Smart Eye Camera: A Validation Study for Evaluating the Tear Film Breakup Time in Human Subjects

PURPOSE: This study aimed to demonstrate the efficacy of a “Smart Eye Camera (SEC)” in comparison with the efficacy of the conventional slit-lamp microscope by evaluating their diagnostic functionality for dry eye disease (DED) in clinical cases. METHODS: This retrospective study included 106 eyes from 53 adult Japanese patients who visited the Ophthalmology outpatient clinics in Keio University Hospital from June 2019 to March 2020. Tear film breakup time (TFBUT) and corneal fluorescence score (CFS) measurements for the diagnosis of DED were compared between the conventional slit-lamp microscope and SEC. RESULTS: The objective findings of DED showed that there was a strong correlation between the conventional slit-lamp microscope and SEC with respect to TFBUT and CFS results (Spearman's r = 0.887, 95% confidence interval [CI] = 0.838–0.922, and r = 0.920, 95% CI = 0.884–0.945, respectively). The interobserver reliability between the conventional slit-lamp microscope and SEC showed a moderate agreement (weighted Kappa κ = 0.527, 95% CI = 0.517–0.537 and κ = 0.550, 95% CI = 0.539–0.561 for TFBUT and CFS, respectively). The diagnostic performance of the SEC for Asia Dry Eye Society diagnostic criteria showed a sensitivity of 0.957 (95% CI = 0.841–0.992), specificity of 0.900 (95% CI = 0.811–0.927), positive predictive value of 0.880 (95% CI = 0.774–0.912), and negative predictive value of 0.964 (95% CI = 0.869–0.993). Moreover, the area under the receiver operating characteristic curve was 0.928 (95% CI = 0.849–1.000). CONCLUSIONS: Compared with the conventional slit-lamp microscope, SEC has sufficient validity and reliability for diagnosing DED in the clinical setting. TRANSLATIONAL RELEVANCE: The SEC can portably evaluate TFBUT in both basic research and clinical care.