CAKE & PIE POST (AAO 2020 Virtual Edition) - Issue 3

Gloria D. Gamat

Advances in Retina From Around the World,

Presented at AAO 2020 Virtual

by Hazlin Hassan

The development of new imaging devices, innovative surgical techniques and novel drugs has fueled an explosion of discovery and innovation in the diagnosis, treatment and management of vitreoretinal diseases.

Renowned experts from around the world and various different time zones came together in this exciting symposium at the annual meeting of the American Academy of Ophthalmology (AAO 2020 Virtual) on Saturday (November 14) to share their pearls and highlight state of the art diagnoses, treatment and management of selected vitreoretinal diseases, such as lamellar macular holes, polypoidal choroidal vasculopathy, large chronic macular holes, myopic traction maculopathy, macular telangiectasia type 2 and treatment-naïve nonexudative macular neovascularization in AMD (age related macular degeneration).

“ART” in macular holes

The relatively new procedure of autologous retinal transplant (ART) in macular holes is achieving hole closure in most cases of large macular holes, as well as better visual acuity (VA), said Tamer H. Mahmoud MD, PhD, ophthalmology professor at Oakland University William Beaumont School of Medicine, and Associated Retinal Consultants in Royal Oak, Michigan, USA.

A total of 130 ART surgeries were performed by 33 vitreoretinal surgeons in a multicenter retrospective case series to treat primary (27%) and refractory (58%) macular holes. All patients underwent

pars plana vitrectomy and ART during the study between January 2017 and December 2019. An 89% rate of macular hole closure was achieved. A total of 43% gained at least 3 lines in VA, and 29% gained at least 5 lines. There were 5 cases of ART graft dislocation, or 3.9%. Fifteen cases, or 12% of patients, had a final VA of 20/50 or better.

Postoperative complications saw 5 cases of retinal detachment (3.9%), 5 cases of ART graft dislocation (3.9%), and 2 cases of subretinal perfluoro-N-octane (1.8%). There was one suspected case of endophthalmitis.

“Learning from that, we can achieve much better outcomes and 100% closure of the

Cont. on Page 3 >>

HOTSHOT

Matt Young, CEO of Media MICE and Publisher of PIE & CAKE Magazines, interviewed KOLs and industry leaders from his new Dessertmobile, parked outside the virtual Luxor hotel in Virtual Las Vegas.

macular holes, which will pave the way to more understanding about macular diseases,” said Dr. Mahmoud.

Updates about MacTel

The discovery of two of the genes that cause macular telangiectasia type 2 (MacTel) may pave the way for a possible cure in the future.

“Macular telangiectasia type 2 (MacTel) was originally thought to be an acquired disease. There is growing evidence that MacTel is actually an inherited retinal disorder,” said Paul S. Bernstein MD, PhD, from the Moran Eye Center, at the University of Utah, USA.

MacTel affects about one in 5,000 people, usually between the ages of 40 to 60 years old, causing a gradual loss of central vision.

In an international study funded by the Lowy Medical Research Institute (LMRI), nine out of 52 siblings were affected and 3 out of 11 parents were affected. “With a disease penetrance of 0.38, the risk that an affected individual’s parent or sibling has MacTel is 19%, very consistent with an inherited retinal disease,” said Dr. Bernstein.

The first causative gene for MacTel was recorded last year. A father and son of a Utah family had MacTel, along with a rare and severe neurological condition called hereditary sensory autonomic neuropathy type 1 (HSAN1), caused by mutations in the SPTLC1 and SPTLC2 subunits of serine palmitoyltransferase (SPT).

The disease damages the peripheral nerves, producing tingling, weakness, and a reduced ability to feel pain and sense hot and cold in the legs and feet. Some patients experience shooting pains. The discovery provides important insights into the molecular mechanisms of MacTel as a disorder of serine and sphingolipid metabolism.

SPTLC1 and SPTCL2 are highly penetrant but are certainly not the only genes for MacTel, said Dr. Bernstein.

This suggests the possibility of both personalized and universal treatments. “Serine supplementation is already an established treatment for HSAN1,” he said, adding that a serine

supplementation trial for MacTel will start soon.

Treatment regimens in PCV

Dr. Gemmy Cheung, professor at DUKE-NUS Medical School, National University of Singapore and head of the Medical Retina Department, Singapore National Eye Center, shared on a recently published set of non-indocyanine green angiography (ICGA) diagnostic criteria for differentiating polypoidal choroidal vasculopathy (PCV) from typical neovascular age-related macular degeneration, which can reduce the need for ICGA in many settings.

A list of nine shortlisted features of PCV include subretinal hemorrhage, orange nodules, sharp peaked pigment epithelial detachment (PED), en face OCT complex RPE elevation, sub-RPE ring-like lesion, thick choroid with dilated Haller’s layer vessels.

The three major criteria are sub-RPE ring-like structure on cross-sectional OCT, complex RPE elevation on en face OCT, and sharp-peaked PED on cross sectional OCT.

Dr. Cheung advised to start anti-VEGF monotherapy if all three criteria are met (positive predictive value of 93%), and to continue monotherapy if there is an optimal response. If there is a suboptimal response, consider ICGA, switching agents, or combining with photodynamic therapy (PDT).

If the three criteria are not met, (negative predictive value 68%), this does not exclude PCV particularly if the polypoidal lesions are small. If there is suboptimal response to initial monotherapy, consider ICGA.

Dr. Cheung also shared that many patients with PCV have a background of bilateral hyperpermeable choroid, and thickened choroid. Dynamic ICGA suggests disturbance in choroidal perfusion pressure may be important in the pathogenesis of pachyvessels, she added.

On myopathic retinoschisis

Retinoschisis, seen in highly myopic eyes, is an eye disease characterized

by the abnormal splitting of the retina’s neurosensory layers, usually in the outer plexiform layer.

It is often seen in eyes with staphyloma. There is a higher incidence of occurrence in Asian populations, and its natural course is “progressive.”

“Vitrectomy including ILM peeling can lead to anatomically- and functionallyimproved myopic retinoschisis,” said Kazuaki Kadonosono MD, Department of Ophthalmology and Micro-technology, Yokohama City University Medical School, Japan.

Membrane peeling for idiopathic epiretinal membranes is a relatively difficult procedure. Myopathic retinoschisis or tractional maculopathy is a challenging surgical procedure and has higher risks of surgical complications. While myopic retinoschisis with subfoveal detachment appears wellsuited for surgery, the evidence for surgery for other types of myopic retinoschisis are less concrete, he concluded.

Dealing with large macular holes

Vitrectomy with the inverted ILM flap technique seems to be a safe and effective surgery for idiopathic large macular holes, improving both functional and anatomic outcomes, said Jose A. Roca, MD, ophthalmologist from Lima, Peru.

“The rationale for peeling the ILM is to relieve traction and enhance the extensibility of the retina and Muller cell gliosis,” he said. The inverted ILM, containing Muller cell fragments, may induce glial cell proliferation, filling the MH and supporting MH closure.

It may also work as a scaffold which helps the proliferation of myofibroblasts fibrocytes and RPE cells, creating a microenvironment that encourages correct photoreceptor positioning and improving postoperative anatomic and functional outcome.

Rizzo et al reported a 97.5% of single-surgery closure rate with this technique, with BCVA and multifocal electroretinography improvement.

Managing IOP Without Eye Drops

by Hazlin Hassan

Glaucoma is one of the leading causes of blindness for people over the age of 60. While glaucoma eye drops are important in managing intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT), they need to be used regularly to be effective, even if the patient has no symptoms.

But what if a patient is too busy and forgets to use the eye drops? What if a patient does not comply after experiencing side effects? This is where the DURYSTA™ (Allergan, Dublin, Ireland) bimatoprost implant comes in.

It is the first sustained-release implant for glaucoma and allows patients to manage their eye pressure without having to use topical eye drops. It continuously delivers bimatoprost, a prostaglandin analog, over several months, helping to reduce and maintain healthy eye pressure levels. Studies have shown that there is consistent IOP control for several months and up to 33% reduction in IOP.

“We all know that many patients have physical challenges. They have Parkinson’s disease, strokes, torn rotator cuffs, arthritis, they have difficulty getting their head back. This is a great answer for those patients with physical challenges,” said Gail F. Schwartz MD, ophthalmologist from Glaucoma Consultants (Baltimore, USA) during her presentation on the safety and effectiveness of DURYSTA at the American Academy of Ophthalmology

(AAO) 2020 Virtual conference on Saturday (November 14).

DURYSTA may also prove beneficial for patients with dementia and other cognitive challenges.

She shared two examples of patients who could not use eye drops and were happy to switch to DURYSTA, one of whom was a priest who had a busy and constantlychanging daily schedule, and another patient who had paranoid delusions.

Another category of patients who may benefit are those who travel all the time.

“I have a patient whose company is in Asia-Pacific, and he is constantly flying and changing time zones and he can’t figure out how to manage his drops within the time zones. This is a wonderful option for him.”

The implant’s extended IOP control over several months has been proven in phase 3 studies. DURYSTA was evaluated in two multicenter, randomized, parallelgroup, controlled, 20-month (including eight-month extended follow-up) studies compared to twice-daily topical timolol 0.5% drops in patients with OAG or OHT.

DURYSTA demonstrated a mean IOP reduction of approximately 5 to 8 mmHg over 15 weeks in patients with a mean baseline IOP of 24.3 mmHg. The implant comes pre-loaded with 10 mcg of bimatoprost in a sterile singleuse applicator that is used to inject the implant directly into the eye. The

medication is preservative-free, and the implant is biodegradable.

“DURYSTA has totally changed what I offer to my patients,” said Dr. Schwartz. The procedure takes 30 seconds and can save patients from having to take eye drops daily. Do take note however, that the DURYSTA is contraindicated in patients with active or suspected ocular or periocular infections, corneal endothelial cell dystrophy, prior corneal transplantation or endothelial cell transplants, absent or ruptured posterior lens capsule, hypersensitivity to bimatoprost or to any of the other components of the implant.

Dr. Schwartz shared how she prepares her patients before using the DURYSTA implant.

Patients get a drop of antibiotic, a drop of Betadine, and lidocaine jelly.

“I don’t use the speculum, I position the patient at the slit lamp, with the technician holding the patient’s head. This is an extremely quick procedure. It really takes 30 seconds once you’re set up,” she said, adding that doctors need not dilate the patient’s pupils beforehand.

She also handed out some troubleshooting tips for potential users, in a scenario where the implant appears to adhere to the needle tip.

“Just wait. Patience, patience, patience. This is where I pause. One of the other things you can do is to very gently rotate the bevel so that the bevel is facing you, and just nudge the implant against the inferior part of the iris and it drops down.”

In summary, DURYSTA is the latest innovation in the treatment of glaucoma.

Just a single implant provides several months of IOP reduction, with targeted delivery to diseased tissues, using a first-in-class, FDA-approved, sustainedrelease, biodegradable intracameral implant for IOP reduction in patients with OAG or OHT.

“This implant is just a total freeing from compliance, freeing from surface issues, freeing from having to remember or those physical limitations. It’s several months pressure-lowering with a single implant.”

Uncovering the Myopia Epidemic in Children

On the second day of AAO 2020 Virtual, experts convened to discuss the epidemic of myopia among children during a symposium titled, “Preventing Myopia Progression in the Pediatric Patient,” co-sponsored by the American Association of Pediatric Ophthalmology and Strabismus (AAPOS).

The genetic factor

“It’s important to note that 4.8 billion people, or about half of the world’s population, is expected to be affected by myopia by 2050,” said Dr. Terri Young. The epidemic is particularly prevalent in urban Asia, where up to 95% of 20-yearolds in cities such as Seoul, Hong Kong and Singapore have this refractive error — a trend that’s expected to occur in other regions, she continued.

So, what are the causes? Dr. Young says it’s a complex interplay between lifestyle and genetic factors.

Recent research has identified many genetic variants for refractive errors, myopia and axial length, she shared, highlighting a point from the CREAM study: “What was interesting was that most of the genes identified that were associated with myopia were related to rod and cone synaptic neurotransmission, some anterior segment morphology and some angiogenesis pathways. So, we’re thinking that some of these light sensitive genes might be more involved in myopic development than we realized before.

