Comparative Study of High Performance Low-Cost Optical Coherence Tomography (Stage 1B, 2 and 3)
Enrolling by invitation · Not applicable
Conditions studied: Optical Coherence Tomography of Retina, Alzheimer Disease
In brief
The purpose of this study is to complete performance testing of our custom optical coherence tomography (OCT) device to verify it can deliver retinal images of similar quality to a commercial OCT device. We will then add an angle-resolved low coherence interferometry (a/LCI module) to the device to make measurements of retinal tissue structure.
Key facts
- Study ID
- NCT07425106
- Run by
- Duke University
- People needed
- 82
- Starts
- 2026-02-13
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-02-25
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- able to provide informed consent
You may not qualify if…
- potentially confounding ocular conditions, such as: glaucoma, current corneal injury, retinal damage, diabetes, corrected distance visual acuity worse than 20/40
- eyes that have had intraocular surgery or retinal surgery, other than cataract surgery
- Participants with Alzheimer's Disease:
- Inclusion:
- mild cognitive impairment (MCI) or dementia due to Alzheimer's disease, confirmed by A/T/N classification
- Healthy Controls:
- Exclusion:
- has a memory or other neurodegenerative diagnosis (including mild cognitive impairment, Parkinson's disease, Alzheimer's disease, traumatic brain injury, post-traumatic stress disorder)
- If two eyes satisfy the inclusion / exclusion criteria, both eyes will be included in the study. If only one eye satisfies the criteria, only the qualifying eye will be included in the study.
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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