Actively Recruiting
Ultracompact Hand-Held Swept-Source Optical Coherence Tomography as a Novel Diagnostic Tool for Early-Onset Retinal Dystrophies in Children
Led by Duke University · Updated on 2025-10-06
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating early-onset inherited retinal dystrophies (EORDs) in children from birth to 8 years old using a new imaging system called SS-HH-OCT. This study aims to detect signs of photoreceptor development and degeneration in young children with EORDs to improve early diagnosis and monitoring. The research will also help establish data standards and retinal dystrophy endpoints for future clinical trials. The study uses a handheld swept-source OCT device that captures high-resolution, non-invasive images of the retina using infrared light. Participants include children with progressive or non-progressive inherited retinal dystrophies as well as children with normal retinal anatomy undergoing strabismus surgery. Imaging is done during clinically indicated eye exams or procedures, without contact or visible light disturbance. Participants will undergo SS-HH-OCT imaging and researchers will measure retinal microanatomy abnormalities and retinal thickness at the fovea and optic nerve areas over a period of up to 24 months. The study will collect data on photoreceptor development and degeneration, setting a foundation for future studies. The total participation includes these imaging sessions aligned with routine clinical care and follow-up assessments.
CONDITIONS
Brief 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 (under 9 years)
- Parent or legal guardian provides consent for the imaging study
- No ocular media opacities that would prevent imaging
- Refractive error is 6 diopters or lower
- For EORD participants: clinical and molecular diagnosis of early-onset inherited retinal dystrophy
- For control participants: no evidence of retinal pathology
You will not qualify if you...
- Parent or legal guardian unwilling or unable to provide consent
- Refractive error higher than 6 diopters
- Participant has media opacities that prevent imaging
- Presence of any non-inherited retinal dystrophy ocular condition that could affect results, such as glaucoma, uveitis, or optic nerve neurological conditions
- For EORD participants: does not meet molecular diagnosis criteria
- For control participants: any suspicion of inherited retinal dystrophy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants undergo imaging with the investigational handheld Swept-Source Optical Coherence Tomography (SS-HH-OCT) device to capture detailed retinal images for analysis of photoreceptor development and degeneration.
Imaging sessions scheduled as part of clinical care or study visits
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
M
Michelle N McCall, MCAPM, BA
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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