Evaluation of the Repeatability of the LacryDiag Ocular Surface Analyzer for Assessment of the Meibomian Glands and Tear Film.

Evaluation of the Repeatability of the LacryDiag Ocular Surface Analyzer for Assessment of the Meibomian Glands and Tear Film.
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DOI:
10.1167/tvst.10.9.1
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发表时间:
2021-08-02
影响因子:
3
通讯作者:
Robertson DM
Robertson DM
中科院分区:
医学3区
文献类型:
--
作者:
Ward CD;Murchison CE;Petroll WM;Robertson DM

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本研究旨在确定新型LacryDiag眼表分析仪的观察者内和观察者间可重复性,并将其与类似的一体化设备OCULUS Keratograph 5 M进行比较。本研究招募了30名18岁及以上的健康受试者。所有患者均无任何现有眼部病理。使用LacryDiag眼表分析仪评价泪液半月板高度、干涉测量、无创泪膜破裂时间(NIBUT)和睑板造影。使用OCULUS Keratograph 5 M进行相同或类似的检查。试验等效用于比较相应检查的数据。配对t检验和变异系数用于确定观察者间和观察者内的重复性。Bland-Altman分析用于确定器械之间的一致性水平。两种器械的观察者之间的泪液半月板高度、NIBUT或泪膜干涉测量的平均值无差异。当使用LacryDiag时,观察者之间的睑板造影存在显著差异(损失百分比计算P = 0.008,分级量表P = 0.004)。角膜曲率计的NIBUT观察者内变异性显著更高(观察者A的P = 0.0003,观察者B的P < 0.0001)。对于给定的观察者,器械之间的相关性良好,但一致性较差。这可能受到重复测试和非干眼症队列的影响。测试设备的可重复性和多个结局指标的使用对于干眼病(DED)患者的诊断和监测至关重要。
This study aimed to determine the intra- and interobserver repeatability of the new LacryDiag Ocular Surface Analyzer and compare it to a similar all-in-one device, the OCULUS Keratograph 5M. Thirty healthy subjects aged 18 years and above were recruited for this study. All patients were free of any existing ocular pathology. The LacryDiag Ocular Surface Analyzer was used to evaluate tear meniscus height, interferometry, noninvasive tear break-up time (NIBUT), and meibography. The same or analogous exams were performed using the OCULUS Keratograph 5M. Test equivalation was used to compare data from corresponding examinations. Paired t-tests and coefficient of variation were used to determine inter- and intraobserver repeatability. Bland-Altman analysis was used to determine level of agreement between devices. There were no differences in mean values for tear meniscus height, NIBUT, or tear film interferometry between observers for either device. Significant differences were found between observers for meibography when using the LacryDiag (P = 0.008 for percent loss calculation and P = 0.004 for grading scale). Intra-observer variability for NIBUT was significantly higher for the Keratograph (P = 0.0003 for observer A and P < 0.0001 for observer B). There was a good correlation but poor agreement between devices for a given observer. This was likely influenced by the use of repeated testing and the non-dry eye cohort. Both the repeatability of the testing device and the use of multiple outcome measures are essential for the diagnosis and monitoring of patients with dry eye disease (DED).
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