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Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)
Sponsor: Duke University
Summary
Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime. This study tests high-speed optical coherence tomography (OCT) technology compared to conventional color photographs at the bedside of very preterm infants in the intensive care nursery, to characterize previously unseen abnormalities that can predict a need for referral for ROP treatment, or poor visual or neurological development later in life, up to pre-school age. Our long-term goal is to help improve preterm infant health and vision via objective bedside imaging and analysis that characterizes early critical indicators of ROP, and poor visual function and neurological development, which will rapidly translate to better early intervention and improved future care.
Official title: Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 2 and School Age Follow on Study (BabySTEPS2)
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
236
Start Date
2021-08-16
Completion Date
2026-03-31
Last Updated
2025-10-06
Healthy Volunteers
Yes
Conditions
Interventions
Investigational ultracompact OCT and OCTA system
Handheld bedside retinal OCT and OCT angiography imaging with an investigational portable system with ultracompact handpiece
retinal photographs
retinal photographs with a commercial portable bedside widefield fundus camera system
Locations (2)
Duke University Eye Center
Durham, North Carolina, United States
University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics
Philadelphia, Pennsylvania, United States