Diagnostic Accuracy of Pediatrician-performed Digital Retinal Imaging with 3nethra neo for ROP Screening.

Abstract

Objectives: To evaluate the accuracy of pediatrician-performed wide-field digital retinal imaging (WFDRI) for diagnosing Retinopathy of prematurity (ROP), as compared to binocular indirect ophthalmoscopy (BIO) as the reference standard.

Methods: Eligible infants undergoing ROP screening were enrolled consecutively. BIO was performed by trained ophthalmologists, followed by WFDRI (using "3nethra neo" camera) by a pediatrician. An expert pediatric ophthalmologist reviewed de-identified images for quality, presence, and severity of ROP. She was masked to the findings of BIO and the pediatrician. Diagnostic accuracy for detecting any ROP, ROP requiring treatment (Type 1), and ROP requiring referral (Type 1 or 2) were calculated for WFDRI, considering BIO as the reference standard.

Results: The analysis included 427 eyes. The sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic accuracy, and diagnostic odds ratio of WFDRI were 0.88 (95% CI: 0.81, 0.93), 0.89 (0.85, 0.92), 7.8 (5.7, 10.9), 0.14 (0.09, 0.21), 0.89 (0.85, 0.91), and 58.3 (31, 110) respectively for detection of 'any ROP'. For detecting ROP requiring treatment (Type 1), the sensitivity, specificity, NLR, and diagnostic accuracy were 0.90 (0.75, 0.97), 1.00 (0.99, 1.00), 0.11 (0.04, 0.27), and 0.99 (0.98, 1.00) respectively. For ROP requiring referral, the sensitivity, specificity, NLR, and diagnostic accuracy of pediatrician-performed WFDRI were 0.92 (0.80, 0.98), 1.00 (0.99, 1.00), 0.08 (0.03, 0.21), and 0.99 (0.98, 1.00) respectively. No serious adverse events were noted. The pediatrician and ophthalmologist had a near-perfect (k-1.00) and strong (k-0.88) agreement for ROP requiring treatment and any ROP, respectively.

Conclusions: Pediatrician-performed WFDRI is feasible, safe, and has excellent diagnostic accuracy for identifying ROP requiring treatment.