MyVisionTrack, an app that allows patients with degenerative eye disease to monitor their own visual function, has received 510(K) clearance from the FDA.
This iPhone 4S app is designed so that patients can do a self evaluation at home.
The motivation for the app was based on the difficulty patients had with self-detection of eye problems using paper charts. This was combined with the importance of timely identification and treatment of diseases such as proliferative diabetic retinopathy or diabetic macular edema.
MyVisionTrack works based on a test that shows 3 circles. One of the circles is distorted and the patient is asked to select it. The distortion increases and decreases based on correct and incorrect answers respectively. Based on the results, an algorithm is used to calculate the results. The test is not affected by the distance between the user and the phone. The test’s sensitivity and specificity were comparable or higher than the relevant clinical tests.
The creator of MyVisionTrack, Vital Art and Science, plans to develop an app for the iPad as well. Unfortunately, it would be difficult for them to develop for the Google mobile platform due to the variability between devices.
Vital Art and Science President Mike Bartlett explained, “For tests such as ours, the FDA has made it clear they want to see our tests results on each new platform and approve those one by one.” This makes development costly and time consuming for the Android platform. Bartlett says that the testing and approval cannot be completed before the devices are already obsolete.