Ophthalmology Business

JUL 2013

Ophthalmology Business is focused on business topics relevant to the entrepreneurial ophthalmologist. It offers editorial, opinion, and practical tips for physicians running an ophthalmic practice. It is a companion publication of EyeWorld.

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had memorized the visual acuity chart, so at first I just set out to build a chart where each line could be randomized. Professionals began using it and I realized that having a visual acuity exam in a format they were familiar with in a mobile device was useful. I worked with doctors who used the product to add additional features, one at a time." In addition, an iPhone or iPod can be used as a remote to control the iPad app with the Eye Chart Pro Remote Contol app. The iPad can be placed on the examination room wall and used instead of a projector, with features including a shutter to isolate individual lines on the chart. Physicians outside of ophthalmology can find the app useful in diagnosing visual acuity issues that could require a referral to an ophthalmologist. "It's not designed for patients. We purposefully stayed away from diagnosing acuity. We'd rather provide medical professionals with a tool to help them in their jobs," Mr. Lakkur said. Patient diagnostic app Diagnostic apps for patients include the SightBook app from DigiSight Technologies (Portola Valley, Calif.), the first web-based system for the mobile monitoring of vision for retina patients. Mark S. Blumenkranz, MD, member of the DigiSight Board of Directors (BOD), and professor and chairman, Stanford University, Stanford, Calif., co-developed the app with fellow DigiSight BOD member David Palanker, PhD, three and a half years ago. "The diagnostic apps that I think are most useful to ophthalmology are those that allow patients to be able to monitor their vision outside of the office and to provide more data with regard to how they're doing. [These include patients who] have diseases that place them at risk for vision loss, as well as patients who are on active therapy and who are on some of the more recent drugs that have come out, like Lucentis [ranibizumab, Genentech, San Francisco], Avastin [bevacizumab, Genentech], and EYLEA [Regeneron Pharmaceuticals, Tarrytown, N.Y.], in which we tend to tailor the treatment according to how the patient's doing," said Dr. Blumenkranz. Patient adherence Another platform technology that includes an app is CheckedUp. This app is in its clinical beta-testing mode now and enrolling key practices across the country. Richard Awdeh, MD, professor of ophthalmology, Bascom Palmer Eye Institute, Miami, and a member of the CheckedUp team, started development of this app in late 2011. "Mobile technology lends itself very nicely to us as ophthalmologists. The ability to monitor our patients' adherence to treatment plans and monitor their disease progression while they are out of the clinic revolutionizes our ability to care for our patients," Dr. Awdeh said. "Imagine having data points that are taken on a daily or hourly basis, rather than intermittent data points that are taken every three or six months during a clinic visit." CheckedUp is focused on engaging patients in their treatment care plan. FDA regulation Because these medical mobile apps are diagnosing and monitoring health issues, the U.S. Food and Drug Administration has taken notice, with draft guidance on the matter in 2011. It defined a "small subset" of medical apps as those that "impact or may impact the performance or functionality of currently regulated medical devices" and as a result would be more closely regulat- ed than other medical apps, according to a release from the FDA. The subset is considered to be apps used as accessories to medical devices already FDA-regulated and those that change a mobile device into a regulated medical device. According to news reports, final guidance is expected from the FDA by the end of fiscal year 2013. "The draft guidance suggests that things that measure refractive error, like refractometers or vision charts for instance, are thought to be considered Class I because they essentially replicate," Dr. Blumenkranz explained. "There's no potential for harm, and they represent another way of measuring vision, analogous to putting up a cardboard light panel with letters of different sizes on the wall." He said the FDA's draft guidance seems to have the right idea about regulating more impactful diagnostic apps. "I think when devices are used to make a specific diagnosis or when they directly indicate that you should use more or less of this drug at home, insulin for instance, based on your glucose reading, then that's a different thing. I think those kinds of devices need to be more strictly regulated. It depends on the nature of the app," he said. OB Editors' note: Dr. Awdeh has financial interests with CheckedUp. Dr. Blumenkranz has financial interests with the SightBook app. Mr. Lakkur has financial interests with the Eye Chart Pro app. Contact information Awdeh: richard.awdeh@gmail.com Lakkur: eyechartpro@gmail.com Blumenkranz: Mark.s.blumenkranz@gmail.com July 2013 • Ophthalmology Business 19

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