Validation of an Automated Screening System for Diabetic Retinopathy Operating under Real Clinical Conditions

Abstract

Background. Retinopathy is the most common microvascular complication of diabetes mellitus. It is the leading cause of blindness among working-aged people in developed countries. The use of telemedicine in the screening system has enabled the application of large-scale population-based programs for early retinopathy detection in diabetic patients. However, the need to support ophthalmologists with other trained personnel remains a barrier to broadening its implementation. Methods. Automatic diagnosis of diabetic retinopathy was carried out through the analysis of retinal photographs using the 2iRetinex software. We compared the categorical diagnoses of absence/presence of retinopathy issued by family physicians (PCP) with the same categories provided by the algorithm (ALG). The agreed diagnosis of three specialist ophthalmologists is used as the reference standard (OPH). Results. There were 653 of 3520 patients diagnosed with diabetic retinopathy (DR). Diabetic retinopathy threatening to vision (STDR) was found in 82 patients (2.3%). Diagnostic sensitivity for STDR was 94% (ALG) and 95% (PCP). No patient with proliferating or severe DR was misdiagnosed in both strategies. The k-value of the agreement between the ALG and OPH was 0.5462, while between PCP and OPH was 0.5251 (p = 0.4291). Conclusions. The diagnostic capacity of 2iRetinex operating under normal clinical conditions is comparable to screening physicians.