Imaging Retinal Vasculature in Infant Eyes

Recruiting

• Conditions: Retinopathy of Prematurity
• Interventions: Device: Handheld Optical Coherence Tomography with OCT Angiography

• Registration Number: NCT05558059
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-28
• Status Verified: 2024-10
• Study Start: 2024-10-03
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Handheld Optical Coherence Tomography with OCT Angiography	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 Measures

Name	Time	Method
Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea	During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)	Measured by retinal OCTA imaging.

Secondary Outcome Measures

Name	Time	Method
Change in vascular density of superficial vascular plexus at the fovea and perifovea	During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)	Measured by retinal OCTA imaging.
Change in avascular zone size of superficial, intermediate and deep vascular plexus	During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)	Measured by retinal OCTA imaging.
Change in network length of intermediate and deep vascular plexus	During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)	Vascular density of superficial vascular plexus at the fovea and perifovea; Avascular zone size of superficial, intermediate and deep vascular plexus; Network morphology of intermediate and deep vascular plexus; Network length of intermediate and deep vascular plexus.

Trial Locations

Locations (2)

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States