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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT06612541
- Acronym / sponsor ID
- ROP Imaging / 231251
- Conditions
- Retinopathy of Prematurity (ROP), ROP Examination
- Keywords
- Retinopathy of Prematurity, ROP, Prematurity, OCT Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 24 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm male and female infants born at 24-34 weeks gestational age and weighing \<1500g at birth.
Key inclusion criteria (1 listed)
- Preterm male and female infants born at 24-34 weeks gestational age and weighing \<1500g at birth
Key exclusion criteria (2 listed)
- Infants surgically treated for ROP
- Infants with significant health concern that would preclude noninvasive retinal imaging as noted by the primary inpatient team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinal imaging in pediatric ROP patients
Time frame: Weekly 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity (ROP) and ROP Examination, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irina De la Huerta, MD, PhD (615-936-2020, CTU.ROP@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal imaging in pediatric ROP patients (time frame: Weekly imaging until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.