How Will An FDA-Cleared Online Eye Exam Affect Patients and Clinicians?

For years, optometrists have pushed back against remote, digital refractions, which allow patients to renew spectacle or contact lens prescriptions without setting foot in a clinician’s office. An online exam can significantly cut costs for the patient, with some companies charging as little as $15 — all while offering other intangible benefits such as convenience, comfort, and safety.¹ But shrinking profit margins and a fear of losing patients aren’t the only things concerning eye care professionals. Optometrists have long lamented the online eye exam’s inability to detect not only ocular pathologies such as glaucoma, retinopathy, or cataracts, but other potentially life-threatening diseases such as cancer, stroke, or vascular disease — conditions with signs that frequently manifest in the eye.² And for years, the US Food and Drug Administration (FDA) has withheld approval for any online vision test. 

In fact, 3 years ago, online visual acuity test maker, Visibly was forced to recall its online test due to a lack of 510(k) clearance.³ Now, Visibly is back online, having obtained the necessary FDA 510(k) clearance.⁴ 

Optometrists may hold steadfast in their disapproval of this technology, but will the FDA’s clearance persuade patients to feel otherwise? 

Safety and Efficacy

The FDA awarded 510(k) clearance to Visibly after a prospective, randomized clinical trial (ClinicalTrials.gov Identifier: NCT05026658) demonstrated that the online test was safe and effective and “substantially equivalent to the standard eye test.”⁴ But few clinicians are likely to argue that the procedure itself presents a danger to their patients. Rather, optometrists such as David Meltzer, OD, assistant professor at Salus University, are concerned that patients will continually skip comprehensive ocular exams, allowing potential pathologies to go undetected. With this option “you’re discounting the patient getting their health check,” he said. 

The FDA approval is only for adults aged 22 to 40 years and it explicitly states that the test does not serve as a replacement for a comprehensive eye health exam with a qualified provider.⁴ Despite the FDA’s disclaimer, Weston Barney, OD, Immediate Past President of the Utah Optometric Association, expressed his concern that patients will not necessarily be able to differentiate between a visual screening and a comprehensive eye exam. 

“Patients should understand that the Visibly online vision test is not an eye exam. It can only test visual acuity and not access the heath of the eye,” he said. “My fear is that patients will not understand the difference.”

The Eye Exam in a Post-Pandemic World

Surgical masks and gloves may not be the mainstream apparel they were just a couple of years ago, but lingering concerns about COVID-19 continue to keep some individuals homebound. Such patients may continue to seek online health-related solutions as a means of “staying safe” and avoiding potential nosocomial infections. Dr Meltzer acknowledges this concern and that many practitioners continue to take precautions. 

“We’re still double masking and cleaning chairs after every patient,” he explained. “Every practice I know is doing their due diligence to keep patients safe and quell their fears.” For patients who continue to worry that loosened restrictions may put them at risk, Dr Meltzer recommends that patients call their doctor’s office directly and have a discussion about precautions their provider may or may not be taking. 

Although these tests are designed to be performed at home, Dr Barney expressed skepticism about patients’ ability to perform the test correctly. “I’d be very hesitant to sign my name to that piece of medical information,” he said. But Dr Barney isn’t only concerned about inaccuracies in testing. He is also concerned that Visibly may profit from sharing patient information with other businesses. He highlights Visibly’s terms of service agreement which explicitly states that “Visibly may use the information you provide (including your medical information) to present offers to you from Visibly or 3rd party vendors.”⁵

Ramifications for Optometry

Some optometrists express concern not only for their patients, but for optometry students who will compete with computerized examinations once the technology is out of its infancy and becomes more mainstream. “I’m scared for [my students],” Dr Meltzer said. “They’re losing more patients.” 

Although Dr Barney expressed disapproval with this particular FDA decision, he said optometrists will ultimately have to adapt to a practice of accommodating more remote patients as technology continues to evolve. 

“Sadly, I feel the vision care industry is shifting into a more ‘consumer-convenient’ model and if ODs want to compete, we will need to adapt and find ways to integrate remote patient care into our practices. I don’t think the technology is currently adequate to provide remote patients with quality vision care, but I think it’s coming. If we could provide a quality eye exam including refraction and high-resolution visualization of the eye to the same standard of care now provided, I could see some optometrists enjoying the ability to provide vision care to or from anywhere in the world.”

If Dr Barney’s prediction holds true, it could potentially afford clinicians future opportunities to increase their patient base and allow for limitless practice expansion. 

“I fully understand that vision care is changing, and innovations will come to our profession. However, we must make certain they are able to consistently provide the same standard of care that optometrists provide and more importantly that the public understands the limitations of these online vision tests,” Dr Barney said. 

Clinicians cannot prevent their patients from obtaining online refractions. However, taking the time to educate patients on the benefits of attending routine in-person comprehensive eye examinations and stressing the importance of a thorough eye health checkup may help patients to understand the value associated with a visit to your office.