- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01596881
Using Optical Coherence Tomography to Capture Retinal Microvascular Changes Associated With Multiple Sclerosis (OCT in MS)
Using OCT to Capture Retinal Microvascular Changes Associated With MS
Study Overview
Status
Conditions
Detailed Description
Background data including age, sex, medical history, and neurologic history and status will be gathered prior to the study/OCT testing visit. At the single study/testing visit, subjects will have their blood pressure and intraocular pressure checked (using numbing drops that last 15-20 minutes), undergo vision testing and then have their eyes dilated with standard dilating drops. They will then undergo optical coherence tomography testing to determine the blood flow of the retinal blood vessels and to take other measurements of the back of the eye including thicknesses of the nervous tissue elements of the retina.
OCT Procedure: The subject will be seated and have their head positioned on a chin rest. They will be asked to look at a target (a lighted spot) while a beam of light scans the front part of the eye. The light is infrared and will not be visible or cause any sensation. A cotton tip swab may be used to help hold the eyelid open temporarily if necessary.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria (Subjects with MS):
- Physician-confirmed diagnosis of MS (any subtype acceptable, e.g. relapsing- remitting, secondary progressive, primary progressive)
- Age 18-70 years old
- Able to comply with study procedures
- Corrected visual acuity at least 20/200 in either eye
Inclusion Criteria (Healthy subjects):
- Age 18-70 years old
- Able to comply with study procedures
- Able to maintain stable fixation for OCT imaging
- Corrected visual acuity of at least 20/40 in either eye
Exclusion Criteria (all participants):
- Intravenous or oral steroids in the prior 30 days
- Evidence on ophthalmological exam within the last year of other ocular diseases or pathology that would confound the assessment of MS and optic nerve head (e.g. glaucoma, diabetic or hypertensive retinal disease, amblyopia, etc.)
- Previous intraocular surgery except for uncomplicated cataract surgery
- Inability to maintain stable fixation for OCT imaging
- Refractive error greater than +3 or -7 diopters
- MS exacerbation in the prior 60 days.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Multiple Sclerosis Patients
Physician-confirmed diagnosis of multiple sclerosis.
Any subtype is acceptable.
For example, relapsing-remitting, secondary progressive, primary progressive
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Healthy Normal Subjects
Volunteers with healthy eyes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with MS who also have reduced blood flow in the retina and/or changes in the blood flow to the retina compared to healthy subjects
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with MS who have different blood flow response than healthy subjects to visually stimulating patterns.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rebecca Spain, MD, MSPH, Oregon Health & Science Universtiy
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OHSU IRB #00008179-MS
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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