App-based vision test gets second FDA clearance, remote trial with Scripps, Roche

By Jonah Comstock
11:07 am

mVTnew-1Vital Art and Science, developers of myVisionTrack, a vision test service for patients with age-related macular degeneration or diabetic eye disease, has received a second FDA clearance for their platform, which includes an app and a provider dashboard. They will also soon launch a major clinical trial in partnership with the Scripps Translational Science Institute and Roche, according to the study's website.

mVT addresses age-related macular degeneration, which is one of the leading causes of blindness. It allows patients to track subtle changes in their vision and automatically alerts their physician, which enables doctors to launch an intervention early, before the patient loses more of their vision. (See a video explanation of the technology here.)

The new version, which is due to launch in the next week, doesn't substantially alter the product offering, but the company has made big changes to the user interface in preparation for their commercial launch, according to Chief Marketing Officer George Mavro.

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"We’ve changed everything up to go commercial," Mavro told MobiHealthNews. "We’re commercializing the product which means we’re going out to ophthalmologists, optometrists, eye care specialists. We work with them, they prescribe it to patients. The patients take the prescription code, they enter it into the app, [and] they start testing from home. All the results go to their doctor that prescribed them mVT, and any changes in their vision alert the doctor’s office to bring them in for an assessment and possibly treatment. And all of that means that potentially the patient gets to prolong their vision."

Since the FDA clearance, the company has signed on its first clinic customer and has three more ready to go. The new user design has been a challenge, Mavro said, because the app still needs to be easy to use for patients with poor vision, which means large text and high contrast, neither of which are associated with good modern app design. The company has opted for an approach that they hope will be more aesthetic than the previous version without sacrificing any usability.

The study, called the Pivot study, is being sponsored by Roche. It will assess the effectiveness of home vision testing using mVT, and will also help Roche test online patient recruitment procedures, including social media strategies. The goal is to recruit at least 250 patients, and as many as 1,000, according to the study website. It will be a remote trial that won't require patients to make additional in-person visits.

"The whole goal here is to provide these patients a tool to monitor their vision in the comfort of their home," Mavro said. "After dinner, before breakfast, after an event, whenever. In the comfort of their own home, on the couch even, to be able to quickly monitor their vision and not have the fear or anxiety of 'what happens when something changes?'"

In addition to the Pivot study and one other ongoing trial, Vital Art and Science is also planning to integrate with EHR companies, Mavro said, that will enable them to tie their backend directly into a patient's electronic health record. They're also pursuing a relationship with NASA to help investigate the effects of microgravity on visual acuity.


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