FDA approves medical device that helps patients monitor their vision

Vital Art and Science Inc. has a U.S. Food and Drug Administration (FDA) clearance to market myVisionTrack, a prescription-only medical device that enables patients with retinal diseases to monitor their vision function between regular visits to their eye-care professional to help ensure they obtain timely care and treatments.

Using a proprietary shape discrimination hyperacuity test, myVisionTrack enables patients to regularly assess their vision function. The device stores test results, tracks disease progression and automatically alerts a health care provider if it suspects significant deterioration of visual function in the patient.

Age-related macular degeneration (AMD), diabetic retinopathy (DR) and other retinal diseases afflict more than 40 million people in countries with advanced health care systems. Roughly 13 million people suffer from these diseases in the United States. During the past decade, new therapies have been developed for these degenerative eye diseases, but timely diagnosis and treatment are critical to their effectiveness.

Clinical studies demonstrate that myVisionTrack’s shape discrimination hyperacuity test has comparable or higher sensitivity and specificity as compared to clinically available standard visual function tests for detecting advanced maculopathy from high-risk moderate maculopathy.

The app can be used in a physician’s office or at home by patients with maculopathy to help track disease progression, detect disease condition changes for earlier intervention and document treatment effects. Research confirms high satisfaction and compliance rates among patients able and willing to self-test at home with myVisionTrack.

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