16 Participants Needed

Imaging Retinal Vasculature in Infant Eyes

Recruiting at 1 trial location
XC
MN
Overseen ByMichelle N McCall
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

XC

Xi Chen, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

ROP Screening and Imaging

Preterm infants undergo ROP screening and imaging to assess perifoveal vascular development

12 weeks
Multiple visits (in-person) between 32 and 44 weeks PMA

Follow-up

Participants are monitored for changes in vascular density and network morphology after initial imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Handheld Optical Coherence Tomography with OCT Angiography
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Cohort 1Experimental Treatment1 Intervention
16 preterm infants undergoing ROP screening to optimize methods to acquire and process beside infant perifoveal vascular imaging and assess rigor and reproducibility. The visits in the ICN (Intensive Care Nursery) will occur between 32 and 43 weeks post menstrual age at the time of ROP screening exams. Study visits will include, but are not limited to: * Ocular examination * OCT imaging of retinal microanatomy * OCTA imaging of retinal microvasculature * Medical and ocular history * Adverse event documentation

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

University of Pennsylvania

Collaborator

Trials
2,118
Recruited
45,270,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security