“If you have a child with high myopia, and it’s not connected to an identifiable tissue disorder, have them undergo electrophysiology testing — we’re finding that they may have some sort of retinal degenerative-type issue,” shared Dr. Young.

by Brooke Herron

Near work, outdoor time and myopia

“The eye is not meant to focus on near [distance] for an extended amount of time,” said Dr. Paul Rychwalski. “There is constant ciliary muscle contraction required to hold a near object in focus.”

And lifestyle factors, like near work, have been blamed for myopia progression. “There have been many studies recently looking at near work and myopia, however most of these are quite inconclusive,” he said, adding the results for screen time and myopia have also been mixed. “Further studies are needed that look at objective measurements of screen time, but also look at some of the other factors such as illumination, distance, and angle of the screen from the eyes, and also the decreased outside activity that may all be intertwined and leading to more myopic progression.”

Adding to the importance of outdoor time was Dr. Noha Ekdawi: “There’s been several studies that have shown that when children spend sufficient time outdoors (more than two hours per day) their risk of myopia was reduced, even when they had two myopic parents and continued to perform near work,” she shared.

Contact lenses and atropine to prevent myopia progression

Dr. Amy Hutchinson covered two types of contact lenses — multifocal and overnight orthokeratology (OrthoK) lenses — to prevent myopia progression in children.

“Both types of contact lenses are thought to have a similar mechanism of action to slow myopic progression

... and that mechanism is to eliminate peripheral hyperopic defocus and induce peripheral myopic defocus.

“Multifocal lenses and overnight orthokeratology lenses can provide a clinically meaningful slowing in myopic progression,” said Dr. Hutchinson, adding that further research is needed on the timing and duration of treatment.

Another potential solution to prevent myopia progression is low dose atropine.

“Low dose atropine is safe and effective at slowing myopic progression in children, and .05% may be more effective than .01%,” said Dr. Cynthia Beauchamp, who shared clinical data, as well as her protocol for using atropine.

Currently used off-label, she noted that FDA trials are underway for commercial distribution which will increase access, ease of use for families and reduce personal expense.

Acute Neuro-Ophthalmic Problems Should I treat? Should I refer?

by Olawale Salami

In a busy comprehensive ophthalmology practice, a patient with a possible neuro-ophthalmic problem such as sudden vision loss or eye pain diplopia must be evaluated thoroughly and managed expeditiously. Immediate referral to a neuro-ophthalmologist may be appropriate, but practical issues of access and distance may preclude this solution. The comprehensive ophthalmologist needs to recognize these neuro-ophthalmic problems and arrange for timely and appropriate diagnostic studies and management until the referral is possible.

Sudden vision loss with pain: Expect the unexpected

“Always consider optic neuritis in a young white female who presents with a sudden onset of painful vision loss,” advised Dr. Tariq Bhatti of the Mayo Clinic (USA), during his presentation at AAO 2020 Virtual in a session where application approaches to neuroophthalmic cases were discussed.

The most common cause of acute vision loss in a young person is acute demyelinating optic neuritis due to optic neuropathy. It is characterized by rapid, unilateral, painful vision loss, decreased color vision, rapid visual field defect, and optic edema in about a third of cases.

According to Dr. Tariq Bhatti, our understanding of optic neuritis comes from the optic neuritis treatment trial, a randomized study that evaluated the efficacy of steroid treatment in acute optic neuritis and its relationship with multiple sclerosis. The trial enrolled 457 patients who were randomized to receive either oral prednisolone, IV solumedrol + oral prednisolone or oral placebo. Most of the enrolled participants were young white females.

“At the end of the study, over 90% of patients in the two-treatment arms recovered vision of 20/40 or

better. Besides, patients who received solumedrol recovered faster, compared to other groups. The authors also found an association between optic neuritis and multiple sclerosis based on brain MRI images,” said Dr. Bhatti.

However, when is optic neuritis NOT optic neuritis? According to Dr. Bhatti, here is published evidence showing that up to 60% of diagnosed cases were not optic neuritis, and were simply headaches and functional vision loss. The reasons for misdiagnosis were broad. There was over-reliance on a history of pain with eye movements, a family history of multiple sclerosis, failure to consider an alternative diagnosis, error in interpreting physical exam findings, and misinterpretation of the MRI.

Physicians should consider an alternative diagnosis: bilateral simultaneous vision loss, progressive, irreversible vision loss, painless vision loss, non-white race, retinal pathology, and history of constitutional symptoms.

Sudden vision loss in an elderly patient: Be expeditious!

“When elderly patients present with a sudden loss of vision, always think of a stroke, and if you examine and find evidence of a central or branch retinal

artery occlusion, immediate referral to a stroke centre or emergency department is required,” said Dr. Sophia Chung, Clinical Professor of Ophthalmology and Visual Sciences, Clinical Professor of Neurology, University of Iowa Carver College of Medicine (USA).

Both the American Heart Association (AHA) and American Stroke Association (ASA) include retinal ischemia in their case definitions of stroke, and these patients are at an increased risk of stroke. Several studies have shown that up to a quarter of patients with retinal ischemia have MRIs that show silent infarctions, and up to 65% have multiple lesions.

“When fundus examination shows features of anterior ischemic optic neuropathy, this is an emergency as the risk of contralateral vision loss is up to 75%. Here it’s important to institute high dose corticosteroids treatment before referral,” said Dr. Chung.

According to Dr. Chung’s key message during her presentation, all patients with acute retinal ischemia, pituitary apoplexy, and homonymous hemianopia should be referred to the nearest stroke center. “Patients with arteritic anterior ischemic optic neuropathy should be treated with high dose steroids, while patients with non-arteritic ischemic optic neuropathy should be managed conservatively,” she said.

Artificial Eyes in 2020 and Beyond (Including Telehealth)

Artificial eyes are something we are all familiar with and they have been present in the popular imagination for some time. Perhaps best associated with pirates or roguish characters (which would be fitting for somewhere like Las Vegas), artificial eye development has advanced light years of late. The future is bright for this area of ophthalmology, and perhaps surprisingly, this could be partially due to the coronavirus pandemic.

