Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04995341
NA

Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)

Sponsor: Duke University

View on ClinicalTrials.gov

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

Interventions

DEVICE

Investigational ultracompact OCT and OCTA system

Handheld bedside retinal OCT and OCT angiography imaging with an investigational portable system with ultracompact handpiece

DEVICE

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