An interventional study of retinal imaging with low-cost OCT device and retinal imaging with commercial OCT device in Optical Coherence Tomography of Retina, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Duke University · Not applicable, Interventional, and Device feasibility
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.
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.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Exclusion Criteria:
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.
Compare performance characteristics of custom OCT device with commercial OCT device.
Device: retinal imaging with low-cost OCT device · Device: retinal imaging with commercial OCT device
Retinal imaging with low-cost OCT device
retinal imaging with commercial OCT device
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.
Time frame: during study procedures (30 minutes)
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.
Time frame: during study procedures (30 minutes)
Plan to share: No
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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