NCT05558059

Imaging Retinal Vasculature in Infant Eyes

Elucidating Perifoveal Vasculature Development in Infants

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 16 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 2 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Retinopathy of Prematurity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-03
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2022-09-28
• Last updated: 2025-10-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study