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

NCT ID: NCT06612541

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2030-02-28

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.

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.

Conditions

Retinopathy of Prematurity (ROP); ROP Examination

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 24 Weeks
• Maximum Eligible Age: 34 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Irina De la Huerta

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Irina De la Huerta, MD, PhD

Role: CONTACT

CTU.ROP@vumc.org

615-936-2020

Marybeth Carter

Role: CONTACT

CTU.ROP@vumc.org

615-936-1639

Facility Contacts

Marybeth Carter

Role: primary

marybeth.l.carter@vumc.org

615-936-1639

Other Identifiers

231251

Identifier Type: -

Identifier Source: org_study_id