Eye-Testing App Draws Optometric Association’s Ire
In a letter to the Food and Drug Administration this week, the head of the American Optometric Association called on the agency to regulate a startup that he says is offering an online vision test using a process that could endanger consumers.
Just because you can do a vision exam with your smartphone doesn’t mean it’s a good idea.
That’s the consensus of the American Optometric Association (AOA), which sent a letter to the Food and Drug Administration (FDA) this week about the startup Opternative, currently offering a free online vision test that can be taken via a website and a smartphone app. The Chicago-based company then allows customers to order prescription glasses and contact lenses (for $40 each or $60 for both) without visiting an optometrist—a practice that AOA opposes.
In the letter, AOA President Steven Loomis, O.D., argues that Opternative—which has raised $9.5 million in funding since its 2015 launch—improperly allows consumers to test their vision through technology that has not been proved to be effective or safe. He points out that the FDA has not verified the startup’s claims about its product, as required by law, so Opternative should not be marketing it.
“Specifically, the device relies on new, self-administered tests of visual performance to generate a prescription, rather than on assessment by an eye care professional of the underlying eye conditions affecting vision,” Loomis wrote [PDF]. “There are many reasons to doubt the accuracy of prescriptions generated by this approach. Worse yet, use of the device will result in the forgoing of an examination by an eye doctor that is designed to detect a variety of conditions that could affect vision or general health and that require medical treatment.”
Loomis contends that the company’s product, which is currently registered as a Class 1 device by the FDA and therefore doesn’t require market approval, should be subject to more stringent testing, as it creates significant health risks for consumers, including the misdiagnosis of eye diseases and little input from trained eye doctors.
“The lack of provider involvement in Opternative’s self-administered tests is particularly concerning in that Opternative provides prescriptions for contact lenses,” Loomis said.
The letter outlines the issues AOA has with the online exam and the prescription process, including the use of technologies that could result in the wrong type of prescriptions being ordered, and recommends that the FDA force the device’s removal from the market until it “has reviewed the safety and efficacy issues raised by the device.”
In a news release, Loomis emphasized AOA’s role as an authority on eye issues.
“The AOA—as an authority on quality care and an advocate for our nation’s health—is committed to ensuring that the public is not misled, essential care is not diverted or dangerously delayed, and patient safety laws are not ignored,” Loomis explained.
In comments to Politico, Opternative CEO and Cofounder Aaron Dallek rebutted AOA’s claims, saying that the association is mischaracterizing the technology used and that the company relies on trained professionals in administering its online tests.
“We are very clear throughout the patient experience that Opternative is not a replacement for an eye health exam. It’s on our website, in the exam itself, and repeated to the patient in any necessary follow up care,” Dallek said.
Opternative, an eye-diagnosis app that relies on a series of online tests. (Handout photo)