Imaging Retinal Vasculature in Infant Eyes

NCT ID: NCT05558059

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-03
• Study Completion Date: 2027-08-31

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.

Conditions

Retinopathy of Prematurity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Handheld Optical Coherence Tomography with OCT Angiography

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Handheld OCT and OCTA

Eligibility Criteria

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)

• Maximum Eligible Age: 2 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xi Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Site Status: RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Xi Chen, MD

Role: CONTACT

xi2.chen@duke.edu

(919) 684-8434

Michelle N McCall

Role: CONTACT

michelle.mccall@duke.edu

(919) 684-0544

Facility Contacts

Xi Chen, MD

Role: primary

xi2.chen@duke.edu

919-684-8434

Michelle N McCall, MCAPM, BA

Role: backup

michelle.mccall@duke.edu

(919) 684-0544

Gui-Shuang Ying, PhD

Role: primary

gsying@pennmedicine.upenn.edu

215-615-1514

Other Identifiers

1R01EY03413401

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00111105

Identifier Type: -

Identifier Source: org_study_id