Imaging Retinal Vasculature in Infant Eyes
Elucidating Perifoveal Vasculature Development in Infants
2 other identifiers
observational
16
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2024
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2022
CompletedFirst Posted
Study publicly available on registry
September 28, 2022
CompletedStudy Start
First participant enrolled
October 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
October 6, 2025
October 1, 2025
2.9 years
September 6, 2022
October 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea
Measured by retinal OCTA imaging.
During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)
Secondary Outcomes (3)
Change in vascular density of superficial vascular plexus at the fovea and perifovea
During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)
Change in avascular zone size of superficial, intermediate and deep vascular plexus
During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)
Change in network length of intermediate and deep vascular plexus
During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)
Study Arms (1)
Cohort 1
16 preterm infants undergoing ROP screening to optimize methods to acquire and process beside infant perifoveal vascular imaging and assess rigor and reproducibility. The visits in the ICN (Intensive Care Nursery) will occur between 32 and 43 weeks post menstrual age at the time of ROP screening exams. Study visits will include, but are not limited to: * Ocular examination * OCT imaging of retinal microanatomy * OCTA imaging of retinal microvasculature * Medical and ocular history * Adverse event documentation
Interventions
OCT systems are in vivo optical imaging technology that allows non-contact imaging of early-stage ocular pathology. They create real-time, non-invasive images of ocular microstructure and have become standard-of-care instruments in ophthalmic imaging in clinics and operating rooms. In contrast to the visible light used in clinical eye examinations, because infrared light is not visible, the participant is not disturbed by the light. OCT imaging allows the capture of hundreds of B-scan (cross-sectional) images in seconds. These B-scans are analyzed for depth-resolved information and can also be stacked to create a volume and the stack may be summed up to create a retinal image. OCT angiography (OCTA) is an extension of the OCT systems, by taking images at the same location over time to extract retinal vascular flow information. It has been utilized to assess the ocular blood flow in many adult and pediatric patients.
Eligibility Criteria
Preterm infants undergoing screening for retinopathy of prematurity
You may qualify if:
- 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 may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- University of Pennsylvaniacollaborator
- National Institutes of Health (NIH)collaborator
Study Sites (2)
Duke University
Durham, North Carolina, 27710, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xi Chen, MD
Duke University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2022
First Posted
September 28, 2022
Study Start
October 3, 2024
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
October 6, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be made available after the completion of the study.
- Access Criteria
- Data requests must be submitted to the PI or the Statistical Analysis Center. Approved recipients will need to enter into a data sharing agreement. Costs for compilation and access to the datasets will be the responsibility of the recipients.
The Elucidating Perifoveal Vascular Development in Infants study data cannot be analyzed for publication until they are released by the study Principal Investigator upon final review and approval by the Data Safety and Monitoring Committee. Data will be made available as follows: * A summary, de-identified data set available upon request through direct inquiries to the Study PI or Statistical Analysis Center a year after publication. * By the end of the funding period, de-identified SAS data sets and form images corresponding to all data collection forms, as well as key derived variables, will be put on file with a data repository. * Researchers may request limited access data sets. * The raw and analyzed imaging datasets will be made available after the completion of this study. Approved recipients will need to enter into a data sharing agreement. Costs for compilation and access to the datasets will be the responsibility of the recipients.