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.
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 objective of this device feasibility study is to compare performance characteristics of our custom OCT instrument to a commercial OCT instrument. Once we have optimized our device, we may use it in future studies to identify retinal structure changes that could be possible AD biomarkers. For this study, the team will recruit healthy volunteers to attend one study visit that is about 30 minutes long. This visit will include examination with our custom OCT instrument, followed by examination with a commercial OCT system.
Interventions
DEVICEretinal imaging with low-cost OCT device
Retinal imaging with low-cost OCT device
DEVICEretinal imaging with commercial OCT device
retinal imaging with commercial OCT device
Sponsors
Duke University
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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, other than cataract surgery 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. |
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