Screening for Diabetic Retinopathy : 1 and 3 Nonmydriatic 45-degree Digital Fundus Photographs vs 7 Standard Early Treatment Diabetic Retinopathy Study Fields

Purpose: To evaluate if simple- or multiple-field digital color nonmydriatic (NM) retinal images can replace 7 standard stereoscopic fundus photographs in the screening of diabetic retinopathy (DR). Design: Prospective, masked, comparative case series. Methods: One hundred and eight eyes of 55 diabetics were studied to determine single lesions and to grade clinical levels of DR and diabetic macular edema (DME) using both 1 and 3 NM digital color retinal images compared with the Early Treatment Diabetic Retinopathy Study (ETDRS) 7 standard 35-mm stereoscopic color fundus photographs (7F-ETDRS). All eyes underwent NM 45-degree field images of 1 central field (1F-NM), NM 45-degree field images of 3 fields (3F-NM), and, after pupil dilatation, 30-degree 7F-ETDRS photography. Images were analyzed by 2 independent, masked retinal specialists (S.V. and E.B.), lesion-by-lesion according to the ETDRS protocol and for clinical severity level of DR and DME according to the international classification of DR. Results: Using 7F-ETDRS as the gold standard, agreement was substantial for grading clinical levels of DR and DME (κ = 0.69 and κ = 0.75) vs 3F-NM; moderate for DR level (κ = 0.56) and substantial for DME (κ = 0.66) vs 1F-NM; almost perfect for detecting presence or absence of DR (κ = 0.88) vs both 1F-NM and 3F-NM; and almost perfect for presence or absence of DME (κ = 0.97) vs 3F-NM and substantial (κ = 0.75) vs 1F-NM. Sensitivity and specificity for detecting referable levels of DR were 82% and 92%, respectively, for 3F-NM and 71% and 96%, respectively, for 1F-NM. Conclusions: Three color 45-degree NM fundus fields may be an effective tool in a screening setting to determine critical levels of DR and DME for prompt specialist referral. One central 45-degree image is sufficient to determine absence or presence of DR and DME, but not for grading it.