That was one of the subjects discussed during The Artificial Eye: 2020 and the Dawn of Innovation, a symposium organized on day two of the annual meeting of the American Academy of Ophthalmology (AAO 2020 Virtual). The forty-five minute long session offered an extensive discussion on artificial eyes in 2020. Split into three distinct sections, the symposium also included the Parker Heath Lecture which highlighted incubation and entrepreneurial initiatives to guide research in artificial eye development.

Seeing into the future with artificial eyes

The first section was Corneal Cell Therapy with Magnetic Nanoparticle Delivery by Dr. Jeffrey Goldberg. Pointing to significant results in human trials, Dr. Goldberg stated that both epithelial and endothelial cell transplants hold ‘great promise for vision replacement across many diseases.’ Pointing out that corneal transplants have consistently risen in demand year on year in the United States, Dr. Goldberg also reported on the potential of magnetic cell delivery technology.

This acts as a regenerative platform where human corneal endothelial cells are expanding in culture. Reportedly, a single donor cornea can yield enough cells for 100s of patients, thus alleviating considerable donor shortages.

by Andrew Sweeney

The first human clinical trial was carried out successfully and a phase 1b trial in the United States is underway, lasting 18 months.

Next up was Dr. Mark Humayun who presented Bioelectronic Artificial Sight, an in-depth look at artificial sight technologies and implants. Dr. Humayun reported on the considerable developments in prostheses for sight, pointing to the Argus II (an epiretinal prosthesis) and the Pixium (a subretinal prosthesis) as showing particular promise. He also reported that a number of both software and hardware developments are underway to improve prosthesis technology.

Self-reported use of the Argus II, according to Dr. Humayun, has been generally positive, with patients even being able to participate in activities like archery and bowling. Base visual acuity with the Argus II implant was reported at 20/1200 to 20/480, however this remains under review. Baseline visual

acuity for the Pixium was reported at 20/400.

The future’s bright, the future’s telehealth

The last segment was the Parker Heath Lecture: The Accelerated Move to Digital Healthcare, given by Dr. Tom Giannulli. The session covered the transformation of the healthcare system via digitization, accelerated by the coronavirus pandemic and telehealth uptake. Dr. Giannulli reported that telehealth usage had increased by up to 45% in the last six months.

This will impact the development of artificial eye and prosthesis devices as wearable monitoring and artificial intelligence technology will increase in both quantity and quality. Dr. Giannulli reported that there is a potential $250 billion market in this area. He also states that 20% of all emergency visits could also be avoided thanks to digitization.

These three segments were subsequently followed by a short discussion segment. The main presenters involved in the symposium discussed bionic eye development, as well as infection rates and adverse reactions involving corneal implants. Stimulation applied to the retina, as well as to the visual cortex, was also raised, bringing an interesting end to the symposium.

AAO 2020 Exhibitor Showcase

Reporting on the newest products and launches from ophthalmology’s leading companies

by Brooke Herron

A Truly Virtual Experience

Another can’t miss stop at the AAO 2020 Virtual exhibition is Santen’s virtual booth.

Optimized IOLs

Founded in 1989, Aaren Scientific aims to develop the most scientifically advanced intraocular lenses (IOLs) and surgical products for the ophthalmic industry.

Positioned as a global distributor of IOLs, Aaren Scientific has remained committed to the core directive of

Sustained Release Specialty Pharmaceuticals

“EyePoint Pharmaceuticals is a specialty pharmaceutical [company] dedicated to preventing blindness,” said President and CEO Nancy Lurker in the company’s opening video. “We’re one of the leading drug delivery companies in ophthalmology, transitioning from a R&D company to a fully integrated, specialty pharmaceutical company.”

EyePoint is commercializing its two products in the United States: DEXYCU® (dexamethasone intraocular suspension) 9% and

delivering state-of-the-art products with the highest visual acuity. These include IOLS such as Aqua-Sense®, BioVue® and Adaptiv™ Aspheric IOLs

Manufactured using Aaren’s proprietary P.U.R.E. System (Precision UnResolvedmaterials Extraction), Aqua-Sense IOLs have enduring optical clarity and enhanced biocompatibility.

P.U.R.E. removes materials and extraneous processing materials found in hydrophilic lenses that are not fully polymerized.

Another proprietary feature is heparin surface modification (HSM). All BioVue IOLs feature HSM, designed with the ultimate biocompatibility available in IOLs today. Meanwhile, the company’s Adaptiv Aspheric IOLs are designed to compensate for aberrations of the eye, even in cases of clinically occurring IOL misalignment or tilt, and give the patient better intermediate vision after cataract surgery. Visit https://aareninc.com for more information.

Santen is a global specialized company dedicated exclusively to ophthalmology and the research, development, and commercialization of pharmaceutical, surgical and OTC eye care products. Headquartered in Osaka, Japan, Santen provides innovative solutions in retina, glaucoma, uveitis, dry eye, ocular allergy and infection to patients around the world.

After registering, wander around the company’s virtual booth to learn more about its products or chat with Santen representatives. For more information, visit www. SantenUSA. com.

Growth, During the Pandemic

YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18mg.

“DEXYCU is the first and only FDA approved sustained release steroid (dexamethasone) for the prevention of postoperative inflammation,” said Lurker, adding that it will be commercialized for cataract surgery.

YUTIQ was approved in Q4 2018. It’s indicated for the treatment of chronic noninfectious uveitis affecting the posterior segment; YUTIQ has been proven to reduce uveitis recurrence. For more details, visit https:/ eyepointpharma.com

President and CEO Shervin Korangy welcomes attendees in the featured video at the BVI booth at AAO Virtual 2020: “You may have noticed that in the past months we’ve been busy, bringing more innovation to market. We are committed to working with world-class surgeons and making a difference in ophthalmology,” he began, noting that while some companies have pulled back during COVID-19, BVI has made progress.

“This summer, we launched our first IOL into the U.S. market: iPure®, which is a preloaded aspheric monofocal IOL. iPure’s unique three zone aspheric optic has been well-received by surgeons across the U.S. as they seek to streamline cataract surgery,” shared Korangy.

“I hope you have a successful conference and enjoy the products we’ve chosen to feature from our broad portfolio,” he concluded. BVI is also highlighting its Malosa® Single-use Instruments for cataract and refractive surgery and the company’s custom Procedure Packs to improve OR efficiency.

