Using Optical Coherence Tomography to Capture Retinal Microvascular Changes Associated With Multiple Sclerosis (OCT in MS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01596881
First received: May 9, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Using OCT to Capture Retinal Microvascular Changes Associated With MS

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
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)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study will enroll both males and females and include all ethnic and racial groups through clinical practices. The study will enroll subjects from 18 to 70 years of age. Participants older than 70 years are excluded as cooperation with tests may be difficult. For similar reasons, participants who have MS and vision worse than 20/200 are excluded. The study also excludes those with any eye disease that would interfere with of assessment of MS. Otherwise people with any health status are eligible for enrollment. Two groups of participants are recruited: people with healthy, normal eyes and people with any type of MS.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596881

Contacts
Contact: Janice Ladwig, COT (Healthy Volunteers) 503-494-8024 ladwig@ohsu.edu
Contact: Denny Romfh, OD (healthy volunteers) 503-494-4351 romfhd@ohsu.edu

Locations
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         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Rebecca Spain, MD, MSPH Oregon Health & Science Universtiy
  More Information

No publications provided

Responsible Party: David Huang, Rebecca Spain, MD, MSPH, Assistant Professor of Neurology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01596881     History of Changes
Other Study ID Numbers: OHSU IRB #00008179-MS
Study First Received: May 9, 2012
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Multiple sclerosis
Blood flow
Optical Coherence Tomography
Imaging

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014