New imaging technology for diagnosing retinopathy of prematurity in infants
Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity
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 |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 24 Weeks to 34 Weeks |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06612541 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this approach is innovative, similar imaging technologies have shown promise in other studies, suggesting potential for success in this context.
Eligibility criteria
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 this trial is running
Nashville, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.