Alzheimer Disease, Optical Coherence Tomography of Retina
Conditions
Brief summary
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.
Detailed description
There is some evidence that certain changes in retinal structures could be an indicator of Alzheimer's disease (AD). We are developing a new technology that combines optical coherence tomography (OCT) and angle-resolved low coherence interferometry (a/LCI) to make light scattering measurements of retinal tissue structure. The first objective of this study is to compare performance characteristics of our custom OCT instrument to a commercial OCT instrument. Once we have optimized our device, the second objective will be to use the custom OCT-a/LCI device to identify retinal structure changes that could be possible AD biomarkers. For this study, the team will recruit volunteers to attend one study visit that is about 30 minutes long. For arm 1A (registered under NCT05530460), this visit will include examination with our custom OCT instrument, followed by examination with a commercial OCT system. For arms 1B and 2/3, the visit will include examination with the custom OCT-a/LCI instrument. This study will recruit participants with Alzheimer's disease and healthy controls.
Interventions
DEVICEretinal imaging with low-cost OCT-a/LCI device
retinal imaging with low-cost OCT-a/LCI device
Sponsors
Duke University
National Institute on Aging (NIA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
All Participants: Inclusion Criteria: * able to provide informed consent
Exclusion criteria
* 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 /
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Acceptable OCT Image Quality as Measured by Low-Cost OCT Device | during study procedures (30 minutes) | measured by: ability to see clearly defined and recognizable structures of the retina with the low-cost OCT device. |
| RNFL Thickness | during study procedures (30 minutes) | Thickness of retinal nerve fiber layer, measured in microns |
| GCL Thickness | during study procedures (30 minutes) | Thickness of ganglion cell layer, measured in microns. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contrast-to-Noise Ratio (CNR) | during study procedures (30 minutes) | Measure of OCT image quality comparing level of image contrast to level of background noise. CNR = (mean of signal of region of interest \[i.e., retina\] - mean of background noise) divided by square root of (the square of the standard deviation of the region of interest + the square of the standard deviation of the background noise). Therefore, CNR is unitless. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdam Wax, Ph.D.
Duke University
Outcome results
None listed