iPhone App for Vision Tests Gains FDA Approval

By Brian T. Horowitz  |  Posted 2013-04-11

iPhone App for Vision Tests Gains FDA Approval

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.

iPhone App for Vision Tests Gains FDA Approval

"For new tests such as ours, the FDA has made it clear they want to see our test results on each new platform and approve those one by one," Bartlett said. "The big challenge in developing a medical app for Android is that not only are the screen sizes different but every manufacturer customizes the Android operating system as well," he explained. "This makes developing apps like ours very challenging, and by the time we get through the verification and validation testing and then the FDA approval, the smartphone is obsolete," Bartlett said.

Many "serious" medical apps are developed for Apple iOS because of the "relative stability to the hardware and operating system," Bartlett said.

In studies conducted using the MyVisionTrack app, tests resulted in sensitivity and specificity that were either higher than or comparable to clinical tests, VAS reported. The app can be used inside or outside a doctor's office.

The National Eye Institute, a division of the National Institutes of Health performed a "proof of concept" study on the app in 2010 at the University of Texas Southwestern Medical Center and Retina Foundation of the Southwest, Bartlett noted.

"In this study we had 36 diabetic retinopathy patients who tested at home for six months, and it demonstrated the basic capability of patients to self-test at home with good results," he said.

A 2011 study by a major drug company on 160 wet, age-related macular degeneration (AMD) patients revealed the results of MyVisionTrack matched up well with visual acuity testing by a doctor, Bartlett said.

MyVisionTrack stores the results on the iPhone locally and encrypts test results using an algorithm compliant with the Health Insurance Portability and Accountability Act (HIPAA).

Although MyVisionTrack isn't available for download yet from iTunes, a doctor may distribute iPhones with the software already installed.

The company is looking to distribute the app commercially and has not set pricing for the product, according to Mobihealthnews. VAS is working with Novartis, which offers the wet AMD drug Lucentis and funded a clinical trial for the app.

"Our goal is to collaborate with the drug companies producing the therapies for these retinal diseases to quickly deploy our test out to their patients," Bartlett said. Drugs such as Lucentis "can help control the disease, but are not a cure, and so patients need a way to monitor their own disease progression at home to ensure they get timely treatments," he said. "We want to do everything we can to help those suffering from one of these diseases to save their vision."

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