Advancing Pediatric Retinal Imaging With Auto-aligned OCT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorDuke University
About this trial
The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Group 1: Healthy adult volunteers
Subject is able and willing to consent to study participation
Subject is more than 18 years of age
Healthy adult volunteers without known ocular issues other than refractive error
Disqualifiers
Group 1: Healthy adult volunteers
Students or employees under direct supervision of the investigators
Subjects with prior problems with pupil dilation
Pregnant woman if receiving dilating drops
Trial design
Design model
Parallel
Treatments tested in this trial
Auto-aligned OCT
DeviceSwept Source OCT system with improved hand-held probe technology for auto-alignment to the patient's eye, as well as on-line detection of image quality and auto-saving at the proper time
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: Group 1: Healthy adult volunteersExperimental treatment 1 intervention
Group B: Group 2: Adult patients in ophthalmology clinicsExperimental treatment 1 intervention
Group C: Group 3: Pediatric patients in ophthalmology clinicsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with abnormal retinal microanatomy
Measured by optical coherence tomography (OCT) reading.
Time frame
Up to 4 single imaging sessions at clinical visits over 2 years2
Severity of abnormal retinal microanatomy
Measured by optical coherence tomography (OCT) reading.
Time frame
Up to 4 single imaging sessions at clinical visits over 2 years3
Retinal thickness (microns) at the fovea and surrounding optic nerve as measured by OCT analysis
Measured by optical coherence tomography (OCT) analysis.
Time frame
Up to 4 single imaging sessions at clinical visits over 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Eye Institute (NEI)
Collaborator
Source ClinicalTrials.gov