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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 2 Months |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 2 sites (Durham, North Carolina and 1 other locations) |
| Status | Recruiting |
| Started | October 3, 2024 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | October 19, 2026 |
| Trial ID | NCT05558059 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
- Principal investigator: Xi Chen, MD — Duke University
- Study coordinator: Xi Chen, MD
- Email: xi2.chen@duke.edu
- Phone: (919) 684-8434
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study looks at how often and how severely babies with retinopathy of prematurity experience low oxygen levels during bedside eye injections with topical anesthesia.
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This study tests if a nasal spray of dexmedetomidine can help reduce pain for premature infants during eye exams.
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Assessing retinal health in preterm infants with advanced imaging techniques
This study is testing a new imaging technique to see if it can better spot eye problems in very preterm infants at risk for vision issues compared to regular photos.
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Registry for infants with Retinopathy of Prematurity in Europe
This study is collecting information about infants with Retinopathy of Prematurity across Europe to better understand how the condition varies and how it's treated.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.