Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age24-34
SponsorVanderbilt University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Preterm male and female infants born at 24-34 weeks gestational age and weighing <1500g at birth
Disqualifiers
Infants surgically treated for ROP
Infants with significant health concern that would preclude noninvasive retinal imaging as noted by the primary inpatient team
Trial population
Preterm male and female infants born at 24-34 weeks gestational age and weighing \<1500g at birth.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
Weekly imaging until 45 weeks, cessation of ROP screening, or first therapeutic intervention, whichever comes firstSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vanderbilt University Medical Center
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov