Deep Learning Algorithm for Automated Diagnosis of Retinopathy of Prematurity Plus Disease

This study describes the initial development of a deep learning algorithm, ROP.AI, to automatically diagnose retinopathy of prematurity (ROP) plus disease in fundal images.

ROP.AI was trained using 6974 fundal images from Australasian image databases. Each image was given a diagnosis as part of real-world routine ROP screening and classified as normal or plus disease. The algorithm was trained using 80% of the images and validated against the remaining 20% within a hold-out test set. Performance in diagnosing plus disease was evaluated against an external set of 90 images. Performance in detecting pre-plus disease was also tested. As a screening tool, the algorithm's operating point was optimized for sensitivity and negative predictive value, and its performance reevaluated.

For plus disease diagnosis within the 20% hold-out test set, the algorithm achieved a 96.6% sensitivity, 98.0% specificity, and 97.3% ± 0.7% accuracy. Area under the receiver operating characteristic curve was 0.993. Within the independent test set, the algorithm achieved a 93.9% sensitivity, 80.7% specificity, and 95.8% negative predictive value. For detection of pre-plus and plus disease, the algorithm achieved 81.4% sensitivity, 80.7% specificity, and 80.7% negative predictive value. Following the identification of an optimized operating point, the algorithm diagnosed plus disease with a 97.0% sensitivity and 97.8% negative predictive value.

ROP.AI is a deep learning algorithm able to automatically diagnose ROP plus disease with high sensitivity and negative predictive value.

In the context of increasing global disease burden, future development may improve access to ROP diagnosis and care.