Safety of Retinopathy of Prematurity Examination and Imaging in Premature Infants

Objectives To describe adverse events (AEs) and noteworthy clinical or ocular findings associated with retinopathy of prematurity (ROP) evaluation procedures. Study design Descriptive analysis of predefined AEs and noteworthy findings reported in a prospective observational cohort study of infants <1251 g birth weight who had ROP study visits consisting of both binocular indirect ophthalmoscopy (BIO) and digital retinal imaging. We compared infant characteristics during ROP visits with and without AEs. We compared respiratory support, nutrition, and number of apnea, bradycardia, or hypoxia events 12 hours before and after ROP visits. Results A total of 1257 infants, mean birth weight 802 g, had 4263 BIO and 4048 imaging sessions (total 8311 procedures). No serious AEs were related to ROP visits. Sixty-five AEs were reported among 61 infants for an AE rate of 4.9% infants (61/1257) or 0.8% total procedures (65/8311 BIO + imaging). Most AEs were due to apnea, bradycardia, and/or hypoxia (68%), tachycardia (16%), or emesis (8%). At ROP visit, infants with AEs, compared with those without, were more likely to be on mechanical ventilation (26% vs 12%, P = .04) even after adjustment for weight and postmenstrual age. Noteworthy clinical findings were reported during 8% BIO and 15% imaging examinations. Respiratory and nutrition support were not significantly different before and after ROP evaluations. Conclusions Retinal imaging by nonphysicians combined with BIO was safe. Noteworthy clinical findings occurred during both procedures. Ventilator support was a risk factor for AEs. Monitoring rates of AEs and noteworthy findings are important to the safe implementation of ROP imaging protocols. Trial registration Clinicaltrials.gov: NCT01264276.