THE WORLD’S SECOND FUNKY OPHTHALMOLOGY MAGAZINE
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THE GAMING ISSUE Dec 2021/Jan 2022 cakemagazine.org
LETTER TO READERS
What has gaming brought to the table?
Dear Readers, nce upon a time, I was a super-tech evangelist. I thought the advent of high-powered consumer technology — smartphones with high-powered cameras and powerful processors, and consumer virtual reality (VR) headsets like Oculus Rift — would transform medicine in general, and ophthalmology in particular. I also thought that everyone would have VR headsets by Christmas 2017, and that a universe (or what the company formerly known as Facebook would call a "Metaverse") of augmented reality (AR) and virtual presences would kick off in a big way.
O
It didn't happen. Big tech is still making big bets that it will. But for now, you're currently more likely to see a VR headset in an interactive museum exhibit than
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in a friend's living room. I like big buts (and I cannot lie) and the big but is that in ophthalmology, we really do live in the AR age. My thesis is: Where VR and AR have a useful use-case in medicine, science, technology and education, it's already there, and the technology has been mature enough for long enough for it to be both useful and reliable. Even my car has a head-up display (HUD), and it's something I quickly found indispensable. The change in the game has been the shift from purely optical surgical imaging video feeds with overlays — mainly in HUDs, but also in some of the newer surgical microscopes. It started with this information being relayed to the surgeon on external, auxiliary displays (for example, surgeons have been able to align toric intraocular lenses [IOLs] for
over a decade by looking at a screen), but it's the integration into a single realtime, low-latency visual feed that has changed the game. But think about where you first saw these ideas in action. Okay, if you're a former Top Gun Navy Pilot like Steven Schallhorn, you'll have seen them first in your F14. But for the rest of us, it would have been in a computer game. How many lives do I have left? What's my score? And that was just Pac-Man. In silico, I was driving cars with HUDs back in the mid-1990s, playing Sega Rally in the arcade machines at the Glasgow University Union. It was 2021 before I drove any car with a HUD. If you've played a first-person shooter, you'll often find little graphical representations of your character's health status. As a surgeon, you'll more likely be holding a scalpel rather than an Uzi 9mm (although you're one of the few people likely to have access to a laser blaster of sorts), but it will be your patients' health-related statistics on screen. What is so beautiful about this is that through gaming, the user interfaces are defined and refined, based on the feedback of many hundreds of thousands of gamers, and so when it comes to deploying something similar onto the display of a surgical device, in many respects, that work has been done — it just needs to be adapted. What I'm saying is, where gaming pioneers, real-life follows, and ophthalmic surgery is no exception. I decided to see what the state-of-theart was in terms of video games that involve surgery, and quickly found that it's more comedy and against-the-clock drama than anything particularly useful for the education of wannabe doctors. (I mean, just view the video that autoplays at surgeonsim.com to see the kind of level it's at: "You are the surgeon. Bob is the victim.") But, that doesn't mean it isn't possible. While you can have truck driving and farming simulators on your Xbox, you don't have to scroll too far down the game store to see Microsoft's Flight Simulator — something that can sublimely emulate the aeronautical characteristics of many aircraft, and
given enough budget for pedals, switches and joysticks can represent the heart of your own home-built Boeing Dreamliner if you so desired (and this is one of the few areas in gaming to-date where VR headsets really do deliver). But if you investigate what's state-of-the-art in surgeon training, you'll find everything from slit lamps and surgical microscopes with built-in displays that allow trainees to practice a wide range of surgical procedures whenever they have the time. So are gaming and training converging? I hope so. If there's one thing you want as a surgeon — particularly when you're performing micro-surgery in the eye — it's steady hands with great hand-eye coordination. Gaming lets you practice that. In fact, there are plenty of studies out there using VR surgical simulators that regular gaming is associated with better microsurgical performance, with gamers being faster and more accurate than non-gamers. Serious gaming — particularly in role-playing and sandbox games like Minecraft — also rewards patience, planning, collaboration and strategic thinking, which is directly transferable to life in general, and surgery in particular. What's that, Mom? Dinner? Hang on, I'm practicing to be a better surgeon, I'll come down after I've finished this level…
Best,
Mark Hillen
Dr. Mark Hillen
Director of Communications ELZA Institute, Zurich, Switzerland Editor-At-Large | CAKE
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IN THIS ISSUE...
Cataract
Anterior Segment
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10 12 14 16
Can Cataract Surgery Lower IOP and Minimize the Need for Medication?
08 Into the Future Robotic-assisted Cataract Removal Surgery
Let it Flow, Let it Flow, Let it Flow
Matt Young CEO & Publisher
Broadening the Horizons of Refractive Surgery Artificial Intelligence and Anterior Segment Practice
Hannah Nguyen COO & CFO
Robert Anderson Media Director
Gloria D. Gamat Chief Editor
Cover Story
Brooke Herron Editor
Mark Hillen Editor-At-Large International Business Development
Ruchi Mahajan Ranga Brandon Winkeler Writers
Kudos
24 26
Restoring Sight Where It’s Needed Most
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Nasal Spray FDA Approved for Dry Eye Disease
VUITY I Drop for Presbyopic Eye Drops
Enlightenment
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Where are the Women Editors in Medical Journals?
Andrew Sweeney Ben Collins Elisa DeMartino Hazlin Hassan Jillian Webster Joanna Lee Leon Ash Sam McCommon Maricel Salvador Graphic Designer
Published by
Conference Highlights
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ESCRS Conference Highlights Cool New Tech AAO 2021 A Snapshot of the Best Scientific Posters Individualized Cross-Linking Room for Improvement
Media MICE Pte. Ltd.
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6001 Beach Road, #19-06 Golden Mile Tower, Singapore 199589 Tel: +65 8186 7677 / +1 302 261 5379 Email: enquiry@mediamice.com www.mediaMICE.com
We are looking for eye doctors who can contribute articles to CAKE magazine. Interested? Let's talk! Send us an email at editor@mediamice.com. To place an advertisement, advertorial, symposium highlight, video, email blast, or other promotion in CAKE magazine contact sales@mediamice.com. | Dec 2021/Jan 2022 4
ADVISORY BOARD MEMBERS SOCIETY FRIENDS
Arunodaya Charitable Trust (ACT) Prof. Jodhbir S. Mehta
Prof. Jodhbir S. Mehta, MBBS, FRCOphth, FRCS(Ed), FAMS, PhD(UK), 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. Prof. Mehta has won several awards from the AAO and ARVO, among others, the latest of which was from the ASCRS in 2018. Prof. Mehta is also a favorite keynote speaker and presenter in several international conferences. jodmehta@gmail.com
ASEAN Ophthalmology Society
Asia-Pacific Academy of Ophthalmology
Dr. William B. Trattler
He Eye Specialist Hospital
Dr. William B. Trattler, MD, is a refractive, corneal and cataract eye surgeon at the Center For Excellence In Eye Care in Miami, Florida, USA. He performs a wide variety of cataract and refractive surgeries, including PRK; all laser LASIK; no injection sutureless cataract surgery; as well as laser cataract surgery. He has been an investigator for next generation technologies (like the Tetraflex accommodating intraocular lens) and procedures like corneal collagen crosslinking (CXL). His involvement in the FDA-approval study for CXL led to its approval in 2016. In addition to his private practice, Dr. Trattler is on the Volunteer Faculty at the Florida International University Wertheim College of Medicine, as well as the University of Miami’s Bascom Palmer Eye Institute. He is board certified by the American Board of Ophthalmology and has been an author of several articles and abstracts. wtrattler@gmail.com
Ophthalmology Innovation Summit
Dr. Chelvin Sng
Orbis International
Dr. Chelvin Sng, BA, MBBChir, MA(Cambridge), MRCSEd, FRCSEd, MMed, FAMS, 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 co-author of “The Ophthalmology Examinations Review”, Dr. Sng has also written several book chapters and publications in various international journals. Proficient in conventional glaucoma surgery and trained in complex cataract surgery, Dr. Sng co-invented a new glaucoma drainage device, which was patented in 2015. When not working, Dr. Sng can be found volunteering in medical missions in India and across Southeast Asia. chelvin@gmail.com
Dr. Harvey S. Uy, MD, is a clinical associate professor of ophthalmology at the University of the Philippines, and medical director at the Peregrine Eye and Laser Institute in Makati, Philippines. He completed his fellowships at St. Luke’s Medical Center (Philippines) and the Massachusetts Eye and Ear Infirmary (USA). Dr. Uy is a pioneer in femtosecond cataract surgery, accommodation restoration by lens softening, modular intraocular lenses and intravitreal drugs. He has published over 30 peer-reviewed articles and is on the editorial board of the American Journal of Ophthalmology Case Reports. He is a former president of the Philippine Academy of Ophthalmology (PAO) and current council member of the APVRS.
Russian Ophthalmology Society (ROS)
Young Ophthalmologists Society of India ( YOSI )
Dr. Harvey S. Uy
harveyuy@yahoo.com
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ATARACT
SURGERY
Can Cataract Surgery Lower IOP and Minimize the Need for Medication? by Hazlin Hassan
P
erforming cataract surgery on patients with ocular hypertension may lower intraocular pressure (IOP) and reduce the need for medication. This is according to a study* published in the American Journal of Ophthalmology. “We found that cataract surgery alone produced sustained reductions in the average number of ocular hypotensive medications and transient reductions in intraocular pressure in patients that were treated with ocular hypotensive medications,” said Dr. Steven L. Mansberger, an ophthalmologist at Legacy Health (Portland, Oregon, USA).
include minimally invasive glaucoma surgery.”
OHTS: Data crunching Many patients suffering from ocular hypertension or glaucoma develop a visually significant cataract and require cataract surgery. Studies suggest that cataract surgery lowers IOP, and that this reduction is generally proportional to pre-surgical IOP.
“Cataract surgery has risks, but these would be the same in any other patient,” he continued.
Several papers have also reported a decrease in ocular hypotensive medications with cataract surgery. While these reports are helpful, they rarely examine the change in both IOP and ocular hypotensive medications, nor the changes over a long period of time.
“Further studies are needed to determine the rationale for cataract surgery alone in ocular hypertension and glaucoma patients, and when to
In a retrospective case control study of results from a multi-center randomized clinical trial, Mansberger and colleagues analyzed data from
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the medication group of the Ocular Hypertension Treatment Study (OHTS). The OHTS sought to determine the safety and efficacy of ocular hypotensive medication in delaying or preventing the onset of primary openangle glaucoma (POAG) in patients with elevated IOP and began recruitment in 1994 with follow-up until 2009. OHTS participants were randomized and placed in either the observation group or the medication group (clinical providers used ocular hypotensive medications to achieve a target IOP in the medication group). The medication group had a lower five-year risk of developing POAG compared to those in the observation group. However, several participants in the medication group required cataract surgery in one or both eyes. Thanks to the required rigorous measurement of IOP and detailed documentation of the ocular
hypotensive medication prescribed by the OHTS protocol, the OHTS dataset provides a unique opportunity to understand the impact of cataract surgery on IOP, ocular hypotensive medication use, and the likelihood of a glaucoma endpoint.
Effects of cataract surgery The study by Mansberger and colleagues sought to determine the change in IOP and ocular hypotensive medication use for those in the OHTS medication group who underwent cataract extraction, compared to those who did not have surgery (control). A total of 92 patients (n=149 eyes) of the OHTS medication group underwent cataract surgery in at least one eye during the study, and 531 (n=1,004 eyes) did not undergo cataract surgery. The participants’ ages ranged between 40 and 80 years old, with IOP between 24 mmHg and 32 mmHg in one eye, and between 21 mmHg and 32 mmHg in the other eye. Included participants had no glaucomatous structural or functional damage at enrolment, and recorded a best-corrected visual acuity of at least 20/40 in both eyes, with no evidence of visually significant cataract. Researchers compared data from the cataract surgery group after their first postoperative visit with the control group’s 15th visit. As the OHTS database did not include the exact date of surgery, Mansberger and colleagues used a “split date”, defined as the first study visit date that cataract surgery was reported for the cataract surgery group, and the 15th visit in the control group. This was to ensure that the median number of study visits prior to the split date was the same for both groups, minimizing differences between the groups in the prescribing patterns of IOP-lowering medications. The primary outcome was the difference in preoperative and postoperative IOP, and the number of classes of ocular hypotensive medications between the cataract and control group over a 72-month period. Results showed that cataract surgery significantly decreased the number
of ocular hypotensive medications at all postoperative visits (mean -0.4 medications, p ≤ 0.005) through the 48-month postoperative visit compared to the control group. At the split date, 13.8% to 23.3% of eyes were medication-free, and 40.9% of eyes had a reduced medication burden. The cataract surgery group resulted in a decrease in IOP (p < 0.001), but the difference in IOP between them and the control group reduced over time and became non-significant after 12 months. The authors concluded: “Cataract surgery in ocular hypertension patients produced sustained reductions in the average number of ocular hypotensive medications and transient reductions in intraocular pressure.” Further, “this study showed that cataract surgery produced a lowering of IOP for about one year after surgery in the medication group of the OHTS and decreased medication burden for a prolonged period.”
Further findings Glaucoma conversion or incidence of POAG decreased after cataract surgery when considering optic disc as an endpoint, but not for visual field, nor when combining either visual field or optic disc endpoints. “Together, these data suggest modest benefits of cataract surgery (beyond the visual improvement resulting from cataract surgery) in reducing IOP and medication burden when a studyspecified target IOP was used,” said Mansberger and colleagues. The paper’s findings provide further information regarding the IOP-lowering effect of cataract surgery in eyes with ocular hypertension who are treated with ocular hypotensive medications. In the first two study visits after the participant reported cataract surgery, the IOP decreased by 1.4 mmHg at the split date, and 0.9 mmHg six months later when compared to the control group.
The IOP became statistically similar (0.0 to -0.5 mmHg lower IOP in the cataract group) at all subsequent time points. It also compared the postoperative IOP to the preoperative IOP and found that the IOP decreased by a range of -1.3 to -2.2 mmHg over 48 months from the preoperative baseline of 18.9 mmHg in the cataract group. In untreated ocular hypertension participants, a previous study in the OHTS observation group showed an even larger IOP decrease after cataract surgery with 4.1 mmHg (from 23.9 to 19.8 mmHg) of lowering after cataract surgery, and a longer duration of effect in which IOP remained statistically significantly lower for more than three years despite a gradual diminution over time (0.05 mmHg/month). These findings suggest that cataract surgery may result in different IOP responses between studies when they include different proportions of POAG versus ocular hypertension, and when participants are treated with ocular hypotensive medications preoperatively and postoperatively.
* Mansberger SL, Gardiner SK, Gordon M, Kass M, Ramulu P. Cataract surgery lowers intraocular pressure and medication use in the Medication Group of the Ocular Hypertension Treatment Study. Am J Ophthalmol. 2021;S0002-9394(21)00375-5.
Contributing Doctor Dr. Steven L. Mansberger, MD, MPH, is the Chenoweth Chair and director of Glaucoma Services at Legacy Devers Eye Institute in Portland, Oregon, USA. Dr. Mansberger completed an ophthalmology residency at the University of California, San Diego, and a glaucoma fellowship at Devers Eye Institute. He also earned a Masters in Public Health degree (MPH Biostatistics/Epidemiology) from Oregon Health Science University. His research interests include functional and structural testing in glaucoma, and general and ocular epidemiology. smansberger@deverseye.org
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ATARACT
SURGICAL TOOL
Into the Future Robotic-Assisted Cataract Removal Surgery by Hazlin Hassan
I
magine a future where cataract removal could be performed by a robot...
As it turns out, this could become a reality in the near future, thanks to the Intraocular Robotic Interventional Surgical System (IRISS) developed by a group of researchers from the University of California, Los Angeles. Indeed, this innovative group carried out a study which found that lens extraction could be autonomously performed by the intraocular robotic system on ex vivo pig eyes. “Since this study was conducted, we have improved the vision guidance such that the IRISS can now identify intraocular tissues and structures during surgical procedures and react accordingly,” said Dr. Matthew Gerber from the Stein Eye Institute in the Department of Ophthalmology at the University of California, Los Angeles, who collaborated in the study.
“Since this study was conducted, we have improved the vision guidance such that the IRISS can now identify intraocular tissues and structures during surgical procedures and react accordingly.” — Dr. Matthew Gerber, PhD, Stein Eye Institute in the Department of Ophthalmology, University of California, Los Angeles
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Cute, but not the robot you want to assist with cataract surgery...
“The IRISS has also been redesigned to improve the mechanical accuracy and precision of the device itself and extend the range of surgical instrument capabilities,” said Dr. Gerber, who performed the hardware design for optical coherence tomography (OCT) stage motorization, automated OCT registration, tool alignment, insertion, and digital ACCURUS control.
Considerations in roboticassisted surgery According to statistics, cataracts — an opaque clouding of the lens in the eye — are the leading cause of blindness in the world. Thankfully, cataract-induced blindness can be
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treated by cataract surgery, which is the most frequently performed surgical procedure in the U.S. It is also one of the most successful intraocular procedures with a success rate of over 90%. But because of the physiological limitations of a human surgeon, such as inherent hand tremor and an inability to sense forces below those of human tactile perception, there are still risks to the procedure, including posterior capsule rupture (1.8% to 4.4%), incomplete lens removal (1.1%), and corneal incision leakage (1.2%). These issues do not apply to a robotic system to the same degree. To visualize intraocular tissues, non-invasive imaging technologies
such as magnetic resonance imaging (MRI), ultrasound biometry, and OCT have been developed and used in preoperative and postoperative diagnoses. MRI provides high-contrast and highresolution images but is unsuitable for intraoperative surgical procedures due to space constraints, high field strengths, and low frame rates. Meanwhile, ultrasound biometry provides real-time, high-resolution images, but requires a contact medium between the probe and the eye to reduce signal reflection. On the other hand, OCT provides a non-contact, real-time, highresolution imaging modality that can be integrated into surgical instruments and microscopes. Of note, it has been shown that intraocular tissues can also be visualized in OCT scans in both anterior and posterior segments. The paper noted that even if provided with the “best” visual feedback, a surgeon cannot perform surgical procedures with absolute accuracy unless the physiological limitations of tactile control are overcome. The authors added that despite advances in both robotic platforms and OCT-based technologies, several unresolved issues remain, particularly in the case of cataract extraction. For example, the location where a surgical instrument passes through the cornea must be constrained throughout surgery to decrease undesirable trauma in adjacent corneal tissue. However, the methods in existing work to align the remote center of motion of the robot to the corneal incision are contact-based and require wellcalibrated kinematics. In addition, no methods exist to automate the procedure or to guarantee successful alignment and insertion. Next, despite the wealth of anatomical information provided by OCT-based systems, no existing work uses OCT scans to reconstruct the surgical environment for trajectory planning of the surgical instrument or for
automation of the surgical procedures. Lastly, the surgical information required from real-time OCT used in previous work is noisy and insufficient to represent the constantly changing intraocular environment. In a nutshell, an automated surgical platform must be capable of adapting, in real-time, to the dynamic nature of its surgical workplace, said the paper.
Robotics in action In the study, an OCT system is integrated into the IRISS robot. The OCT images were used for preoperative planning and intraoperative intervention in a series of automated procedures. Taking into account the changing surgical environment, several strategies for monitoring and intervening in the autonomous cataract extraction were implemented. The developed system was validated by performing lens extraction on 30 postmortem pig eyes — there was no posterior capsule rupture among all 30 eyes. Complete lens extraction was achieved on 25 eyes and “almost complete” extraction was achieved on the remainder. Five cases experienced small particles of lens material left behind due to the inability of the OCT to sense them. Therefore, the imperfect success rate was attributed to limitations of the sensing technology. The authors expect that with improved sensor feedback, such as ultrasound biometry or intraocular OCT, the completeness of lens extraction can be ensured. “A series of engineering measures demonstrated that the OCT-guided system has sufficient capability to perform automated cataract extraction,” noted the authors adding that the IRISS successfully
demonstrated semi-automated OCTguided lens removal with real-time supervision and intervention. While no side effects were reported in this study, the surgical environment was well-maintained and therefore was an unrealistic representation of real surgical practice, said Dr. Gerber. He added that the IRISS platform, as of today, is not ready for human use as the current technology cannot properly adapt to changes in the surgical environment — for example, eye motion. “The vision guidance must be extended to all aspects of cataract surgery, from initial corneal incision to final implant injection and placement. Additional trials on more realistic models and eventual validation through clinical trials are also necessary,” said Dr. Gerber. Due to the preliminary nature of the paper, further studies will be required before the IRISS can be validated in clinical trials on live patients. The preclinical evaluation on postmortem pig eyes is the first step to validate the effectiveness of the proposed robotic system for semi-automated lens extraction. Before further evaluations are performed on a live animal model or on a cadaveric or live human eye, several limitations of the current system must be addressed.
Contributing Doctor Dr. Matthew J. Gerber, PhD, received his BS and MS degrees in mechanical engineering from Ohio State University in 2013 and 2014, and a PhD degree in mechanical engineering from the University of California, Los Angeles in 2019. In 2020, he joined the Stein Eye Institute in the Department of Ophthalmology at the University of California, Los Angeles, where he currently works as a postdoctoral scholar. His research interests include vision-guided surgical robotic systems. gerber211@ucla.edu
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NTERIOR SEGMENT
MIGS
Let it Flow, Let it Flow, Let it Flow
by Elisa DeMartino
D
espite it being winter in other parts of the world, the weather is anything but frightful in Singapore, home of the Media MICE headquarters. In this tropical metropolis you won’t catch snow, but you might hear about flow from Adjunct A/Prof. Chelvin Sng, National University of Singapore (NUS). Speaking of things oh-so-delightful, during a plenary session on subconjunctival filtration surgery organized by the World Glaucoma Association (WGA), Dr. Sng discussed the benefits of a neat little gadget that has the potential to reduce complications in glaucoma surgeries. The professor tuned in to the virtual event brimming with case studies and visual demonstrations of minimally invasive glaucoma surgery (MIGS) using the PRESERFLO™ microshunt (Santen, Osaka, Japan) as a potential alternative to standard trabeculectomy.
