Clinical trial Recruiting at 1 site Observational Ages Any age to 2 Months

Imaging the blood vessels in the eyes of premature infants

Official title: Elucidating Perifoveal Vasculature Development in Infants

Run by Duke University · NCT05558059 · Data updated 2026-11-12

This study is testing how blood vessels in the eyes of premature infants grow to better understand retinopathy of prematurity and help prevent childhood blindness.

More Retinopathy of Prematurity trials

Quick facts

Study typeObservational
AgesAny age to 2 Months
SexAll
Enrollment16 (estimated)
SponsorDuke University
Academic / other
Locations2 sites (Durham, North Carolina and 1 other locations)
StatusRecruiting
StartedOctober 3, 2024
Main results expectedAugust 31, 2027
Study endsAugust 31, 2027
Registry record updatedOctober 19, 2026
Trial IDNCT05558059 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are infants under 34 weeks postmenstrual age who are being screened for retinopathy of prematurity.

Probably not a fit

Infants with significant eye conditions that prevent proper imaging or those with severe brain development issues unrelated to prematurity may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the development of retinal blood vessels in infants diagnosed with retinopathy of prematurity (ROP), a condition that can lead to childhood blindness. Using handheld Optical Coherence Tomography (OCT) with angiography, researchers will analyze how these blood vessels form around the fovea, a crucial area for vision. The study seeks to enhance understanding of vascular development in the context of ROP and preterm birth, potentially informing future interventions.

Why it matters

Potential benefit: If successful, this research could lead to improved screening and treatment strategies for infants at risk of vision impairment due to retinopathy of prematurity.

How similar studies have gone: While the approach of using OCT to study retinal vasculature is established, this specific application in premature infants with ROP is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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)

Where it's running

  • Duke University
    Durham, North Carolina, United States
    Recruiting
  • University of Pennsylvania
    Philadelphi, Pennsylvania, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.