Imaging Retinal Vasculature in Infant Eyes

Duke University

Status: Enrolling

Conditions: Retinopathy of Prematurity

Treatments: Device: Handheld Optical Coherence Tomography with OCT Angiography

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05558059

Pro00111105

1R01EY03413401 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: Under 2 months old

Volunteers: No Healthy Volunteers

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)

Trial design

16 participants in 1 patient group

Cohort 1

Description:

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

Treatment:

Device: Handheld Optical Coherence Tomography with OCT Angiography