View Clinical Trial (Medical Research Study)
Using OCT to Capture Retinal Microvascular Changes Associated With MS
| City: |
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Portland |
| State: |
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Oregon |
| Zip Code: |
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97239 |
| Conditions: |
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Multiple Sclerosis |
| Purpose: |
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Recent studies have shown that people with multiple sclerosis (MS) who also have diseases
related to vascular health such as high cholesterol, high blood pressure, diabetes,
cardiovascular disease, and others, may end up more disabled than people with MS who don't
have those diseases. This has led to a growing interest in the role of vascular diseases in
MS since they may provide another avenue of MS treatment. Some also think that vascular
disease may even be a cause of MS. The back of the eye, the retina, is well-suited to
studying vascular diseases as blood vessels can be seen even on routine examination of the
eye by eye doctors. These specialists are used to seeing changes in retinal blood vessels
due to diseases known to affect the eyes such as glaucoma and diabetes. Sophisticated
techniques for examining the retina allow for not only visualization of blood vessels, but
the rate of blood flow through the blood vessels as well. These blood flow changes are
thought to come before changes in what the blood vessels look like, and so may be able to
detect problems even earlier than routine examination of the retina by eye doctors. Retinal
blood flow has never been carefully studied in MS. Given that MS affects the retina due to
the late effects of inflammation of the optic nerve, or optic neuritis, the investigators
expect to see altered blood flow in the retinal blood vessels of people with MS compared to
healthy control subjects. If so, the investigators can then use retinal blood flow as a way
to measure therapies that target vascular diseases in the MS population and determine if
those therapies can alter the course of disease.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT01596881 |
| Primary Contact: |
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Principal Investigator
Rebecca Spain, MD, MSPH
Oregon Health & Science Universtiy
Janice Van Norman, COT (Healthy Volunteers)
Phone: 503-494-8024
Email: vannorma@ohsu.edu
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| Backup Contact: |
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Email: zerizefc@ohsu.edu
Courtney Zerizef (Patients with MS)
Phone: 503-494-0174
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| Location Contact: |
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Portland, Oregon 97239
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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