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
This trial does not accept healthy volunteersQualifiers
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 population
Preterm infants undergoing screening for retinopathy of prematurity
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Handheld Optical Coherence Tomography with OCT Angiography
DeviceOCT 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.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Cohort 11 intervention
Trial outcomes
Primary outcomes
1
Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea
Measured by retinal OCTA imaging.
Time frame
During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)Secondary outcomes
1
Change in vascular density of superficial vascular plexus at the fovea and perifovea
Measured by retinal OCTA imaging.
Time frame
During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)2
Change in avascular zone size of superficial, intermediate and deep vascular plexus
Measured by retinal OCTA imaging.
Time frame
During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)3
Change in network length of intermediate and deep vascular plexus
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.
Time frame
During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
University of Pennsylvania
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov