Clinical trial NCT06612541: Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity
Official title: Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinopathy of Prematurity (ROP)
ROP Examination
Keywords: Retinopathy of Prematurity
ROP
Prematurity
OCT Imaging
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-09-25
Enrollment: 90
Sex: ALL
Minimum age (years): 24
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm male and female infants born at 24-34 weeks gestational age and weighing \&amp;lt;1500g at birth.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Preterm male and female infants born at 24-34 weeks gestational age and weighing \&amp;lt;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

Primary outcomes:
measure: Retinal imaging in pediatric ROP patients
timeFrame: Weekly imaging until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes first
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: