Diagnostic accuracy of a digital fundus photographic system for detection of retinopathy of prematurity requiring treatment (ROP-RT)

OBJECTIVES: To evaluate the diagnostic accuracy of a digital fundus photographic system that consists of taking fundus photographs by a trained technician using a RetCam(®) shuttle and interpreting fundus images by an expert to detect Retinotapthy of Prematurity requiring treatment (ROP-RT) which defined as type I ROP according to the Early Treatment for ROP study (ETROP). MATERIALS AND METHODS: One hundred infants were examined by (1) an expert ophthalmologist experienced in ROP care using indirect ophthalmoscopy; (2) digital wide-field imaging by a trained technician using a RetCam(®) shuttle and images were sent remotely for interpretation by two ophthalmologists experienced in ROP care (Reader A, and Reader B); and (3) local ophthalmologists using indirect ophthalmoscopy. The diagnostic acurracy consisting of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) were calculated. Agreement between all examiners and readers were evaluated. RESULTS: A total of 100 infants (mean gestational age 31.1 weeks, mean birth weight 1,511.1 grams) participated in the study. Nine infants were classified as ROP-RT. Reader A and B had very good agreement in detection of ROP- RT (Kappa 1.00, 95% CI 1.00, 1.00). For reader A, diagnostic performance parameters (95% confidence intervals) for detecting ROP-RT were; sensitivity 100.0% (66.4, 100.0), specificity 97.8% (92.1, 99.7), PPV 81.8% (48.2, 97.7), NPV 100.0% (95.8, 100.0), LR+ 44.5 (11.3, 175.2), and LR- 0.1 (0.0, 0.8). For reader B these were; sensitivity 100.0% (66.4, 100.0), specificity 95.6% (89.0, 98.8), PPV 69.2% (38.6, 90.9), NPV 100.0% (95.8, 100.0), LR+ 22.5 (8.6, 58.6), LR- 0.1 (0.0, 0.8). No adverse events were reported. CONCLUSIONS: Diagnosis of ROP-RT from RetCam(®) images taken by trained technicians and evaluated remotely by an expert ophthalmologist had good diagnostic accuracy for screening purposes.