Association Calls on FDA to Regulate Online Vision Exam as Medical Device

Regulatory NewsRegulatory News | 05 April 2016 |  By 

The American Optometric Association (AOA) has submitted a complaint to the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) over an online eye exam that may not accurately generate prescriptions for eyeglasses or contact lenses.

The complaint is directed at Opternative, which is marketing its online eye exam directly to consumers and claiming that it can provide a prescription for eyeglasses or contact lenses “as accurate as an in-person refractive eye exam.”

The AOA said in its letter to CDRH’s Office of Compliance Director Robin Newman: “Although it poses significant health risks to consumers and is not substantially equivalent to any currently marketed device, the Food and Drug Administration (FDA) has never reviewed the safety or efficacy of the device or the promotional claims made for the device in its labeling. The Opternative device relies on unproven technology that has never, to our knowledge, been shown to be safe or effective in accurately determining a lens prescription.”

What’s worse, according to the AOA, is that use of this online 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.”

Opternative’s method of refraction appears to rely on a series of tests that use eye charts displayed on the user’s personal computer and smartphone, along with other information entered by the user, according to AOA. This method, described on the company’s website and in a patent application, uses some eye charts that appear to be modified versions of eye charts commonly used in the practice of optometry and ophthalmology, while others appear to be entirely new eye charts developed by Opternative.

“Opternative also attempts to ascertain if the individual is nearsighted or farsighted by asking for details about the user’s prior lens prescription and by asking whether the user experiences eye strain during near or distance viewing activities. Most refractive errors that require correction are asymptomatic, however. These errors of refraction cannot be determined by self-report of symptoms,” AOA says.

The association says the website should be classified as a Class III device, meaning it needs pre-market approval.

“A number of underlying conditions or diseases, which would be apparent to a clinician performing an in-person refractive exam with previously classified ophthalmic devices, are likely to be misdiagnosed by Opternative’s device as a refractive error requiring a lens prescription— or missed entirely. AOA is concerned that use of the Opternative device will result in harmful delay in the diagnosis of such eye diseases as glaucoma, cataracts, and macular degeneration,” the letter says, noting that at a minimum, CDRH should require that Opternative and every manufacturer of a similar device submit an application that details all of the methods used to generate components of a prescription from vision tests, data validating each method, labeling that provides directions for self-administration of the tests, and data demonstrating the ability of patients to appropriately test themselves when following the directions.

Opternative did not respond to a request for comment.


Letter to FDA



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