Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 2 and School Age Follow on Study (BabySTEPS2)

What this Trial Is About

Retinopathy of prematurity (ROP) affects the development of the retina and its blood vessels in very preterm infants, potentially impacting their vision throughout life. Researchers are evaluating high-speed optical coherence tomography (OCT) technology at the bedside compared to traditional color photographs to identify early retinal abnormalities. The goal is to predict which infants may need treatment for ROP or face poor visual and neurological outcomes up to preschool age, aiming to improve early intervention and long-term care. The study involves four groups: children previously enrolled in a related study who will undergo follow-up neurodevelopmental and visual testing; infants at risk for ROP who will receive investigational bedside OCT imaging combined with earlier data; a subgroup receiving both investigational OCT and conventional retinal camera imaging to compare effectiveness and stress; and healthy adults and some children imaged during system development. The investigational OCT device is a portable, handheld system designed for non-contact, rapid retinal imaging in fragile infants. Participants will undergo imaging sessions at the bedside or under anesthesia, with assessments including retinal thickness, microanatomy, vascular severity, visual acuity, visual function, and neurodevelopmental scores at various ages up to five years. Researchers will also evaluate the stress and ease of imaging. Data from these assessments will help understand retinal changes linked to ROP and developmental outcomes. The study is ongoing with follow-up planned through 2027.

Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)