目的评价智能可穿戴设备Eye-Monitor客观量化近视相关环境因素的准确性和稳定性。
方法采用诊断试验研究设计，2021年12月于山东中医药大学招募42名受试者，年龄18~25岁。采用简单随机抽样方法从80台设备中抽取42台智能可穿戴设备，对近视相关环境危险因素进行静态和动态试验，其中静态试验包括用眼距离、坐姿头部倾斜角和光照强度测量，动态试验包括近距离工作时长、户外活动时长和看电子设备时长测量。选取总相对误差绝对值之和最大的设备，采用Spearman秩相关分析评价设定值与Eye-Monitor测量值的相关性；采用Bland-Altman一致性分析评价其客观监测值的准确性。通过变异系数评价各个设备客观监测值的稳定性。
结果用眼距离、坐姿头部倾斜角、室内光照强度、近距离工作总时长、平均持续近距离用眼时长、户外活动时长、看计算机屏幕时长和看手机时长测量值与设定值之间均呈强正相关( r s＝0.999、0.998、0.999、0.998、0.976、0.959、0.992、0.997，均 P<0.001)，95%一致性界限(LoA)分别为－1.23~2.32 cm、－1.49~4.24°、－13.90~26.90 lx、－6.46~0.11 min、－4.50~1.20 min、－4.01~1.34 min、－2.54~1.94 min和－2.15~0.45 min，超过95%的点在LoA内，准确性临床可接受。测量值变异系数分别为1.23%~2.99%、2.39%~8.25%、0.87%~8.03%、1.49%~12.52%、6.63%~13.59%、0.00%~14.15%、1.20%~8.33%和1.49%~12.51%，稳定性均较好。Eye-Monitor在测量户外光照强度的95% LoA为－336.50~130.00 lx，95%的点在LoA内，准确性较好。
结论智能可穿戴设备能够客观量化用眼距离、坐姿头部倾斜角、室内光照强度、近距离工作总时长、平均持续近距离用眼时长、户外活动时长、看计算机屏幕时长和看手机时长，并具有较好的准确性和稳定性。
ObjectiveTo evaluate the accuracy and stability of Eye-Monitor, a smart wearable device, in quantifying environmental risks related to myopia.
MethodsA diagnostic test study was conducted.Forty-two subjects aged 18-25 years old were recruited from Shandong University of Traditional Chinese Medicine in December 2021.Forty-two Eye-Monitors were selected from 80 devices using the simple random sampling method.Static and dynamic tests were carried out to compare environmental risks related to myopia.The static tests included measurements under different working distances, different head tilt angles when sitting, and different light intensities.The dynamic tests included measurements under different near-work time, different outdoor activity time, different time watching computers, and different phone viewing time.Eye-Monitor with the largest sum of absolute values of total relative error was selected, Spearman rank correlation analysis was used to analyze the correlation between the set values and Eye-Monitor measurements, and the accuracy of the objectively measured values was evaluated by Bland-Altman consistency analysis.The stability of the objectively measured values from Eye-Monitor was evaluated by the coefficient of variation.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine (No.HEC-KS-2021005KY). Written informed consent was obtained from each subject.
ResultsThere were significant correlations between the measured values and setting values in the working distance, head tilt angle when sitting, indoor light intensity, total near-work time, average continuous near-work time, outdoor activity time, time watching computers, and time viewing phones ( r s=0.999, 0.998, 0.999, 0.998, 0.976, 0.959, 0.992, 0.997; all at P<0.001), with the 95% limits of agreement (LoA) of-1.23-2.32 cm, -1.49-4.24°, -13.90-26.90 lx, -6.46-0.11 minutes, -4.50-1.20 minutes, -4.01-1.34 minutes, -2.54-1.94 minutes and-2.15-0.45 minutes, respectively.More than 95% of dots were within the clinically acceptable LoA.The coefficients of variation of the measured values ranged from 1.23%-2.99%, 2.39%-8.25%, 0.87%-8.03%, 1.49%-12.52%, 6.63%-13.59%, 0.00%-14.15%, 1.20%-8.33 and 1.49%-12.51%, respectively, showing good stability.Eye-Monitor had good accuracy in measuring outdoor light intensity (95% LoA: -336.50-130.00 lx).
ConclusionsThe smart wearable device Eye-Monitor can be used to objectively monitor working distance, head tilt angle when sitting, indoor light intensity, total near-work time, average continuous near-work time, outdoor activity time, time watching computers, and time watching phones, which are with good accuracy and stability.
吴紫云,霍环环,刘艺,等. 智能可穿戴设备定量分析近视相关环境因素的准确性和稳定性[J]. 中华实验眼科杂志,2023,41(08)：746-754.
DOI:10.3760/cma.j.cn115989-20230209-00042版权归中华医学会所有。
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吴紫云：直接参与选题、酝酿和设计试验、实施研究、采集数据、分析/解释数据、起草及修改文章；霍环环：实施研究、收集数据、分析/解释数据；刘艺：实施研究、收集数据；王兴荣：直接参与选题；胡媛媛：直接参与选题、酝酿和设计试验、分析/解释数据；毕宏生：直接参与选题、酝酿和设计试验、分析/解释数据、对文章知识性内容的审阅和智力性内容的修改及定稿
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