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
Qualifiers
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
Treatments tested in this trial
- SS-HH-OCT
Treatment groups
80 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov