NCT06177977Completed
SS-HH-OCT as a Novel Diagnostic Modality for Early-Onset Retinal Dystrophies (EORDs)
Ultracompact Hand-Held Swept-Source Optical Coherence Tomography (SS-HH-OCT) as a Novel Diagnostic Modality for Early-Onset Retinal Dystrophies (EORDs)
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 137 (actual)
- First submitted
- 11 Dec 2023
- Start date
- 1 Mar 2024
- Primary completion date
- 5 Feb 2026
- Lead sponsor
- Duke University
- Diseases
- Retinitis pigmentosa
- NCT number
- NCT06177977
What you commit to
- Study type: Interventional
- Participants enrolled: 137
- From 1 Mar 2024 to the primary completion date, 5 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any non-IRD ocular condition that confound results interpretation such as glaucoma, uveitis, neurologic conditions affecting the optic nerve, etc.
- For EORD participants (Groups 1-2): Does not meet molecular diagnosis criteria
- For Controls (Group 3): Any suspicion of IRD
Other
- For all participants:
- Parent/legal guardian unwilling or unable to provide consent
- Refractive error higher than 6.00 diopters
- Participant has media opacities that preclude imaging
Who the study is looking for
- For all participants:
- 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
- For EORD participants (Groups 1-2):
- Meets clinical and molecular diagnosis of EORD (clinical determined by PI). Molecular diagnosis criteria:
- Autosomal dominant gene: One pathogenic or likely pathogenic variant that meets the clinical phenotype
- Autosomal recessive gene: two pathogenic or likely pathogenic variants in-trans which meet the phenotype.
- X-linked gene: one pathogenic or likely pathogenic variant which meets the phenotype.
- For Controls (Group 3): No evidence of retinal pathology
Age in the registry: 0 years to 8 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Eye Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.