Retinopathy of Prematurity (ROP)ROP ImagingNCT06612541
Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity
An observational study of Retinopathy of Prematurity (ROP) and ROP Examination, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The goal of this proposal is to develop novel HH-SECTR technology for visualizing and quantifying diagnostic disease features in prematurely born infant retinopathy of prematurity (ROP) patients that lead to more informed clinical decision making. Read more about this study
- Who is it for?
- Ages 24 to 34 weeks
- Conditions the study is for
- Retinopathy of Prematurity (ROP), ROP Examination
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to Feb 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm male and female infants born at 24-34 weeks gestational age and weighing \<1500g at birth.
Who may be able to join
- Preterm male and female infants born at 24-34 weeks gestational age and weighing \<1500g at birth
Who cannot join
- Infants surgically treated for ROP
- Infants with significant health concern that would preclude noninvasive retinal imaging as noted by the primary inpatient team
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Marybeth Carter, 615-936-1639, marybeth.l.carter@vumc.org
Irina De la Huerta, MD PhD
About this study
The goal of this proposal is to develop novel HH-SECTR technology for visualizing and quantifying diagnostic disease features in prematurely born infant retinopathy of prematurity (ROP) patients that lead to more informed clinical decision making. Providing depth-resolved vascular information has not been adequately investigated for its diagnostic potential. Furthermore, we seek to identify disease features not currently accessible by standard examination methods to better inform clinical decisions.
Read the detailed description
Imaging studies using HH-SECTR will be performed to assess and quantify structural and vascular disease features associated with ROP. Weekly HH-SECTR imaging will be performed concurrently with standard-of-care weekly ROP screening. No additional treatments will be given to study patients to benefit HH-SECTR imaging (e.g., sedation, dilation, etc.). Study patients will primarily be imaged in the NICU, but may also be performed under sedation or anesthesia in the operating room concurrent with standard-of-care exams. Because this study will evaluate diagnostic features prognostic of ROP progression and severity, HH-SECTR imaging will be performed until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first. Both eyes will undergo HH-SECTR imaging. Diagnostic imaging data will be analyzed following each imaging session. No experimental data will be used to alter the management of patients from the standard-of-care.
Research materials obtained from subjects will include digital HH-SECTR images, digital fundus photography images, and documented examination timeline as part of the standard-of-care. Patient medical records will be used to determine eligibility to participate in the study and will be used as the source documents for following post-examination clinical variables.
The duration of the study will be 5 years. The study records and information will be indefinitely archived per NIH rules using the methods noted above.
- Conditions
- Retinopathy of Prematurity (ROP), ROP Examination
- Keywords
- Retinopathy of Prematurity, ROP, Prematurity, OCT Imaging
- Medical subject headings
- Retinopathy of Prematurity, Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal imaging in pediatric ROP patients
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
Measured: Weekly imaging until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Feb 2025
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of Prematurity (ROP)Studies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Irina De la Huerta, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612541
- Sponsor's protocol ID
- 231251
- Acronym
- ROP Imaging
- Status last verified
- Aug 2026
- First submitted
- 21 Sep 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No