Red reflex examination for early detection of pediatric cataract using a novel red-reflex screening device

Early detection of pediatric cataracts is essential to prevent irreversible visual impairment; however, effective screening remains limited in many settings. This study evaluated the diagnostic performance of the CatScreener, a self-designed handheld red-reflex screening device, when operated by non-expert examiners. A total of 250 eyes from 250 infants and young children (≤8 years) underwent CatScreener screening and slit-lamp examination. Images were independently interpreted by two medical students and two junior ophthalmologists. Diagnostic outcomes were compared with an expert-defined reference standard. Cumulative summation (CUSUM) analysis was used to assess the learning curve for operational proficiency. Diagnostic accuracy did not differ significantly between CatScreener screening and slit-lamp examination across all examiners (all p > 0.05). The CatScreener demonstrated high sensitivity (84.9%-87.1%) and specificity (89.2%-91.0%), with excellent agreement with slit-lamp examination (Kappa = 0.856–0.952) and good inter-examiner consistency (Kappa = 0.792–0.920). Sensitivity and specificity remained stable across chronological operation stages and age-stratified subgroups. CUSUM analysis indicated that approximately 50 cases were required to achieve operational proficiency. The CatScreener is an effective and user-friendly tool for the early detection of pediatric cataracts, demonstrating high diagnostic accuracy, strong agreement with conventional examination methods, and consistent performance across examiners with varying levels of clinical experience.