The diagnostic accuracy of an intelligent and automated fundus disease image assessment system with lesion quantitative function (SmartEye) in diabetic patients

BACKGROUND: With the diabetes mellitus (DM) prevalence increasing annually, the human grading of retinal images to evaluate DR has posed a substantial burden worldwide. SmartEye is a recently developed fundus image processing and analysis system with lesion quantification function for DR screening. It is sensitive to the lesion area and can automatically identify the lesion position and size. We reported the diabetic retinopathy (DR) grading results of SmartEye versus ophthalmologists in analyzing images captured with non-mydriatic fundus cameras in community healthcare centers, as well as DR lesion quantitative analysis results on different disease stages. METHODS: This is a cross-sectional study. All the fundus images were collected from the Shanghai Diabetic Eye Study in Diabetics (SDES) program from Apr 2016 to Aug 2017. 19,904 fundus images were acquired from 6013 diabetic patients. The grading results of ophthalmologists and SmartEye are compared. Lesion quantification of several images at different DR stages is also presented. RESULTS: The sensitivity for diagnosing no DR, mild NPDR (non-proliferative diabetic retinopathy), moderate NPDR, severe NPDR, PDR (proliferative diabetic retinopathy) are 86.19, 83.18, 88.64, 89.59, and 85.02%. The specificity are 63.07, 70.96, 64.16, 70.38, and 74.79%, respectively. The AUC are PDR, 0.80 (0.79, 0.81); severe NPDR, 0.80 (0.79, 0.80); moderate NPDR, 0.77 (0.76, 0.77); and mild NPDR, 0.78 (0.77, 0.79). Lesion quantification results showed that the total hemorrhage area, maximum hemorrhage area, total exudation area, and maximum exudation area increase with DR severity. CONCLUSIONS: SmartEye has a high diagnostic accuracy in DR screening program using non-mydriatic fundus cameras. SmartEye quantitative analysis may be an innovative and promising method of DR diagnosis and grading.