Actively Recruiting
SS-HH-OCT as a Novel Diagnostic Modality for Early-Onset Retinal Dystrophies (EORDs)
Led by Duke University · Updated on 2025-10-06
80
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SS-HH-OCT as a Novel Diagnostic Modality for Early-Onset Retinal Dystrophies (EORDs)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant's age is between 0 through 8 years (<9 years)
- Parent/legal guardian provides consent for the imaging study
- No ocular media opacities that could prevent imaging
- Refractive error equal to or less than 6 diopters
- For EORD participants: clinical and molecular diagnosis of early-onset inherited retinal dystrophies with genetic confirmation
- For control participants: no evidence of retinal disease
You will not qualify if you...
- Parent/legal guardian unwilling or unable to provide consent
- Refractive error higher than 6 diopters
- Media opacities that prevent imaging
- Any non-inherited retinal dystrophy eye condition that could affect results interpretation, such as glaucoma, uveitis, or optic nerve neurological conditions
- For EORD participants: lack of molecular diagnosis confirmation
- For control participants: any suspicion of inherited retinal dystrophies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Duke University Eye Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
R
Ramiro Maldonado, MD
CONTACT
M
Michelle N McCall, MCAPM, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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