A multi-center prospective evaluation of THEIA to detect diabetic retinopathy (DR) and diabetic macular edema (DME) in the New Zealand screening program

Purpose: to assess the efficacy of THEIA, an artificial intelligence for screening diabetic retinopathy in a multi-center prospective study. To validate the potential application of THEIA as clinical decision making assistant in a national screening program. Methods: 902 patients were recruited from either an urban large eye hospital, or a semi-rural optometrist led screening provider, as they were attending their appointment as part of New Zealand Diabetic Screening programme. These clinics used a variety of retinal cameras and a range of operators. The de-identified images were then graded independently by three senior retinal specialists, and final results were aggregated using New Zealand grading scheme, which is then converted to referable\non-referable and Healthy\mild\more than mild\vision threatening categories. Results: compared to ground truth, THEIA achieved 100% sensitivity and [95.35%-97.44%] specificity, and negative predictive value of 100%. THEIA also did not miss any patients with more than mild or vision threatening disease. The level of agreement between the clinicians and the aggregated results was (k value: 0.9881, 0.9557, and 0.9175), and the level of agreement between THEIA and the aggregated labels was (k value: 0.9515). Conclusion: Our multi-centre prospective trial showed that THEIA does not miss referable disease when screening for diabetic retinopathy and maculopathy. It also has a very high level of granularity in reporting the disease level. Since THEIA is being tested on a variety of cameras, operating in a range of clinics (rural\urban, ophthalmologist-led\optometrist-led), we believe that it will be a suitable addition to a public diabetic screening program.