FDA clears at-home visual acuity test
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The FDA announced that it cleared the Visibly Digital Acuity Product, a web-based, self-guided software application for testing visual acuity at home.
The technology, which the FDA cleared Aug. 12, is intended for use by adults between 22 and 40 years old for evaluation with or without correction, the agency stated on its website.
The results obtained through the testing are meant to be “supportive recommendations” that an eye care provider will use in conjunction with the patient’s medical history and profile, prior corrective prescriptions and subjective vision data, according to the FDA.
“This device does not provide screening or diagnosis of eye health or other disease and does not replace an eye health exam with a licensed provider,” the agency stated.
Visibly, formerly known as Opternative, stated in a press release that its Visibly Digital Acuity Product (VDAP) is the first FDA-cleared online visual acuity test on the U.S. market.
“With their newly acquired 510(k) clearance from the FDA, Visibly’s telemedicine platform can continue to expand affordable access to vision care for millions of consumers,” Visibly stated in the release.
The company explained that the user can access the test, which can be completed in about 6 minutes, at any time through a combination of a touchscreen mobile device and computer.
“Completed vision test results are made available to eye care professionals immediately and securely, helping them evaluate the best course of action for each patient,” the company said.
Visibly COO Paul Foley said in the release that a prospective multicenter clinical study showed that VDAP’s safety and efficacy are “substantially equivalent” to an ETDRS visual acuity lane test.
“VDAP’s clinical performance will aid eye care professionals in the remote evaluation of visual acuity and connect patients with care in a way that was not available before,” Foley said.
The company stated in the release that it is “eager to accelerate its mission to partner with the leading optical organizations to equip eye care professionals and their patients with a convenient and affordable way to get information about how well people are seeing from their own homes.”
This FDA action “increases oversight authority,” according to a statement the American Optometric Association provided to Healio.
“[This] comes after the company faced an array of consequences, including a 2018 FDA warning letter, arising from a long series of inaccurate and potentially harmful claims,” the AOA stated.
The association said it is “carefully reviewing the FDA’s findings and will continue to insist that Congress and all federal and state enforcement agencies prioritize the fight against false product claims and misguided barriers to a doctor’s care.”
Reference:
- FDA Roundup: August 16, 2022. https://www.fda.gov/news-events/press-announcements/fda-roundup-august-16-2022. Published Aug. 16, 2022. Accessed Aug. 17, 2022.
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