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Clinical trialNCT04995341RecruitingInterventional

Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)

SponsorDuke UniversityEnrollment236Retinopathy of Prematurity
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Duke University Eye Center

    Durham, North Carolina, United States

    Charles M Cotten, MD, MHSChristian Viehland, PhDJoseph A Izatt, PhDKathryn E Gustafson, MDLejla Vajzovic, MDSara Grace, MDSharon F Freedman, MDSusapin G Prakalapakorn, MDXi Chen, MD, PhD
    Recruiting
  • University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics

    Philadelphia, Pennsylvania, United States

    Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
16 Aug 2021
Primary completion
31 Mar 2027
Completion
31 Mar 2027
Last update posted
22 May 2026
Registered enrollment
236
Registry id
NCT04995341

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.