Objective To evaluate the sensitivity and specificity of fundus photograph in detecting diabetic macular edema (DME) in screening for diabetic retinopathy (DR).

Methods Data of 1 438 patients with DR were collected. All patients received uncorrected visual acuity, best corrected visual acuity, color fundus photography, and spectral domain optical coherence tomography (SD-OCT). Using SD-OCT as the gold standard for the diagnosis of DME, the sensitivity, specificity and area under receiver operator characteristic (ROC) curve (AUC) of fundus color photography were evaluated.

Results A total of 1 438 patients with an average age of (57.7±11.0) years were enrolled in this study, with a total of 2 326 eyes. There were 1 412 eyes of background DR (group R1), 710 eyes of pre-proliferative DR (group R2) and 204 eyes of proliferative DR (group R3). The sensitivity of DME detected by fundus photograph was 78.8% (95%CI, 76.1% to 81.2%), the specificity was 56.6% (95%CI, 54.0% to 59.3%), and the AUC was 0.677 (95%CI, 0.659 to 0.696). In group R1, the sensitivity, specificity and AUC of DME detected by fundus photograph were 68.6% (95%CI, 64.2% to 72.7%), 58.8% (95%CI, 69.4% to 75.4%) and 0.637 (95%CI, 0.611 to 0.664), respectively; in the R2 group, the sensitivity, specificity and AUC were 86.3% (95%CI, 82.3% to 89.4%), 52.0% (95%CI, 46.8% to 57.2%) and 0.691 (95%CI, 0.660 to 0.723), respectively; in R3 group, the sensitivity, specificity and AUC were 89.3% (95%CI, 83.8% to 93.2%), 42.9% (95%CI, 28.0% to 59.1%) and 0.661 (95%CI, 0.575 to 0.747), respectively.

Conclusion The sensitivity of fundus photograph to detect DME in DR screening is high, but the specificity is low, and the use of fundus color imaging alone to screen DME will lead to transfer treatments of nearly half of the patients.