Imaging Retinal Vasculature in Infant Eyes
ConditionRetinopathy of Prematurity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 2
SponsorDuke University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Treatments tested in this trial
- Handheld Optical Coherence Tomography with OCT Angiography
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Duke University
Lead sponsor
University of Pennsylvania
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov