Retinopathy of PrematurityNCT05558059
Imaging Retinal Vasculature in Infant Eyes
An observational study of Retinopathy of Prematurity, run by Duke University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 months
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Handheld Optical Coherence Tomography with OCT Angiography
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Oct 2024to 31 Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 months
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants undergoing screening for retinopathy of prematurity
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27710
Xi Chen, MD, (919) 684-8434, xi2.chen@duke.edu
Michelle N McCall, MCAPM, BA, (919) 684-0544, michelle.mccall@duke.edu
- Not yet recruiting
University of Pennsylvania
Philadelphi, Pennsylvania, 19104
Gui-Shuang Ying, PhD, (215) 615-1514, gsying@pennmedicine.upenn.edu
Gui-Shuang Ying, PhD
About this study
Official title: Elucidating Perifoveal Vasculature Development in Infants
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
- Being tested
- Handheld Optical Coherence Tomography with OCT Angiography
- Keywords
- Retinopathy of Prematurity, Optical Coherence Tomography, Perifoveal vasculature, Vascular development, Macular edema, ROP, OCT, Prematurity, Optical Coherence Tomography Angiography, OCTA
- Medical subject headings
- Retinopathy of Prematurity, Macular Edema, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handheld Optical Coherence Tomography with OCT AngiographyDevice
Also called Handheld OCT and OCTA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Handheld Optical Coherence Tomography with OCT Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea
Measured by retinal OCTA imaging.
Measured: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)
Secondary outcomes (3)
Change in vascular density of superficial vascular plexus at the fovea and perifovea
Measured by retinal OCTA imaging.
Measured: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)
Change in avascular zone size of superficial, intermediate and deep vascular plexus
Measured by retinal OCTA imaging.
Measured: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)
Change in network length of intermediate and deep vascular plexus
Vascular density of superficial vascular plexus at the fovea and perifovea; Avascular zone size of superficial, intermediate and deep vascular plexus; Network morphology of intermediate and deep vascular plexus; Network length of intermediate and deep vascular plexus.
Measured: During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start3 Oct 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Xi Chen, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558059
- Sponsor's protocol ID
- Pro00111105
- Other IDs
- 1R01EY03413401
- Status last verified
- Oct 2026
- First submitted
- 6 Sep 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Elucidating Perifoveal Vascular Development in Infants study data cannot be analyzed for publication until they are released by the study Principal Investigator upon final review and approval by the Data Safety and Monitoring Committee. Data will be made available as follows: * A summary, de-identified data set available upon request through direct inquiries to the Study PI or Statistical Analysis Center a year after publication. * By the end of the funding period, de-identified SAS data sets and form images corresponding to all data collection forms, as well as key derived variables, will be put on file with a data repository. * Researchers may request limited access data sets. * The raw and analyzed imaging datasets will be made available after the completion of this study. Approved recipients will need to enter into a data sharing agreement. Costs for compilation and access to the datasets will be the responsibility of the recipients.