South Carolina judge overrules Visibly challenge to consumer protection law

South Carolina’s Eye Care Consumer Protection Law (ECCPL) is constitutional, a judge rules, effectively holding remote vision testing technologies to the same standard of care as eye care physicians.

On June 19, Hon. Kristi Curtis, a judge of the 3rd Judicial Circuit Court of South Carolina, granted the South Carolina Optometric Physicians Association’s (SCOPA’s) motion for summary judgement in a legal challenge against remote vision testing application, Visibly (formerly known as Opternative), closing the latest chapter in a nearly eight-year-long dispute following the law’s passage. The announcement came as optometry’s advocates convened for the AOA House of Delegates during Optometry’s Meeting®, June 18-22, in Nashville, Tennessee.

“The court has ruled that this law is indeed constitutional,” announced Johndra McNeely, O.D., SCOPA past president and current AOA State Government Relations Committee (SGRC) chair, to applause from gathered optometric leaders in the House.

She added: “Always keep advocating for your patients’ safety because everyone needs and deserves the highest-quality eye care.”

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South Carolina’s ECCPL ensures that remote vision testing technologies and telehealth services enhance care, deliver the best outcomes and strengthen the doctor-patient relationship at the heart of sound health care decision-making by holding kiosks and online technologies accountable for providing the same standard of care that is expected of a qualified, competent eye care physician.

Jointly supported by SCOPA and the South Carolina Medical Association, the bipartisan S. 1016 (ECCPL) passed the General Assembly in May 2016 only to be vetoed by then-Gov. Nikki Haley and, in-turn, countermanded by the legislature days later.

“Doctors of optometry will continue to provide the highest-quality care to our patients, and the AOA remains committed to scrutinizing any and all self-assessment tools, devices and apps that falsely claim to provide a so-called ‘eye exam,’” noted then-AOA President Steven A. Loomis, O.D., upon the ECCPL’s approval.

At the time, South Carolina became one of a dozen states having enacted critical patient protection safeguards that reinforced the criticality of comprehensive eye examinations.

Online vision test app challenges ECCPL

Such eye care consumer protection laws originated in response to mounting concerns over vision test kiosks and online applications providing refractive-only tests that decoupled vision acuity from a comprehensive eye health examination. The same year as South Carolina’s ECCPL, the AOA filed an expansive U.S. Food and Drug Administration (FDA) complaint against one such online vision test, Visibly (Opternative), for posing a significant health risk to the public and failing to receive premarket approval for its device. At the same time, a “Good Morning America” investigation of Visibly (Opternative) found the test completely missed risk factors for glaucoma while also yielding vastly different acuity results than an in-person exam with an eye doctor.

The AOA’s concerns were validated in a 2017 FDA warning letter and a 2019 FDA enforcement action against Visibly (Opternative). The renamed Visibly Digital Acuity Product did receive FDA clearance as a visual acuity assessment for healthy people ages 22 to 40 in 2022, not to be used as a replacement for a comprehensive eye examination.

However, in 2016, Visibly (Opternative) filed a legal challenge against South Carolina’s ECCPL only to have the lawsuit dismissed in 2018. A renewed attempt to void the law ultimately failed with the court’s most recent action on June 19.