UPDATE: AOA, affiliates continue to challenge online ‘eye exams’
Safeguarding consumers against the misleading claims made by online "eye exam" services, the AOA continued its ongoing offensive with direct outreach to the U.S. Food and Drug Administration (FDA) this week.
While online programs tout consumer convenience, albeit with ambiguous and misleading claims, the AOA contends there are severe pitfalls in separating refractive tests from annual comprehensive eye exams performed in person by an eye care professional.
This message is being reinforced at every level by educating the public, news media, health providers and government officials, including state legislators and attorneys general, members of Congress, and now medical device regulators at the FDA.
"The AOA continually monitors and advocates for the public in many areas," says AOA Immediate Past-President David A. Cockrell, O.D. "We are concerned where violations of Federal or state law might exist. The AOA and our state associations will be monitoring and pressing for enforcement of all regulations and statutes. If state or federal laws need to be clarified or more specific to better protect the public, we will advocate in every arena for passage."
Update: Apprising the FDA
As part of these ongoing efforts, AOA President Steven A. Loomis, O.D., asked the FDA on Aug. 18 to investigate these misleading claims connected to the unproven use of a medical device by one such "online eye exam" service, calling itself Opternative.
The letter calls into question the company's news release for asserting that its smartphone-derived technology is "Food and Drug Administration registered," a claim appearing to convey that the FDA has performed an assessment of this technology and views it favorably.
Additionally, the letter notes 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. That should qualify the mobile app as a medical device that should not be on the market until FDA officials complete all essential oversight.
"The AOA respectfully requests the FDA to take prompt steps to clarify the accuracy of Opternative's public assertions about its status with the FDA and the capabilities of its so-called 'online eye exam,'" Dr. Loomis stated in the letter.
Reaching out to ophthalmology
With patient health and safety at stake as never before, and some "online eye exams" relying on a network of affiliated ophthalmologists as prescribers, Dr. Loomis sent a letter asking the president of the American Academy of Ophthalmology (AAO) to also make a stand.
Dr. Loomis called on the AAO to rebuke what he believes are dangerously inaccurate product claims made by "online eye exams" and work alongside the AOA to safeguard public health and healthy vision.
"Given the insidious nature of this threat to public health and the central role of ophthalmologists in the health care claims connected to it, I ask you to join me in educating your member ophthalmologists and the public about these substandard models of care," Dr. Loomis' letter states.
Affiliate contests online exam business in Illinois
Days after Opternative launched in its state, the Illinois Optometric Association (IOA) challenged the company's business model as a direct violation of the Illinois Optometric Practice Act.
Michael Horstman, IOA executive director, penned a letter to the Illinois Department of Financial and Professional Regulation, alleging the "online eye exam" company is practicing optometry without a license on the basis that Illinois law defines a practicing doctor of optometry as one who:
- Performs refractions or employs any other determinants of visual function.
- Prescribes corrective lenses, prism.
- Practices or offers or attempts to practice optometry as defined by (the practice act) either on his or her own behalf or as an employee of a person, firm or corporation whether under the supervision of his or her employer or not.
The letter states, furthermore, the company's "advertising would appear to mislead the patient ... they claim to be equivalent to a doctor-delivered eye exam when, in fact, what they are doing is but one component of such exam." Horstman says new technology cannot come at the expense of patients.
"We believe that a patient's eye health should not be compromised for either price or convenience, and we will take whatever steps are needed to ensure that this doesn't happen," Horstman says. "We are hopeful that the State of Illinois will agree and take appropriate action."
Read how another state association challenged a mobile refractive service.
Campaign reaches tens of millions
Although "online eye exams" might draw a few headlines, it's AOA's leadership role in an ongoing eye health public awareness campaign that's getting noticed.
The importance of in-person, annual comprehensive eye exams and full-scope care provided by doctors of optometry has reached tens of millions of Americans on more than 20 primetime cable TV networks, drive-time radio, Internet radio and digital ads through the Think About Your Eyes Campaign (TAYE).
In the past year, TAYE—with ads presented by the AOA—helped increase eye exams by more than 8% with millions of prospective patients searching the TAYE website and locating AOA members.
Online contact lens retailer, Vision Direct UK, to halt sales without required prescriptions after AOA complaints
After years of the AOA alerting the company of regulatory and legal requirements regarding contact lens sales, Vision Direct recently announced on its website that it was halting its no-prescription service.
The advocacy collaborative fighting for patient safety and the doctor-patient relationship reports on a productive 2020, despite COVID-19 challenges, and recently welcomed Alcon as its newest member.
At Nov. 17 FDA workshop, doctors of optometry warn of a lack of communication regarding the safety of online vision tests. The AOA, which continues to educate the public on these mobile apps and to hold them accountable, offers its expertise.