Using Optical Coherence Tomography to Capture Retinal Microvascular Changes Associated With Multiple Sclerosis

NCT01596881 | Completed

• 1 other identifier: OHSU IRB #00008179-MS
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Blood flow; Optical Coherence Tomography; Imaging

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (1)

• Number of patients with MS who have different blood flow response than healthy subjects to visually stimulating patterns.

  1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rebecca Spain, MD, MSPH

  Oregon Health & Science Universtiy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rebecca Spain, MD, MSPH, Assistant Professor of Neurology

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 11, 2012
• Study Start: April 1, 2012
• Primary Completion: February 8, 2017
• Study Completion: February 8, 2017
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

US (1)