Department of Optics and Optometry and Vision Sciences, University of Valencia , Burjassot, Spain.
Light and Life Vision Sciences R&D, Essilor International , Paris, France.
Expert Rev Med Devices. 2020 Nov;17(11):1221-1230. doi: 10.1080/17434440.2020.1837623. Epub 2020 Oct 27.
To assess the performance of a new device for the clinical determination of light discomfort on a large sample of healthy human subjects.
A total of 489 subjects ranging from 20 to 70 years old (241 men, 248 women) were evaluated with the LUMIZ™ 100 to determine light discomfort. Repeatability was assessed by means of within-subject standard deviation, coefficient of variation (CoV), and intraclass correlation coefficient (ICC). Repeated measures ANOVA, Kruskal-Wallis, and correlation analysis were applied to test for differences between repeated measures, and effect of age on reliability.
Discomfort thresholds obtained are well distributed across the light intensity range available (25 to 10211 lux). Intrasession ICCs are higher than 0.849 for all thresholds, and 85% of CoV are below 10%. Thresholds obtained in the first set of measurements are highly correlated with the median of three sets (r2 > 0.8). Intersession, 64% of CoV are below 10%. Age does not affect discomfort thresholds (p = 0.30), nor affect reliability (variance on CoV, p = 0.368).
The new device provides good intrasession repeatability for the clinical determination of light discomfort thresholds, although variance is slightly greater between sessions. The system is useful for the clinical determination of light discomfort.
评估一种新设备在大量健康人体受试者中临床测定轻度不适的性能。
共有 489 名年龄在 20 至 70 岁之间的受试者(241 名男性,248 名女性)接受了 LUMIZ™ 100 测试以确定轻度不适。通过个体内标准差、变异系数(CoV)和组内相关系数(ICC)评估重复性。重复测量方差分析、Kruskal-Wallis 检验和相关分析用于检验重复测量之间的差异,以及年龄对可靠性的影响。
获得的不适阈值在可用的光照强度范围内分布良好(25 至 10211 lux)。所有阈值的日内 ICC 均高于 0.849,85%的 CoV 低于 10%。第一组测量中获得的阈值与三组中位数高度相关(r2>0.8)。日间 64%的 CoV 低于 10%。年龄不影响不适阈值(p=0.30),也不影响可靠性(CoV 的方差,p=0.368)。
新设备为临床测定轻度不适阈值提供了良好的日内可重复性,尽管在两次测量之间的差异略大。该系统可用于临床测定轻度不适。