Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity

NCT06612541 | Recruiting

• 1 other identifier: 231251
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this proposal is to develop novel HH-SECTR technology for visualizing and quantifying diagnostic disease features in prematurely born infant retinopathy of prematurity (ROP) patients that lead to more informed clinical decision making. Providing depth-resolved vascular information has not been adequately investigated for its diagnostic potential. Furthermore, we seek to identify disease features not currently accessible by standard examination methods to better inform clinical decisions.

Conditions

Retinopathy of Prematurity (ROP); ROP Examination

Keywords

Retinopathy of Prematurity; ROP; Prematurity; OCT Imaging

Outcome Measures

Primary Outcomes (1)

• Retinal imaging in pediatric ROP patients

  Real-time noninvasive optical imaging of the retina will be performed out to the ora serrata and ROP diagnostic markers will be evaluated in post-processing and compared against clinical examination

  Weekly imaging until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first

Eligibility Criteria

• Age: 24 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm male and female infants born at 24-34 weeks gestational age and weighing \<1500g at birth.

You may qualify if:

• Preterm male and female infants born at 24-34 weeks gestational age and weighing \<1500g at birth

You may not qualify if:

• Infants surgically treated for ROP
• Infants with significant health concern that would preclude noninvasive retinal imaging as noted by the primary inpatient team

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Retinopathy of Prematurity; Premature Birth

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Irina De la Huerta, MD, PhD

CONTACT

615-936-2020; CTU.ROP@vumc.org

Marybeth Carter

CONTACT

615-936-1639; CTU.ROP@vumc.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: September 25, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)