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NCT Number: NCT05558059

Imaging Retinal Vasculature in Infant Eyes

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.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Macular Degeneration Macular Edema Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Retinal Degeneration Retinal Diseases Urogenital Diseases

Age range

Up to 2 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University, Durham, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Handheld OCT and OCTA

Primary outcomes

  1. 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)

    Measured by retinal OCTA imaging.

Secondary outcomes

  1. Change in vascular density of superficial vascular plexus at the fovea and perifovea

    Time frame: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)

    Measured by retinal OCTA imaging.

  2. Change in avascular zone size of superficial, intermediate and deep vascular plexus

    Time frame: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)

    Measured by retinal OCTA imaging.

  3. Change in network length of intermediate and deep vascular plexus

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle N McCall

CONTACT

[email protected]

(919) 684-0544

Xi Chen, MD

CONTACT

[email protected]

(919) 684-8434

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institutes of Health (NIH)
  • University of Pennsylvania

Registry information

Official study title

Elucidating Perifoveal Vasculature Development in Infants

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 28, 2022
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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