Objective To observe the preliminary clinical application value of the handheld non-mydriatic visual electrophysiological diagnostic system RETeval in screening for diabetic retinopathy (DR).Methods Retrospective clinical study. Fifty-eight patients with type 2 diabetes mellitus and 16 normal subjects who were admitted to Wuhan General Hospital of the PLA from November 2017 to May 2018 were enrolled in this study. All patients had not received any ophthalmologic treatment. All patients were examined by the default “DR assessment protocol” model of the RETeval device, and the “DR score” were measured by the system. The FFA results were used as the gold standard, and the DR was graded according to the international DR grading standard established in 2002. Patients were divided into vision threatening DR (VTDR) positive group and VTDR (−) group, DR (+) group and DR (−) group. Two independent sample t tests was used to compare the implicit time, amplitude, and pupil area ratio between eyes of different groups. Spearman correlation analysis was used to analyze the relationship between “DR score” and DR severity. The receiver operating characteristic area under the curve (AUC) assesses the sensitivity and specificity of RETeval in detecting DR and VTDR. The threshold of sensitivity and specificity was determined by using the maximum Youden index as a standard.Results The AUC of DR was 0.936, the sensitivity was 81%, the specificity was 92%; the AUC of VTDR was 0.976, the sensitivity was 96% and the specificity was 70%. Compared with DR (−) group, the implicit time of DR (+) group was delayed and the amplitude and pupil area were decreased (t=－13.43, 5.49, 6.09; P=0.000, 0.000, 0.000). Compared with VTDR (−) group, the implicit time of VTDR (+) group was delayed and the amplitude and pupil area were decreased (t=－11.05, 7.46, 5.73; P=0.000, 0.000, 0.000). The “DR score” was significantly correlated with the severity of DR (r=0.89, P＜0.05).Conclusions The “DR score” measured by the RETeval instrument has a high degree of specificity and sensitivity in the diagnosis of DR and VTDR. It is highly correlated with the severity of DR.

Citation： Li Wenqing, Song Yanping, Ding Qin. The clinical value of screening for diabetic retinopathy with a new mydriasis-free, full-feld ficker electrophysiological recording device. Chinese Journal of Ocular Fundus Diseases, 2020, 36(2): 94-98. doi: 10.3760/cma.j.issn.1005-1015.2020.02.002 Copy