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Search / Trial NCT05558059

Imaging Retinal Vasculature in Infant Eyes

Launched by DUKE UNIVERSITY · Sep 23, 2022

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Retinopathy Of Prematurity Optical Coherence Tomography Perifoveal Vasculature Vascular Development Macular Edema Rop Oct Prematurity Optical Coherence Tomography Angiography Octa

ClinConnect Summary

This clinical trial is studying how the blood vessels in the eyes of premature infants develop, especially around a part of the retina called the fovea, which is important for seeing clearly. The trial aims to better understand how these blood vessels form and change when infants have a condition called retinopathy of prematurity (ROP), which can lead to vision problems and is a common cause of childhood blindness. By learning more about this process, researchers hope to improve care and treatments for infants at risk of ROP.

To participate in the trial, infants must be less than 34 weeks old at their first visit and meet certain health criteria for screening. Parents or guardians need to provide consent for their child to take part. Those who participate can expect to undergo eye examinations and retinal imaging to help researchers gather important information about eye development. It's also important to note that infants with certain eye conditions or significant health issues that affect brain development may not be eligible for this study.

Gender

ALL

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)

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Philadelphia, Pennsylvania, United States

Durham, North Carolina, United States

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Xi Chen, MD

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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