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.

Clinical Observation of Allergic Conjunctival Diseases with Portable and Recordable Slit-Lamp Device.

BACKGROUND: The incidence of allergic conjunctival diseases (ACDs) is gradually increasing worldwide. Both ophthalmologists and non-ophthalmologists prescribe eye drops to treat ACDs; however, there are many cases which are treated without sufficient examination and diagnosis of the eyes. We have invented a portable, recordable, and smartphone-attachable slit-lamp device-Smart Eye Camera (SEC). The purpose of this study was to compare the diagnostic abilities of ACDs between the SEC and the conventional, non-portable slit-lamp microscope. METHODS: This prospective observational study included 32 eyes of 17 Japanese patients (mean age: 21.5 ± 14.8 years; range: 11-51 years; female: 5). The severity of 10 objective signs in the palpebral conjunctiva, bulbar conjunctiva, limbus, and cornea were scored on a grading scale of 0 to 4 (0 = normal; 1+ = mild; 2+ = moderate; 3+ = severe), respectively. First, the conventional slit-lamp microscope was used to examine the grade of the ACDs. Second, another ophthalmologist filmed the eyes using the SEC and two other ophthalmologists evaluated the grades on another day. The correlation and inter-rater reproducibility in total scores among the two devices were determined. RESULTS: Total scores of clinical signs, evaluated by the two approaches, correlated significantly (both eyes: r = 0.918 (95% CI: 0.839 to 0.959; p < 0.001)), with substantial inter-rater agreement (weighted κ value = 0.631 (95% CI: 0.601 to 0.661; p < 0.001)). CONCLUSIONS: The SEC is as reliable as the conventional non-portable slit-lamp microscope for assessing ACDs.

A Study Validating the Estimation of Anterior Chamber Depth and Iridocorneal Angle with Portable and Non-Portable Slit-Lamp Microscopy.

This study assessed the anterior chamber depth (ACD) and iridocorneal angle using a portable smart eye camera (SEC) compared to the conventional slit-lamp microscope and anterior-segment optical coherence tomography (AS-OCT). This retrospective case-control study included 170 eyes from 85 Japanese patients. The correlation between the ACD evaluations conducted with the SEC and conventional slit-lamp was high (r = 0.814). The correlation between the Van-Herick Plus grade obtained using two devices was also high (r = 0.919). A high kappa value was observed for the Van-Herick Plus grading (Kappa = 0.757). A moderate correlation was observed between the ACD measured using AS-OCT and the slit-lamp image acquired with the conventional slit-lamp microscope and SEC (r = 0.609 and 0.641). A strong correlation was observed between the trabecular-iris angle (TIA) measured using AS-OCT and Van-Herick Plus grade obtained with the conventional slit-lamp microscope and SEC (r = 0.702 and 0.764). Strong correlations of ACD evaluation and high kappa value of the Van-Herick Plus grading indicated the adequate subjective assessment function of the SEC. Moderate correlations between the ACD objective measurement and evaluation and strong correlation between the TIA and Van-Herick Plus grade suggested the good objective assessment function of the SEC. The SEC demonstrated adequate performance for ACD evaluation and angle estimation.

Corneal higher-order aberrations in phlyctenular keratitis.

PURPOSE: To characterize tomographic patterns and quantify corneal higher-order aberrations (HOAs) in eyes with corneal scar due to phlyctenular keratitis. STUDY DESIGN: Retrospective consecutive case series. METHODS: This study included 51 eyes of 38 patients (24 women; 14 men) with corneal scar due to phlyctenular keratitis. HOAs of the total cornea, and of the anterior and posterior surfaces were measured using anterior segment optical coherence tomography (AS-OCT). Corneal tomographic patterns were classified into five types: increased regular astigmatism, ectasia, asymmetric, flattening and minimal change patterns. The correlation between corneal HOAs and visual acuity was evaluated. RESULTS: Mean months from onset was 50.7 ± 74.7 and mean number of recurrences 2.1 ± 1.1 (1-5). Mean logarithm of the minimal angle of resolution (logMAR) was 0.19 ± 0.31. AS-OCT showed ectasia pattern in 16 eyes (31.4%), asymmetric pattern in 12 eyes (23.5%), increased regular astigmatism pattern in 9 eyes (17.6%), flattening pattern in 3 eyes (5.9%) and minimal change pattern in 11 eyes (21.6%). HOAs of the total cornea were 0.57 ± 0.44 µm and 1.16 ± 0.77 µm within a 4-mm and 6-mm diameter, significantly larger than in normal controls (P < 0.0001). LogMAR visual acuity was significantly correlated with corneal HOAs (4-mm: r = 0.558, P < 0.0001, 6-mm: r = 0.566, P < 0.0001), central corneal thickness (r = - 0.349, P = 0.016), and corneal astigmatism (r = 0.414, P = 0.004), but not with average keratometric value (r = - 0.092, P = 0.537). CONCLUSIONS: The most common tomographic pattern was ectasia, followed by a asymmetric pattern in eyes with phlyctenular keratitis. Corneal HOAs were associated with decreased visual acuity in phlyctenular keratitis patients.