical element in its design, according to Zeiss Global President of Ophthalmic Devices James Mazzo. “With ARTEVO 800, we are entering a new era of ophthalmic visualization for more certainty in surgery by providing the best resolution for our customers,” said Mr. Mazzo. “Developed with surgeons for surgeons, the ARTEVO 800 is going to change the future of surgical care by revolutionizing visualization, information, comfort and workflow in the operating room.” Among its advantages, ARTEVO 800 comes with a new feature called “DigitalOptics”, which provides

unmatched depth of field, drastically reduced light intensity requirements, and real color impression for increased certainty. “The display itself is wonderful, and I think the optics are superior in many cases to looking through the oculus . . . the lighting can be changed . . . everything can be optimized for the surgeon,” said Dr. Brandon Ayers, a U.S. cornea and anterior segment specialist, who spoke during the unveiling at ASCRS 2019 in San Diego. “The increased depth of focus is noticeable during surgery – you don’t have to step on the focus pedal nearly as much, and that speeds up the workflow in the operating room,” added Dr. Ayers. Using ARTEVO 800, surgeons can also make immediate decisions based on real time data with AdVision, which places critical data where it is needed:

September/October 2019

into the view of the surgeon, without blocking the surgical field. This includes intraoperative optical coherence tomography (OCT) imaging, cataract assistance functions, phaco vitrectomy values and patient identification. “The ability to look at your surgical field and overlay that with data – whether it’s patient data, demographics, biometrics, surgical tracking or intraoperative OCT – that’s when your eyes really open and you say ‘this is the next wave of surgery,’” said Dr. Ayers. In addition, ARTEVO 800 is integrated into the Zeiss Cataract Suite, allowing the entire cataract workflow to seamlessly connect to the cloud – from the office to surgery, and from surgery back to the office. For more information about ARTEVO 800 or other Zeiss products, visit www.zeiss.com.

CONFERENCE HIGHLIGHTS ASCRS 2019 Coverage

A Lowdown on the Latest in

Anterior Segment ‘Trends’ by Olawale Salami

eld in May in California, USA, this year’s combined annual meetings of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators (ASCRS-ASOA) organized by ASCRS, proved to be yet another success. Anterior segment surgeons, practice management staff, and ophthalmic technicians and nurses convened in San Diego for one of the industry’s biggest events. In case you missed the important details, we’ve compiled five highlights of the latest in anterior segment news below.

Going beyond the fovea with EyeMax Mono in dry AMD “EyeMax Mono offers a potential step change in the management of patients with dry age-related macular degeneration (AMD) who undergo cataract surgery.” Studies have shown that cataract surgery in patients with dry AMD has the potential to improve visual acuity without increasing the risk of progression to exudative AMD. As patients experience progressive loss of visual function in the fovea, their phakic refractive lens (PRL) may shift to the peripheral macula. At ASCRS 2019, Dr. Andreas Borkenstein, a private practitioner from Privatklinik der Kreuzschwestern Graz, Austria, provided further insight in his presentation titled, “A new class of intraocular lens designed specifically for patients with center-involving macular disorders”. Dr. Borkenstein noted that currently available surgically implanted intraocular lenses (IOLs) used in patients with AMD include standard monofocal IOLs, prism

All eyes on positive patient outcomes at ASCRS. IOLs and telescopic IOLs. However, these lenses have a range of limitations when implanted into patients with dry AMD. In particular, standard monofocal IOLs offer limited functional benefits to patients with dry AMD, as they are designed to focus light onto the fovea the area of greatest functional loss with this disease. EyeMax Mono (LEH Pharma, London, UK), a new type of IOL designed specifically for patients with centerinvolving macular disorders, shows promise. Dr. Borkenstein described his experience with EyeMax Mono, a singlepiece, soft, hydrophobic, acrylic IOL. “It is designed to increase breadth of focus and reduce blur, thereby improving image quality across all areas of the macula lens optics, it’s wavefrontoptimized to provide an enhanced quality of image to an area extending up to 10 degrees from the foveal center,” he shared. He added that the goal of this IOL is to supply the highest quality image to PRLs and other functioning areas of the retina that a patient with dry AMD becomes dependent on as macular disease progresses. “Laboratory simulations have showed that EyeMax Mono delivers superior image quality

compared with standard monofocal IOLs at up to 10 degrees of eccentricity,” he noted. Dr. Borkenstein presented a case of an 83-year-old Caucasian female with poor contrast sensitivity and color perception, and increasing glare during the preceding year. Examination revealed progressive cortical cataract (C5) stable, dry AMD, best corrected distant visual acuity (BCDVA) of 0.2, and best corrected near visual acuity (BCNVA) of 0.05. The patient underwent standard phacoemulsification cataract surgery with a small incision, with capsular bag implantation of EyeMax Mono. The surgery was completed with no complications, and the patient’s visual acuity progressively improved after EyeMax Mono implantation. “The patient’s visual acuity stabilized after three months, consistent with a neuro-adaptive component that may occur with this IOL. Therefore, no vision rehabilitation training was required,” explained Dr. Borkenstein. “The observed improvements in visual acuity are consistent with previously published results. EyeMax Mono offers a potential step change in the management of patients with dry AMD who undergo cataract surgery,” he concluded.

September/October 2019

CONFERENCE HIGHLIGHTS ASCRS 2019 Coverage Does cap thickness determine patient outcomes with SMILE? “SMILE procedures with 120μm and 140μm cap thicknesses provide excellent and predictable outcomes for the correction of refractive errors.” Small incision lenticule extraction (SMILE) is an all-in-one femtosecond laser refractive surgery which has been widely used for the correction of myopia or myopic astigmatism worldwide. At ASCRS, Dr. Ikhyun Jun and colleagues from the Institute of Vision Research, Yonsei University College of Medicine, Seoul, Korea, presented a paper where they evaluated clinical outcomes and biomedical changes in patients after SMILE based on two different cap thicknesses of 120µm and 140µm. “SMILE may preserve corneal biomechanics better than LASIK. This is because the tensile strength of the cornea gradually decreases from anterior to posterior, thus, creating a deeper refractive lenticule which has been considered to result in a stronger cornea by preserving more of the anterior lamellae of the cornea,” explained Dr. Jun. He clarified further: “On the contrary, leaving a sufficient residual stromal bed has been known to be important in preventing iatrogenic corneal ectasia, hence creating a thin cap may be effective and desirable because the amount of spherical equivalent correction increases with increasing cap thickness.” Dr. Jun and colleagues collaborated with surgeons from the London Vision Clinic and Ohio State University to conduct a prospective, comparative case series of 150 eyes of 150 patients who underwent SMILE procedures with a cap thickness of either 120μm (91 eyes) or 140μm (59 eyes). They found no significant differences at baseline between the two patient groups, who were all between 20- and 45-years-old, with myopia of < 8.0D and corrected distance visual acuity of ≥ 0.8. The study team excluded patients with keratoconus, cataract, glaucoma, retinal disorders, previous history of ocular surgery or severe ocular surface disease.

“Post-operative visual refractive outcomes were similar between the two groups,” shared Dr. Jun. “Furthermore, there were no significant differences between pre- and postoperative higher order aberrations between the two groups.” However, he observed that “because the thick cap group needs a thicker lenticule to correct the same spherical equivalent, weakening of corneal biomechanics was less in the thin cap group”. Dr. Jun and colleagues concluded: “SMILE procedures with 120μm and 140μm cap thicknesses provide excellent and predictable outcomes for the correction of refractive errors.”

Halting keratoconus in its tracks: The role of femtoassisted crosslinking “Crosslinking of posterior corneal stroma deeper than 250 microns could be better achieved with femto laser-assisted CXL than conventional procedures.” Corneal crosslinking (CXL) is a minimally invasive outpatient procedure designed to treat progressive keratoconus. It strengthens and stabilizes the cornea by creating new links between collagen fibers within the cornea. In a study presented at ASCRS, Dr. Lional Raj and colleagues from the Dr. Agarwal’s Eye Hospital, Tirunelveli, India, sought to compare femto-assisted crosslinking with the conventional procedure. The investigators designed a phase 1 prospective, non-randomized clinical trial which compared the two treatment options and explored the significance of the concept that deeper stromal crosslinking is more efficacious on inhibiting the progression of keratoconus. According to Dr. Raj, 21 patients were enrolled into the conventional treatment group and 25 patients into the femto-assisted CXL group. Study eligibility was defined by age between 15 and 30 years, history of progressive keratoconus with the thinnest pachymetry >400µm, and endothelial cell density of >2000 cells/mm2. In the femtosecond CXL group, a stromal bed (140 to 160 microns deep, 8.5mm to 9.0mm diameter)

