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Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care

NCT07738874 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2026-07-31

No results posted yet for this study

Summary

Retinopathy of prematurity (ROP) is a disorder of development of the retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime. A major barrier to improving ROP outcomes is the lack of easy access and low stress means to obtain objective measures of ROP disease severity across the retina in these infants. The long-term goal of this program is to provide information which will improve preterm infant health and vision via objective bedside imaging and analysis that characterizes retina-wide ROP level of disease, its response to treatment and development, and to rapidly translate this for better early intervention and improved future vision care.

Conditions

  • Retinopathy of Prematurity (ROP)

Interventions

DEVICE

Ultra-widefield Optical Coherence Tomography (UWF-OCT)

Handheld retinal OCT imaging at the bedside or in clinic with an ultra-widefield handheld optical coherence tomography

DEVICE

Wide-field ophthalmic imaging system

Handheld wide-field ophthalmic fundus imaging at the bedside or in clinic

Sponsors & Collaborators

Principal Investigators

  • Xi Chen, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Days
Max Age
9 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2031-06-30
Completion
2031-12-31
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 NCT07738874 on ClinicalTrials.gov