Diagnostic performance of an artificial intelligence software for diabetic retinopathy organised screening in a pilot study

Diabetic retinopathy (DR) is one of the most common complications of diabetes mellitus (DM) with a prevalence that varies from 10% to 61% in different countries. From healthcare to the precise prevention, diagnosis, and management of diseases, Artificial Intelligence (AI) is progressing rapidly in interdisciplinary fields, including ophthalmology. We aimed to explore the efficacy of artificial intelligence (AI)-based screening for diabetic retinopathy in type 2 DM patients. High-resolution colour fundus photographs were obtained for all patients using a non-mydriatic camera (Nidek AFC-330). DAIRET software uses a machine learning algorithm to identify the most important signs of DR. The software provides an output with a binary result: negative, in case of no referable disease or positive, when the presence of signs of DR is detected. The photographs were also manually graded negative or positive for DR by an expert ophthalmologist, masked to AI responses. Expert clinical opinion was used as the reference (gold standard), and the results were compared with those of the AI responses. A significant association was observed between DAIRET and expert diagnosis (χ 2 = 18.6, p < 0.001). Disease prevalence, according to expert assessment, was 20.2% (33/163). Observed agreement between DAIRET and Expert diagnosis was 69.3%. Agreement metric was: Gwet’s AC1 = 0.47 (95% CI: 0.33–0.61), indicating moderate agreement. Diagnostic performance of the DAIRET test indicates good sensitivity (73%), a specificity (68%) and high negative predictive value (NPV=90.8%), suggesting that DAIRET is more effective at excluding diabetic retinopathy than at confirming it. ROC analysis stratified by gender showed no difference in performance (p>0.05). Overall, these results suggest that DAIRET may be effectively integrated into screening workflows to rule out diabetic retinopathy, reduce specialist workload, and prioritize referrals. In particular, for daily practical use, DAIRET is managed within the MètaClinic electronic medical record. In-house data processing without going to an external cloud is a significant strength. Larger, prospective studies are needed to validate these findings, optimise thresholds, and assess performance across diverse populations and clinical settings.