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Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)

NCT04995341 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Retinopathy of Prematurity

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

Sponsors & Collaborators

Principal Investigators

  • Cynthia A Toth, MD · Duke University Eye Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-16
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04995341 on ClinicalTrials.gov