Back to resultsSwept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging (SWEPT)
Primary Purpose
Retinal Vascular Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Swept-Source Optical Coherence Tomography
Sponsored by
About this trial
This is an interventional device feasibility trial for Retinal Vascular Disease focused on measuring retinal vascular disease, Swept-Source Ocular Coherence Tomography, SSOCT
Eligibility Criteria
Inclusion Criteria:
- Capable and willing to provide consent
- history of clinically-diagnosed retinal microvascular diseases, including but not limited to diabetic retinopathy, retinal vein occlusion, idiopathic macular telangiectasias, hypertensive retinopathy, and age-related macular degeneration
- At least 18 years of age
Exclusion Criteria:
- Unable or unwilling to give consent
- Under 18 years of age
Sites / Locations
- Duke Eye Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
retinal vascular occlusion arm
Arm Description
Patients with existing retinal microvascular disease will undergo imaging.
Outcomes
Primary Outcome Measures
OCT images and metrics derived from the OCT images
Distributions, means, and standard deviations will be reported.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01834196
Brief Title
Swept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging
Acronym
SWEPT
Official Title
Swept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
No active study enrollment for a 2 years.
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a clinical pilot study to assess the feasibility of using a swept-source optical coherence tomography (SSOCT) system to perform noninvasive imaging of the retinal vasculature in patients with existing microvascular disease.
Detailed Description
This project is being conducted under an abbreviated IDE. Subjects with existing retinal microvascular disease will be recruited from among the patients of the Duke Eye Center and/or its associated satellite clinics. Following informed consent, subjects undergo imaging, per established standard operating procedure, at the Duke University Medical Center/Duke Center or at one of the Duke Eye Center satellite clinics. Pharmacologic dilation of eyes will not be necessary for completion of imaging and will not be used for the purposes of this study. The resulting images will not be used in the clinical care of any of the subjects recruited for this project.
Subjects will be identified from patients presenting for ophthalmologic consultation at the Duke Eye Center and/or its satellite clinic locations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vascular Disease
Keywords
retinal vascular disease, Swept-Source Ocular Coherence Tomography, SSOCT
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
retinal vascular occlusion arm
Arm Type
Other
Arm Description
Patients with existing retinal microvascular disease will undergo imaging.
Intervention Type
Device
Intervention Name(s)
Swept-Source Optical Coherence Tomography
Intervention Description
Noninvasive imaging of the retinal vasculature in patient with existing microvascular disease.
Primary Outcome Measure Information:
Title
OCT images and metrics derived from the OCT images
Description
Distributions, means, and standard deviations will be reported.
Time Frame
Day of imaging, approximately 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Capable and willing to provide consent
history of clinically-diagnosed retinal microvascular diseases, including but not limited to diabetic retinopathy, retinal vein occlusion, idiopathic macular telangiectasias, hypertensive retinopathy, and age-related macular degeneration
At least 18 years of age
Exclusion Criteria:
Unable or unwilling to give consent
Under 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prithu Mettu, MD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Swept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging
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