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An ab-externo approach with good results This CE-marked device was designed to lower intraocular pressure (IOP) by ensuring better drainage of aqueous humor from the eye. Its 70 micron lumen is sufficiently large to pass sloughed endothelial cells, yet small enough to prevent hypotony. It prevents device migration and peri-implant leak around the device. The 8.5 mm-long insert is made from bio-inert poly(Styrene-blockIsoButylene-block-Styrene or SIBS), a material which has a long track record in the medical field. It has been used for more than 15 years (in more than one million patients) as a cardiac-stentcoating, and for more than eight years in the eye. This stretchy hydrophobic material has proven biocompatibility, leading to minimal scarring with no chronic inflammation.
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“The longest term study on the microshunt showed that it reduced intraocular pressure (IOP) to the low teens with 0.7 medications at three years,” said Dr. Sng. “The safety profile of the microshunt was good in this study with no long-term hypotony reported.”
“The longest term study on the microshunt showed that it reduced intraocular pressure (IOP) to the low teens with 0.7 medications at three years.” — Adjunct A/Prof. Chelvin Sng, National University of Singapore (NUS) Referencing Battle et al., Dr. Sng reported that compared to trabeculectomy, usage of the microshunt
resulted in fewer complications. Indeed, the 1-year result of a randomized clinical trial comparing microshunt and trabeculectomy reported that trabeculectomy produced a greater incidence of hypotony (51.1% vs 30.6%), bleb leaks and lens opacity.
Optimal conditions, optimal outcomes The Singaporean MIGS expert said that glaucoma management during preoperative, intraoperative, and postoperative stages is key for determining and influencing surgical outcomes. The first crucial step for determining postoperative success is to consider the state of the conjunctiva. “It is well-recognized that long-term use of glaucoma medications can lead to conjunctival injection, which is more prone to fibrosis, and this reduces the success rates of glaucoma surgery,” said Dr. Sng. She recommended giving patients “a holiday” from eye drops and putting them on Diamox (acetazolamide) for a few weeks. She also suggested prescribing preoperative topical steroids and treating aggravating factors such as blepharitis. “Perhaps the most important factor in having a good microshunt outcome is picking the right battles,” she continued. And these wise words from Dr. Sng are applicable to many kinds of surgeries: “Do not fight a losing battle if the odds are all stacked against you.” Dr. Sng said: “I would avoid the
microshunt if the conjunctiva is very scarred and inflamed; in the presence of failed trabeculectomy; if there was a previous cataract surgery; if there is vitreous in the anterior chamber; and also if the patient is an aggressive scarrer, for example a keloid scarer,” the NUS professor explained.
Intraoperative use Dr. Sng emphasized two important intraoperative considerations when using the microshunt. First, applying 0.4 mg/ml of Mitomycin-C (MMC) is associated with lower mean IOP compared with 0.2 mg/ml, with similar complication rates between the groups. Lower IOP was achieved with the MMC applied near limbus rather than away from limbus. “But when applying MMC, be careful that it doesn’t get to the anterior surface of the conjunctiva, as this can result in an avascular bleb,” the expert continued. The second important consideration is the entry site of the microshunt. Because it’s inserted externally, it’s very difficult to be precise about its entry point in the anterior chamber. “My two-year data suggests that if the microshunt enters the eye anterior to Schwalbe’s line, which is fortunately only 10% of my patients, there seems to be a decline in the endothelial cell count,” Dr. Sng noted. “Hence now I verify with [an] intraoperative gonioscopy [to ensure] that the implant is posterior to Schwalbe’s line before completing the surgery.”
Post-op and takeaways Dr. Sng reported that in her study of PRESERFLO™ on more than 60 eyes, most blebs were posterior and diffuse, and she only encountered scarred blebs occasionally. One simple practice she recommended is to encourage the patient to perform digital ocular compression in the early post-op period. Ask the patient to look up, then apply firm pressure on the lower inner corner of the eye for about 10 seconds. If, in spite of that, the bleb still scars up, she prefers bleb revision over needling. “The microshunt bleb is actually quite hard to needle because the device is under the Tenon’s capsule,” she cautioned. If the latter is preferred, such as for financial reasons, it’s doable so long as the surgeon is careful not to pull the microshunt out of the eye while needling. Looking at the big picture, Dr. Sng’s efficacy data with the PRESERFLO™ microshunt demonstrates that at 12 months post-op, 84.8% of eyes were medication-free, with 77.4% of eyes medication-free at 24 months. “With pre-op, intra-op, and postop optimization, I have been quite happy with my microshunt outcomes, with mean IOP of 12 mmHg, 0.5 medications at two years, and about three-quarters of eyes being medicationfree,” concluded Dr. Sng.
DISCLAIMER: The Santen styreneblockisobutylene-block-styrene (SIBS) Microshunt is CE-marked in The European Union and currently marketed under the brand name of PRESERFLO™. It is not yet approved for use in other countries except Canada, Australia, Singapore, Malaysia and The Philippines. This educational article is based on the speaker’s own presentation and does not necessarily reflect the official policy or position of Santen.
Editor’s Note: The Plenary Session – Dissecting Subconjunctival Filtration Surgery, organized by the World Glaucoma Association (WGA) was held on 3 September 2021. Reporting for this story took place during the event.
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OCULUS CORNER
Broadening the Horizons of Refractive Surgery by Elisa DeMartino
C
urrently, the decision to perform LASIK, SMILE, PRK, or none of the above, is made on the basis of corneal topography. Yet there has been no tool to predict outcomes related to postoperative excessive biomechanical weakening, which can lead to ectasia in a normal eye. However, one unique software product could (literally) broaden horizons when it comes to patients’ visual acuity by allowing physicians to predict postsurgical corneal ectasia. This could create the possibility to operate on those patients who might otherwise be turned away as non-ideal candidates. Introducing the AcuSimX (Narayana Nethralaya Foundation, India): A userfriendly, AI-based program that can be loaded onto any basic computer to enable selection of the safest procedure.
We all want the safest surgery
bioengineering calculations that run in the background,” said Dr. Abhijit Sinha Roy, the software’s founder and chief scientist of imaging and biomechanics at the Narayana Nethralaya Foundation in Bangalore, India. Speaking to CAKE magazine, he explained that AcuSimX was designed to accept patient data directly from the Corvis® ST and the Pentacam® devices, made by the German ophthalmic instruments developer OCULUS. The Corvis® ST evaluates corneal biomechanical response, tonometry and pachymetry; it records the cornea’s response to a defined air pulse using a high-speed camera that snaps 4,300 images per second. The OCULUS Pentacam®, meanwhile, is an office favorite designed to measure the entire cornea from limbus to limbus without contact as part of surgical screening.
“In terms of usage, it’s extremely simple for anyone to use. You don’t need to have any expertise with respect to complex engineering or
The AcuSimX software processes all relevant data from these machines with a few clicks of a button and creates a simple report. “In addition to that, in the recent version of the software, we also have come up with a nice decision tree which evaluates
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the predictive stiffness with respect to the historical database of eyes that did end up with ectasia after refractive surgery … so the surgeon is also given a guideline with respect to the prediction,” explained Dr. Roy. Right now, he says, there’s no competitor on the market. “These tools are readily available in the research domain, but in the clinical domain there [are] none. We always wanted to keep it simple, and the architecture with respect to the models that exist are well-validated and we have also published extensively on those.” In cases where surgeons are uneasy about performing LASIK or SMILE on a patient — or are wavering on whether or not a surgery should be performed at all — they may find that once evaluated through the AcuSimX, the subject is perfectly suitable for PRK. “[It] helps the clinician to make an informed decision based on the scientific basis of corneal biomechanics using the power of biomechanical simulations — and at the end of the day, they’re also increasing their refractive volumes. It’s possible that clinicians would have let go of some of these patients because they weren’t sure.” Dr. Roy added that the software is a great add-on to the tools that already exist within the Pentacam® and Corvis® ST, and it gives excellent outcomes using AI and scientific models. “Now, because you’re able to perform these simulations where the effect of refractive surgery is also included, you have that additional confidence,” concluded Dr. Roy.
Contributing Doctor Dr. Abhijit Sinha Roy, PhD, is head of the imaging and biomechanics lab at the Narayana Nethralaya Foundation, India. He has conducted extensive research in the field of corneal biomechanics and its clinical relevance. He is one of the foremost experts in the world in this field (among the top 20 as per Expertscape). asroy27@yahoo.com
INDUSTRY UPDATE
Presbyopia-correcting IOL Gets IDE Approval from the FDA
P
atients suffering from both cataracts and presbyopia may find some sight-saving relief sooner than later, thanks to a new intraocular lens (IOL) from LensGen (Irvine, California, USA), a privately held ophthalmic medical device company. The IOL mentioned here is the Juvene® Presbyopia-Correcting Intraocular Lens, which received Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) in November 2021. The IDE was granted to initiate a pivotal study of the Juvene IOL for patients with cataracts. "We are proud to achieve this significant milestone for the company, which allows us to move
forward with the IDE pivotal trial with the ultimate goal of seeking premarket approval in the largest eye care market in the world," said Ramgopal Rao, LensGen CEO. Designed to permanently restore clear and continuous vision at all distances — including near and intermediate — the LensGen Juvene IOL is modular and has a fluid optic component that changes shape to adjust focus on demand for today's active lifestyles. This includes viewing mobile devices and computer screens, to high-quality distance vision in a broad range of lighting conditions. The lens is implanted using the same surgical techniques used with traditional IOLs.
"Based on the Grail study clinical data, and my direct experience with surgery and observations of the patients implanted with Juvene IOL, LensGen technology has the potential to provide a significant new and superior option to our patients," said Dr. Eric Donnenfeld, clinical professor at the New York University Grossman School of Medicine and founding partner of Ophthalmic Consultants of Long Island. LensGen is currently in the process of raising a Series B financing and is expected to close in the first half of 2022.
Tango®
Optimis Fusion®
Vitra 810®
Not for sale in the U.S.
www.ellex.com www.quantel-medical.com | D e c 2 0 2 1 / J a n 2 0 2 2 13
NTERIOR SEGMENT
SURGICAL PEARLS
Artificial Intelligence and Anterior Segment Practice by Leon Ash
W
ith all the hoopla surrounding the breathtaking artificial intelligence (AI) developments in diabetic retinopathy (DR) screening and diagnosis, one might think anterior segment practices are a long way behind. So below, CAKE deep-dives into cuttingedge anterior segment AI practices and investigates their potential to revolutionize ophthalmological workflow.
Rise of the machines Let’s kick off with some definitions. Artificial intelligence (AI) is software that exhibits intelligent behavior, often mimicking and eclipsing human abilities, like pattern recognition, visual perception, and self-learning. Machine learning uses complex algorithms to crunch prepared data sets and learn without being explicitly programmed.1 Deep learning, a subset of machine learning, uses multiple layers of neural networks to parse multimodal (mixture of media types) data. Big data is data that contains greater variety, arriving in increasing volumes and with more velocity. This is also
14
known as the three “V’s”. Put simply, big data is larger, more complex data sets, especially from new data sources.2 Now that we’re on the same page, let’s dive in…
We’re gonna need a better test! Today, people are living longer. This, coupled with a global shortage of ophthalmologists, means that effective diagnostic tools and early detection has never been more critical. But unlike retinal conditions that hinge on ophthalmoscopy, multiple examinations are required to diagnose anterior segment diseases, given the complexity of its structure and physiological functions.3 Diagnostic tests normally used include slit lamp biomicroscopy, optical coherence tomography (OCT), corneal tomography, tonometry and others. And these devices produce vast amounts of data. Could this information be better utilized with the help of AI?
