The FDA has granted Class II prescription-only 510(K) clearance for an iPhone-enabled vision test. The software, called myVisionTrack, was developed by Vital Art and Science. The FDA clearance applies to the software when run on an iPhone 4S.
Vital Art and Science has developed the test for patients with serious degenerative eye conditions such as diabetic retinopathy (DR) and age-related macular degeneration (AMD), who will be able to use it to monitor their vision regularly at home. The software compares results to previous results, and can automatically alert a physician if a significant change has occurred, so the physician can respond with an appropriate therapy in a timely way. As the product is developed, the company also plans to enable it to send patients' results to their EHRs in a safe, HIPAA-compliant way.
According to President Mike Bartlett, the company hopes to have a downloadable app version of the platform eventually. But because the software is only currently cleared for prescription use, the initial form factor will probably be to distribute pre-loaded iPhones to patients.
"Right now we're looking for collaboration opportunities like clinical drug trials," he told MobiHealthNews. "In all of the clinical drug trials [for degenerative eye diseases], all of the data is being collected in the clinic. We want to enable them to collect data as often as hourly or daily instead of every month or so. Because of the nature of vision problems, we expect the first big deployments will be done by the drug companies."
The company is already in talks with Novartis, makers of Lucentis, which is prescribed for DR and AMD. Novartis funded a clinical trial of myVisionTrack. Bartlett hopes the software will be prescribed along with drugs like Lucentis and paid for by patients' health plans.
The app runs a test called shape discrimination hyperacuity (SDH), which is licensed from the Retina Foundation of the Southwest, whose research showed it to be one of the most likely vision tests to work on an electronic device. This is partly because, unlike the famous Snelling test typically used in opthamologist offices, the SDH is distance insensitive, which means patients using it at home can hold it at any natural distance from their faces without effecting the accuracy. In two different clinical trials, Vital Art and Science found the test to be equal to or better than a Snelling test in terms of accuracy. In the test, patients are repeatedly presented with three shapes and have to tap the one that looks different.
Bartlett believes over-the-counter clearance is something that will come along for diagnostic apps, once they've become more commonplace.
"We felt from the beginning we wanted to develop the regulatory approved version," said Bartlett. "The one that's going to be used and trusted by doctors."