Industry News
Visibly Becomes First FDA-Cleared Online Vision Test in the United States
Visibly, formerly known as Opternative, a telehealth Chicago-based company, founded in 2012, which provides online vision tests and generates eyeglasses and contact lens prescriptions for site visitors has announced that, as of August 12, 2022, it has received 510(k) Clearance from the United States Food and Drug Administration for its Visibly Digital Acuity Product (VDAP). Visibly becomes the first FDA-cleared online visual acuity test on the US 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. Consumers can access Visibly's on-demand, self-administered visual acuity test using a touchscreen mobile device and a computer connected to the internet. Consumers can take the test at any time and complete the entire experience in about 6 minutes. Completed vision test results are made available to Eye Care Professionals immediately and securely, helping them evaluate each patient's best course of action.
"After many years working with the FDA, we are excited to receive this clearance …", says Brent Rasmussen, CEO of Visibly. "...We look forward to fulfilling our mission of bringing affordable, accessible vision care to the masses."
Visibly will continue to offer a convenient, affordable way to assess vision at home.
Paul Foley, Visibly's COO, commented, "We are thrilled to achieve this milestone. 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. 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."
As of 2019, 39 US states allow optometrists to issue prescriptions over the Internet. Some states, however, have attempted to ban the company from doing business. In 2016, for example, the state of Indiana passed a law prohibiting the use of online eye exams for the issuance of eyeglasses prescriptions for the production of any "ophthalmic device". Visibly filed suit against the state in April 2019, claiming that the incorporation of ophthalmic devices in the telehealth ban— which also included abortion drugs and opioids— was the result of pressure from optometrists and the eyeglasses industry rather than concern for public health, and was being used unfairly, listing the Medical Licensing Board of Indiana, Indiana Attorney General Curtis Hill and the state Director of the Consumer Protection Division, Betsy Dinardi, as defendants.
In May 2019, after heavy pressure from the American Optometric Association (AOA), the online vision test had been recalled by the company, according to the U.S. Food & Drug Association (FDA).
In April 2020, in response to the Coronavirus outbreak, the FDA issued guidance to expand the capability of remote ophthalmic assessment, and facilitate patient care during the pandemic. Visibly announced it will globally provide optometrists, ophthalmologists, and optical service providers free access to its virtual vision test technology, to help patients meet their eye health needs during the pandemic.
