Recruiting

Observational Study

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06612541

Conditions

Retinopathy of Prematurity (ROP)

ROP Examination

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06612541

Start date

Feb 1, 2025

Status verified date

Aug, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Retinal imaging in pediatric ROP patients [ Time Frame: Weekly imaging until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first ]

Central Contacts and Locations

Central contacts

Irina De la Huerta, MD, PhD

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

Marybeth Carter

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

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Marybeth Carter

615-936-1639marybeth.l.carter@vumc.org

Principal Investigator:

Irina De la Huerta, MD PhD

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Keywords

  • Retinopathy of Prematurity
  • ROP
  • Prematurity
  • OCT Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-08-04.