The AOA recently sent a letter to the FDA requesting the investigation of alleged misleading and inaccurate claims made by the online eye exam administrator Opternative that its technology, which offers $40 eye exams by computer or smartphone, is FDA registered. 

According to the AOA, the Chicago-based company launched its online platform in July and issued a subsequent press release making these false claims, which appear to convey that the FDA has in some way performed an assessment of this technology and may view it favorably. Additionally, Opternative’s claims appear to indicate functionality beyond Class I (general controls), due to the intention to provide primary diagnosis or treatment decisions and perform patient-specific analysis. Such capabilities should qualify the mobile app as a medical device, which should not be on the market until FDA officials complete all essential oversight, the AOA’s letter states. 

The AOA says it embraces cutting-edge technology when it enhances quality patient care. “However, whenever and wherever technology is abused in a manner that undermines critical public and patient safety, or provides a false sense of security when there is undetected, unknown and early onset disease, the AOA remains committed to acting to ensure the public receives the care they expect and deserve,” the AOA further states in its letter.

AOA President Steven A. Loomis, OD, says the AOA is firm in its position that there is no substitute for an in-person, comprehensive eye exam performed by a doctor of optometry, and a comprehensive eye exam is the only consistent and trustworthy method to detect not just refractive errors, but also the full range of eye health and vision conditions, many of which have no obvious signs or symptoms.

“We have a serious concern about separating the refraction from a comprehensive eye examination,” Dr. Loomis says. “A refraction does not simply yield an eyeglass or contact lens prescription. A refraction is a diagnostic test that yields information about potential health concerns like diabetes, cataracts and retinal issues, to name only a few. These online ‘exams’ are completely insufficient to meet those needs. Of added concern is that patients are likely quite unaware of the deficiency of the product they have just purchased. That is why the AOA and its state affiliate associations are actively combating misleading claims made by these so-called ‘online eye exams.’”

The AOA has already taken action against online eye exams, including the passage of Resolution 1987, “Potential Health Risks of Emerging Technologies in Eye Care,” in the House of Delegates at Optometry’s Meeting in June in Seattle, Wash. In addition, the AOA recently sent a letter to the president of the American Academy of Ophthalmology (AAO) to make a stand. “I’ve called on the AAO to rebuke the dangerously misleading product claims made by ‘online eye exams’ and to work alongside the AOA to safeguard public health and healthy vision,” Dr. Loomis says.