with two incisions 180 degrees apart was fashioned with femto lasers into which isotonic riboflavin 0.1% w/v was infused every five minutes, in addition to transepithelial application every two minutes for 25 minutes, followed by UV irradiance for 30 minutes. Finally, the bed was washed with balanced salt solution at the end of the procedure. An epi-off procedure with Dresden protocol of 3 mW/cm2 was utilized in the conventional treatment group. The study showed that uncorrected visual activity (UCVA) was improved by 2 lines and 1 line in femto-CXL and conventional-CXL groups, respectively, (p = 0.005). Furthermore, there was no significant intergroup differences in the best corrected visual activity (BCVA) improvement. The investigators showed that the minimal central pachymetry was maintained in the femto-CXL group and reduced by 25µm (p < 0.05) in the conventional-CXL group. Furthermore, patients in the femto-CXL group showed better retention of corneal thickness (p = 0.01). The investigators also reported that crosslinking flattened corneas in both the femto-CXL treatment group and the conventional treatment group. “Astigmatism was reduced in the femtoCXL group by 0.22D and increased by 0.27D in the conventional-CXL group, while no endothelial changes were noted in either treatment groups,” highlighted Dr. Raj. In conclusion, Dr Raj noted: “Crosslinking of posterior corneal stroma deeper than 250 microns could be better achieved with femto laser-assisted CXL than conventional procedures. Femto laser-assisted CXL leads to an effective stabilization of keratoconus in terms of preventing steepening and further thinning of cornea, as a proof of ‘deeper the better’ concept.” He further stated that “femto-assisted crosslinked corneas clinically remained stable with no progression after two years”. Editor’s Note: ASCRS-ASOA 2019 was held in San Diego, California, USA, from May 3 to 7, 2019. Reporting for this story also took place at ASCRS-ASOA 2019.

CONFERENCE HIGHLIGHTS OIS@ASCRS 2019

IN FOCUS

Age-related Eye Diseases and Latest Innovations in Ophthalmology by Olawale Salami

uring the Ophthalmology Innovation Summit at the American Society of Cataract and Refractive Surgery congress 2019 (OIS@ASCRS), held in San Diego, California, a panel of leading experts in research and development in ophthalmology, led by Dr. Richard Lindstrom, founder and attending surgeon at Minnesota Eye Consultants and adjunct clinical professor emeritus at the University of Minnesota, discussed recent global trends and their impact on innovation in ophthalmology.

Experts’ take on innovations in eye care Undoubtedly, the aging population is one of the biggest concerns in eye care. “Above the age of 65, cataract, glaucoma, retinal diseases and dry eye-related problems become more significant,” said Dr. Lindstrom. “In addition, the millennial population is huge, and innovations in ophthalmology are needed to address growing problems related to refractive errors utilizing pharmacology, corneal surgeries and lens surgeries.” A member of the panel, Dr. Jag Dosanjh, senior vice president, US Eye Care at Allergan, noted: “Costs associated with age-related eye diseases are rising significantly across the globe. Therefore, it will be increasingly important to think of how we generate data to support payment and continued innovation in the long term.” Furthermore, Dr. Andy Corley, principal consultant at Yelroc Consulting, shared his thoughts on opportunities and risks associated with innovation. “Every time you watch the news, you

Innovation speeds forward in ophthalmology.

hear that the U.S. healthcare budget is 20% of the domestic gross national product (GNP), and there’s a good reason for that,” he shared. “That’s what seems important to the people of this country. We seem to be extremely privileged in the eye world because vision is so valued that people will pay for it.” As to risks to innovation, he noted: “The larger the market, the better the chances of recovery, so innovation has less risks in large markets.” On the other hand, Dr. Ali Satvat of the private equity firm KKR shared: “What we have seen outside traditional U.S. markets, largely in the emerging globally, is a growing demand for good quality eye care. Historically, devices and pharmaceutical products are where the opportunities have been.” Meanwhile, Tom Frinzi, worldwide president, Surgical, Johnson & Johnson Vision, affirmed that people are living longer, healthier lives and the demand on ophthalmologists is increasing. “The result of this will be that doctors of medicine (MDs) will be more occupied performing eye surgeries and less available for standard medical care, which will drive a symbiosis between MDs and optometrists,” he shared.

Innovation: What drives it? The recent years have witnessed numerous mergers and acquisitions across small and large companies. Dr. Lindstrom and panelists discussed whether mergers can dampen innovation. “Both big and small acquisitions have been instrumental in driving innovation,” noted Dr. Finzi. “Either it’s a big or small acquisition, it is healthy and helps foster the innovation ecosystem.” Dr. Corley also shared his opinion on this subject. “A key consideration on risks is the strength of the technology,” he said. “Is the technology an improvement or a breakthrough? The answer to this will guide the amount of investment needed.” Furthermore, he stressed that innovation is risky, and there are pitfalls in every part of the innovation cycle. “When you get to the point of commercialization, ensure that you’ve actually got something that can live in the market.” Meanwhile, Dr. Ali Satvat described some peculiar factors associated with the innovation cycle in ophthalmology. “I think what’s interesting about innovation in ophthalmology is the presence of a really strong ecosystem where you have

