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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 24 Weeks to 34 Weeks |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Status | Recruiting |
| Started | February 1, 2025 |
| Main results expected | February 2029 |
| Study ends | February 2030 |
| Registry record updated | August 4, 2026 |
| Trial ID | NCT06612541 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
- Study coordinator: Irina De la Huerta, MD, PhD
- Email: CTU.ROP@vumc.org
- Phone: 615-936-2020
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Imaging retinal structure in premature babies to guide care
This study tests whether bedside ultra-widefield eye imaging can better guide treatment decisions for retinopathy of prematurity in preterm infants.
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Does early red blood cell transfusion affect complications and neurodevelopment in premature infants?
This study tests whether giving blood transfusions in the first month of life in premature babies is linked to early complications like ROP, NEC, BPD, IVH, and to later neurodevelopmental outcomes.
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Testing FLQ-101 for retinopathy of prematurity in very premature newborns
This will test whether giving FLQ-101 to very premature babies (born at 26+0 to 27+6 weeks and weighing ≥650 g) is safe and produces the expected drug effects in their bodies.
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Low-dose Conbercept treatment for Retinopathy of Prematurity
This study is testing if a low-dose eye treatment called Conbercept can help preterm infants with Retinopathy of Prematurity feel better and improve their vision.
-
Evaluating pain relief methods during eye exams for premature infants
This study is testing two different ways to hold premature infants during eye exams to see which one helps reduce their pain better.
-
Incidence of hypoxia during intravitreal ranibizumab injections for retinopathy of prematurity under topical anesthesia
This study looks at how often and how severely babies with retinopathy of prematurity experience low oxygen levels during bedside eye injections with topical anesthesia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.