‘GMA’ investigates raises red flag on Opternative

August 9, 2016
AOA president calls Opternative test “foolhardy” and “dangerous.”

Convenience at the expense of proper, quality care puts Americans' eye health at risk, and a national morning show popular with millions illustrated as much in its own investigative report.

"Good Morning America" delved into the online "vision test" known as Opternative with a "GMA" Investigates segment, aired Aug. 5, that took the company's claims to task and confirmed AOA's concerns that such an inadequate service can pose a threat to patient health.

What the "GMA" segment uncovered completely validates patient safety alarms, and drew a strong response from viewers who saw optometry on the side of the public, fighting for the highest quality eye care.

In rebuttal to Opternative's claims, AOA President Andrea P. Thau, O.D., succinctly summed up optometry's concerns, noting that the unproven technology does not completely cover any one of the 12 components of a multi-faceted comprehensive eye examination necessary to ensure patients' complete eye and vision health. The one aspect that Opternative does purport to provide—a refractive measurement—is based on tenuous-at-best data to back up its accuracy.

"It would be analogous to taking a picture of your teeth and sending it to someone, and having a filling sent to you," Dr. Thau told "GMA."

"This is really foolhardy and really dangerous. It is taking a risk because you're doing one small fraction of the whole eye exam with a potential for missing things that can be very significant to your eye health and your systemic health."

Opternative misses significant disease marker

And, in fact, Opternative did miss the important early signs of a potentially serious eye condition. In an independent evaluation led by "GMA" Investigates, eight volunteers used the refraction-only test and were then examined by an unaffiliated ophthalmologist. One volunteer's risk factor for glaucoma—elevated intraocular pressure—was completely missed by Opternative, prompting the participating ophthalmologist to acknowledge the public health threat caused by delaying timely care: "Anybody who has a risk factor for disease should be screened out and probably not given a prescription online," she noted.

Furthermore, three more participants of the "GMA" Investigates trial were issued prescriptions "slightly different" from those determined by the ophthalmologist.

However, this is not the first time that an investigative media report independently expressed doubts about Opternative's test. Earlier in May, the producer of WZZM-TV, a Michigan news outlet, compared the online test's results to that of an eye exam provided by a local eye doctor. The ABC news affiliate concluded:

  • "[The producer's] visit to the eye doctor takes about the same amount of time as her online eye exam but yields vastly different results.
  • 'We determined that she was a little bit farsighted and had a little bit of astigmatism, and I believe her online analysis suggested she might have been a little nearsighted—the opposite of what our outcome was,' [the eye doctor] said.
  • And [the eye doctor] doesn't think [the producer] needs glasses.
  • Which once again is different from the online exam which 24 hours later sent [the producer] a prescription for nearsightedness ... Had [the producer] filled her online prescription, it may have done her more harm than good—the doctor said the eyes have to work harder." -WZZM 13

Perhaps more troubling, the news segment points out that this comparative test took place after Michigan's Department of Licensing and Regulatory Affairs issued Opternative a cease and desist order on Feb. 12, 2016, to immediately halt actions violating the state's Eye Care Consumer Protection Law. According to the law, Opternative's "prescriptions" do not constitute a legal prescription for contacts and/or eyeglasses because the service's rudimentary refractive data provides no ocular health and visual assessment, and was not conducted by a Michigan-licensed doctor.

AOA, affiliates continue advocacy

These examples clearly underscore why AOA has taken such a resolute stance against online "vision tests" and their marketing tactics that appeal to the public's sense of convenience while sweeping very real health concerns under the rug. Despite Opternative's rhetoric, AOA contends that it's not only the inferior accuracy that's a problem, but also the misleading and ambiguous marketing that critically delays patients from accessing timely care for asymptomatic, sight-threatening diseases.

That's why AOA filed an expansive, formal complaint to the U.S. Food and Drug Administration's (FDA's) Center for Devices and Radiological Health on April 4, citing Opternative's continued marketing to consumers without federal approval—and without the FDA's formal review of the product's claims—under the Food, Drug and Cosmetic Act. Although Opternative attempts to mislead consumers, saying it is "FDA–registered," the AOA maintains this device has not cleared premarket approval and is being marketed unlawfully. The Chicago Tribune recently cited the FDA as commenting "anyone can self-list as registered."

With members of Congress working in their districts throughout August, AOA and state associations have launched a summertime full-court press aimed at updating key U.S. Senators and House members about the information the FDA has about Opternative.

On Aug.3, AOA Trustee and Federal Keyperson, Jim DeVleming, O.D., briefed his congressional representative, Rep. Cathy McMorris Rodgers (R-Wash.), chair of the House Republican Conference, about AOA's concerns and the complaint itself. For added impact, Dr. DeVleming was joined by Steven A. Loomis, O.D., AOA immediate past president, who oversaw the complaint's drafting and formally submitted it to FDA officials.

"Leaders of the Optometric Physicians of Washington have provided me with a copy of their complaint to the U.S. Food and Drug Administration regarding Opternative's new testing device," said Congresswoman McMorris Rodgers. "They have outlined why they see the potential for the public to be misled and why they've asked for enforcement action. While we must continue to support technological innovations in the medical field, the health and safety of patients should be our number one priority. I believe it is of the utmost importance to fully understand how the FDA intends to respond, and what actions they may take in the future to ensure compliance with the law."

Also, Peter Theo, Wisconsin Optometric Association executive director, whose leaders have been actively educating the public about inaccurate claims about online vision tests, participated in a roundtable discussion with the Speaker of the House, Rep. Paul Ryan (R-Wis.).

Eleven states (member login required) have enacted critical patient protection laws that reinforce the benefits of in-person, comprehensive eye exams, including Georgia, Indiana, Nebraska and South Carolina, among others.

Watch the full "GMA" Investigates segment.

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