Imaging Retinal Vasculature in Infant Eyes

Conditions

• Retinopathy of Prematurity

Eligibility Criteria

Sex

ALL

Age

N/A - 2 Months

Healthy Volunteers

Not accepted

Interventions

• Handheld Optical Coherence Tomography with OCT Angiography — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Oct 3, 2024

Status verified

Oct 2025

Primary completion

Aug 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

16 participants (estimated)

Arms

• Arm: 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

Primary Outcome Measure

Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea [ Time Frame: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA) ]

Central Contacts

• Xi Chen, MD
  (919) 684-8434
  [email protected]
• Michelle N McCall
  (919) 684-0544
  [email protected]

Locations (2)

Find similar trials in Durham, NC

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