Aim: Diabetic retinopathy (DR) represents the main cause of vision loss among working age people. A prompt screening of this condition may prevent its worst complications. This study aims to validate the in-built artificial intelligence (AI) algorithm Selena+ of a handheld fundus camera (Optomed Aurora, Optomed, Oulu, Finland) in a first line screening of a real-world clinical setting. Methods: It was an observational cross-sectional study including 256 eyes of 256 consecutive patients. The sample included both diabetic and non-diabetic patients. Each patient received a 50°, macula centered, non-mydriatic fundus photography and, after pupil dilation, a complete fundus examination by an experienced retina specialist. All images were after analyzed by a skilled operator and by the AI algorithm. The results of the three procedures were then compared. Results: The agreement between the operator-based fundus analysis in bio-microscopy and the fundus photographs was of 100%. Among the DR patients the AI algorithm revealed signs of DR in 121 out of 125 subjects (96.8%) and no signs of DR 122 of the 126 non-diabetic patients (96.8%). The sensitivity of the AI algorithm was 96.8% and the specificity 96.8%. The overall concordance coefficient k (95% CI) between AI-based assessment and fundus biomicroscopy was 0.935 (0.891-0.979). Conclusions: The Aurora fundus camera is effective in a first line screening of DR. Its in-built AI software can be considered a reliable tool to automatically identify the presence of signs of DR and therefore employed as a promising resource in large screening campaigns
