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 I 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 (kappa = 0.69 and kappa = 0.75) vs 3F-NM; moderate for DR level (kappa = 0.56) and substantial for DME (kappa = 0.66) vs 1F-NM; almost perfect for detecting presence or absence of DR (kappa = 0.88) vs both 1F-NM and 3F-NM; and almost perfect for presence or absence of DME (kappa = 0.97) vs 3F-NM and substantial (kappa = 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. (Am J Ophthalmol 2009;148: 111-118. (C) 2009 by Elsevier Inc. All rights reserved.)