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

Robert P L Wisse, Marc B Muijzer, Francesco Cassano, Daniel A Godefrooij, Yves F D M Prevoo, Nienke Soeters, Robert P L Wisse, Marc B Muijzer, Francesco Cassano, Daniel A Godefrooij, Yves F D M Prevoo, Nienke Soeters

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://ichgcp.net/clinical-trials-registry/NCT03313921.

Keywords: digital refraction; easee; medical informatics; refractive error; telemedicine.

Conflict of interest statement

Conflicts of Interest: YP is founder and shareholder of Easee BV. FC is employed by Easee BV. RW is employed by the UMC Utrecht and medical advisor and shareholder of Easee BV. MBM is employed by the UMC Utrecht and a consultant for Easee BV. NS and DG have no potential conflicts of interest, and they supervised the medical and statistical contents of the manuscript.

©Robert P L Wisse, Marc B Muijzer, Francesco Cassano, Daniel A Godefrooij, Yves F D M Prevoo, Nienke Soeters. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 08.11.2019.

Figures

Figure 1
Figure 1
Optics of the eye. A: With no refractive error, the image is focused properly on the retina, providing perfect uncorrected visual acuity. B and D: In hyperopia (far-sightedness; B) and myopia (nearsightedness; D) the image falls either behind or in front of the retina, respectively. C and E: Lenses can be used to re-focus the image on the retina, restoring visual acuity.
Figure 2
Figure 2
An impression of the online refraction exam and its comparator the manifest refraction.
Figure 3
Figure 3
The difference between the refractive error measurement of the first (red) and second generation (blue) online refraction test compared to the outcome of the manifest refraction with respect to the non-inferiority limit (green area) and 95% confidence interval (dashed lines).
Figure 4
Figure 4
Refractive error measured using the online test was plotted against refractive error measured using manifest refraction; each symbol represents an individual eye measured in a participant who was tested using the first-generation algorithm (red squares) or the second-generation algorithm (blue circles). The 45° dashed line represents an ideal fit. Outliers are identified particularly in the high-myopia group (bottom-left), and these differences are reduced in the second generation cohort. SEQ: spherical equivalent.

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