Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT05530460
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2022-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of High Performance Low-Cost Optical Coherence Tomography
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Comparative Study of High Performance Low-Cost Optical Coherence Tomography
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01AG072732 | NIH | None | https://reporter.nih.gov/quic… | View |