Validity, Usefulness and Cost of RETeval System for Diabetic Retinopathy Screening.

PURPOSE: We studied the validity, usefulness, and relative cost to detect diabetic retinopathy (DR) and sight-threatening DR (STDR) by using a hand-held electrophysiologic tool compared to digital fundus photography.

METHOD: Patients with diabetes attending the screening unit of King Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia were evaluated by "RETeval", Amsler grid, and digital dilated fundus photography. Fundus images were evaluated by a retina specialist to determine grade of DR. The sensitivity and specificity of STDR and DR screening compared to photography were calculated, as well as "RETeval" combined with Amsler grid testing. The area under the curve (AUC) of "RETeval" screening outcome was calculated.

RESULT: We analyzed data of 400 diabetic patients. The prevalence of DR of any grade was 48.8% (95% confidence interval [CI], 43.9-53.7) while the prevalence of STDR was 27% (95% CI, 22.6-31.4). The outcome of RETeval test was "fail" (based on 20 μV or more amplitude of electrophysiologic spikes) in 351 (87.8%; 95% CI, 84.5-91.0) eyes. The sensitivity of the device was 95.4% and the specificity was 17.5%. Thus, the sensitivity of sequential testing with RETeval and Amsler grid test was 30.1% and the specificity was 80.1%. The AUCs for STDR and DR in general were 76.6% and 50.6%, respectively.

CONCLUSIONS: "RETeval" is a rapid screening device with excellent sensitivity for detecting STDR. It has potential as a first level screening tool to detect patients who require further evaluation.

TRANSLATIONAL RELEVANCE: Retinal function, such as electrophysiology, can be used as a new concept for screening for DR.