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NOT YET RECRUITING
NCT07738874
NA

Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care

Sponsor: Duke University

View on ClinicalTrials.gov

Summary

Retinopathy of prematurity (ROP) is a disorder of development of the retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime. A major barrier to improving ROP outcomes is the lack of easy access and low stress means to obtain objective measures of ROP disease severity across the retina in these infants. The long-term goal of this program is to provide information which will improve preterm infant health and vision via objective bedside imaging and analysis that characterizes retina-wide ROP level of disease, its response to treatment and development, and to rapidly translate this for better early intervention and improved future vision care.

Official title: Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 3 (BabySTEPS3)

Key Details

Gender

All

Age Range

0 Days - 9 Months

Study Type

INTERVENTIONAL

Enrollment

175

Start Date

2026-10-01

Completion Date

2031-12-31

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

DEVICE

Ultra-widefield Optical Coherence Tomography (UWF-OCT)

Handheld retinal OCT imaging at the bedside or in clinic with an ultra-widefield handheld optical coherence tomography

DEVICE

Wide-field ophthalmic imaging system

Handheld wide-field ophthalmic fundus imaging at the bedside or in clinic

Locations (2)

Duke University Eye Center

Durham, North Carolina, United States

University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics

Philadelphia, Pennsylvania, United States