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Cohort 1 for Retinopathy of Prematurity

N/A
Waitlist Available
Led By Xi Chen, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during hospitalization (at approximately 32-44 weeks post menstrual age, pma)
Awards & highlights

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.

Eligible Conditions
  • Retinopathy of Prematurity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during hospitalization (at approximately 32-44 weeks post menstrual age, pma)
This trial's timeline: 3 weeks for screening, Varies for treatment, and during hospitalization (at approximately 32-44 weeks post menstrual age, pma) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Structure of fovea centralis
Secondary outcome measures
Change in avascular zone size of superficial, intermediate and deep vascular plexus
Change in network length of intermediate and deep vascular plexus
Structure of fovea centralis

Trial Design

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 Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,424 Previous Clinical Trials
3,066,068 Total Patients Enrolled
3 Trials studying Retinopathy of Prematurity
696 Patients Enrolled for Retinopathy of Prematurity
University of PennsylvaniaOTHER
2,053 Previous Clinical Trials
43,013,111 Total Patients Enrolled
4 Trials studying Retinopathy of Prematurity
5,661 Patients Enrolled for Retinopathy of Prematurity
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,495 Total Patients Enrolled
1 Trials studying Retinopathy of Prematurity
2,000 Patients Enrolled for Retinopathy of Prematurity
~11 spots leftby Aug 2027
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