NCT05558059 Imaging Retinal Vasculature in Infant Eyes
| NCT ID | NCT05558059 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Retinopathy of Prematurity |
| Study Type | OBSERVATIONAL |
| Enrollment | 16 participants |
| Start Date | 2024-10-03 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 16 participants in total. It began in 2024-10-03 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Retinopathy of prematurity is a leading cause of childhood blindness worldwide. The fovea, a critical location in the retina determining visual acuity and visual function, and the blood vessels around it, are abnormally developed in infants with retinopathy of prematurity. However, how these blood vessels form during development of the human fovea remains unclear. This research will advance our understanding of the fundamental knowledge of how the blood vessels around the fovea form in infants, and how they change in diseased states such as preterm birth or retinopathy of prematurity.
Eligibility 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)
Contact & Investigator
Xi Chen, MD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT05558059 clinical trial?
This trial is open to participants of all sexes, up to 2 Months, studying Retinopathy of Prematurity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05558059 currently recruiting?
Yes, NCT05558059 is actively recruiting participants. Contact the research team at xi2.chen@duke.edu for enrollment information.
Where is the NCT05558059 trial being conducted?
This trial is being conducted at Durham, United States, Philadelphi, United States.
Who is sponsoring the NCT05558059 clinical trial?
NCT05558059 is sponsored by Duke University. The principal investigator is Xi Chen, MD at Duke University. The trial plans to enroll 16 participants.