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Imaging Retinal Vasculature in Infant Eyes for Retinopathy of Prematurity

This study is looking at how blood vessels in the eyes of infants with Retinopathy of Prematurity (ROP) develop. ROP is a serious eye condition in premature babies that can lead to blindness. Researchers will use a special imaging device called Handheld Optical Coherence Tomography with OCT Angiography to take pictures of the blood vessels around the fovea (the central part of the retina responsible for sharp vision). The goal is to better understand how these vessels form in infants and how they are affected by ROP. This study is for infants up to 2 months old who meet the criteria for ROP screening. The main goal is to measure changes in the density of blood vessels in the fovea and surrounding area during hospitalization.

Study design
This is an observational study with a planned enrollment of 16 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured during hospitalization (at approximately 32-44 weeks post menstrual age, PMA).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05558059

Imaging Retinal Vasculature in Infant Eyes

Recruiting
Not specifiedUp to 2Observational
Duke University
~16 participants
Updated 2025-10-06 on ClinicalTrials.gov
What's tested:Handheld Optical Coherence Tomography with OCT Angiography

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea
Measured over During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)

Conditions

Retinopathy of Prematurity

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Retinopathy of Prematurity

NCT05558059

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Duke University

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvaniastudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Xi Chen, MD · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

Xi Chen, MD
[email protected]
(919) 684-8434
Email the study team

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Eligibility criteria

Inclusion

Health care provider, knowledgeable of protocol, agrees that study personnel could contact the Parent/Legal guardian
Parent/Legal Guardian is able and willing to consent to study participation for the infant
Infant meets the American Association of Pediatrics eligibility of ROP screening, and is age less than 34 6/7 weeks postmenstrual age at first visit

Exclusion

Participant or Parent/Legal Guardian unwilling or unable to provide consent
Infant has a health or eye condition that preclude eye examination or retinal imaging (e.g. corneal opacity such as with Peter's anomaly or cataract)
Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly)

What this trial measures

  • Change in vascular density of intermediate and deep vascular plexus at the fovea and perifoveaDuring hospitalization (at approximately 32-44 weeks post menstrual age, PMA)

    Measured by retinal OCTA imaging.