Abstract：Objective: To investigate the repeatability and consistency of two ocular surface analyzers, Keratograph 5M and DED-1L, in diagnosing dry eye disease. Methods: A cross-sectional comparative study was conducted from September to November 2021 at the Department of Refractive Surgery, Eye Hospital, Wenzhou Medical University, using a random sampling method to recruit 45 dry eye patients (all with left eyes only). On the same day, the same operator used Keratograph 5M and DED-1L to measure tear meniscus height (TMH), upper meibomian glands loss (UMGL), lower meibomian glands loss (LMGL), and noninvasive breakup time (NIBUT). Image J software was used to draw and calculate the TMH, UMGL, and LMGL. One-way ANOVA, paired t-test, and Bland-Altman plots were used to analyze the data. Results: In TMH, UMGL, and LMGL, Keratograph 5M had within-subject standard deviations (Sw) of less than 0.025, test-retest repeatability (TRT) coeffcients of less than 0.069, coeffcients of variation (Cov) of less than 10.43%, and intraclass correlation coefficients (ICC) of greater than 0.868. For the frst NIBUT (fNIBUT) and average NIBUT (avNIBUT), the Sw was greater than 4.382, TRT was greater than 12.138, Cov was greater than 34.34%, and ICC was less than 0.464. DED-1L had Sw of less than 0.030, TRT of less than 0.082, Cov of less than 11.26%, and ICC of greater than 0.860 for TMH, UMGL, and LMGL. For the fNIBUT and avNIBUT, the Sw was greater than 2.858, TRT was greater than 7.918, Cov was greater than 35.31%, and ICC was less than 0.244. The difference between Keratograph 5M and DED-1L in UMGL and LMGL was not statistically signifcant (P>0.05), while the difference in TMH, the fNIBUT, and avNIBUT was statistically signifcant (t=-2.63, P=0.012; t=6.97, P<0.001; t=6.68, P<0.001, respectively). In the Bland-Altman plot, the mean differences between TMH, UMGL, and LMGL detected by 5M and DED-1L were -0.033 mm, -0.004, and 0.004, respectively. The 95% LoAwere (-0.15, 0.10) mm,(-0.07, 0.07) and (-0.08, 0.09), respectively. Outside of 95% LoA, they accounted for 6.67% (3/45), 4.44% (2/45), and 6.67% (3/45), respectively; The mean differences between fNIBUT and avNIBUT detected by 5M and DED-1L were 5.7 s and 4.6 s, respectively. The 95% LoAwere (-5.1, 16.6)s and (-4.5, 13.8)s, respectively. Outside of 95% LoA, both of them accounted for 2.22% (1/45). Conclusions: DED-1L can be used interchangeably with Keratograph 5M in diagnosing dry eye disease based on TMH, UMGL, and LMGL, but not for the fNIBUT and avNIBUT.
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