Actively Recruiting
Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity
Led by Vanderbilt University Medical Center · Updated on 2025-05-15
90
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a new imaging technology called HH-SECTR to better visualize and measure features of retinopathy of prematurity (ROP) in prematurely born infants. This study aims to improve clinical decision-making by providing detailed, depth-resolved information about the eye's vascular structure, which is not currently captured by standard methods. The study focuses on identifying disease features that could help predict ROP progression and severity. In this observational study, infants will undergo weekly HH-SECTR imaging alongside their routine weekly ROP screenings. Imaging will primarily take place in the neonatal intensive care unit (NICU) but may also be performed under sedation or anesthesia during standard clinical exams. Both eyes will be imaged until the baby reaches 45 weeks, stops ROP screening, or requires the first treatment. No additional treatments or procedures will be used to enhance imaging. Participants will have digital HH-SECTR images, fundus photographs, and clinical examination data collected throughout the study. Patient medical records will help determine eligibility and track clinical outcomes. The research team will analyze imaging data after each session but will not change patient care based on study results. The study will last five years, with all records archived indefinitely according to NIH guidelines.
CONDITIONS
Brief Title
Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm male and female infants born at 24-34 weeks gestational age
- Birth weight less than 1500 grams
You will not qualify if you...
- Infants who have had surgical treatment for retinopathy of prematurity
- Infants with significant health concerns preventing noninvasive retinal imaging as determined by the primary inpatient team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first
Participants undergo weekly HH-SECTR imaging concurrent with standard-of-care ROP screening to assess and quantify structural and vascular disease features.
Weekly visits for imaging
Duration - Up to 5 years
Imaging data and clinical variables are analyzed and archived for ongoing research and evaluation after completion of imaging visits.
No additional visits required; data analyzed from records
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
I
Irina De la Huerta, MD, PhD
M
Marybeth Carter
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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