AI in glaucoma Glaucoma is the leading cause of
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irreversible blindness globally,4 so the pressure (pun intended) is on for early detection and intervention. A crucial parameter of visual function is visual field (VF) during glaucoma progression, so a glaucoma diagnostic model was created with AI trained on VF, fundus images and OCT scans. It’s been found that these models have shown excellent performance in classification of glaucoma and healthy eyes in a short time.5 Additionally, deep learning may also pinpoint and gauge novel risk factors in the evolution and treatment of glaucoma. AI algorithms, trained on multiple physicians’ clinical expertise, could overcome professional oversight or errors — indeed, they could become superhuman detectors of eye conditions. Glaucoma progression and risk assessment could be enhanced by informatics and genomic science. Genomic tests could flag referrals for AI screening of glaucoma, thereby freeing up specialists to focus on treating critical cases.
AI in dry eye Another area AI could assist in the anterior segment is in the detection of dry eye. A deep-learned diagnosis of tear film proteins by artificial neural networks has detected dry eye with an
AUC (area under the curve) of 0.93, and a specificity and sensitivity of approximately 90%.3
AI in keratoconus Early detection in keratoconus is also paramount, so treatments like corneal collagen crosslinking can be applied in time, and thus, prevent a major deformation of the cornea.3 The Support Vector Machine algorithm developed by Hidalgo et al. identifies five different corneal patterns: keratoconus, forme fruste keratoconus, astigmatism, after refractive surgery and normal. Its accuracy was reported as 88.8%, with a weighted sensitivity of 89.0% and specificity of 95.2%, suggesting the potential of this model.3 Other algorithms, like the one pulbished in 2019 by Kamiya et al., reported a higher sensitivity (99.1%) and specificity (98.4%) for keratoconus grading with a convoluted neural network. Meanwhile, the Lavric and Valentin deep learning algorithm, trained using 1,350 healthy eyes and 1,350 keratoconus eye topographies, managed to improve accuracy to 99.3%.1
AI in cataract A leading cause of visual impairment globally, cataracts are responsible for more than 50% of blindness in developing countries. Trained on slit-lamp microscopy, visible wavelength images and fundus photographs, most AI researches have attempted to automate the classification of cataract severity into normal, mild, moderate and severe. And advances are not exclusively on the diagnostic side: Models using clinical and biometric variables have also been built. These can be used to optimize postoperative refractive outcomes, and estimate the risk of pediatric cataracts or posterior capsule opacification.3
Eye screening? There’s an app for that!
computers are down” means all bets are off. But imagine a critical diagnostic intelligence breaking down, a malfunctioning algorithm duplicating diagnostic errors, or the legal conundrums involved in a claim against AI error. What happens when an algorithm proves itself fallible? It seems a human mind as overseer is still the preferred solution.
AI and deep learning could also make great strides in telemedicine by connecting clinicians and specialists with patients remotely, processing visual data, and plotting disease progression under the rubric of an integrated neural network. It’s even anticipated that with advances in mobile photography and deep learning of multimodal data, a patient photographed by a remote clinician using only a smartphone and slit lamp adapter could return an initial diagnosis or referral on multiple eye conditions. This potential for mass screening could greatly improve the capabilities for diagnosis where it’s most needed. Imagine that!
And what of patients? While a great many will calculate the merits of improved efficiency and accuracy in diagnosis, as well as potentially quicker treatment duration, others could be perturbed by a non-human intervention, or may have ethical objections that run the whole gamut from rational to irrational. The implicit trust and bond between patient and physician is crucial. But what about between patient and processor? After all, we don’t really know how a deep learning machine gets from A to Z (the black box problem) — only that the outcome is useful and effective.
The human factor Advances in deep learning and AI could lead to a sea change in ophthalmology. While ophthalmologists remain the central figure, the future could also see an array of IT support and data specialists, software coders and programmers joining the workflow.
Coming soon Ultimately, the fourth industrial revolution — as AI has been described — not only represents significant advances in diagnostic and treatment improvements in ophthalmology, but could also enable physicians to reach more patients, more efficiently, with better outcomes. It’s the future, and ready or not, it’s coming soon...
More effective screening, diagnosis and testing could also eliminate unnecessary treatment and streamline workloads. However, expectations must be measured against budgetary concerns in the real world. There is also the risk that AI provision becomes something only wealthy countries or patients have access to. Finally, many of these deep learning algorithms have REFERENCES: yet to be tested outside of controlled 1. Nuzzi R, Boscia G, Marolo P, Ricardi F. The data sets or approved by national Impact of Artificial Intelligence and Deep regulatory health boards/agencies Learning in Eye Diseases: A Review. Front Med (Lausanne). 2021;8:710329. (the FDA, for example, currently only 2. What is big data? Available at https://www. approves AI for diabetic retinopathy). This ultimate diagnostic tool could prove something of a Faustian bargain. Will clinical practitioners be wary of these new technologies? Human error happens in medical practice, but what about machine error? It’s easy to see how digital automation has both enabled and disabled society. Idiomatically, we know “the
oracle.com/uk/big-data/what-is-big-data/. Accessed on Dec. 16, 2021.
3.
Wu X, Liu L, Zhao L, et al. Application of artificial intelligence in anterior segment ophthalmic diseases: diversity and standardization. Ann Transl Med. 2020;8(11):714.
4.
Kang JM, Tanna AP. Glaucoma. Med Clin North Am. 2021;105(3):493-510.
5.
Balyen L, Peto T. Promising Artificial Intelligence-Machine Learning-Deep Learning Algorithms in Ophthalmology. Asia Pac J Ophthalmol (Phila). 2019;8(3):264-272.
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NTERIOR SEGMENT
SURGICAL INNOVATION
by Andrew Sweeney
I
f you’re a parent, then we have to start this article with an apology: You might be about to lose an argument against video games with your children. Indeed, far from being the intellectual rot and eyesight diminisher that is frequently associated with gaming, computer games may well actually prove beneficial. This is a subject of some discussion in many areas, including psychology, mathematics and emotional development. And now, we’re happily jumping on the bandwagon by writing about the benefits of video games from an ophthalmology perspective.
What sparked our interest in the subject (beyond several members of the Media MICE team being enthusiastic gamers in their personal lives) was a letter published in the Asia-Pacific Journal of Ophthalmology entitled “Does Video Gaming Improve Ophthalmological
Surgical Proficiency?” Written by Drs. Philip Samuel Rothschild and Rahul Chakrabarti, the letter examined whether or not video gaming holds promise as a mechanism to maintain microsurgical skills in the context of COVID-19, which saw many “elective” ophthalmic procedures canceled or postponed. This may have had a detrimental effect on the motor skill component of ophthalmic surgery,
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Gamifying surgery
including hand-eye-foot coordination, dexterity and 3-dimensional spatial awareness. Drs. Rothschild and Chakrabarti carried out a review of 21 articles of research papers that included the terms “video gaming” and “surgical skill”. They focused on areas like video game piloting, using gaming to transition to performance on simulators,
motivating trainees, identifying surgical subspecialty selection, as well as prevocational exposure to surgery. The format of these included nonrandomized projects, comparative cohorts, randomized controlled trials, and case controls.1 Drs. Rothschild and Chakrabarti found that regular video gameplay “seemed to enhance microsurgical performance when assessed with a surgical simulator.” They argued that the very accessibility of video gaming made it particularly beneficial: Trainees and students who enjoyed video gaming before surgical training showed higher aptitude with microsurgical skills and were more likely to consider becoming surgeons. The researchers also argued that there is “increasing evidence that video game players perform better compared with non-video game players, specifically in the domains of visual tasks, and are faster and more accurate in surgical simulation, although further evidence is needed before determining what recommendations should be given regarding video game use.” So, to all of you parents out there hoping to raise the next generation of ophthalmic surgeons, it just might be a good idea to let the kids play video
games (just make sure they get to bed at a reasonable hour).
Replacing eye patches with controllers Can video game technology be used to not only improve personal abilities but to also treat patients? It might sound like a novel idea, but there is some evidence to suggest that gaming can provide real benefit to patients. “Video Game Use in the Treatment of Amblyopia: Weighing the Risks of Addiction” was a study carried out by a group of researchers based at the department of ophthalmology at the Yale School of Medicine (New Haven, Connecticut, USA). This research examined the dual facets of video games in treating vision impairment in amblyopia, as well as their potential for overuse and addiction. The researchers approached the subject from a biopsychosocial perspective, recognizing that overuse of gaming technology can lead to diminished mental health. However, the same aspects of video games that make them potentially addictive also make them an ideal platform for a highly compliant treatment. This includes attractive graphics requiring visual discrimination
in gameplay, varied visual tasks, immediate feedback and rewards for visual tasks, among other aspects. Our Yale researchers examined children who played Medal of Honor® (a World War II combat game) or Simcity® (an in-world city builder) for a total of 40 hours (two hours per day) using the amblyopic eye while the fellow eye was patched. Twenty patients (aged 1561 years) significantly improved their visual acuity by a factor of 1.6, roughly two lines on the LogMAR letter chart. In addition, subjects had significant improvements in positional acuity, spatial attention and stereopsis, and enjoyed a recovery rate approximately five times faster than that observed in children treated with conventional eye patching.2 The study concluded that video games used as therapy could provide considerable benefit to the estimated 15 million children under the age of five who have amblyopia. The market size for therapeutic video games is even larger, considering older children and adults with amblyopia, making the concept not just medically useful, but also commercially viable. While emphasizing that addiction is an issue of concern, the researchers also stated that whether the therapeutic use of video games will lead to an increase in video game addiction remains to be investigated. Video games are unlikely to melt the eyes of kids who play them too much. But for sure, unsupervised or uncontrolled consumption is not going to be good for anyone. Like any good medicine or treatment, using gaming in a controlled, responsible manner, could provide benefits to clinicians and patients alike. So, let’s see how the ophthalmology community can make the best use of it. If you want to join in, ask the Media MICE staff what their user names are, let’s play.
REFERENCES: 1.
Rothschild PS, Chakrabarti R. Does Video Gaming Improve Ophthalmological Surgical Proficiency? Asia Pac J Ophthalmol (Phila). 2020;9(5):476.
2.
Xu CS, Chen JS, Adelman RA. Video Game Use in the Treatment of Amblyopia: Weighing the Risks of Addiction. Yale J Bio Med. 2015; 88(3):309–317
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COVER STORY
by Sam McCommon
I
t’s been 25 years since Jamiroquai’s hit single “Virtual Insanity” hit the airwaves. If the tune just jumped into your head, first, you’re welcome — it’s darn catchy — but second, and more importantly, consider just how far technology has come in those 25 years. It’s insanity, yes, but it’s not virtual anymore, except for the virtual reality (VR) part.
smartphone, measure biometrics like blood glucose levels, give heads-up displays with information on individuals and inanimate objects alike, and essentially make the “Android” aspect of an Android phone more accurate.
And VR is augmented by augmented reality (AR), which has been purported to be just on the cusp of being available in contact lenses for several years now. Since 2014, major companies like Samsung, Sony and Verily — Alphabet’s life science’s division — have been investing time and resources into developing smart lenses, both intraand extra-ocular.
