Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT05558059

Conditions

Retinopathy of Prematurity

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Handheld Optical Coherence Tomography with OCT Angiography

Study Details

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.

Conditions

Retinopathy of Prematurity

Study ID

NCT05558059

Start date

Oct 3, 2024

Status verified date

Oct, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

16 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

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

Interventions

Handheld Optical Coherence Tomography with OCT Angiography

OCT systems are in vivo optical imaging technology that allows non-contact imaging of early-stage ocular pathology. They create real-time, non-invasive images of ocular microstructure and have become standard-of-care instruments in ophthalmic imaging in clinics and operating rooms. In contrast to the visible light used in clinical eye examinations, because infrared light is not visible, the participant is not disturbed by the light. OCT imaging allows the capture of hundreds of B-scan (cross-sectional) images in seconds. These B-scans are analyzed for depth-resolved information and can also be stacked to create a volume and the stack may be summed up to create a retinal image.

OCT angiography (OCTA) is an extension of the OCT systems, by taking images at the same location over time to extract retinal vascular flow information. It has been utilized to assess the ocular blood flow in many adult and pediatric patients.

Primary outcome measure

  • Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea [ Time Frame: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA) ]

Central Contacts and Locations

Central contacts

Xi Chen, MD

(919) 684-8434xi2.chen@duke.edu

Michelle N McCall

(919) 684-0544michelle.mccall@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Xi Chen, MD

919-684-8434xi2.chen@duke.edu

Michelle N McCall, MCAPM, BA

(919) 684-0544michelle.mccall@duke.edu

Principal Investigator:

Xi Chen, MD

More Information

Sponsor

Duke University

Last update posted

Oct 6, 2025

Last verified

Oct, 2025

Keywords

  • Retinopathy of Prematurity
  • Optical Coherence Tomography
  • Perifoveal vasculature
  • Vascular development
  • Macular edema
  • ROP
  • OCT
  • Prematurity
  • Optical Coherence Tomography Angiography
  • OCTA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2025-10-06.