September/October 2019

CONFERENCE HIGHLIGHTS OIS@ASCRS 2019 the clinician involved and the more you can get that feedback of how a new product is going to work not just in a theoretical boardroom, but when it’s actually out there in the hands of a practitioner.” More discussions among the panelists focused on areas of unmet needs. Dr. Lindstrom noted: “One area that is expanding globally, and which demands increased human and financial resource investments, is in the management of refractive errors. When I entered ophthalmology, 25% of the US population was myopic. Now its 42%.” Finally, panelists suggested that with a potential increase in age-related conditions, there’s need for more technology-driven innovation in eye care.

Shining light on glaucoma In glaucoma, vision loss is caused by death of retinal ganglion cells. Today, there are several ways of measuring retinal ganglion loss, including optical coherence tomography (OCT) based measurement of retinal cell bodies and adaptic optics, which facilitate direct counting of ganglion cells in the retina. Dr. Vivek Srinivasan and colleagues from the UCSD presented data on their latest work on the early ganglion cell

changes in glaucoma. Their work was supported by the Glaucoma Research Foundation, a non-profit nationwide research foundation at the forefront of funding research aimed at improving the treatment of glaucoma. “Early glaucomatous changes in retinal dendrites precede changes in retinal cell bodies,” said Dr. Srinivasan. “Notably, ganglion cells that connect in the plexiform layer have been shown to demonstrate the earliest changes.” But how do we apply this knowledge into early detection and treatment of glaucoma? Dr. Srinivasan and colleagues tried to determine early time points when cells are degenerating before they die. This discovery could revolutionize patient diagnosis, facilitating treatment in earlier stage, and perhaps the triaging of cases to treat more aggressively to prevent vision loss. OCT imaging can be a useful biomarker. “With OCT, we know we can improve resolution by increasing the bandwidth,” shared Dr. Srinivasan. “However, we took the approach of reducing the wavelength. Instead of using infrared light as done on commercial OCTs, we switched to visible light wavelength to enable us to get micron level resolution, and potentially, sub-micron resolution in the future. We designed and built a

INDUSTRY UPDATE

visible light OCT system and optimized it over several years, working with several collaborators.” This system was deployed in the Stanford University Eye Clinic. Dr. Srinivasan and colleagues arrived at astounding results. “We found that the bands that were not visible in the outer human retina have become visible,” he noted. “Particularly at the outer edge of the retina, we can see thin bands corresponding to Bruck’s membrane, which is particularly valuable in evaluating age-related macular diseases.” He added that using their platform, the sub-laminations of the inner plexiform layer of the retina also becomes visible and measurable with more averaging, and reflective changes can be measured as well. “These additional measurements provide better calibration of patient monitoring in glaucoma,” he shared. In conclusion, Dr. Srinivasan said: “These measurements are currently being used in clinical studies in patients with varying degrees of glaucoma, as well as in patients undergoing novel neuroprotective regenerative therapies.” Editor’s Note: OIS@ASCRS was held in San Diego, California, USA, on May 2, 2019. Media MICE Pte. Ltd. and CAKE Magazine are official media partners of all OIS events. Reporting for this story also took place at OIS@ASCRS 2019.

A ‘Wiser’ Way to Analyze Data with Schwind’s WiseNET

etter patient outcomes could be on the horizon, thanks to WiseNET, a new development from Schwind eye-tech-solutions (Kleinostheim, Germany). WiseNET is a web-based database that captures refractive data quickly and precisely to ensure and optimize treatment outcomes. This data is then presented graphically – diagrams show visual acuity, refraction (including astigmatism), and follow-up periods, so outcomes can be monitored and improved. This database is not only useful in individual analysis and in single

practices, but in large eye clinics as well. WiseNET also meets the requirements for peer-reviewed publications. It helps to meet regulatory requirements for the long-term documentation of treatment outcomes – and therefore, can be used in scientific studies and presentations at congresses. The user can access data gathered previously, analyze it systematically by topic, and present it visually. In addition, using the Schwind Cloud Community, treatment results can be shared and compared with other members using the company’s products. Patient data is anonymized,

September/October 2019

and the user can select which data is shared and with whom – whether it’s a study group, private group or the wider Schwind group (available to all WiseNET users). And data can be accessed at any time, from any internet-capable device with a sufficiently large display. Schwind produces and markets a comprehensive product portfolio for the treatment of vision defects and corneal diseases, including excimer laser systems, diagnostic systems and treatment planning tools for a wide scope of applications. For more information, visit www.eye-tech-solutions.com.

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