- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03323307
Low Cost OCT for Point of Care
November 12, 2019 updated by: Duke University
Low Cost Optical Coherence Tomography for Point of Care
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27517
- University of North Carolina Kittner Eye Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients scheduled to receive standard OCT testing as part of their clinical visit
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OCT imaging
OCT device images retina
|
imaging of retina using OCT device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Acceptable OCT Image Quality
Time Frame: day 1
|
measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Central Macular Thickness
Time Frame: day 1
|
compare measurements of central macular thickness obtained with low cost OCT system and Heidelberg Spectralis OCT system
|
day 1
|
Total Macular Volume
Time Frame: day 1
|
compare total macular volume measurements obtained with low cost OCT system and Heidelberg Spectralis OCT system
|
day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adam Wax, Ph.D., Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2018
Primary Completion (Actual)
December 13, 2018
Study Completion (Actual)
December 13, 2018
Study Registration Dates
First Submitted
October 24, 2017
First Submitted That Met QC Criteria
October 25, 2017
First Posted (Actual)
October 27, 2017
Study Record Updates
Last Update Posted (Actual)
December 5, 2019
Last Update Submitted That Met QC Criteria
November 12, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- Pro00087122
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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