FDA gives approval to online visual acuity test
The US Food and Drug Administration has highlighted that the Visibly Digital Acuity Product should not replace an eye examination
25 November 2022
The US Food and Drug Administration (FDA) has cleared an online visual acuity test for use by adults between the ages of 22 to 40.
The technology has been approved for people who have the capability to perform a self-test at home, to aid in the evaluation of visual acuity with or without correction.
In a statement published in August, the FDA highlighted that the results produced by the Visibly Digital Acuity Product are intended to support a qualified eye care provider, alongside patient history, prescriptions and subjective vision data.
“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 FDA emphasised.
In a press release, chief operating officer of Visibly, Paul Foley, highlighted that the technology would aid eye care professionals in the remote evaluation of visual acuity and connect patients with care in a way that was not available before.
Visibly is a Chicago-based healthcare technology company founded in 2012.
Clinical and professional director at the AOP, Dr Peter Hampson, highlighted that the FDA-approved technology would not be compatible with the Opticians Act in the UK, as additional tests beyond refraction are not performed.
“This is an interesting development and in the US healthcare system you can almost see the attraction. However this speaks to one of the main themes the AOP fed back to the GOC on the recent call for evidence. In our response the AOP highlighted the risk to patients of potentially separating eye health and the determination of refractive status. It is clear from this fairly narrow FDA approval that others share that concern,” he said.