myVisionTrack: An At-Home App for Monitoring Eye Disease Receives FDA Clearance
myVisionTrack ™ is a hand-held, prescription-only medical device, provided as an app for the iPhone 4S, that has received clearance by the United States Food and Drug Administration (FDA) on March 24, 2013 to be marketed as an at-home method for monitoring the progression of degenerative eye diseases, such as macular degeneration and diabetic retinopathy.
The myVisionTrack™ medical device is produced by Vital Art and Science (VAS), Inc., a Richardson, Texas-based biotechnology firm. VAS was founded in 2006 by a multi-disciplinary team with expertise in ophthalmology, electronics, software, and business development to identify, advance, and commercialize innovative home diagnostics for treatable chronic diseases.
How myVisionTrack ™ Works
The myVisionTrack ™ app displays three side-by-side circles on the screen; initially, one circle is significantly different from the others (with a wavy or jagged edge, for example).
To perform a self-check, the patient covers one eye and then selects/touches what he or she determines to be the "differently-shaped" circle. Each time the patient makes a selection, subsequent screens display three additional circles with increasingly subtle differences among the three. The test is then repeated with the other eye.
The device stores the self-check test results, tracks eye disease progression, and automatically alerts a health care provider if a significant deterioration of visual function is suspected.
Prior Research with myVisionTrack ™
Researchers at the University of Texas Southwestern Medical Center and the Retina Foundation of the Southwest tested a prototype device in an eight-month clinical trial that was funded by the National Eye Institute.
In that trial, 40 subjects who were diagnosed with diabetic retinopathy used the myVisionTrack ™ monitoring device weekly at home. The subjects' test results revealed a significant correlation with an ophthalmologist's reading of their retinal images, which were taken at the beginning, midpoint, and end of the study. The myVisionTrack™ device underwent additional clinical testing for two more years before receiving clearance by the FDA.
FDA Clearance for myVisionTrack ™
From a Vital Art and Science press release:
Vital Art and Science, Inc. has received U.S. Food and Drug Administration 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 patented shape discrimination hyperacuity (SDH) 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.
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.
myVisionTrack™ 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™.
According to Mike Bartlett, Vital Art and Science Inc. president, the company is seeking strategic partnering opportunities for marketing and distribution of myVisionTrack ™.
VisionAware will provide updates on myVisionTrack ™ as they become available.
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