Optical Coherence Tomography (OCT) of the Retina Clinical Trial
Official title:
Low Cost Optical Coherence Tomography for Point of Care
| Verified date | November 2019 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to compare the performance of a prototype optical coherence tomography (OCT) machine with currently available high resolution OCT machines.
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | December 13, 2018 |
| Est. primary completion date | December 13, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - patients scheduled to receive standard OCT testing as part of their clinical visit Exclusion Criteria: - none |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of North Carolina Kittner Eye Center | Chapel Hill | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University | University of North Carolina, Chapel Hill, Wallace H. Coulter Foundation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Acceptable OCT Image Quality | measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device | day 1 | |
| Secondary | Central Macular Thickness | compare measurements of central macular thickness obtained with low cost OCT system and Heidelberg Spectralis OCT system | day 1 | |
| Secondary | Total Macular Volume | compare total macular volume measurements obtained with low cost OCT system and Heidelberg Spectralis OCT system | day 1 |