客观监测近视眼相关环境因素的新设备'云夹'的准确性和稳定性研究

摘要

目的 评价一种能客观监测近视眼相关环境因素的新设备"云夹"的准确性和稳定性.方法 实验研究.研究分两部分.①静态实验:随机选取15个样机,分别在14个测量距离、19种光照强度以及有或无紫外线情况下获取相关数据.以误差最大样机的测量值与真实值间的差异分析其准确性;以所有样机测量结果之间的变异程度分析其稳定性.②动态实验:30名受试者配戴"云夹"2 d,通过微信实时汇报具体场景,并与"云夹"的后台数据进行比对,包括开始/结束近距离工作的时间点、室外/室内切换的时间点以及取下/戴上"云夹"的时间点.Pearson相关分析和Bland-Altman一致性分析方法用于评价"云夹"测量的精准水平.结果 ①静态实验:距离和光照强度的测量值与真实值之间均具有高度相关性(r=0.998,P<0.001;r=0.999,P<0.001),95%一致性界限分别为0.18~3.10 cm和1.02~1.35 lx,相对误差分别为2.4%~6.5%和8.9%~20.0%;各样机在不同水平的距离和光照强度下的变异系数分别为2.3%~4.3%和0.4%~5.6%;所有样机监测紫外线的正确率均为100%.②动态实验:"云夹"在区分是否近距离工作 、室内/室外环境是否配戴方面的正确率分别为94.6%、96.5%和96.0%.结论 "云夹"监测近视眼相关环境因素的准确性和稳定性均符合临床需求,并且其还能提供这些因素的时间作用模式,可用于进一步研究环境因素在近视眼发病中的作用.%Objective To evaluate the accuracy and stability of the novel device Clouclip TM (Glasson Technology Co., Ltd, Hangzhou, China) designed to record myopic environmental risks. Methods This experimental study consisted of static and dynamic evaluations. In the static evaluation, 15 devices were randomly selected to measure working distances and ambient illuminance and ultraviolet radiation. The device with the greatest measurement error was chosen to represent the accuracy, while the variance of the measurement error among all devices was utilized to assess the stability. In the dynamic evaluation, 30 volunteers were enrolled to wear the devices for two days. They were requested to report the environmental features dynamically via social media (Wechat), including the time of doing or not doing near-work, outdoor or indoor activities, and wearing or not wearing of the device. The data reported by the subjects were compared with the data detected by ClouclipTM to further evaluate the accuracy. Pearson and Bland-Altman analysis were used to assess the accuracy of the ClouclipTM. Results For the static evaluation: there was significant correlation between the measured and actual values both in distance and illuminance (r=0.998, P<0.001 and r=0.999, P<0.001, respectively). The 95% limit of agreement in working distance and illuminance was 0.18-3.10 cm and 1.02-1.35 lx, respectively. The relative errors for working distance and illuminance were 2.4%-6.5% and 8.9%-20.0%, respectively. The coefficient of variance among all samples was 2.3%-4.3% for working distance and 0.4%-5.6% for illuminance. The rate of correct ultraviolet radiation detection was 100% for all samples. For the dynamic evaluation, the rate of correctly identifying near or far work, indoor or outdoor environment and the wearing or not wearing status was 94.6%, 96.5% and 96.0%, respectively. Conclusion ClouclipTM was able to not only record myopic environmental risks with satisfactory accuracy and stability, but it was also able to determine the temporal pattern for these risk factors. It therefore provides a valuable tool to investigate the role of environmental factors in myopia pathogenesis.