iPhone App for Vision Tests Gains FDA Approval

The U.S. Food and Drug Administration has authorized use of an iPhone app to allow retinal disease patients to monitor their vision between visits to the doctor.

The U.S. Food and Drug Administration has approved use of the MyVisionTrack iPhone app from Vital Art and Science (VAS), an ophthalmic medical device company, to allow patients to monitor their vision in between visits to the doctor.

MyVisionTrack was developed for elderly patients with serious retinal diseases, such as age-related macular degeneration and diabetic retinopathy. It incorporates a proprietary shape discrimination hyperacuity (SDH) test by the Retina Foundation of the Southwest, which developed an eye exam that's suitable for a PC or smartphone and is unaffected by factors such as user distance, Mike Bartlett, president of VAS, told eWEEK in an email.

The test consists of three circles, one of which is distorted, Bartlett said. The app instructs patients to "touch the circle that is different," he explained. "As they get it right, the distortion gets smaller; when they miss, the distortion gets bigger," he said.

Then the test moves to the user's threshold until the distorted circle is no longer visible. An algorithm determines a patient's vision threshold using statistics generated by the app.

The app can store test results and monitor disease progression using the Apple device. In addition, MyVisionTrack automatically notifies a doctor if a patient's vision deteriorates significantly.

Founded in 2006, VAS announced the FDA's approval on April 5.

The approval consists of Class II prescription-only 510 (K) clearance for use on an iPhone 4S by prescription only, Mobihealthnews reported. VAS designed the app according to FDA requirements, Bartlett said.

Patients can only use the app with a doctor's prescription, he noted. "If we do detect a significant change in the users' vision in a short period of time, we need to notify the physician and then they decide if the patient should come in to see them," Bartlett said.

The current app is suitable only for the iPhone 4S's screen size and can detect the hardware on that device, Bartlett said, but a newer version undergoing a study will work with the iPad's larger screen.

"For our patients with very poor vision, the larger screen size makes the instruction screens much more readable," he said.

Although MyVisionTrack could run on any smartphone or tablet with a color screen, medium resolution and touch-screen input, with the varying screen sizes of Android devices, the Google mobile OS isn't currently suitable for MyVisionTrack, according to Bartlett.