Human Lacrimal Production Rate and Wetted Length of Modified Schirmer's Tear Test Strips

PURPOSE: To assess and compare the wetting kinetics of sheathed and unsheathed Schirmer's tear test (STT) strips, and to determine the repeatability of 5-minute wetted length (WL) and basal tear production rate (BTPR). METHODS: Seventeen subjects underwent two sheathed and unsheathed STTs each for both eyes on four visits on separate days. After administration of topical anesthetic, WLs were measured every 30 seconds for 5 minutes, and BTPRs were calculated for sheathed strips. Limits of agreement (LoA), difference-versus-mean plots (DVM), and the coefficient of repeatability (CR) assessed WL and BTPR repeatabilities. Variance estimates were used to calculate sample sizes for future study. RESULTS: For the unsheathed STT, the mean (SD) difference in WLs between visits was 0.74 (5.05) mm, LoA were [−9.17, 10.64], and CR was 9.17 mm; for the sheathed STT, the mean (SD) intervisit difference was 0.16 (5.94) mm, LoA were [−11.49, 11.8], and CR was 10.53 mm. Eight of 48 sheathed STTs and 20 of 44 unsheathed STTs showed constant WL for the final 90 seconds of the test. The mean (SD) difference between repeated visits for BTPR was approximately 0.0 μL/min, LoA were [−1.82, 1.82], and CR was 1.91 μL/min. CONCLUSIONS: Repeatability of sheathed and unsheathed 5-minute WL and BTPR is inadequate for measuring within-subject changes, but is sufficient for group studies with moderate sample sizes. Constant WL for the final 90 seconds with the eight sheathed STT measurements suggests varying BTPR, whereas constant WL with the unsheathed STT can be explained by balancing evaporation and BTPR. TRANSLATIONAL RELEVANCE: Repeatability of the modified STT is evaluated clinically to establish quantitative BTPRs rather than inference from a strip WL.