If part of that sounds like a Black Mirror episode, that’s because it is: The show’s third episode of its first season, entitled “The Entire History of You” follows people who have lenses that record all aspects of their lives. This leads to conflict, of course, and may be a bit grim for those with an optimistic view of AR-led lives. But recalling that that episode was made in 2011 demonstrates most certainly that either life imitates art or, at least, Charlie Brooker (the show’s head writer) was way ahead of his time. As we’ve
These lenses offer nearly unlimited potential, as breathless prognosticators would have you believe. In addition to making video games nearly indistinguishable from reality, they’ll be able to help you take photos or record video to your
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seen, however, the current trend is for science fiction to become science fact. So it goes. As of this writing, however — the tail end of 2021— smart lenses are not on the market, though the word “soon” has been on everyone’s lips for some time now. So, how did we get here, where are we, and where does it look like we’ll go? Let’s take a look with our real eyes as well as our mind’s eye, since we can’t use AR eyes yet.
Google Glass and the pre-lens era Even science fiction writers had to update their concept of futuristic vision enhancement devices between Star Trek: The Next Generation and the newer series of films. The show’s Geordie LaForge goes from the famous headband-overthe-eyes look to updated blindness-curing lenses in the more recent films. So, that may give you an indication of the role Google Glass played in the AR lens landscape. They were essentially already obsolete before they ever took root: Google Glass seemed neat at the time, but they were largely a novelty as they were cumbersome, too heavy on one side, and generally even too geeky for geeks. While Google Glass had great promise on paper, it’ll likely be viewed in the future as one of those in-between technological relics, like floppy discs or Apple’s Newton (a protosmartphone) in the mid 1990s — an ambitious attempt, but beyond the technological capabilities of the time.
Companies on the cusp In addition to the tech titans that have already thrown their hat in the smart lens ring, two smaller companies are getting closer to making smart lenses a reality. These are Mojo Vision (Saratoga, California, USA) and Innovega (Bellevue, Washington, USA), each with their own process, capabilities, benefits and drawbacks. That these companies are located in some of the world’s leading tech hotspots might give you an indication of the type of vision the companies have (no pun intended). Silicon Valley and Seattle are deservedly famous for producing cutting-edge technology, so we’re looking at yet another potentially world-altering bit of tech arising from the same institutional background as Apple, Facebook, Google, Amazon, and so on. But because these smart lenses are considered a medical device, they’ll need to be approved by the FDA. That means that, at the least, they’ll need to provide some sort of medical benefit rather than simply being a tech novelty — or so one would think, at least. For reference, Mojo Vision currently uses a scleral lens, whereas Innovega is working with a soft lens. The technology that goes into each makes the manufacturing process more than a bit challenging, though each has come up with their own solution. Mojo Vision’s Mojo Lens will handle most of the processing ability in the lens itself, whereas Innovega’s lens will work with hardware in accompanying glasses and a device around the neck. The display capabilities of these lenses is quite impressive. For reference, Mojo Vision’s lens will have some 14k pixels per inch beamed directly to a part of the retina, meaning ultra-super-duper high definition imaging.
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COVER STORY
Both companies are still in the prototype phase, with the visually impaired as their first target audience. At least, that’s certainly what they’re saying.
A tech arms race? While the visually impaired may be the first civilian audience, there’s no doubt that militaries around the world are salivating at the concept of lenses that can enhance a soldier’s combat abilities. Imagine image and video recording, zoom capabilities, a heads-up display to help with targeting and threat identification, biometric readings, and more. Does that sound like something the Pentagon or Kremlin would be interested in? Not only is the answer to that question a clear and resounding “yes”, you can rest assured they’re multiple steps ahead of whatever civilian technology currently exists. For example, the U.S. Defense Advanced Research Projects Agency (DARPA) has announced its interest in a wireless contact lens developed by the French University IMT Atlantique (Nantes, France). DARPA has long sought a smart lens for American soldiers, even funding developments from Innovega as long ago as 2012. Where there’s fat government contracts to be had, there will be technological developments, and you can bet the American government is not the only one behind smart lenses. The FDA hurdle will be for civilian purposes; the military applications will be an entirely different process.
We don’t usually cover geopolitics in this publication, but smart lenses play a clear role in what’s clearly a worldwide tech arms race in our current multipolar power system. Optics have played a role in politics for centuries by providing better sights for militaries. It was only a matter of time before such tech got down to the individual and ophthalmic level. In a way, it’s exciting, and in another way, it’s a bit scary. As the recent Nagorno-Karabakh war between Azerbaijan and Armenia showed, a technical leg up is the most surefire guarantee of victory — and lagging technically is not an option if the stakes are high. Azerbaijan’s acquisition of advanced drone technology from Turkey made mincemeat of Armenia’s previouslyconsidered-decent army, and that lesson has not been lost on any government paying attention — which you can rest assured any military power is. Now, take the concept of smart lenses and apply it to soldiers, and you can see just how there is most certainly a rush to develop this tech. Sure, it’s potentially wonderful for civilian use and for novelties like AR, but the real driving market here is bound to be the lenses’ military applications. Time and time again throughout history, tech developed for the military filters its way down to the civilian population later. You can bet good money that’s what’s happening now, too.
Bioethics and smart lenses Certainly, there are valuable medical applications of smart lenses. They can
help enhance vision in the visually impaired, keep track of biometrics for those suffering from conditions like diabetes, or even cure color blindness. These are all medically valid and laudable causes, and they’re the main medical argument for smart lenses. But they’ll raise a host of bioethical questions, which we’ll likely spend years discussing over the near future. As a serious biological upgrade to the wearer, these lenses are in a way the vanguard of the transhumanist movement. One obvious question is that of privacy — a concept already on the ropes after years of big data collection by all sorts of organizations, both public and private. If a person can record a photo or video with their smart lens — and without the other party even being aware — well, where does that put us? It seems impossible to stop, so how do we handle it as a society? This is an open question: No answers seem readily apparent. What’s more, where does one draw the line between the medical applications and the practical applications? For example, most people wouldn’t argue with giving smart lenses to a visually impaired person. But what about in something seemingly innocuous as professional sports? A player wearing smart lenses that give a more detailed picture, zoom functions, or projected trajectory of a ball would clearly have an advantage over a player not wearing smart lenses. So then, will all professional athletes start wearing them to remain competitive? There’s no shortage of money in professional sports, so lenses finding their way into this realm seems inevitable. Is that what we want as a society, though? Will sports become more about the biological upgrades one can afford than natural athleticism? Perhaps the reader can see just what kind of path this takes us down. If smart lenses are one of the first body upgrades available and we accept and encourage them, where will we later draw the line? Or should we draw any line at all?
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Economics and smart lenses Although the last few decades have witnessed billions of people lifted out of poverty, they’ve also given rise to widening economic gulfs between haves and have nots. In effect, this has led to class stratification and a decrease in economic mobility, especially in developed economies.
We can be reasonably sure that smart lenses won’t be cheap for some time. Indeed, the economic ramifications and realities of these lenses are barely even a cogent thought yet. How will insurance or national health care systems handle them? Assuming they pass medical approval via relevant agencies, at what point will physicians be able to prescribe them for their patients, and what kind of regulatory hurdles will exist?
From this writer’s perspective, it seems likely that smart lenses will become a symbol of affluence, providing the already wealthy yet another economic advantage over others. Having biometric data available as a heads-up display, for example, will help the wealthy keep track of their health much better than before, leading to a widening gulf in metrics as broad as life expectancy.
become an even greater part of our lives than they already are. Consider how Facebook renamed itself Meta in anticipation of the Metaverse — the VR simulation world many predict will be the Next Big Thing.
More questions than answers Clearly, smart lenses lead to deeper questions than may appear on the surface level. They represent a seismic shift in technological developments — that of not just repairing the human body, but improving it in fundamental ways. What this looks like in another 25 years is anyone’s guess. However, guesses from 25 years ago about today’s technology were largely wrong, so making predictions about future tech is a fool’s errand.
One thing is for sure: We at CAKE magazine will be watching these developments very closely and will keep you up to date with developments. It’s not often we get to deeply explore the implications of ophthalmic developments on the world at large, but this particular case was quite à propos.
This could be the point of divergence of near-permanent economic classes. Of course, we can also look at the more entertainment-oriented aspects of the lenses as well — AR and VR are making huge headways in the world of gaming, for example, which may quickly
We’d love to hear comments and feedback from you on this topic. What do you think are the broader ramifications of smart lenses? Just how soon will we see them on the market? Are they an innocuous and largely beneficial development, or is there a real potential for them to mark a darker turn? Are they simply a logical step in our development as a society?
Thanks for reading, and stay tuned for more. Things are about to get wild.
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21
Ocular Effects of Computer Gaming In this issue, we’ve looked at how gaming technology like AI can translate into ophthalmic practice. But gaming can also have other impacts, including on patients’ ocular and physical health. Addiction to gaming has become a social problem in countries worldwide, including Korea. The WHO has even classified gaming addiction as a mental health disorder. Thus, Lee et al., investigated the effects of prolonged continuous computer gaming on physical and ocular health and visual function in young healthy individuals.*
Study participants
50
Methods
healthy college students with no binocular vision problems and no reported history of ocular disease
35 male
15 female
Participants played continuously for 4 hours from 6-10 p.m. Convergence, accommodation, phoria and blink rate were assessed before and after continuous computer gaming
Results
Aged 19-35
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Four hours of continuous computer gaming resulted in convergence and accommodation disturbances and increased physical and ocular discomfort.
Changes in Ocular Symptom Scores
Changes in Binocular Function
Before Gaming
Before Gaming
After Gaming
After Gaming
2.5
20
2.0
15 10
1.5
5
1.0
0
0.5
-5
0.0
-10
Overall Ocular Discomfort
Blink Rate Vergence Facility
Eyestrain
Accommodative Facility Phoria (at near)
Tired Eyes
Phoria (at distance)
Dry Eyes Blurred Vision
Near Point of Accommodation (NPA)
Aching Eyes
Near Point of Convergence (NPC)
• Near phoria showed an exophoric shift, whereas distance phoria showed no change. • The accommodative and vergence facilities and blink rate were significantly decreased. • All visual functions recovered to the baseline levels by the following morning.
“Our findings suggest that excessive and continuous computer gaming impairs visual functions and causes ocular and physical fatigue … adequate breaks are necessary to reduce physical and visual discomfort during computer gaming.” REFERENCE * Lee JW, Cho HG, Moon BY,2 Kim SY, Yu DS. Effects of prolonged continuous computer gaming on physical and ocular symptoms and binocular vision functions in young healthy individuals. PeerJ. 2019; 7: e7050.
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23
UDOS
OPHTHALMIC CHARITY
Restoring Sight Where It’s Needed Most by Ben Collins
T
he good folks at Cure Blindness and the Himalayan Cataract Project (HCP) continue their fantastic efforts to eradicate unnecessary blindness globally — this time with a massive surgery drive in Harar, Ethiopia. Based out of Bidizimo Hospital, the team led by Dr. Matt Oliva (HCP board member, global cataract eradication campaigner, avid traveler and all around good guy), performed more than 1,050 sight-restoring surgeries in just two weeks!
in conjunction with local partners and surgeons, have been doing this for a long time. The HCP was established in 1995 and Dr. Oliva has been heavily involved with sight restoration initiatives (especially in Africa) for over a decade.
