SEP 01, 2022
FDA Approves Online Vision Exam Technology
The U.S. Food and Drug Administration (FDA) has approved a remote online vision test from the company Visibly (formerly known as Opternative).
The self-guided software application is for adults from 22 to 40 who have the ability to perform a self-test at home to aid in the evaluation of visual acuity with or without correction.
The system is designed for renewals only, not for first-time wearers of eyeglasses or contacts. It requires patients to submit their medical and vision care history. Test results are then sent to an eye care provider licensed by the patient’s state, who evaluates the results and issues a new prescription if necessary, but only if there is no change in the patient’s vision.
Although similar applications have been on the market since 2014, Visibly’s product is the first to win FDA approval.
The Academy’s position on the use of remote online vision exams remails neutral, leaving decisions on use of this option to individual ophthalmology practices. However, we do oppose optometry-backed state legislative efforts to ban the technology. Since 2014, organized optometry has led a national effort to prohibit the tests, succeeding in Georgia, Michigan, Maine, Nebraska and South Carolina. Indiana enacted an optometry-supported prohibition on this technology but then repealed it in 2020.
As indicated in our clinical statement on this issue, the Academy recommends that ophthalmologists evaluate these technologies as they would any other diagnostic modalities, including (but not limited to):
- FDA approval (if required)
- Evidence of reliability and reproducibility from clinical trials or studies
- Evaluation of risk to the patient, (for example, situations that pose low risk to patients would be refractive assessments)
- Provisions for protecting security of health information