Clinical trial Recruiting at 1 site Observational Ages 24 Weeks to 34 Weeks

New imaging technology for diagnosing retinopathy of prematurity in infants

Official title: Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity

Run by Vanderbilt University Medical Center · NCT06612541 · Data updated 2026-11-12

This study is testing a new imaging technology to help doctors better see and understand eye problems in premature infants with retinopathy of prematurity.

More Retinopathy of Prematurity (ROP) trials

Quick facts

Study typeObservational
Ages24 Weeks to 34 Weeks
SexAll
Enrollment90 (estimated)
SponsorVanderbilt University Medical Center
Academic / other
Locations1 site (Nashville, Tennessee)
StatusRecruiting
StartedFebruary 1, 2025
Main results expectedFebruary 2029
Study endsFebruary 2030
Registry record updatedAugust 4, 2026
Trial IDNCT06612541 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are preterm infants born between 24-34 weeks gestational age and weighing less than 1500 grams at birth.

Probably not a fit

Patients who have undergone surgical treatment for ROP or have significant health concerns that prevent noninvasive imaging will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop and utilize a novel imaging technology called HH-SECTR to visualize and quantify diagnostic features of retinopathy of prematurity (ROP) in preterm infants. The imaging will be conducted weekly alongside standard ROP screenings without altering patient management. The goal is to identify vascular and structural disease features that are not currently accessible through standard examination methods, thereby enhancing clinical decision-making. The study will involve imaging both eyes of eligible infants until they reach 45 weeks or require therapeutic intervention.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic capabilities for retinopathy of prematurity, potentially enhancing outcomes for affected infants.

How similar studies have gone: While this approach is innovative, similar imaging technologies have shown promise in other studies, suggesting potential for success in this context.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Vanderbilt University Medical Center
    Nashville, Tennessee, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.