Actively Recruiting
Elucidating Perifoveal Vasculature Development in Infants Using Handheld OCT with Angiography
Led by Duke University · Updated on 2025-10-06
16
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
U
University of Pennsylvania
Collaborating Sponsor
AI-Summary
What this Trial Is About
Retinopathy of prematurity is a major cause of childhood blindness worldwide, affecting the development of blood vessels around the fovea, a key area in the retina responsible for sharp vision. This research aims to improve understanding of how these retinal blood vessels form in infants and how they may change due to preterm birth or retinopathy of prematurity. The study focuses on infants undergoing screening for this condition to gain insights into normal and abnormal vascular development. Participants in this observational study will undergo imaging using handheld Optical Coherence Tomography (OCT) with OCT Angiography (OCTA), a non-invasive method that captures detailed images of the retina and its blood vessels without disturbing the infant. The study will include a cohort of 16 preterm infants who will have several visits in the Intensive Care Nursery between 32 and 43 weeks post menstrual age during their routine retinopathy of prematurity screening exams. Each visit will include ocular examinations, retinal imaging, medical and eye history collection, and documentation of any adverse events. During the study, researchers will measure changes in the density and network length of different layers of retinal blood vessels as well as the size of avascular zones, all within the hospitalization period. These assessments will help track the development of retinal vasculature in infants. The total participation period aligns with the infants' hospital stay during which regular evaluations will take place to ensure safety and gather comprehensive data on retinal blood vessel formation.
CONDITIONS
Brief Title
Imaging Retinal Vasculature in Infant Eyes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Between 32 and 43 weeks post menstrual age during hospitalization
Participants undergo imaging and ocular examinations to assess retinal vasculature development.
Visits occur alongside routine ROP screening exams in the Intensive Care Nursery
Duration - Approximately 11 weeks from 32 to 44 weeks post menstrual age
Participants are monitored for changes in retinal vascular density and avascular zone size during hospitalization.
Multiple visits during hospitalization depending on ROP screening schedule
Trial Site Locations
Total: 2 locations
1
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
Research Team
X
Xi Chen, MD
M
Michelle N McCall
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here