Opinion

Less Than Meets the Eye With Online ‘Vision Tests’ Product Claims

Doctors of optometry have long embraced an array of new technologies that support medical advancements and improve patient access and outcomes. Today, the rapid rise of telehealth-based care is transforming the delivery of eye care and provides an important connection point with patients. 

While telehealth cannot replace all elements of an in-person exam, it can serve as a critical tool to identify patients necessitating in-person care and those who can be provided physician direction remotely. We’ve witnessed this firsthand as thousands of doctors of optometry quickly adapted their practices and began using the technology to provide essential care to patients during the COVID-19 public health emergency. However, with the expansion of virtual care services, it’s more important than ever to fight against technology-based care that is substandard and puts patients at risk. 

To ensure responsible and effective use of telemedicine in today’s changing health care landscape – and to protect America’s eye, vision and overall health — the American Optometric Association, along with eye health care leaders and organizations, recently issued guidelines to set the path for future care and implementation. The policy makes clear that “the standard of care for eye, health and vision services must remain the same regardless of whether services are provided in-person, remotely via telehealth, or through any combination thereof.” Unfortunately, as doctors of optometry were setting the direction of responsible eye telehealth services, some companies saw an opportunity to exploit the current public health crisis by asserting that their devices make it easy to conduct an eye exam at home. 

The truth of the matter is there is no U.S. Food and Drug Administration-approved, at-home device or app that people can use to self-conduct all of the elements of a proper eye examination. Yet, too often, we see new products working to completely subvert the doctor-patient relationship by encouraging patients to use medical devices without any real physician oversight. Claiming to be able to renew an eyeglass or contact lens prescription outside of the established doctor-patient relationship, these online vision tests potentially take the place of the annual in-person eye exam and could give patients a false sense of security that their eye health has been thoroughly examined.

Through an in-person, comprehensive exam — the gold standard in eye health — a doctor of optometry is able to assess the health of the eyes and eye tissue, potentially identifying health- and sight-threatening diseases, including hypertension, stroke and diabetes, that can be cured or slowed through early diagnosis and treatment. Just last month, a colleague treated a patient who indicated that she only wanted to come in to get a new contact lens prescription, and was able to identify optic nerve head drusen (abnormal collections of protein and calcium that accumulate within the optic nerve), which can lead to loss of vision. While patients may be focused on their primary goal of obtaining high-quality medical devices for vision correction, this is a prime example of why the comprehensive exam is critical for assessing total eye health.

The AOA, our member doctors of optometry and state affiliates are first and foremost focused on protecting our patients’ health and safety and safeguarding the doctor-patient relationship. Together, we are working on the ground to educate legislators about the appropriate use of technology and telemedicine tools and to ensure the right state laws are in place to protect patients. Although 25 states currently have patient protection legislation in place, more needs to be done. This is especially important in the midst of a pandemic that is having a devastating effect on Americans’ collective health and wellness. 

That’s why the AOA is calling on the FDA to help ensure that those who undervalue the benefits of an in-person exam cannot continue to undermine the highest standard of comprehensive care that Americans need and deserve. Just recently, I joined colleagues and other representatives from optometry to share our concerns during the FDA’s virtual public meeting around improving communications to the public about medical device safety. Actions like this are critical since FDA’s regulation of medical devices and their obligation to protect the public extends not only to well-established medical devices such as contact lenses, but to newer online mobile applications that are used to make health care decisions.  

In fact, just last year, the FDA announced the recall of the online vision test Visibly, formerly known as Opternative. Prior to the recall, for more than three years, the AOA had raised concerns with FDA that the online test marketed by Visibly potentially posed serious health risks to the public and did not comply with federal law. Today, a number of other new products have entered the market. In addition to ensuring that these new apps meet appropriate regulatory standards, we must also ensure regulation enforcement efforts that are relaxed during the ongoing pandemic do not allow the reemergence of apps that we know violate rules aimed at protecting the public.  

The AOA will continue to educate the public, the news media, elected officials and regulators that there is less than meets the eye when it comes to these online tests, and we are calling on the FDA to join our efforts.

 

William T. Reynolds, O.D., is the president of the American Optometric Association.

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