Overcoming challenges in Ethiopia
If that sounds like a lot, it’s because it is. However, the HCP and Dr. Oliva,
As you can imagine, delivering highquality surgeries, in what remains as one of the most impoverished places on earth, has its challenges. Previous operations have been carried out in makeshift field hospitals, utilizing schools, sports grounds, and other
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community facilities. “Although HCP has been working at building capacity at Bidizimo Hospital for a decade now, there still remains a large backlog of patients who are cataract-blind,” said Dr. Oliva. Ethiopia has one of the highest rates of blindness/low vision in the world. In a country of roughly 100 million people, around 3.6 million are affected. With limited resources — currently there are only about 130 trained ophthalmologists in the region — it's not difficult to imagine the scale of the problem. Blindness doesn’t only affect the
individual either. It has a crippling effect on families and communities as well. Someone who is afflicted with cataract blindness or low vision becomes a burden. Not only are they unable to work/support themselves, but they also need someone to support and look after them. This essentially means that for every affected individual, two potentially able-bodied contributors to the community are lost. Life expectancy for those with vision impairments in impoverished countries can be reduced by one-third. Sufferers often also experience a loss of social standing and authority within their families and communities. With 85% of cataract blindness easily curable through surgery, it’s not hard to see just how crucial this kind of charitable work is to a country like Ethiopia.
“Although HCP has been working at building capacity at Bidizimo Hospital for a decade now, there still remains a large backlog of patients who are cataract-blind.”
the hundreds, or sometimes even thousands, of dollars required to have the kind of life-altering surgeries that Dr. Oliva and his team deliver with these outreach programs. So how does HCP mitigate this and provide surgeries (to the same exacting standards achieved in Western hospitals) for a fraction of the cost?
have a huge impact, it’s not enough to tackle such a vast problem. That’s why the HCP is so committed to training surgeons and support staff in low- to middle-income countries. Since its inception, the HCP has been responsible for supporting the training of some 18,000 ophthalmic staff in low- to mid-income countries.
First, they utilize locally sourced materials and equipment. HCP cofounder Dr. Ruit, in conjunction with The Fred Hollows Foundation, had the foresight and ingenuity to establish the first low-cost intraocular lens manufacturer (based out of Kathmandu). They were able to produce the same high-quality lenses (which cost around $200 in the U.S.), for a fraction of the cost (around $4) — and thus, drastically reducing the material outlay of the operation. Affordable, transportable, and durable operating microscopes and YAG lasers are also used. So a surgery that would normally cost thousands of dollars can be performed for around $25!
Third is technical innovation. Dr. Ruit developed a technique for delivering high-quality intraocular surgeries in the field safely, effectively, and efficiently. His suture-less surgeries take only 10 to 15 minutes to perform under local anaesthesia, and the patient is usually fully recovered within 24 hours. The HCP is constantly innovating and training ophthalmologists in the latest surgery procedures and technology as well, including phacoemulsification.
Putting resources to work
Partnerships with local hospitals, eye clinics, and other health providers are also essential. The HCP has made a huge effort to improve eye care infrastructure in Ethiopia. This has included providing equipment for eye care centers, promoting excellence in the ophthalmic surgery field, and raising awareness of the importance of eye health, in general.
Given its socio-economic status, the average Ethiopian is quite obviously going to be unable to afford
Second is training. Although bringing in specialists (such as Dr. Oliva) to lead teams and run surgery drives can
— Dr. Matt Oliva, HCP board member
Ethiopia is the latest country to receive sight-saving care and surgery from Cure Blindness and the HCP.
Finally, sponsorship, funding, and a kind of “pay it forward” or subsidiary system have also been key to maintaining the ongoing sustainability of the HCP. The wealthy pay full price for their surgeries and this subsidizes costs for the less fortunate. The HCP has also been incredibly creative with their funding and sponsorship drives. For example, one initiative offered sponsors the opportunity to train with some of Ethiopia’s elite distance runners in exchange for their contributions. With more than one million (and counting) sight-restoring surgeries performed since its inception, this project has had a profound effect on the people of this impoverished region. Stories of wonderment and gratitude abound. The latest drive included around 50 children, many of whom had lost vision in both eyes. They shared their wonder at being able to look at a photograph of themselves, or the simple pleasure of being able to take in the view from their village again. Many burst into tears of joy, and some even danced! To learn more, or get involved through donating, volunteering or even partnering with this fantastic project, it’s well worth having a look around their website: www.cureblindness.org. You’ll find everything you need to know and more, and will likely come away with a whole bunch of warm fuzzies!
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UDOS
TREATMENT INNOVATION
VUITY I Drop for Presbyopic Eye Drops by Sam McCommon
hours. Best of all, it improves near and intermediate vision without impacting distance vision.
How does it work? VUITY is a formulation of pilocarpine, which is already used to reduce intraocular pressure (IOP) in glaucoma patients. It’s also used to treat dry mouth, which is the sort of thing that might make you say, “huh, neat.” More importantly, for the treatment of presbyopia, pilocarpine is known for its ability to constrict the pupil, and has previously been used to do so after dilation for treatment or ophthalmic diagnosis. Combining this constriction with AbbVie’s pHast™ technology means VUITY can quickly adjust to the pH of the tear film. So, we’re looking at a stable pH level combined with natural eye constriction to improve near and intermediate vision. Cool stuff, right?
The clinical background
W
e love it when there’s a dose of good news, and that certainly seems to be the case with a new eye drop treatment for presbyopia. Allergan (Dublin, Ireland), an AbbVie company, has had their VUITY™ drops approved by the U.S. Food and Drug Administration (FDA) and now it appears that the drops are off to the races. In what was either an ironic or clever tiny-font press release online, AbbVie (Allergan’s parent company) detailed both the specifics of the treatment and its approval status. Nearly 130 million people in the U.S. suffer from presbyopia, as well as hundreds of millions of others worldwide, and the condition is only becoming more common due to aging populations around the globe. So, a simple, nonsurgical treatment like VUITY will likely play a pivotal role in presbyopia management starting essentially right now.
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VUITY for you and me (metaphorical “me”, of course) You may notice the “me” part in the section title above, as well as the sneakily small font on the press release. While this particular writer is far too prideful (and young, dang it) to consider presbyopia, the fact that the treatment is totally non-invasive gives it a significantly broad appeal. If it’s such a minor commitment and doesn’t require pokey things, lasers or more, the odds are strong that many people who would otherwise be adverse to ophthalmic treatment will be willing to try it. Again, not that I need it, but hey, if it helps me read a bit better… In addition to being non-invasive, the treatment is a simple once-daily method. According to AbbVie, the drop’s effectiveness begins in as little as 15 minutes and can last up to six
| Dec 2021/Jan 2022
VUITY was approved by the FDA after the successful GEMINI 1 and 2 studies. These were randomized studies of some 750 patients between 40 and 50 years old, with an equal distribution of placebo and VUITY. The results were promising: Patients treated with VUITY gained three lines of vision in mesopic, high contrast and near to intermediate vision, without losing more than one line of distance visual acuity at the end of a month. And even more reassuringly, there were no serious adverse events observed in any patient in either of the studies. The only adverse events reported were headache and eye redness, and those in fewer than 5% of patients. CAKE magazine has spent increasing time covering presbyopia lately as the condition comes more to the forefront of ophthalmic science. Most specifically, promising treatments are more available than ever — which certainly makes us optimistic. Now, if we could just have a word with whomever made the font so small on AbbVie’s press release … just kidding.
NEW DED THERAPY
Nasal Spray FDA Approved for Dry Eye Disease by Jillian Webster
R
elief may be around the corner for the millions of people suffering from dry eye disease.
Dry eye disease (DED) affects millions of people and in most cases, it’s chronic. Defined by a global consensus panel, DED is characterized by deficient tear film. This deficiency can cause discomfort and potential visual impairment.1 DED can also lower quality of life. It can be very uncomfortable and cause stinging, itching, or a burning sensation in the eye.
When used as prescribed, clinical trial participants experienced noticeable increase in tear film production. Below, we take a look into ONSET-2, a controlled, double-masked study that evaluated the safety and efficacy of OC01 (now TYRVAYA) nasal spray in adult patients with dry eye disease.1
Testing the science In ONSET-2, 758 patients were randomized to self-administer OC-01 0.6 mg/ml nasal spray (n=260), OC-01 1.2 mg/ml nasal spray (n=246), or placebo (n=252) twice daily.
potential for benefit across the spectrum of dry eye disease severity.” Another benefit for patients? The route of administration. The authors explained that nasal spray offers advantages of topical eye drops minus the irritation — namely, avoiding the ocular surface, which may reduce painful instillation in irritated eyes. Other benefits include its nasal administration, which some patients may find easier, and its ability to stimulate tear film production via a pathway independent of the ocular surface’s nerves, which can be damaged in patients with chronic disease.
Looking to the future At the end of the day, this is excellent news from DED sufferers as tear film production will soon be enhanced by a fresh, new therapy to eliminate the discomfort associated with DED. TYRVAYA Nasal Spray has been available with a prescription since November 2021, and samples that provide 15 days of treatment will also be made available to eye care providers.
Fortunately, there may be an innovative solution on the horizon in the form of a nasal spray treatment. Oyster Point Pharma (Princeton, New Jersey, USA) recently announced FDA approval for TYRVAYA™ varenicline solution nasal spray to aid in the treatment of DED. The new therapy was studied in the ONSET-1, ONSET-2 and MYSTIC clinical trials, which included more than 1,000 patients with mild, moderate or severe DED.2
UDOS
The researchers found that tear film reduction — a main sign of DED — was meaningfully increased. The percentage of patients who achieved a 10 mm improvement (Schirmer’s Test Score; STS) or more at week 4 was statistically significantly greater in groups treated with OC-01 compared with placebo. The investigators noted that in the OC-01, the percentage of patients who improved was 47.3% for the 0.6 mg/ ml group and 49.2% for the 1.2 mg/ ml group, compared with 27.8% for placebo. The most common adverse event was mild, transient sneezing. According to the authors, their results “suggest that the novel OC-01 nasal spray treatment can activate the trigeminal parasympathetic pathway to promote tear film production and improve symptoms, and may have
"I see many patients in my practice whose lives are impacted by dry eye disease,” said Dr. Ed Holland, director of Cornea Services at Cincinnati Eye Institute. “TYRVAYA Nasal Spray is a new pharmaceutical approach with a differentiated mechanism of action for the dry eye disease community. Having a product that provides clinically meaningful production of basal tear film as early as four weeks is incredible for the dry eye patient."
REFERENCES: 1.
Wirta D, Vollmer P, Paauw J, et al. Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease: the ONSET-2 Phase 3, Randomized Trial. Ophthalmology. 2021; S01616420(21)00836-8.
2.
Oyster Point Pharma. (2021 Oct 18.) Oyster Point Pharma Announces FDA Approval of TYRVAYA™ (varenicline solution) Nasal Spray for the Treatment of the Signs and Symptoms of Dry Eye Disease [Press Release]. Available at: https://investors.oysterpointrx.com/newsreleases/news-release-details/oyster-pointpharma-announces-fda-approval-tyrvayatmvarenicline.
