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Published on: December 31, 2015
Safety of Retinopathy of Prematurity Examination and Imaging in Premature Infants
Kelly C Wade1, Maxwell Pistilli2, Agnieshka Baumritter3
1Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA.
Insights
Retinopathy of prematurity (ROP) evaluation procedures, including digital retinal imaging and indirect ophthalmoscopy, were found to be safe for infants. Mechanical ventilation was identified as a risk factor for adverse events during these ROP eye exams.
Area of Science:
- Ophthalmology
- Neonatology
- Medical Device Technology
Background:
- Retinopathy of prematurity (ROP) is a leading cause of visual impairment in premature infants.
- ROP screening is crucial for early detection and intervention to prevent vision loss.
- Standard ROP evaluation involves indirect ophthalmoscopy, with digital imaging emerging as a complementary tool.
Purpose of the Study:
- To document adverse events (AEs) and significant clinical or ocular findings during retinopathy of prematurity (ROP) evaluation procedures.
- To assess the safety and identify risk factors associated with ROP diagnostic examinations.
Main Methods:
- A prospective observational cohort study was conducted on infants with a birth weight under 1251g.
- Infants underwent ROP evaluations using both binocular indirect ophthalmoscopy (BIO) and digital retinal imaging.
- Adverse events and clinical findings were systematically recorded and analyzed, comparing infants with and without AEs.
Main Results:
- A total of 8311 procedures were performed on 1257 infants; 65 AEs (0.8%) were reported in 61 infants (4.9%).
- The majority of AEs were mild, primarily consisting of apnea, bradycardia, hypoxia, tachycardia, and emesis.
- Infants on mechanical ventilation were significantly more likely to experience AEs during ROP evaluations (26% vs 12%).
- Noteworthy clinical findings were observed in 8% of BIO and 15% of imaging sessions.
Conclusions:
- Combined digital retinal imaging and BIO for ROP assessment are safe procedures.
- Mechanical ventilation is a risk factor for adverse events during ROP evaluations.
- Continuous monitoring of AEs and clinical findings is essential for safe ROP imaging protocol implementation.
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.