Remote Monitoring with Confidence

With a focus on providing patient-centric ophthalmic diagnostic services, Notal Vision’s ForeseeHome is a home-based monitoring program for intermediate dry age-related macular degeneration (AMD) patients to detect the conversion to wet AMD earlier. This helps extend monitoring from the clinic into the home to further support patient care. These types of devices are even more important now during the COVID-19 pandemic, when less elderly patients are less inclined to make regular office visits.

Clinical data has shown that the ForeseeHome has clear benefits for patients. For example, using the ForeseeHome, 94% of patients who progressed to wet AMD retained functional vision (≥20/40); versus only 62% of patients using standard detection methods alone. Further, adding ForeseeHome reduced vision loss at wet AMD diagnosis by 6 letters compared with standard care alone.

They also found that office visits triggered by using ForeseeHome as part of a home monitoring plan were 16 times more likely to catch new cases of wet AMD, compared with routine scheduled office visits. For more information about ForeseeHome, visit www.foreseehome.com.

DMEK Wet Labs Available

Seattle, Washington-based CorneaGen is a mission driven company: “Even in the midst of a global pandemic, we at CorneaGen are committed, more than ever, to fulfilling our mission to eliminate corneal blindness by 2040,” said J.D. Osbourne, vice president of surgical products and services at CorneaGen.

Based in Seattle, CorneaGen supports corneal surgeons and their patients with the latest products, delivery of the highest-quality tissue, surgeon education, and advocacy for patient access and reimbursement policies. The company offers products including

All about MIGS

The Hydrus® Microstent from Ivantis is a revolutionary canal-based minimally invasive glaucoma surgery (MIGS) device for adult patients with mild to moderate open-angle glaucoma undergoing cataract surgery. The device is 8mm in length, and it is contoured to the curvature of the Schelmm’s canal; it also features a rounded distal tip, for easy entry into the Schemm’s canal.

Further, its open scaffold design provides pathways for aqueous outflow; while its aqueous inlet bypasses the trabecular meshwork to restore flow from the anterior chamber into Schlemm’s canal. The featured video continues with more product details, including its straightforward delivery system, with a tracking wheel and adjustable cannula.

The company shares that the Hydrus Microstent is also the first and only MIGS device with clinical results from a pivotal trial reported at four years (HORIZON). For more information about Ivantis and the Hydrus Microstent, visit www.ivantisinc.com

the Geuder Pre-Loaded Glass Cannula for DMEK; Intacs® for Keratoconus; Nano-Thin™ Tissue for DSEK; VisionGraft®; and tissue storage media with antifungal Ampho B.

With a focus on innovation and education, CorneaGen has also developed a safe, DMEK wet lab opportunity for those who would like to transition over to DMEK.

“We want you to know that we continue to be vigilant during the pandemic to ensure we are providing safe donor tissue,” said Osbourne, adding that virtual consultations are now available for all products and services. For more, visit https:// corneagen.com

Reduce the Medication Burden in Glaucoma

At the Iridex AAO 2020 Virtual booth, the MicroPulse P3® Delivery Device, a versatile and non-incisional glaucoma treatment with MicroPulse® transscleral laser therapy.

New York-based ophthalmologist

Dr. Nathan Radcliffe recommends MicroPulse laser therapy to a variety of patient types within his practice. “This is a treatment option for patients who are unhappy or uncomfortable on their current glaucoma medications, and who are also uncomfortable with the idea of traditional glaucoma surgery, which may have higher risks,” he explained in the featured video.

Next, Dr. Oluwatosin Smith shared her experience: “I’ve done many MicroPulse laser [treatments] on patients and patient outcomes have been really good; intraocular pressure has been reduced and the laser has been effective in achieving the goals that I’ve set — like reducing the number of medications that they’re on.”

For more information, visit www.iridex. com

Would you like to see your company’s products featured in our daily Exhibitor Showcase? Contact matt@mediamice.com for more information.

Mitigating Cyber Security Threats in Healthcare

Cybersecurity. It’s no doubt a word you’ve come across in the news or among colleagues and cohorts countless times in the last several years. In 2020 this term has become a focal point of attention, for as technological innovation grows so do opportunities for data theft. This is especially true with our growing reliance on technology and remote capacities during the COVID-19 pandemic.

Under AAO 2020 Virtual’s On Demand selection Jeffrey Daigrepont, Senior Vice President at the Coker Group, spent the better part of an hour programming viewers to account for cybersecurity threats in the medical industry in his presentation titled Cybersecurity Update: New Threats for 2020 and Beyond and Internet of Things Risk. We can’t be more appreciative of this fact-filled briefing of a topic that is sometimes only skimmed by decision-makers.

Types of threats

Mr. Daigrepont familiarized us by outlining the ways in which a hacker might obtain private information. Some of the methods he went over include:

• Ransomware: Computer malware that installs covertly onto a victim’s computer and demands a ransom payment for information stolen.

• Social engineering: Finding personal information about an employee on a personal level and using it to trick them into doing something.

• Baiting: Presenting false incentives to the target to tempt them into taking a certain action that makes them susceptible.

• Phishing: Sending emails from addresses that look legitimate, linking to fraudulent websites or dangerous downloads.

by Elisa DeMartino

Additionally, this expert of 20 years reminded that all health providers and health plans are legally obligated under HIPAA to incorporate cybersecurity measures and can receive fines, penalties, etc. for failing to do so even if no data breach occurs.

Modern considerations

He provided an interesting explanation of the reasoning behind such methods. “Criminals by nature are very lazy. They’re desperate people.” He elaborated that “they’re not very interested in working very hard, otherwise they’d have real jobs… And so they basically seek out soft targets, and they find that doctor’s offices are oftentimes very, very soft targets.”

What’s at risk?

By utilizing the aforementioned tactics, the presenter explained, all sorts of information would be vulnerable to a hacker. The risks include, but are not limited to:

• Loss of financial cash flow

• Permanent loss or corruption of electronically protected health information

• Temporary loss or unavailability of medical records

• Damage and loss of physical assets

• Damage to reputation and public confidence

• Threats to patient safety and privacy

• Threats to employee safety and privacy

• Litigation

He urged that viewers keep in mind the ever-broadening Internet of Things (IoT) which includes smart watches, refrigerators, cars, smart TVs, and even doorbells and coffee makers. “As these Internet of Things start showing up in your office, and [staff] are connecting them to your network, you have to be aware that it creates a whole new layer of threats that we’re not really used to dealing with.” He advised doubling down on traffic monitoring of your network for IoT devices.

