Clinical trial NCT05558059: Imaging Retinal Vasculature in Infant Eyes
Official title: Elucidating Perifoveal Vasculature Development in Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinopathy of Prematurity
Keywords: Retinopathy of Prematurity
Optical Coherence Tomography
Perifoveal vasculature
Vascular development
Macular edema
ROP
OCT
Prematurity
Optical Coherence Tomography Angiography
OCTA
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: National Institutes of Health (NIH)
First posted: 2022-09-28
Enrollment: 16
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants undergoing screening for retinopathy of prematurity

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.


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)

Primary outcomes:
measure: Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea
timeFrame: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)
Secondary outcomes:
measure: Change in vascular density of superficial vascular plexus at the fovea and perifovea
timeFrame: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)
measure: Change in avascular zone size of superficial, intermediate and deep vascular plexus
timeFrame: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)
measure: Change in network length of intermediate and deep vascular plexus
timeFrame: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Duke University
name: Xi Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: