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

Purpose: 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. Methods: 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. Results: 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). Conclusions: 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. Translational Relevance: 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).

Automated summary

This study compared the intra- and interobserver repeatability of the LacryDiag Ocular Surface Analyzer and the OCULUS Keratograph 5M, finding good correlation but poor agreement between the devices for tear-related parameters. Both the repeatability of testing devices and the use of multiple outcome measures are crucial for diagnosing and monitoring patients with dry eye disease.