An especially fresh factor is the growing telemedicine practice of 2020 as a result of COVID-19. Mr. Daigrepont warned that lack of encryption or perhaps even having Alexa listening in the background could risk exposure of private patient information discussed in telehealth sessions.

How to minimize security threats in 2020

The presenter listed several practices that should be employed for adequate threat minimization. Encryption, audits, firewalls, backup servers (particularly with many things being on the cloud nowadays), anti-virus software, and frequent software updates were among those listed.

He also recommended carrying out security risk assessment by identifying threats and vulnerabilities and coming up with a plan to protect your data, and finally to seek cybersecurity insurance that will provide resources and tools for this.

“Almost all ransomware attacks rely on poor judgement.” Mr. Daigrepont shrugged off this final piece of guidance for us. “I wish I could tell you today there was software to prevent poor judgement…We just have to be mindful.”

Ophthalmic Imaging Light-Speed Into the Future

Dr. Schuman suggested this may indicate there’s untapped data hidden in OCT images that we aren’t yet aware of. This indicates that the AI’s success is possibly due to this hidden data. For now, we’re just beginning to learn where to look — but we’re definitely learning that we can learn from deep learning algorithms.

Four-dimensional MIOCT for subretinal surgery

Let’s begin with a noncontroversial statement: It’s important for a surgeon to know what they’re doing. Being able to see what they’re doing can be extremely valuable, especially when working in delicate places like the subretinal space.

Technology moves fast these days. That’s no secret nor a shock to anyone. But some sectors within technology move blisteringly fast — so fast that it’s a challenge for even experts in the field to consistently keep abreast of new developments. Such is the case with ophthalmic imaging, which is in the middle of what appears to be exponential growth in power and capabilities.

Imaging technology was the focus of a discussion on the second day of the AAO 2020 Virtual conference. Describing all of the information presented would take significantly more space than we have here, so we’ll focus on two aspects discussed: the increasing capabilities of artificial intelligence (AI) in imaging and the intrasurgical use of imaging technology.

AI In OCT Imaging: Deep learning shows promise

Dr. Joel Schuman presented data gathered from a collaboration with IBM’s

Watson team in Australia — and there were some surprises. Most notably, the team compared traditional methods of using machine learning to glaucoma — in which parameters and assumptions are given to the AI — to “agnostic” AI, which is fed the entire dataset with no set parameters or assumptions.

What they found was that the agnostic algorithm performed better than the preprogrammed one, meaning that there’s lots to be learned from deep learning tools.

The team applied the same concept to predicting visual fields from OCT data. The result? The agnostic algorithm achieved an overall estimation error of only 2% compared to the 5% they experienced using conventional biomarkers.

In one further step, the team tested deep learning algorithms to forecast retinal nerve fiber layer (RNFL) thickness and compared it to using conventional regression models. Yet again, the deep learning algorithm outperformed the conventional methods.

To wit, Dr. Lejla Vajzovic provided a brief exploration of the history of intraoperative OCT. In short, it’s witnessed revolutionary change over the last decade and a half. As recently as 2009, surgeons would have to pause surgery to see a 2D image via microscope. The Zeiss Rescan was a big step forward with a heads-up display a few years later. But the last few years have seen exponential growth in the power of Duke University’s microscope-integrated OCT (MIOCT) which can vastly improve a surgeon’s ability to see their own surgery in real time.

The initial 2015 prototype used spectral domain OCT at 20 khz with no volumetric imaging; the 2019 model used sweptsource OCT at 400 khz with a 12.5 hz real-time volumetric measurement rate. The higher the frequency, the better the image. So, to call this progress a step forward is...well, an understatement.

But the next generation of 4D MIOCT will blow all that away. It’s integrated with a graphic processor unit (GPU) to display real-time 3D imaging with nearreal time volumetric control. The SS-OCT can be displayed side by side with the microscopic image, meaning surgeons will have more depth-related information while performing maneuvers. The image can be rotated with a foot pedal during the surgery.

Oh, and in case you’re curious, the 4D refers to measuring volume over time — since time is the fourth dimension and all that.

Advanced Endothelial Keratoplasty, Making it Less Complicated

On the second day of AAO 2020 Virtual, experts convened (virtually, of course!) to discuss the overview and surgical pearls on advanced endothelial keratoplasty. Here are some of the highlights...

DMEK: Avoiding surgical entanglements

“Overall, DMEK is the next generation of lamellar surgery. It is challenging but feasible in most patients, and with care, many of the complications seen before, during, and after surgery can be avoided,” said Dr. Brandon Ayres, codirector of the cornea fellowship program of the WillsEye Hospital in Philadelphia (USA).

In his presentation, Dr. Ayres shared important tips on how to avoid complications associated with DMEK surgeries. He said that proper patient selection is the best way to avoid complications of DMEK (Descemet’s membrane endothelial keratoplasty). “Keep it simple for the first several cases, and make sure you have a pseudophakic patient with an IOL in the bag and mild-to-moderate corneal edema,” noted Dr. Ayres.

It’s important to stay away from patients with tubes, crowded anterior chambers and post vitrectomy cases, according to Dr. Ayres. “In addition, to reduce the risk of rejection, try to select patients

by Olawale Salami

who can lie reclined for a few days to allow graft attachment,” he said.

Intraoperative complications of DMEK can occur at several steps: from the graft preparation, insertion, donor unfolding or visualization. Postoperatively, graft detachments will happen, and except if they are large, these can be ignored. Infectious keratitis remains a significant risk postoperatively.

Is DMEK superior to DSAEK?

“Eyes with good anterior chamber views, normal anatomy and potential for VA of 20/20 are ideal candidates for DMEK,” said Dr. Massimo Busin, professor of ophthalmology, University of Ferrara (Italy).

During his presentation, Dr. Massimo Busin reported that over the past decade, DMEK has gained increasing popularity with over ten thousand cases performed in 2019. “I have advocated that the choice of an operative procedure selected should be based on the preoperative status of the patient and eyes with good anterior chamber views, normal anatomy and potential for VA of 20/20 are ideal candidates for DMEK,” he shared.

