To evaluate the diagnostic accuracy of artificial intelligence (AI)-based automated diabetic retinopathy (DR) screening in real-world settings.

Systematic review and meta-analysis

We conducted a systematic review of relevant literature from January 2012 to August 2022 using databases including PubMed, Scopus and Web of Science. The quality of studies was evaluated using Quality Assessment for Diagnostic Accuracy Studies 2 (QUADAS-2) checklist. We calculated pooled accuracy, sensitivity, specificity, and diagnostic odds ratio (DOR) as summary measures. The study protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO - CRD42022367034).

We included 34 studies which utilized AI algorithms for diagnosing DR based on real-world fundus images. Quality assessment of these studies indicated a low risk of bias and low applicability concern. Among gradable images, the overall pooled accuracy, sensitivity, specificity, and DOR were 81%, 94% (95% CI: 92.0-96.0), 89% (95% CI: 85.0-92.0) and 128 (95% CI: 80-204) respectively. Sub-group analysis showed that, when acceptable quality imaging could be obtained, non-mydriatic fundus images had a better DOR of 143 (95% CI: 82-251) and studies using 2 field images had a better DOR of 161 (95% CI 74-347). Our meta-regression analysis revealed a statistically significant association between DOR and variables such as the income status, and the type of fundus camera.

Our findings indicate that AI algorithms have acceptable performance in screening for DR using fundus images compared to human graders. Implementing a fundus camera with AI-based software has the potential to assist ophthalmologists in reducing their workload and improving the accuracy of DR diagnosis.