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Accuracy of a low-cost, portable, refractive error estimation device: Results of a diagnostic accuracy trial

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Purpose To assess the accuracy of refraction measurements by ClickCheckTM compared with the standard practice of subjective refraction at a tertiary level eye hospital. Design Diagnostic accuracy trial. Methods All… Click to show full abstract

Purpose To assess the accuracy of refraction measurements by ClickCheckTM compared with the standard practice of subjective refraction at a tertiary level eye hospital. Design Diagnostic accuracy trial. Methods All participants, recruited consecutively, underwent auto-refraction (AR) and subjective refraction (SR) followed by refraction measurement using ClickCheckTM (CR) by a trained research assistant. Eyeglass prescriptions generated using ClickCheckTM and the resulting visual acuity (VA) was compared to SR for accuracy. Inter-rater reliability and agreement were determined using Intra-class correlation and Bland Altman analysis respectively. Results The 1,079 participants enrolled had a mean (SD) age of 39.02 (17.94) years and 56% were women. Overall, 45.3% of the participants had refractive error greater than ±0.5D. The mean (SD) spherical corrections were -0.66D (1.85) and -0.89D (2.20) in SR and CR respectively. There was high level of agreement between the spherical power measured using SR and CR (ICC: 0.940 (95% CI: 0.933 to 0.947). For the assessment of cylindrical correction, there was moderate level of agreement between SR and CR (ICC: 0.493 (0.100 to 0.715). There was moderate level of agreement between the VA measurements performed by using corrections from SR and CR (ICC: 0.577 (95% CI: 0.521–0.628). The subgroup analysis based on the age categories also showed high level of agreement for spherical corrections between the two approaches (ICC: 0.900). Bland Altman analysis showed good agreement for spherical corrections between SR and CR (Mean difference: 0.224D; 95% LoA: -1.647 D to 2.096 D) without evidence of measurement bias. Conclusions There was a high level of agreement for spherical power measurement between CR and SR. However, improvements are needed in order to accurately assess the cylindrical power. Being a portable, low-cost and easy-to-use refraction device, ClickCheckTM can be used for first level assessment of refractive errors, thereby enhancing the efficiency of refractive services, especially in low- and-middle-income countries.

Keywords: accuracy; level agreement; refraction; level; diagnostic accuracy

Journal Title: PLoS ONE
Year Published: 2022

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