“In order to simplify the procedure for new surgeons or those just transitioning from Descemet stripping automated endothelial keratoplasty (DSAEK), I recommend the bimanual pull through maneuver,” he added. In a review by the American Academy of Ophthalmology, the authors concluded that DMEK was superior to DSAEK. However, this assessment did not consider the fact that DSAEK has evolved towards a use of thinner grafts, now known as UT-DSAEK, explained Dr. Busin.

“Therefore, based on data from the most current randomized controlled trials, there is no compelling evidence that DMEK is superior to UT-DSAEK, especially for complex eyes,” said Dr. Busin.

Artificial iris in complex DMEKs

“For more complex cases with AC abnormalities, I first reconstitute the anatomy of the chamber by removing abnormal iris, reestablishing the posterior surface of the AC with the artificial iris,” said Dr. Donald Tan, Arthur Lim Professor at the Singapore National Eye Centre (SNEC) and DukeNUS Medical School (Singapore), when he discussed how he has perfected the use of artificial irises in the management of complex DMEK cases.

“My current DMEK technique involves a pull through endo-in DMEK technique using the DMEK endoglide donor inserter, which goes through a 2.7mm clear corneal wound,” shared Dr. Tan.

“The clinical trial which we published involved 69 eyes, in which the mean endothelial cell loss was about 33%. This approach provides for enhanced control of the anterior chamber and facilitates DMEK performance in more complex cases,” he added.

What constitutes complex DMEK cases?

Dr. Donald Tan explained that complex DMEK scenarios are those where the anterior chambers are limited by peripheral anterior synechiae (PAS), iris adhesions. In addition, there may be inadequate posterior surface of the anterior chamber. For example in aniridic eyes, eyes with dilated fixed pupils, open vitreous cavity or aphakia. There is an elevated risk of DMEK graft failure in these scenarios.

“The solution I recommend in these situations is to reconstruct the anterior chamber prior to DMEK surgery. This can be done by synechiolysis and removal of the PAS. In addition, reconstructing the posterior surface of the anterior chamber by implanting an artificial Iris. All these are performed as a separate procedure before the DMEK,” explained Dr. Tan.

Pull-through endo-in DMEK approach using the DMEK endoglide provides for enhanced donor control and a controlled chamber depth and can be used in more challenging cases. “With better surgical control we can now perform more complex cases where anterior segment and chamber abnormalities may make conventional DMEK a real challenge,” added Dr. Tan.

Managing The Rare Cancer that is

Vitreoretinal

by Hazlin Hassan

Vitreoretinal lymphoma (VRL) is a rare yet challenging cancer, said Professor Justine Smith, of Flinders University, Australia, in presenting the C Stephen and Frances Foster Lecture on Uveitis and Immunology at the annual meeting of the American Academy of Ophthalmology (AAO 2020 Virtual) on Saturday (November 14).

“Vitreoretinal lymphoma is an extremely challenging disease. The condition may present quite nonspecifically or it may masquerade as a variety of other diseases including viral retinitis,” she said.

The disease, formerly known as ocular reticulum cell sarcoma and intraocular lymphoma, involves the retina, vitreous and optic nerve, and represents a subset of primary central nervous system (CNS) lymphoma. It has an estimated annual incidence of 9 per 10 million adults.

“The vast majority of patients with VRL have Non-Hodgkin’s diffuse large B-cell lymphoma, rarely T-cell lymphoma,” said Prof. Smith.

A total of 41% of patients with VRL will have brain involvement at presentation, and 69% will develop brain involvement over the course of their disease, she added.

Vitreous biopsy yields scant tissue with fragile cells. There are no consensus guidelines on staging and grading.

Classic presentation includes vitreous cells, gray-white retinal lesions, and yellow-white sub-RPE lesions.

Other clues are onset in older adulthood, little anterior chamber activity, no posterior synechiae, vitreous cell outweighing haze, aurora borealis, leopard spot retinal pigmentation, lack of macular oedema, and visual acuity better than expected from examination.

There are also challenges in diagnosing VRL. Traditionally cytology combined with flow cytometry is required. However, the negative predictive value of cytology has been estimated at approximately 60%, meaning that the diagnosis is often delayed and multiple procedures may be needed.

Moving into an era when other investigations may provide diagnosis of VRL if cytology is inconclusive, means that doctors can now carry out cytokine analysis, genetic testing and ophthalmic imaging in order to diagnose the disease.

With very limited medical evidence, there are many approaches to treatments, which varies from center to center, and depending on whether the brain is involved, Most patients will ultimately develop primary CNS lymphoma and the five-year survival is 33%.

Available treatments include chemotherapy, and targeted therapy such as monoclonal antibodies and

small molecules, radiotherapy, and autologous stem cell transplant.

Many chemotherapy and targeted therapy drugs are being used today namely methotrexate, cytarabine, thiotepa, rituximab, nivolumab, ibrutinib, and lenalidomide.

Induction involves multiple drugs based around high dose methotrexate. Whole brain radiotherapy is avoided due to cognitive adverse events. Consolidation may include drugs, low dose whole brain radiotherapy and autologous stem cell transplantation after myeloablation. Treatment is also given to alleviate visual symptoms, limit retinal damage and improve overall survival.

Local therapies often induce ocular remission, although recurrence rates are unclear.

The largest studies (70 to 83 patients, with multiple treatment regimens) show that overall survival is no different for local versus local and extensive regimens.

In conclusion, VRL is a rare cancer with challenges related to non-specific presentation, high rate of false negative cytology, poor survival and lack of medical evidence to guide therapy but there is an expanding armamentarium of investigations, such as cytokine analysis, genetic testing, ophthalmic imaging.

Multinational multidisciplinary collaborative efforts are fuelling progress,” Prof. Smith said. Finally, she touched on HIV-associated VRL, which has been reported in less than 20 patients ranging in age from 26 to 71 years old. HIV-positive persons have 17 times the risk of primary CNS lymphoma but the relative risk of VRL is unknown. It is often misdiagnosed as CMV retinitis. Infectious uveitis may co-exist. Treated with ART and lymphoma-focused local and/or extensive therapies will raise the CD4 count and lower the HIV viral load, leading to better survival for primary CNS lymphoma. If optimally managed, survival outcomes should approach those in HIV-negative persons, she said.