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NLIGHTENMENT
WOMEN IN OPHTHALMOLOGY
Where are the Women Editors in Medical Journals? by Joanna Lee
“I have experienced the glass ceiling myself, so I really think it’s important to address it,” she added. A firm believer that everyone was born the same and should have the same opportunities, Cat said this disparity stems from an early age where girls were taught to believe that they weren’t good enough to be seniors or leaders, while boys were told that it’s in their nature and destiny to be leaders. “It’s wrong and this tends to be more evident in surgery and the surgical specialties,” she said, speaking from experience. Cat was trained in cardiovascular science before pivoting toward her current field, public health research.
A
ccording to a cross-sectional study1 published in September 2021, only one in five women are editorsin-chief at top-ranked medical journals. And for various medical specialties, the proportion of women editors-in-chief ranged from between zero and 82%. Interestingly, ophthalmology was one of the five fields where no women editors-in-chief were represented.
Breaking the glass ceiling
Curiosity led us to the lead author of the study, Dr. Ana-Catarina PinhoGomes, (or Cat, as she prefers to be addressed), who shared her perspectives and discussed some of the issues surrounding womens’ lack of representation in medical journals.
“It’s time to break the chains that prevent women from climbing the academic ladder and becoming leaders in their areas. This is because women have had to work much harder than men to achieve what they deserve,” Cat said of the impetus behind the study.
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A longitudinal cohort study by the University of Michigan showed that 40% of women in the medical field transition to part-time practice or leave the field altogether within six years of completing their residencies.2 Family was cited as the primary reason, despite the increase in the number of women entering the field of medicine over the last 60 years. On the side of
academic medicine, there appears to be a widening gender gap — especially in senior authorship positions — which have the most impact on career advancement.
Other than leadership positions, women have had to compete with men in achieving acknowledgement, participation in committees, and nominations for prizes.
Thus, Cat and her co-researchers set out to analyze the top 10 international medical journals in 41 categories of medical subspecialties (based on the Clarivate Analytics Web of Science Journal Citation Reports in 2019). Their findings brought to light important gaps and questions to be addressed.
Cat mentioned that although there have been successful mentorship programs worth replicating for women in science and in medicine (such as the ones organized by STEM Women in Australia and the Athena SWAN program in the U.K.), more still needs to be done.
Barriers for women in medicine The fact that women shoulder the burden of care in a family, along with “unequal distribution of teaching, pastoral care and administrative responsibilities” are but a few of the multifactorial barriers that impede womens’ progression up the ladder of influence in the area of medical authorship and publication leadership. Cat, a NIHR academic clinical fellow, asserted that COVID-19, especially, has delayed the progress of gender equality in academic medicine. It is not difficult to link this slowdown with the demands presented to women who had to juggle caregiving duties at home, as well as career pressure, during lockdowns. “Being an editor-in-chief is a very reputable, renowned position. And women only get there after many years of being leaders in their fields. And if they can't get to those positions of leadership, then they will not be eligible to become editors-in-chief in that specialty,” Cat said. Beside the tendency for women to take career breaks due to reasons like maternity leave, and the unconscious gender bias against women taking roles of leadership (including being editor-inchief), the study also discussed the lack of adequate mentors and role models to help women climb the career ladder as one of the reasons for their lack of representation. Cat cited that men tend to get other men to replace them in their senior positions through what is called “sponsorship”.
One example? Remove barriers for women to attend more conferences by having breastfeeding rooms, she said. “In general, too, there needs to be a societal movement toward gender parity because these require changing the societal mindset that places the burden of care on women.” These mindsets “are a part of our education or upbringing in societies that are still sexist. Or we may be influenced by beliefs, preconceptions and prejudices that we are not even aware of. So, it's really important to continue to produce research that makes gender gaps evident,” added Cat.
health. It’s also because a wide variety, or diversity of views, is better than a very male-dominant view, which may just be curtailed or one-sided. Women may have different views, an important contribution to the research being done. “It's not just about fighting as women just because it's about fairness. It's because we know that in the end, research done by women and men in balance is better — the views are more comprehensive and it produces a more rounded picture of the world. This results in better research and better outcomes. “These kinds of benefits are for both women and men alike,” she concluded.
REFERENCES: 1.
Pinho-Gomes AC, Vassallo A, Thompson K, Womersley K, Norton R, Woodward M. Representation of Women Among Editors in Chief of Leading Medical Journals. JAMA Netw Open. 2021;4(9):e2123026.
2.
Paturel A. Why women leave medicine. AAMCNews. Posted on Oct. 1, 2019. Available at https://www.aamc.org/news-insights/whywomen-leave-medicine. Accessed on Dec. 7, 2021.
Benefits of female researchers
Contributing Doctor
What about the lack of women editors-in-chief among ophthalmic journals? Cat reiterated the realities of the differences in the nature of practice in various medical fields. “Having a work-life balance that allows women to also raise their families is one of the factors that cause certain medical specialties to be more attractive than others. So, for areas that lack women representation — what are the barriers that prevent women from choosing careers in this specialty?” she continued.
Dr. Ana-Catarina Pinho-Gomes is a NIHR Academic Clinical Fellow in Public Health Medicine and specialty trainee in Public Health in London, U.K. Her academic placement is based in KCL, where she is a teaching fellow in the MSc in Public Health. She works on several research and healthcare public health projects in the Institute for Women and Children’s Health and South London NIHR Applied Research Centre. She is also an honorary clinical research fellow at The George Institute for Global Health and Imperial College London, where she does research on women’s health and sex and gender inequalities. She is visiting research fellow at the Nuffield Department of Population Health in the University of Oxford, where she does research on socioeconomic inequalities and health. She was born in Portugal, where she graduated in Medicine. She then moved to England, where she has been doing her post-graduate medical specialty training. She completed her MPH in KCL and her DPhil in the University of Oxford.
It is important to highlight that there are immense benefits to having more women researchers in positions of influence in medicine. “It has been compellingly demonstrated that research led by women improves the applicability, generalizability and validity of findings, which then ultimately leads to better population
cat.pinho-gomes@kcl.ac.uk
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CONFERENCE HIGHLIGHTS
ESCRS 2021 COVERAGE
ESCRS Conference
Highlights Cool New Tech I by Andrew Sweeney
t should come as no surprise that a company led by a nearly 2-meter (that’s 6’5" for the Americans) tall man, with a penchant for dressing up in banana suit costumes, has an enthusiasm for shiny, new things. Media MICE is sometimes known as the enfant terrible of ophthalmology — an attitude we hope to never lose — and our enthusiasm for the industry is only matched by that for technology. The latest tech news always excites us, and getting the chance to check out the latest innovations during conferences is exhilarating — especially when attending these events in-person.
The 39th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS 2021) in Amsterdam was one of the first major events to go ahead in-person since the pandemic began — and there was technology galore. A major part of the conference’s space was given over to company booths for demonstrations of new products and technologies. For the Media MICE team attending in-person, this aspect of the weekend was fascinating, especially for those new to large ophthalmology congresses like ESCRS.
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Revolutionary loading One of the standout demonstrations was given by ocular equipment manufacturer Geuder AG (Heidelberg, Germany), in cooperation with Prof. Peter Szurman from Augenklinik (Sulzbach, Germany) and the K. Heimann Eye Research Institute. Prof. Szurman demonstrated the first CE-certified DMEK preloading system: DMEK RAPID, a corneal transplantation device designed to offer a streamlined process for the operator. The RAPID system, which stands for “Revolutionary Advanced Preloading Injection Device,” includes two plugs, a transportation holder for the cartridge, and a loading connection. By loading the lamellae into a singleuse transportation cartridge, the DMEK RAPID eliminates the need for preoperative preparation of the membrane, while providing a no-touch handling process that maximizes endothelial cell count. According to
Prof. Szurman, DMEK surgery is usable in 90% of cornea transplantation surgeries and can ensure that patients heal in a matter of minutes. Geuder has already rolled out the device in Germany, the Netherlands, and Italy, and hopes to soon take the DMEK RAPID worldwide. Some of the company booths at ESCRS were stadium-sized, whereas others were smaller with a greater focus on high-class design. For pound-to-pound effectiveness in highlighting their company’s products, however, Oertli Instrumente (Berneck, Switzerland) deserves a solid mention. The company had some fantastic interactive displays to engage with, including its OS 4 platform. Designed as an all-in-one surgical system for cutting-edge eye surgery, the platform was designed to make surgery easier, more comfortable, and safe for operation personnel and surgeons alike. This device, designed for use in glaucoma, retinal and cataract surgery, is powered by a core comprising a three-pump system with vacuum and flow control, specifically designed for highly precise maneuvers. It also has a customizable LED display capability and includes a fully integrated 532 nm endolaser. In fact, this intraocular illumination technology represents a great development in the cuttingedge of vitreoretinal surgery and offers
an optimum mixture of visualization and safety, thanks to low toxicity and extremely good contrast.
Imaging and implants Imaging technology was definitely one of the most noteworthy aspects of the ESCRS 2021. During Day 3 of the conference, we got to examine optical coherence elastography (OCE), a promising imaging technique for high-resolution strain imaging in ocular tissues. It’s designed to reveal elastic material properties in the cornea by mechanically deforming the cornea via micro-puff stimulation, compression, and sound or ambient pressure. After this takes place, an image is taken via OCE and then analyzed to garner deep insights into the artificial deformity. We also got to check out a related technological development, namely optical coherence tomography angiography (OCTA), which is an emerging imaging tool for the retina and posterior segment. However, OCTA also holds considerable potential for anterior segment conditions, as it could be used to diagnose and monitor lesions or tumors on the ocular surface. OCTA
Wow, wow, wow … cool new tech is on the way.
has also been applied in diagnosing abnormal iris vessels, as well as iris tumors and other inflammatory conditions, although some experts warn that good image quality requires technical skills and experience in order to strike a good balance between image resolution and field of view. Imaging technology is pretty cool, but when it comes to the very cutting edge of development, we have to look at implants, and ESCRS 2021 did not let us down on that front either. Ophtec B.V., a Dutch company based in Groningen, released a toric version of their Precizon Aspheric Presbyopic intraocular lens (IOL), designed to correct both presbyopia and astigmatism. This latest toric version utilizes Ophtec’s patented Continuous Transitional Focus (CTF) technology to shape the entire anterior and posterior lens surfaces using multiple segments. Transitional zones of the CTF optic offer a full range of vision from near to far with a smooth transition that enables natural vision at all distances. This creates an elongated focus between two sharp focus points to deliver excellent intermediate vision. According to Ophtec B.V., their lens is different from bifocal IOLs, with one segment for far and one for near. Instead, it has a decentered lens, a unique concept of the multi-segmental optic between close and distance transitions between both powers. It defocuses near and far off vision to deliver excellent intermediate sight. These were just some of the technology highlights of ESCRS 2021, so make sure you check out our other articles on the conference, as well as the organizer’s online virtual platform. If you have your own thoughts about what tech was totally top-notch in Amsterdam, or if you just want to share your favorite toys with us, then get in touch on our social media platforms. Just remember, sharing is caring!
