RecruitingNCT05558059

Imaging Retinal Vasculature in Infant Eyes

Elucidating Perifoveal Vasculature Development in Infants

Sponsor

Duke University

Enrollment

16 participants

Start Date

Oct 3, 2024

Study Type

OBSERVATIONAL

Conditions

Retinopathy of Prematurity

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

Max Age: 2 Months

Inclusion Criteria3

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 Criteria3

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)

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Interventions

DEVICEHandheld 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.