Imaging Retinal Vasculature in Infant Eyes

Purpose

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.

Condition

  • Retinopathy of Prematurity

Eligibility

Eligible Ages
Under 2 Months
Eligible Sex
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Device: Handheld Optical Coherence Tomography with OCT Angiography
    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.
    Other names:
    • Handheld OCT and OCTA

Recruiting Locations

Duke University
Durham, North Carolina 27710
Contact:
Xi Chen, MD
919-684-8434
xi2.chen@duke.edu

More Details

NCT ID
NCT05558059
Status
Recruiting
Sponsor
Duke University

Study Contact

Xi Chen, MD
(919) 684-8434
xi2.chen@duke.edu

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center