The US Food and Drug Administration has recently awarded 501(k) clearance to Visibly for their self-administered online visual test. The Visibly Digital Acuity Product is the first online acuity test to enter the US market.
To use the world’s first at-home digital vision testing platform, individuals are required to use a mobile device, a prescription for their current correction and ten feet of space. According to the developers, the test is most suitable for individuals whose vision hasn’t altered, who have undergone a professional eye exam, and who require the results to purchase new glasses or contact lenses, or renew an expired prescription. The exam may be conducted at any time, and it requires around 6 minutes to perform. Eye Care Professionals are given immediate, safe access to the full results of the vision test, enabling them to determine the best course of action for each patient.
The online visual test was awarded FDA approval after a comprehensive study indicated its safety and effectiveness in comparison to an ETDRS Visual Acuity Lane Test. “We are thrilled to achieve this milestone.” Stated Paul Foley, Visibly’s COO, “Our Performance Data, including our prospective, multi-center clinical study that evaluated the safety and effectiveness of VDAP compared to an ETDRS Visual Acuity Lane Test, demonstrated that the safety and effectiveness of VDAP are substantially equivalent to those of its predicate device.
Despite receiving clearance, the digital visibility test must enter the US market with a number of restrictions. The device is only eligible for use for adults aged 22 to 40 years and is not identified as a suitable placement for an eye health test with a healthcare professional. Rather the outcomes of the digital test must only be used as supporting advice.
Visibility is a healthcare technology development company based in Chicago, Illinois. The developers of the device believe that the digital platform will provide millions of individuals with access to vision care. Visibly hopes to continue leading the optical healthcare market to improve patient care and their communication with physicians.