December 2020


Pandemic pushes remote monitoring and testing

by Liz Hillman Editorial Co-Director

Injectsense implant, smaller than a grain of rice
Source: Injectsense

iCare HOME device
Source: iCare

Tests available on the Verana Vision Test application
Source: Verana Health

The COVID-19 pandemic and the early shutdown of non-essential medical visits propelled innovation on the front of home monitoring, diagnostics, and treatment. Some systems are available now, some in the works, and some still on ophthalmologists’ wish list.
Though in-person clinic visits returned to “normal” several months ago, Ranya Habash, MD, said in September that telehealth visits still comprise almost 30% of the practice at Bascom Palmer Eye Institute. For many around the country, telehealth in some capacity is also here to stay even post-pandemic. As MarketScope put it in a July article announcing its 2020 Diagnostic Equipment Market Report:

Increasing demand for telehealth and mobile applications due to the COVID-19 pandemic has led manufacturers to scramble to add functionality and accessibility to existing devices and protection apparatuses or create new devices.
Regulatory bodies and reimbursement organizations have relaxed rules to enable lower barriers for practices implementing these products and services, giving a rare path forward to a telehealth business model that struggled to find its footing in the past.
Historically, the ophthalmic diagnostic equipment market has been one of the most dynamic spaces within ophthalmology, with several new devices and features added every year.
This was never more true than during the early stages of the pandemic, as physicians struggled to manage chronic patients while many countries were in various states of lockdown.

“People have found that telehealth makes sense. It will only grow with further advances in digital health technology,” Dr. Habash said.
For telemedicine to become even more successful in the very image-reliant specialty of ophthalmology, there are technologies needed to expand this option.
Regular IOP monitoring is one of the most obvious examples. Even though glaucoma services pivoted during the shutdown and many began hybrid visits and drive-thru IOP checks, there is still the need for truly remote monitoring. iCare HOME (iCare) is one option that Dr. Habash mentioned, which performs handheld tonometry and is covered by insurance as a remote monitoring device. Dr. Habash also brought up Injectsense, which is creating an injectable smart sensor that can continuously monitor IOP. It recently received an FDA Breakthrough Device Program designation.
“I think this is really exciting. … This is a missing piece of the puzzle,” she said.
Triggerfish (Sensimed) has been approved since 2016, but it has been used more for research purposes rather than being adopted for the wider patient base.
With remote monitoring devices like these, Dr. Habash said, physicians can access a patient’s data without the necessity of an in-person exam. Physicians get reimbursement for monitoring the data/alerts sent from the device and another fee for discussion held with the patient to go over results. This is a monthly reoccurring payment.
Another simple monitoring tool Dr. Habash uses is an Amsler grid. She screenshares an Amsler grid from her phone or computer during telehealth visits with patients, so patients don’t need to download an app. She also mentioned ForeseeHome (Notal Vision), an AMD home monitoring program that sends an alert to doctors if the patient shows a statistically significant difference in a digital tracing.
“It’s a more subtle way to look for changes in the Amsler grid, with a connected device using Internet of Things (IoT) alerting,” Dr. Habash said.
Remote visual field testing is another tool Dr. Habash thinks will be adopted as a result of the telemedicine push. Several companies are working on technology for this. One challenge practices have been discussing is how to keep the in-office visual field machine clean.
“If the visual field test can be taken on a wearable device like the Microsoft HoloLens or any virtual reality headset, sanitizing becomes much simpler, and you don’t have to worry about masks causing an inferior visual field defect,” Dr. Habash said.
Autonomous diagnostics also play into this discussion. IDx-DR (Digital Diagnostics) was FDA approved to screen for diabetic retinopathy and macular edema in April 2018, and EyeArt (Eyenuk) was approved for autonomous detection of diabetic retinopathy in August 2020.
“This is important because it’s paving the way for other artificial intelligence tools,” Dr. Habash said, noting that she also worked with Microsoft to create an algorithm for multiple retinal disease detection autonomously.
For such tools to really be adopted to enhance telehealth offerings and capabilities, Dr. Habash said regulatory issues and reimbursement are the major factors. CMS, for example, created a code for autonomous diagnostic reads. Next is evidence. People want to make sure the technology is providing outputs as accurate as their in-office counterparts. “In most cases, it’s actually more accurate,” Dr. Habash said.
“These are big moves for this year. We’ve never had any of these things or made progress so fast … and to get the government to act, to cover services, to reimburse us for the care we provide, to create new codes, to give breakthrough clearance, these are momentous accomplishments,” Dr. Habash said.
Michael Singer, MD, discussed various needs for better remote, telehealth visits in ophthalmology as well. He spoke with EyeWorld just as practices were beginning to reopen their doors after the shutdown.
Dr. Singer discussed software like myVisionTrack Vision Monitor (Genentech), as well as Verana Vision Test (Verana Health, formerly DigiSight Technologies). These programs have quantitative processes that could help the physician follow the patient over time and, in theory, show progression or any potential vision loss, he said.
In terms of apps on mobile devices, Dr. Singer said there are a number of different eye charts, tests for color blindness, and more, but many are more directed toward optometry. These apps, at least, can help establish what the patient is seeing or not seeing, Dr. Singer said.
Some technologies are suited for remote examinations but not necessarily home use. For these, Dr. Singer thinks technology could be set up in areas where patients might be going anyway, such as grocery stores. The results from this remote examination/imaging technology could then be sent to the doctor to add value to telehealth visits.
Overall, Dr. Singer said that remote testing and telehealth won’t completely replace traditional, in-office visits, in part due to the social component.
“In our patient population, fear has kept them isolated, but going to the doctor is part of their social experience. But I think there will be a bigger niche [for telehealth] than there was before,” he said.
The perspective of Michael Freeman, JD, is that doctors had previously accepted remote diagnostic, testing, and treatment options in settings where it wasn’t as feasible to have bulky equipment, such as military outposts or in some developing countries.
“Now, it’s just remarkable,” he said of the shift in physicians’ perspectives to broader acceptance of these devices when possible during the pandemic.
Ocutrx, for example, is creating an augmented reality headset (Oculenz) that has eye-tracking capabilities for medical applications. The headset will be able to perform real-time visual acuity, contrast sensitivity, visual field, reading speed testing, and more. Mr. Freeman said when the pandemic hit, several of the KOL supporters of the company emailed him with interest in the technology’s utility at that time, if it were only market ready.
“It’s something that I think the physicians hadn’t thought of adopting before, but there was more of a push from the patient side. Now I think there will be more of a push from the physician and the patient side because … a lot of physicians [were] literally sidelined,” Mr. Freeman said.
Ocutrx received its third patent covering in-home patient visual field test taken within the Oculenz. The patent claims include edge perimeter testing to identify areas of degenerated visual acuity (scotoma) for patients with macular degeneration. As progressive tests are taken, the Oculenz algorithms automatically identify and notify the physician of a change or increase in size or shape of the scotoma.

About the sources

Ranya Habash, MD
Medical Director of
Technology Innovation
Bascom Palmer Eye Institute
Miami, Florida

Michael Singer, MD
Director of Clinical Research
Medical Center Ophthalmology Associates
San Antonio, Texas

Michael Freeman, JD
Founder and CEO
Irvine, California

Relevant disclosures

: Microsoft
Singer: Verana Health
Freeman: Ocutrx



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