Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)
- Disease/Condition
- Retinopathy of Prematurity
- Drug/Device/Intervention
- Investigational ultracompact OCT and OCTA system
- Study type
- Interventional
- Intervention type
- device
- Primary sponsor
- Duke University
- Location
- Durham,Philadelphia, United States of America
- Phase
- N/A
- Start date
- Aug 16, 2021
- End date
- Mar 31, 2026
- Enrollment
- 236 participants
Optotype Visual acuity scores (Cohort 1 only),Visual function scores (Cohort 1 only),Neurodevelopmental scores at 2-year study visit (Cohort 1 only),Retinal thickness at the fovea and surrounding optic nerve as measured by OCT reading (Cohort 1-3),Microanatomy as measured by OCT reading,Microanatomy as measured by retinal photo reading (Cohort 3 only),Microanatomy as measured by clinical exam (Cohort 1-3),Measurement of stress of imaging (Cohort 3 only),Assessment of ease of imaging (Cohort 3 only),ROP vascular severity score (Cohort 3 only)
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.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT04995341
- Type
- Device Trial
Access comprehensive clinical trial information for NCT04995341 through Pure Global AI's free database. This phase not specified trial is sponsored by Duke University and is currently Recruiting. The study focuses on Retinopathy of Prematurity. Target enrollment is 236 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.