Imaging Retinal Vasculature in Infant Eyes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Handheld Optical Coherence Tomography with OCT Angiography.
- Who it may be relevant to
- Registry conditions: Retinopathy of Prematurity. Basic parameters: up to 2 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Elucidating Perifoveal Vasculature Development in Infants
Overview
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.
Interventions
- Device 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-sec
Primary outcome measures
- 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)]
Secondary outcome measures (3)
- 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)]
- 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)]
- Change in network length of intermediate and deep vascular plexus [Time frame: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Duke University — Durham
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT05558059 · Pro00111105 · 1R01EY03413401