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Study identifier: NCT04995341 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)

Condition: Retinopathy of Prematurity  ·  Sponsor: Duke University

PhaseNA
Planned participants236
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Cynthia A Toth, MD  ·  919-684-5631  ·  cynthia.toth@duke.edu

Michelle N McCall, MCAPM, BA  ·  919-684-0544  ·  michelle.mccall@duke.edu

Always discuss trial participation with your own doctor first.

Locations (2)

Duke University Eye CenterDurham, North Carolina, United StatesRecruiting
University of Pennsylvania, Center for Preventive Ophthalmology and BiostatisticsPhiladelphia, Pennsylvania, United StatesNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT04995341