NCT04995341

Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)

Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 2 and School Age Follow on Study (BabySTEPS2)
Duke University·ClinicalTrials.gov·device·Device trialRecruiting
View on ClinicalTrials.gov
Study focus
Drug/Device/Intervention
Investigational ultracompact OCT and OCTA system
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Duke University
Location
Durham,Philadelphia, United States of America
Timeline & enrollment
Phase
N/A
Start date
Aug 16, 2021
End date
Mar 31, 2026
Enrollment
236 participants
Primary outcome

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)

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.

ICD-10 classifications
Retinopathy of prematurityOther proliferative retinopathyBackground retinopathy and retinal vascular changesDiabetic retinopathyRetinal disorder, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04995341
Type
Device Trial
About this record

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.

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