SS-HH-OCT as a Novel Diagnostic Modality for Early-Onset Retinal Dystrophies (EORDs)
ConditionRetinal Dystrophies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-8
SponsorDuke University
About this trial
The goal of this observational study is to utilize a novel imaging system designed for high-resolution retinal imaging of neonates, infants and children to identify the signs of photoreceptor development and degeneration in children with early-onset inherited retinal dystrophies (EORDs). Participants will have research imaging with SS-HH-OCT at the time of clinically-indicated eye examinations or procedures. The investigators aim to establish the basis for utilization of OCT imaging in earlier diagnosis and disease monitoring in children with EORDs. This work will set data reference standards and IRD endpoints that can be used in clinical trials.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participant's age is between 0 through 8 years (<9 years)
Parent/legal guardian gives consents for the imaging study
No ocular media opacities that could preclude imaging
Refractive error equal or lower than 6 diopters
Disqualifiers
Parent/legal guardian unwilling or unable to provide consent
Refractive error higher than 6.00 diopters
Participant has media opacities that preclude imaging
Any non-IRD ocular condition that confound results interpretation such as glaucoma, uveitis, neurologic conditions affecting the optic nerve, etc.
Trial design
Design model
Parallel
Treatments tested in this trial
SS-HH-OCT
DeviceThe investigational swept source OCT systems with handheld UC handpieces used in this study were developed at Duke University. OCT systems are non-contact, in-vivo optical imaging technology. The OCT system creates real-time, non-invasive images of ocular microstructure. OCT devices held above or in front of the eye while the sweeping infrared OCT beam scans across the retina. In contrast to the visible light used in clinical eye examinations, because infrared light is not visible, the participant is not disturbed by the light. OCT imaging allows the capture of hundreds of B-scan (cross-sectional) images in seconds. These B-scans are then stacked to create a volume; the stack may be summed up to create a retinal image. These retinal images are similar to images acquired during retinal photography except that they were captured with infrared light and provide depth information. Each volume and B-scan image can be viewed individually to measure and analyze ocular pathology.
Treatment groups
80 Participants
are divided into 3 treatment groupsGroup A: Group 1 - Progressive Inherited retinal dystrophy (IRD)Active comparator 1 intervention
Group B: Group 2 - Non-progressive Inherited Retinal Dystrophy (IRD)Active comparator 1 intervention
Group C: Group 3 - Control participantsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with abnormal microanatomy as measured by OCT reading
Presence of abnormal retinal microanatomy as measured by OCT reading
Time frame
Up to 24 months2
Thickness of the participants retina at the fovea and surrounding optic nerve as measured by OCT reading
Retinal thickness (microns) at the fovea and surrounding optic nerve
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov