Imaging the blood vessels in the eyes of premature infants
Elucidating Perifoveal Vasculature Development in Infants
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 |
|---|---|
| Enrollment | 16 (estimated) |
| Ages | N/A to 2 Months |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 2 sites (Durham, North Carolina and 1 other locations) |
| Trial ID | NCT05558059 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under 34 weeks postmenstrual age who are being screened for retinopathy of prematurity.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Durham, North Carolina and 1 other locations
- Duke University — Durham, North Carolina, United States (Recruiting)
- University of Pennsylvania — Philadelphia, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.