Study of Retinopathy of Prematurity in Premature Infants Using Eye Exams, Retinal Images, and Genetic Data

What this Trial Is About

Retinopathy of Prematurity ROP is a vascular eye disease affecting the retinas of low birth weight infants and remains a leading cause of childhood blindness in the United States and worldwide. This multi-center observational study is designed to improve understanding of ROP by combining clinical, imaging, and genetic data using artificial intelligence and advanced analytics. The goal is to develop a quantitative framework to enhance ROP diagnosis and screening, building on previous work involving image and genetic data analysis from a large cohort of premature infants. Participants are premature infants hospitalized in neonatal intensive care units at five academic centers who undergo routine ROP screening examinations. During these exams, retinal photographs are taken using an FDA-cleared wide-angle camera designed for premature infants. No interventions are administered as part of the study all procedures are standard care. Imaging data will be collected prospectively from over 2000 eye exams across approximately 375 infants, with images evaluated by remote expert graders and an artificial intelligence system to assess diagnostic accuracy and vascular severity related to ROP. Throughout the study, clinical data, demographic information, and retinal images will be collected during routine eye exams up to three times or more if needed. Genetic samples collected in prior phases will be analyzed but no new genetic samples will be taken. The study will measure the accuracy of the AI system for diagnosing ROP and screening for disease severity. Data will be securely stored in an approved repository and may be used for future research or educational purposes. Participants safety is maintained by following standard care protocols, with ongoing monitoring by neonatologists to ensure exam stability.

Clinical and Genetic Analysis of ROP