Multiple SclerosisOCT in MSNCT01596881
Using Optical Coherence Tomography to Capture Retinal Microvascular Changes Associated With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to 8 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Using OCT to Capture Retinal Microvascular Changes Associated With 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Blood flow, Optical Coherence Tomography, Imaging
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
Number of patients with MS who have different blood flow response than healthy subjects to visually stimulating patterns.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startApr 2012
- Primary completion8 Feb 2017
- Study completion8 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Huang, Oregon Health and Science University
- Investigators
- Rebecca Spain, MD, MSPH, Principal investigator, Oregon Health & Science Universtiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596881
- Sponsor's protocol ID
- OHSU IRB #00008179-MS
- Acronym
- OCT in MS
- Status last verified
- Apr 2018
- First submitted
- 9 May 2012
- Last updated
- 12 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using OCT to Capture Retinal Microvascular Changes Associated With MS
- ClinicalTrials.gov ID
- NCT01596881
- Acronym / sponsor ID
- OCT in MS / OHSU IRB #00008179-MS
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Blood flow, Optical Coherence Tomography, Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- 8 Feb 2017 (actual)
- Study completion
- 8 Feb 2017 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Number of patients with MS who have different blood flow response than healthy subjects to visually stimulating patterns.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Spain, MD, MSPH principal investigator
Oregon Health & Science Universtiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018; AzTrials last refreshed its copy on 27 Oct 2026.