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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG072732 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Performance Testing of OCT-a/LCI (1B) | Experimental | Performance testing of custom OCT-a/LCI device. |
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| Retinal Morphology (2/3) | Experimental | examination with OCT-a/LCI device to examine retinal morphology characteristics of participants with Alzheimer's disease and healthy controls |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| retinal imaging with low-cost OCT-a/LCI device | Device | retinal imaging with low-cost OCT-a/LCI device |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Acceptable OCT Image Quality as Measured by Low-Cost OCT Device | measured by: ability to see clearly defined and recognizable structures of the retina with the low-cost OCT device. | during study procedures (30 minutes) |
| RNFL Thickness | Thickness of retinal nerve fiber layer, measured in microns | during study procedures (30 minutes) |
| GCL Thickness | Thickness of ganglion cell layer, measured in microns. | during study procedures (30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast-to-Noise Ratio (CNR) | 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. | during study procedures (30 minutes) |
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All Participants:
Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Adam Wax, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |