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Purpose: To assess the diagnostic performance of a novel, automated, noninvasive measure of tear film stability derived from Placido disc videokeratography, the tear film surface quality breakup time (TFSQ-BUT), as a clinical marker for diagnosing dry eye disease (DED) relative to a standard of tear hyperosmolarity.

Methods: This prospective, cross-sectional study involved 45 participants (28 DED, 17 controls). Symptoms (Ocular Surface Disease Index) and signs (tear osmolarity, TFSQ-BUT, tear breakup time measured with sodium fluorescein [NaFl-BUT], ocular surface staining and Schirmer test with topical anesthesia) of DED were assessed. Three measures of TFSQ-BUT and NaFl-BUT were taken per eye;“first,”“average,” and “shortest” BUT were analyzed separately. Optimal diagnostic cutoff values were determined using the Youden Index. The repeatability and agreement of the TFSQ-BUT was compared with two clinicians who manually assessed noninvasive BUT (CNI-BUT). Repeatability of methods was assessed using the geometric coefficient of variation (gCoV,%). Agreement between methods was considered with Bland-Altman analysis.

Results: Eyes with DED had significantly shorter TFSQ-BUTs than controls (P< 0.05). There was a significant, moderate correlation between both shortest and average TFSQ-BUT and NaFl-BUT (r= 0.35, P= 0.02 and r= 0.38, P= 0.01, respectively). The receiver-operator characteristic (ROC) curve for shortest TFSQ-BUT showed an area under the curve of 0.92 (P< 0.0001). Shortest TFSQ-BUT with a criterion of 12.1 seconds had a sensitivity of 82% and specificity of 94% for diagnosing DED against …