Imaging Retinal Vasculature in Infant Eyes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Retinopathy of Prematurity
• Intervention / Treatment: Device: Handheld Optical Coherence Tomography with OCT Angiography

• Study Type: Observational
• Enrollment (Estimated): 16

Contacts and Locations

• Study Contact: Name: Xi Chen, MD; Phone Number: (919) 684-8434; Email: xi2.chen@duke.edu
• Study Contact Backup: Name: Michelle N McCall; Phone Number: (919) 684-0544; Email: michelle.mccall@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
      • Contact: Xi Chen, MD; Phone Number: 919-684-8434; Email: xi2.chen@duke.edu
      • Contact: Michelle N McCall, MCAPM, BA; Phone Number: (919) 684-0544; Email: michelle.mccall@duke.edu
      • Principal Investigator: Xi Chen, MD
      • Sub-Investigator: Joseph A Izatt, PhD
      • Sub-Investigator: Cynthia A Toth, MD
      • Sub-Investigator: Sina Farsiu, PhD
      • Sub-Investigator: Christian Viehland, PhD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
      • Contact: Gui-Shuang Ying, PhD; Phone Number: 215-615-1514; Email: gsying@pennmedicine.upenn.edu
      • Principal Investigator: Gui-Shuang Ying, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Preterm infants undergoing screening for retinopathy of prematurity

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Device: 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.; Other Names: Handheld OCT and OCTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea	Measured by retinal OCTA imaging.	During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vascular density of superficial vascular plexus at the fovea and perifovea	Measured by retinal OCTA imaging.	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.	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.	During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of Pennsylvania; National Institutes of Health (NIH)
• Investigators: Principal Investigator: Xi Chen, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: OCT; OCTA; Retinopathy of Prematurity; ROP; Optical Coherence Tomography; Prematurity; Macular edema; Optical Coherence Tomography Angiography; Perifoveal vasculature; Vascular development
• Additional Relevant MeSH Terms: Eye Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Retinal Diseases; Premature Birth; Retinopathy of Prematurity
• Other Study ID Numbers: Pro00111105; 1R01EY03413401 (Other Grant/Funding Number: National Eye Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Data will be made available after the completion of the study.

IPD Sharing Access Criteria

Data requests must be submitted to the PI or the Statistical Analysis Center. 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No