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In a previous opinion article on online eye care we discussed Opternative, an online platform that allows consumers to perform refraction analysis at home. In April 2016, the American Optometric Association (AOA) filed an expansive FDA complaint against Opternative to ban it from providing online eye exams. Prior to this, Opternative was issued a cease and desist order for violating the State’s Eye Care Consumer Protection Law in Michigan. The law states that “prescriptions are valid only after a state licensee performs an ‘examination and evaluation’, defined as an assessment of ocular health and visual status that does not consist solely of objective refractive data generated from an automated device”. Several other states, such as Indiana and Georgia, have passed similar laws prohibiting Opternative from providing prescriptions in their particular state.
The argument against Opternative is the absence of a certified eye care professional during the test. Although in Illinois it partnered with ophthalmologists to sign off computerised prescriptions, the Association feels that the device violates the Food, Drug and Cosmetic Act (FDCA), with the company marketing this service to the public without any premarket approval from the FDA. According to the FDCA, such devices must receive premarket approval (PMA) prior to marketing to ensure consumer safety. The AOA maintains that this is essentially putting a consumer’s eye health at risk. According to the Association and the optometric community, their main concern is that the average consumer, due to a lack of sufficient eye care knowledge, might substitute this test for a comprehensive eye examination, and, in turn, miss out on a proper diagnostic check-up of other health problems.
As the industry matures, we are seeing the introduction of more technology related tools and devices. Similar to Opternative, providing convenience to consumers, Eyenetra is a company producing mobile devices for eye testing. These devices enable eye care practitioners to perform basic eye exams anywhere and at any time. Eyenetra offers three types of product – smartphone autorefractor, lensometer and phoropter.
The smartphone autorefractor, Netra, performs objective measurements of a consumer’s prescription. This is done by measuring how light is changed as it enters the eye. Many eye care practitioners use the results from autorefractor checks as a starting point for a subjective refraction test, which will refine the prescription based on consumer feedback to achieve the best vision for the consumer.
Netrometer, the lensometer, directly measures the current lens power of a consumer’s glasses. Lastly, Netropter, the phoropter, is a hand-held testing device that offers different lens power use during a refractive test.
Conceptually, all three devices are excellent steps towards a better eye care environment. However, due to being in the infancy stage, the accuracy of such devices is often questioned by the optometric community. Many of these new innovations work well as a possible solution in places where access to basic eye care is not available. Such devices, if used by NGOs that provide eye screening for the underprivileged, could help eliminate poverty related eye health problems.
As the industry matures, consumers continue to demand higher quality in both products and services. Innovations such as those from Eyenetra, if indiscriminately marketed to the masses, undermine the need for a trained eye care professional, in turn, causing more damage than good to the wider society. While such devices and innovations represent an excellent contribution to the growth of the industry, one must not forget that these devices require the appropriate support of a trained eye care practitioner to offer meaningful diagnostics for the consumer.