Using Optical Coherence Tomography to Capture Retinal Microvascular Changes Associated With Multiple Sclerosis (OCT in MS)
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Using OCT to Capture Retinal Microvascular Changes Associated With MS|
- 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 ] [ Designated as safety issue: No ]
- Number of patients with MS who have different blood flow response than healthy subjects to visually stimulating patterns. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Multiple Sclerosis Patients
Physician-confirmed diagnosis of multiple sclerosis. Any subtype is acceptable. For example, relapsing-remitting, secondary progressive, primary progressive
Healthy Normal Subjects
Volunteers with healthy eyes.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596881
|Contact: Janice Ladwig, COT (Healthy Volunteers)||firstname.lastname@example.org|
|Contact: Denny Romfh, OD (healthy volunteers)||email@example.com|
|United States, Oregon|
|Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Sub-Investigator: Shannon Overs, MD|
|Sub-Investigator: Dennis Bourdette, MD|
|Sub-Investigator: Bill Rooney, PhD|
|Principal Investigator:||Rebecca Spain, MD, MSPH||Oregon Health & Science Universtiy|