The American Optometric Association (AOA) wrote a letter to the FDA on Tuesday, April 4th urging them to enforce stricter regulations on Opternative, a digital health startup providing smartphone-based refractive eye exams. The AOA believes that the technology’s safety, effectiveness, or marketing claims were not properly reviewed by the FDA, and could lead to patients skipping eye exams entirely.
Opternative first launched their service in July 2015. In lieu of a visit to the ophthalmologist, Opternative gathers data from the user’s most recent eye exam, and guides the user through a maximum 25-minute exam, recorded on a mobile device. A licensed ophthalmologist then reviews the results and pertinent health information and issues a prescription for glasses or contacts.
Because Opternative is a Class I device, it is not subject to FDA premarket approval. According to a statement CEO Aaron Dallek made to MobiHealthNews in February, clinical trials showed that Opternative is “statistically equivalent” to a trip to the office. It is currently approved for use in 37 states.
The AOA does not agree.
“First, the device relies on users to self-administer a variety of visual tests,” writes AOA president Steven Loomis. “This is a significant difference from tests currently used in the generation of lens prescriptions, which are administered by a trained eye doctor. It raises critical questions about whether users are capable of following the directions, administering the tests correctly, and generating reliable results with the device.”
The AOA also expresses concern that Opternative could lead to a misdiagnosis of potentially serious, vision-affecting eye conditions because the device may experience a refractive error or miss something entirely—which is not likely to happen during an eye exam performed by a trained ophthalmologist.
Further, the AOA believes there could be a risk of adverse events for diabetic patients using Opternative.
“In addition, the Opternative device does not appear to take adequate account of undiagnosed or uncontrolled diabetes, which can cause an accumulation of fluid in the eye,” Loomis writes. “This, in turn, can cause significant but temporary refraction errors that mimic those cause by myopia or hyperopia. Because the device relies on technology that does not appear able to distinguish between refractive errors caused by complications of diabetes versus refractive errors caused by myopia or hyperopia, there is potential for the device to generate a lens prescription when the patient should instead be treated for an underlying blood sugar imbalance or other serious disorder.”
In order to ensure the device’s safety and efficacy, the AOA urges the FDA to halt Opternative’s marketing until proper reviews have been made. They further assert that the device was improperly categorized as Class I device, and should be reassigned to Class III—which requires a premarket approval—because it “does not fit within the existing classification regulation for a visual acuity chart or any other existing classification regulation for ophthalmic devices.”
Toward the end of the letter, the AOA urges the FDA to take a closer look at devices like Opternative, one product of the burgeoning mHealth market.
“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,” writes Loomis. “An ongoing requirement for review of these devices, even after classification, is particularly important given the complexity and range of methods that are possible for generating the components of a prescription.”