Observational Study of HH-SECTR Imaging for Retinopathy of Prematurity

This observational study is looking at a new imaging technology called HH-SECTR to better understand Retinopathy of Prematurity (ROP) in premature babies. ROP is an eye condition that can affect babies born early. The study aims to see if HH-SECTR can provide more detailed information about the blood vessels in the eye, which could help doctors make more informed decisions about treatment. You might be able to join if your baby was born between 24 and 34 weeks gestational age and weighed less than 1500g at birth. The study will measure how well HH-SECTR can image the retina (the light-sensitive tissue at the back of the eye) in babies with ROP. The study status is currently unclear, and it plans to enroll 90 participants.

Study design
This is an observational study, meaning it will watch and record information without giving any new treatments. It plans to enroll 90 participants.
What's involved
Your baby would have weekly HH-SECTR imaging done at the same time as their standard ROP screenings. This imaging would continue until 45 weeks gestational age, when ROP screening stops, or if they receive their first ROP treatment.
Compensation
Not stated in the trial record.
Follow-up
Imaging will be performed weekly until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first.

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NCT06612541

Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity

Recruiting
Not specifiedAges 24–34Observational
Vanderbilt University Medical Center
~90 participants
Updated 2026-08-04 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Retinal imaging in pediatric ROP patients
Measured over Weekly imaging until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first
Retinopathy of Prematurity (ROP)
ROP Examination
1 sites across 1 states
Tennessee1

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Eligibility criteria

Inclusion

Preterm male and female infants born at 24-34 weeks gestational age and weighing \<1500g at birth

Exclusion

Infants surgically treated for ROP
Infants with significant health concern that would preclude noninvasive retinal imaging as noted by the primary inpatient team
  • Retinal imaging in pediatric ROP patientsWeekly imaging until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first

    Real-time noninvasive optical imaging of the retina will be performed out to the ora serrata and ROP diagnostic markers will be evaluated in post-processing and compared against clinical examination