Tips to Succeed in Small Private Practice

Thinking of moving into your own private practice? Are you already in one and need advice on how to maintain financial security? Debra L. Phairas, president of Practice & Liability Consultants, offered up some of her 35 years of experience in the physician practice management and healthcare industry. On the 2nd day of AAO 2020 Virtual we tuned in to Survival Skills to Thrive in Private Practice! to hear some of the factors she considers most important to keep in mind as a private equity ophthalmologist.

Private or employed: which is right for you?

One of the first thoughts Ms. Phairas posed was how to decide if you’re better suited for private practice or as an employed physician. She presented some questions to ask yourself when choosing between the two:

1. How much do you like to be in control?

2. Are other physicians in the designated work role happy and satisfied with the work culture?

3. Are you satisfied with the compensation formula?

by Elisa DeMartino

4. If choosing the employment route, can you negotiate a 3-5 year guaranteed salary?

While noting that private equity has been very popular in ophthalmology, she went over some of the pros and cons of each option primarily revolving around salary considerations. One of these considerations was that compensation negotiation is important for those moving to or staying in employment; alternatively, there was a detailed list of steps outlined to plan expenses of a private practice.

Private practice expense planning

In private practice you’ll be responsible for various aspects down to data privacy, areas of liability, and – perhaps the most touched upon by our speaker this afternoon – finances.

Responsible financial practices include benchmarking, or comparing practice costs to other similar practices, and developing detailed expense categories line by line. “You need to know all of this to see… what are the ranges and percentiles; the median is what you should be probably looking at,” the expert explained.

She also suggested finding ways to reduce overhead by investing in an accountant and referring to reports by AAO and MGMA.

Merging considerations

Continuing along the topic of finances, the speaker addressed any viewers thinking of merging, which she described as a process that shouldn’t be rushed for economic, competitive, or managed care pressures.

She warned against merging too quickly just to save costs, saying “just like marriage, money is the biggest reason for a divorce and the biggest reason for why people don’t get along in practice.”

Additional things to keep in mind

Ms. Phairas threw in several more tips for “thriving and surviving” in private practice. She strongly recommended having a planned yearly budget and noted that the October-November time period we’re in now is the best time to create one for the next year.

She also reminded viewers to keep up with fine details such as turnover rate, future trends, and even office clutter that can slow down staff.

On the subject of marketing your practice our speaker suggested you forget about yellow pages and instead focus on search engine optimization and content management of your website. She added that you ought to look at consumer reports and keep an eye on your reputation on rating sites.

Final thoughts

Debra Phairas encouraged everyone that in order to survive and thrive in pirate practice, “you just have to learn some basic business development principles, some finance principles; you have to have some operations improvement knowledge and a good human resources background.” She closed her session by urging that anyone thinking of opening a private practice should, in addition to adopting this well-rounded approach, remember to take care of themselves particularly during this pandemic year.

Through the Looking Glass IOL Updates

No full-scale ophthalmology conference would be complete without a discussion of the newest and best intraocular lenses (IOLs), and AAO 2020 Virtual did not disappoint. Chairs Dr. Bobby Ang and Dr. John Chang led the discussion, which featured not just the best and newest IOLs, but delved into the nitty gritty of techniques and featured a lengthy Q&A session. If you’re an IOL geek, this panel is mustsee TV.

Extended range of focus IOLs

Dr. Robert “Bobby” Ang guided viewers through a bit of the history of multifocal IOLs before delving into the quickly evolving world of extended depth-offocus (EDoF) IOLs. The first EDoF lens to be approved by the FDA was as recent as 2016, so this is fairly new technology indeed.

Dr. Ang explained that EDoF lenses provide a good balance between quality and quantity of vision. They give better vision for gadgets like smartphones or laptops than monofocals, even with less near vision compared to multifocals. There’s also fewer patient complaints of photic phenomena like glare and halo compared to multifocals. Overall, EDoF lenses appear to be a good compromise.

Compared to trifocals, EDoF lenses provide very good distance and intermediate vision, though wearers will likely need reading glasses. Dr. Ang noted they’re valuable for targeting mild myopia or mini-monovision.

EDoF: Small aperture IOL

Continuing with the EDoF discussion, Dr. John Vukich introduced Small Aperture IOLs as a way to produce true extended depth of focus. They’ve been available

by Sam McCommon

in Europe for several years, and can help neutralize astigmatism.

He described the Small Aperture design as a single piece made of hydrophobic acrylic, with a 1.36 mm aperture and 3.23 mm total diameter. It provides a broad range of vision and is tolerant to astigmatism within 1.50 D.

One important note with Small Aperture IOLs is that both fundus photography and retinal OCT are both possible. Differences are minimal compared to both monofocal and multifocal for fundus photography and multifocal for OCT.

Dr. Vukich also suggested Small Aperture IOLs are valuable for irregular corneas, including post-radial keratotomy, postkeratoconus, and post-LASIK patients.

Mix ‘n’ Match: Combining IOLs

Dr. Aylin Cilic explored the possibility of using different IOLs in patients’ eyes

to achieve balance between each IOLs strengths. By combining different lenses, patients can rely on different eyes for different tasks.

Dr. Cilic pointed out that high-add IOLs provide better near vision and worse distance vision, whereas low-add IOLs lead to better distance and intermediate vision. So, applying one each to different eyes can lead to an overall improved field of vision — assuming the patient likes the idea, of course. Overall, patient satisfaction has been high, according to a publication by Yang et al. in a 2018 BMC Ophthalmology paper.

Mixing and matching can lead to a bestof-all-worlds scenario in some cases. In addition to maximizing each lens’s best features, mixing and matching can also reduce common visual side effects of multifocal IOLs like halo, glare, and reduced visual acuity in intermediate and near ranges.

Unfortunately, there is currently no study comparing mix-and-match trifocals compared to bifocals. But if we know anything about studies, we can assume that somebody is either already planning one or is thinking about it.

Dr. Cilic concluded that the mix-andmatch with high- and low-add power lenses is an effective way to achieve good quality of vision over a broad range without affecting quality of vision. The practice also provides another option for patients who want to be free from glasses after cataract surgery.