Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity (ROP Imaging)

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.

Study Overview

• Status: Recruiting
• Conditions: Retinopathy of Prematurity (ROP); ROP Examination

Detailed Description

Imaging studies using HH-SECTR will be performed to assess and quantify structural and vascular disease features associated with ROP. Weekly HH-SECTR imaging will be performed concurrently with standard-of-care weekly ROP screening. No additional treatments will be given to study patients to benefit HH-SECTR imaging (e.g., sedation, dilation, etc.). Study patients will primarily be imaged in the NICU, but may also be performed under sedation or anesthesia in the operating room concurrent with standard-of-care exams. Because this study will evaluate diagnostic features prognostic of ROP progression and severity, HH-SECTR imaging will be performed until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first. Both eyes will undergo HH-SECTR imaging. Diagnostic imaging data will be analyzed following each imaging session. No experimental data will be used to alter the management of patients from the standard-of-care.

Research materials obtained from subjects will include digital HH-SECTR images, digital fundus photography images, and documented examination timeline as part of the standard-of-care. Patient medical records will be used to determine eligibility to participate in the study and will be used as the source documents for following post-examination clinical variables.

The duration of the study will be 5 years. The study records and information will be indefinitely archived per NIH rules using the methods noted above.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Irina De la Huerta, MD, PhD; Phone Number: 615-936-2020; Email: CTU.ROP@vumc.org
• Study Contact Backup: Name: Marybeth Carter; Phone Number: 615-936-1639; Email: CTU.ROP@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Marybeth Carter; Phone Number: 615-936-1639; Email: marybeth.l.carter@vumc.org
      • Principal Investigator: Irina De la Huerta, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: September 21, 2024
• First Submitted That Met QC Criteria: September 21, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Retinopathy of Prematurity; ROP; Prematurity; OCT Imaging
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Infant, Premature, Diseases; Infant, Newborn, Diseases; Eye Diseases; Premature Birth; Retinal Diseases; Retinopathy of Prematurity
• Other Study ID Numbers: 231251

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No