FDA allows home visual acuity testing
August 17, 2022
2 minute read
The FDA announced that it had cleared Visibly Digital Acuity, a web-based, self-guided software application for testing visual acuity at home.
The technology, approved by the FDA on Aug. 12, is intended for use by adults ages 22 to 40 for assessment with or without correction, the agency said on its website.
The results obtained from the tests are meant to be “supporting recommendations” that an eye care provider will use in conjunction with the patient’s medical history and profile, previous corrective prescriptions and subjective vision data, according to the FDA.
“This device does not provide screening or diagnosis for eye health or other disease and is not a substitute for an eye health examination with an approved provider,” the agency said.
Visibly, formerly known as Optionnal, said in a press release that its Visibly Digital Acuity (VDAP) product is the first FDA-approved online visual acuity test in the US market.
“With their newly acquired 510(k) clearance from the FDA, Visibly’s telemedicine platform can continue to expand affordable access to eye care for millions of consumers,” Visibly said 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 a computer.
“Results of completed vision tests are made available to eye care professionals immediately and securely, helping them to assess the best course of action for each patient,” the company said.
Obviously COO Paul Foley said in the release that a prospective, multi-center clinical study has shown the safety and efficacy of VDAP to be “substantially equivalent” to an ETDRS visual acuity pathway test.
“The clinical performance of the VDAP will help eye care professionals assess visual acuity remotely and connect patients to care in a way that was not available before,” Foley said.
The company said in the release that it “looks forward to accelerating its mission of partnering with leading optical organizations to provide eyecare professionals and their patients with a convenient and affordable way to obtain information about quality of people’s view 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 a series of consequences, including a warning letter from the FDA in 2018, stemming from a long series of inaccurate and potentially dangerous claims,” the AOA said.
The association said it is “carefully reviewing the FDA’s findings and will continue to urge Congress and all federal and state enforcement agencies to prioritize addressing false product claims and impediments.” erroneous to a physician’s care”.