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.
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Acknowledgements
The authors acknowledge the help of IIPHH, who donated the device to their institute.
Funding
The authors received no financial support for this study. The “3nethra neo" (Forus Healthcare, Bangalore, India) camera was donated by the Indian Institute of Public Health, Hyderabad (IIPHH). Neither IIPHH nor the camera manufacturer had any role in planning, conducting, or analyzing the study. The results have not been shared with them.
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AG: collected data, drafted the initial manuscript, and critically reviewed and revised the manuscript; JK and DK: conceptualized and designed the study, coordinated, and supervised data collection, analyzed data, and critically reviewed and revised the manuscript for important intellectual content; SD and PK: conceptualized and designed the study, coordinated, and supervised data collection, and critically reviewed and revised the manuscript for important intellectual content. All authors approved the final manuscript as submitted and agreed to be accountable for all aspects of the work. PK will act as guarantor for the manuscript.
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Garg, A., Kumar, J., Katoch, D. et al. Diagnostic Accuracy of Pediatrician-performed Digital Retinal Imaging with 3nethra neo for ROP Screening. Indian J Pediatr (2024). https://doi.org/10.1007/s12098-024-05042-z
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DOI: https://doi.org/10.1007/s12098-024-05042-z