FDA Clears At-Home Visual Acuity Testing System

The Food and Drug Administration (FDA) has granted 510(k) clearance to Visibly Digital Acuity Product, an at-home online visual acuity test for use by individuals 22 to 40 years of age who have the capability to perform a self-test at home, to aid in the evaluation of visual acuity with or without correction.

Using a touchscreen mobile device paired with a computer, individuals can self-administer the visual acuity test, which presents visual stimuli, such as block letters or other symbols in graduated sizes, on a digital display located at the predetermined distance from the patient. Based on the individual’s responses, the device provides an assessment of visual acuity.

The FDA clearance was based on results from a prospective, randomized clinical study (ClinicalTrials.gov Identifier: NCT05026658) that compared the safety and effectiveness of the Visibly Digital Acuity Product with the ETDRS Visual Acuity Lane Test.

Individuals can complete the test in approximately 6 minutes, at which point the test results will be made available to an eye care professional. According to the Company, over 90% of prescriptions are issued within 24 hours with most prescriptions issued in 2 hours.

“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,” said Paul Foley, Visibly’s COO.

The application does not provide screening or diagnosis of eye health or other disease, and does not replace an eye health exam with a licensed provider.

References

1. Visibly becomes first FDA-cleared online vision test in the United States. News release. Visibly. August 16, 2022. Accessed August 22, 2022. https://www.prnewswire.com/news-releases/visibly-becomes-first-fda-cleared-online-vision-test-in-the-united-states-301606088.html
2. FDA Roundup: August 16, 2022. Accessed Aug. 22, 2022. https://www.fda.gov/news-events/press-announcements/fda-roundup-august-16-2022