Actively Recruiting

Age: 0 - 2Months
All Genders
ID05558059

Elucidating Perifoveal Vasculature Development in Infants Using Handheld OCT with Angiography

Led by Duke University · Updated on 2025-10-06

16

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

U

University of Pennsylvania

Collaborating Sponsor

AI-Summary

What this Trial Is About

Retinopathy of prematurity is a major cause of childhood blindness worldwide, affecting the development of blood vessels around the fovea, a key area in the retina responsible for sharp vision. This research aims to improve understanding of how these retinal blood vessels form in infants and how they may change due to preterm birth or retinopathy of prematurity. The study focuses on infants undergoing screening for this condition to gain insights into normal and abnormal vascular development. Participants in this observational study will undergo imaging using handheld Optical Coherence Tomography (OCT) with OCT Angiography (OCTA), a non-invasive method that captures detailed images of the retina and its blood vessels without disturbing the infant. The study will include a cohort of 16 preterm infants who will have several visits in the Intensive Care Nursery between 32 and 43 weeks post menstrual age during their routine retinopathy of prematurity screening exams. Each visit will include ocular examinations, retinal imaging, medical and eye history collection, and documentation of any adverse events. During the study, researchers will measure changes in the density and network length of different layers of retinal blood vessels as well as the size of avascular zones, all within the hospitalization period. These assessments will help track the development of retinal vasculature in infants. The total participation period aligns with the infants' hospital stay during which regular evaluations will take place to ensure safety and gather comprehensive data on retinal blood vessel formation.

CONDITIONS

Brief Title

Imaging Retinal Vasculature in Infant Eyes

Who Can Participate

Age: 0 - 2Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Between 32 and 43 weeks post menstrual age during hospitalization

Participants undergo imaging and ocular examinations to assess retinal vasculature development.

Visits occur alongside routine ROP screening exams in the Intensive Care Nursery

Long-term Monitoring

Duration - Approximately 11 weeks from 32 to 44 weeks post menstrual age

Participants are monitored for changes in retinal vascular density and avascular zone size during hospitalization.

Multiple visits during hospitalization depending on ROP screening schedule

Trial Site Locations

Total: 2 locations

1

Duke University

Durham, North Carolina, United States, 27710

Actively Recruiting

2

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Not Yet Recruiting

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Research Team

X

Xi Chen, MD

M

Michelle N McCall

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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