Validation of an Independent Web-Based Tool for Measuring Visual Acuity and Refractive Error (the Manifest versus Online Refractive Evaluation Trial): Prospective open-label noninferiority clinical trial

Abstract

BACKGROUND: Digital tools provide a unique opportunity to increase access to eye care. We developed a Web-based test that measures visual acuity and both spherical and cylindrical refractive errors. This test is Conformité Européenne marked and available on the Easee website. The purpose of this study was to compare the efficacy of this Web-based tool with traditional subjective manifest refraction in a prospective open-label noninferiority clinical trial. OBJECTIVE: The aim of this study was to evaluate the outcome of a Web-based refraction compared with a manifest refraction (golden standard). METHODS: Healthy volunteers from 18 to 40 years of age, with a refraction error between -6 and +4 diopter (D), were eligible. Each participant performed the Web-based test, and the reference test was performed by an optometrist. An absolute difference in refractive error of <0.5 D was considered noninferior. Reliability was assessed by using an intraclass correlation coefficient (ICC). Both uncorrected and corrected visual acuity were measured. RESULTS: A total of 200 eyes in 100 healthy volunteers were examined. The Web-based assessment of refractive error had excellent correlation with the reference test (ICC=0.92) and was considered noninferior to the reference test. Uncorrected visual acuity was similar with the Web-based test and the reference test (P=.21). Visual acuity was significantly improved using the prescription obtained by using the Web-based tool (P<.01). The Web-based test provided the best results in participants with mild myopia (ie, <3 D), with a mean difference of 0.02 (SD 0.49) D (P=.48) and yielding a corrected visual acuity of >1.0 in 90% (n=77) of participants. CONCLUSIONS: Our results indicate that Web-based eye testing is a valid and safe method for measuring visual acuity and refractive error in healthy eyes, particularly for mild myopia. This tool can be used for screening purposes, and it is an easily accessible alternative to the subjective manifest refraction test. TRIAL REGISTRATION: Clinicaltrials.gov NCT03313921; https://clinicaltrials.gov/ct2/show/NCT03313921.