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CONFERENCE HIGHLIGHTS
AAO 2021 COVERAGE
AAO 2021
A Snapshot of the Best Scientific Posters by Brooke Herron
T
he scientific posters were one of the many highlights of the American Academy of Ophthalmology’s hybrid annual meeting (AAO 2021) — which took place in November both online and in-person in New Orleans. Below, we’ve compiled some of the research honored with the “Best Poster” designation at this year’s meeting.
countries,” said the study authors.
Management of Serious Complications After Cosmetic Iris Implants. In this retrospective case
“Although the use of iris cosmetic implants is strongly discouraged, this surgical practice is still used in many
And what they found was a slew of dangerous complications. Results showed that patients’ endothelial cell density (ECD) was 848 ± 227.5 and 30% of eyes required a corneal transplant. Two eyes had Descemet membrane endothelial keratoplasty; one had penetrating keratoplasty; and three patients were advised that corneal transplant surgery was necessary. Further, 90% of eyes had ocular hypertension, and filtrating surgery
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series, Drs. Jorge Alio and Francesco D'Oria reviewed patients’ medical records who were referred to their clinic for managing complications after cosmetic iris implants.
Ten eyes of five patients were included. Patients received one of two currently available options: NewColorIris (two eyes; Khan Medical Devices) or BrightOcular (eight eyes; Stellar Devices LLC). All eyes had been explanted between one and 60 months postimplantation.
was needed in two cases (20%). Forty percent (40%) of patients required cataract surgery (mean age 36 years). “Despite both products not being CE marked or FDA approved, growing malpractice leads to continuous implantation of such device, and the latest designs have the same problems of the previous implants,” cautioned Drs. Alio and D’Oria. “Patients with cosmetic iris implants have a high risk of definitive loss of vision, as well as other fearsome complications that should be emphasized to patients.”
Patient-reported Outcomes After Incisional Glaucoma Surgery Versus MIGS. This poster by Dr. Daniela Alvarez-Ascencio and colleagues evaluated patient-reported outcomes (PROs) after incisional glaucoma surgery versus minimally invasive glaucoma surgery (MIGS). “There is robust data on the safety and efficacy of MIGS, but patient-reported outcome measures are lacking,” said the authors. Thus, the authors developed an 18-item questionnaire to assess symptoms, daily activities, self-care, social life, emotional symptoms, and satisfaction in 320 patients over 18 years old who underwent glaucoma surgery (with or
without cataract extraction) with at least three months of follow-up. Fifty-eight (58%) percent underwent incisional surgery. Procedures included trabeculectomy (53%), Ahmed valve implant (39%), Ex-press shunt (4%), non-penetrating deep sclerectomy (2%), and Baerveldt implant (2%). The remaining 42% underwent MIGS: Kahook Dual Blade (40%), gonioscopy-assisted transluminal trabeculotomy (GATT; 35%), endocyclophotocoagulation (4%), and iStent (1%). Results showed that MIGS performed better than incisional surgery in all categories — and MIGS patients reported higher satisfaction with the surgical outcome. “In our study, MIGS had significantly better quality of life and PROs regarding visual and non-visual ocular symptoms; less impact in self-care and social life; lower rates of lower postoperative mood; perceived less need of glaucoma medications and follow-up appointments after surgery; and higher overall satisfaction,” concluded the authors.
A Contemporary Retrospective Analysis of Endophthalmitis Following Cataract Surgery Using the IRIS® Registry. To determine the incidence and risk factors for endophthalmitis following cataract surgery, Dr. Michael H. Goldstein and colleagues completed a post
hoc analysis from Jan. 1, 2016 to Dec. 1, 2019 as identified on the AAO’s Iris Registry. Included patients were aged over 22 years, underwent phacoemulsification with intraocular (IOL) lens implantation, and had at least one follow-up visit postoperatively.
“PK in the second eye does not confer rejection risk to the first eye, but the opposite is unknown,” they said. Therefore, the aim of this study was to determine whether a history of prior PK in the contralateral eye is a risk factor for second eye PK graft rejection.
The authors found that in 6.7 million eyes of 4.1 million patients, the incidence of endophthalmitis was low (0.633 per 1,000 surgeries; 95% CI = 0.614-0.652). The following were identified as risk factors for significantly higher rates (P < .0001 for all) of endophthalmitis: complex cataract procedures (OR = 1.67); concurrent vitreous procedures (OR = 4.32); traumatic (OR = 4.84), nuclear sclerotic (OR = 1.18) and posterior subcapsular (OR = 1.21) cataract types; history of proliferative diabetic retinopathy (OR = 1.53) or diabetic macular edema (OR = 2.04); and male sex (OR = 1.19).
A retrospective cohort study of 593 PKs in 593 patients (500 unilateral cases, 93 second eyes) was conducted. The authors defined corneal graft rejection as subepithelial infiltrates, keratic precipitates or anterior chamber inflammation in a previously uninflamed eye. Meanwhile, graft outcomes as influenced by 33 risk factors were assessed by Cox proportional hazards models.
“These data represent one of the largest recent analyses of acute postoperative endophthalmitis following cataract surgery,” the authors said, adding that this can help identify high-risk patients.
Prior Contralateral PKP is a Risk Factor for Second Eye Graft Rejection. Corneal transplants are the most common solid-tissue transplant procedure — and bilateral penetrating keratoplasty (PK) is often needed in conditions affecting both eyes, began poster author Eric J. Shiuey and colleagues.
Study participants’ mean age was 57.3 ± 22.2 years and mean follow-up was 4.00 ± 2.87 years. Of the included grafts, 211 (35.6%) experienced rejection; the incidence of rejection was 34.0% in unilateral cases and 44.1% in second eyes with a history of PK in the contralateral eye. Importantly, prior contralateral PK was a risk factor for rejection (HR = 1.42; 95% CI, 1.01-2.01; P = .045) but was not significantly associated with eventual graft failure (P = .1668), said the authors. Although there were some limitations to this study, the authors concluded that further research is needed to understand the pathophysiology of this association. However, loss of ocular immune privilege is a possible mechanism. “Our results may aid prognostication and management when considering second eye PKs in bilateral corneal pathology,” concluded the authors.
Editor’s Note: The American Academy of Ophthalmology hybrid annual meeting (AAO 2021) took place from Nov. 12-15, 2021 online and in-person in New Orleans, Louisiana, USA. Reporting for this story took place during the meeting.
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CONFERENCE HIGHLIGHTS
AAO 2021 COVERAGE
retrieves data from the Pentacam HR® (Oculus Optikgeräte GmbH, Wetzlar, Germany). The treatment zone size and location are determined by the size, form and location of the keratoconus cone. In terms of energy use, the worse the keratoconus, the more energy needs to be used — anywhere from 7.2 to 15.0 Joules/cm², which are quite high levels.
Individualized Cross-Linking Room for Improvement
A
s approximately one in 2,000 individuals is diagnosed with keratoconus, treating the condition with corneal cross-linking is clearly a crucial treatment. Even with current success rates upwards of 90%, there’s still always room for improvement. In one of the symposiums at the 39th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS 2021), a presentation on how customized cross-linking (CXL) can improve outcomes was discussed in-depth. Because no two eyes are alike, and no two keratoconus cases are alike, individualized treatment makes good sense. This is the argument brought to us by Dr. Anders Behndig, professor of ophthalmology and clinical science at the University of Umea in Sweden.
by Sam McCommon
was caught early in its development. These individualized treatments can be guided by topography and tomography, with the aim of controlling and enhancing the refractive improvement seen after CXL. Dr. Behndig explained that while there are many devices available for CXL, the only device that’s capable of handling individualized treatments is the Mosaic® device by Glaukos (San Clemente, California, USA). It’s a hefty device — “a monster of a machine” as described by Dr. Behndig — because it has functionality many other devices don’t. For example, it has an eye tracker that allows the user to draw on the screen where they’d like to adjust energy use and the treatment zone diameter, create shapes, and more.
As Dr. Behndig pointed out, keratoconus is an individual disease — so individual treatments make sense. For example, some patients come quite late for keratoconus treatment, so they’ll need a different treatment regime than someone whose condition
Dr. Behndig pointed out that the Dresden protocol, first published in 2003, is a fairly old treatment, and nothing is so good that it can't be updated.
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Before treatment begins, Dr. Behndig
But individualized CXL shows refractive advantages over conventional CXL in keratoconus, said Dr. Behndig. A higher energy level makes for a deeper treatment and more crosslinks as well as a stiffer cornea. Higher treatment also gives a deeper demarcation line, likely meaning more crosslinks in the deeper part of the cornea and more stabilization and flattening in the cornea. In addition to the effects of riboflavin concentration, other factors may be at play in the effects of the CXL treatment. One of those other factors is certainly oxygen. The chemical reaction behind CXL is oxygen-dependent, as oxygen is a rate-limiting factor in the in vivo reaction. While using room-level air may not produce adequate effects, flushing extra oxygen around the cornea improves the effects. Simply put, more oxygen gives more cross-linking, especially in epi-on treatment. Patients of Dr. Behndig’s regimen showed lower pain scores than with an epi-off treatment, as well as improved visual acuity across the board. In short, as Dr. Behndig summarized, CXL is a promising approach with more improvement in both corrected and uncorrected visual acuity. Additionally, a high-oxygen, epi-on protocol may comprise an additional improvement on cross-linking, in general. Isn’t it nice when we make measured, controlled steps in the right direction?
Editor’s Note: Editor’s Note: A version of this article was first published in CAKE & PIE POST (ESCRS and ASRS 2021 Edition, Issue 2).
Single-use I preloaded Capsular
Tension Ring Injector
Inside®CTR is an elegant & sophisticated single-use, preloaded Capsular Tension Ring Injector. An essential instrument to simplify the procedure. On-going surveillance of the ophthalmic market enables “O&O mdc” to develop and design highly efficient delivery systems, in line with market trends, that meet and exceed customer expectations. By using a combination of advanced Medical Grade Polymers and sophisticated, high-tech injection moulding techniques, we are able to offer innovative and high-quality single-use Injectors to our customers. The Delivery System is intuitive and user friendly and delivers uncompromising quality, efficiency, consistency and patient safety. The Delivery System has been developed specifically to simplify the safe implantation of a Capsular Tension Ring in order to stabilise the capsular bag before, during and after cataract surgery. •
The injector is equipped with a translucent guide, which allows the surgeon to visualise movement of the CTR in the cartridge funnel right up to the point of insertion.
•
The Inside®CTR, along with its anti-rotation system, guarantees optimum result through safe, consistent and efficient CTR insertion.
Inside®CTR Models: PRELOADED Inside®CTR 15 SERIES
Injector Packaging: TYPE 15
TYPE 15A
TYPE 15B
Size (Compressed)
10.0 mm
11.0 mm
12.0 mm
Size (open)
12.3 mm
13.0 mm
14.5 mm
Zonular Damage
Up to 4 hours (120°)
Incision
2.2 mm
Material
CLEAR PMMA (Compress Moulded)
Direction of Implantation Feature
The Inside®CTR is individually packed in a double blister, sealed with a Tyvek® lid, to ensure easy access and maintain perfect sterile conditions.
RIGHT (Clockwise) One bent eyelet, which reduces a possible puncturing (bulging) of the capsular bag when being dialled into the bag
Website: www.oo-mdc.com - www.ono-inside.com Email: int.sales@oo-mdc.com | Dec 2021/Jan 2022
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