Purpose-To examine the effect of volume and method on fluorescein tear breakup time (TBUT) values, and to evaluate test efficacy in an independent sample free of selection bias.Methods-Subjects were assessed using a battery of dry eye tests. Efficacy study: subjects were randomized to the Dry Eye Test (DET), Standard Strip (SS) and liquid NaFl, on separate days. A masked examiner measured TBUTs from video recordings. Verification study: Subjects were investigated for efficacy using volumes of 5.0 and 2.0 μl microliters of NaFl for TBUT.Results-Efficacy study: 46 subjects completed the study. Log-transformed TBUTs were significantly different, normals vs. drys, for all 3 methods (all p values < 0.001). AUCs, cut-points, sensitivity and specificity were: 1) DET: 0.873, 4.4 secs, 0.97 and 0.67, respectively, 2) 2.0 microliters: 0.901, 3.22 secs, 0.90 and 0.87, respectively, and 3) SS: 0.912, 3.42 secs, 0.97 and 0.80, respectively. Verification study: Data splitting analysis for the 2.0 μl data (n = 174 drys and 97 normals) generated an AUC of 0.917, a cut-point of 6.05 seconds for sensitivity of 0.87 and specificity of 0.81. The 5.0 μl sample yielded an AUC of 0.940, with sensitivity and specificity of 0.92 and 0.83, respectively at a cut-point of 5.5 seconds.
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