Multiple SclerosisNCT01774123
Optical Coherence Tomography in Multiple Sclerosis Patients
An observational study of Multiple Sclerosis and Optic Neuritis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
To evaluate the ability of different spectral domain optical coherence tomography (OCT) devices, as well as different acquisition and analysis packages, to detect disease progression in patients with multiple sclerosis with and without a history of optic neuritis Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Optic Neuritis
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Prospective, case-control study of patients from the Mellen Center and Cole Eye Institute of the Cleveland Clinic in Cleveland Ohio. The study population will consist of MS patients with a prior history optic neuritis in one eye. The affected eye will serve as cases for the study. The contralateral, unaffected eye will be used as the control. Controls will also be recruited from MS patients without a history of optic neuritis and from healthy individuals from Cole Eye Institute.
Who may be able to join
- History of unilateral optic neuritis as a manifestation of multiple sclerosis.
- Age between 18 and 65, inclusive.
- Ability to perform adequate OCT exam.
- Able to provide informed consent to participate in study.
- History of multiple sclerosis without optic neuritis
- Age between 18 and 65, inclusive.
Show all 11Show fewer
- Ability to perform adequate OCT exam.
- Able to provide informed consent to participate in study.
- Age between 18 and 65, inclusive.
- Ability to perform adequate OCT exam.
- Able to provide informed consent to participate in the study.
Who cannot join
- Refractive error greater than ±6 diopters.
- Refractive error greater than ±6 diopters.
- Prior history of neurological disease.
- First degree relative with MS.
- Refractive error greater than ±6 diopters.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the ability of different spectral domain optical coherence tomography (OCT) devices, as well as different acquisition and analysis packages, to detect disease progression in patients with multiple sclerosis with and without a history of optic neuritis
Read the detailed description
Optical coherence tomography imaging of the retina has been shown to be an effective non invasive method to study retinal changes associated with multiple sclerosis induced optic neuritis. The retina is a unique structure in that it is an unmyelinated part of the central nervous system (CNS). However, it is uncertain which layer of the retina provides the best correlation with MS disease. The investigators propose a prospective, case-control study to compare OCT measurements from different parts of the retina of MS patients with optic neuritis, those without optic neuritis, and healthy controls. The investigators will then correlate the OCT measurements to clinical measures of disease. This will allow future studies to use OCT technology as a primary outcome in studying MS axonal and cell body injury of the CNS, as well as evaluating strategies in treating MS.
- Conditions
- Multiple Sclerosis, Optic Neuritis
- Medical subject headings
- Multiple Sclerosis, Optic Neuritis
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 |
|---|---|---|
| Healthy | Healthy controls | |
| MS-ON | Multiple sclerosis with optic neuritis | |
| MS-NON | Multiple sclerosis without optic neuritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of retinal layer
The primary outcome is to determine the thickness of the retinal layers (measured in microns) of optic neuritis-affected eye in MS patients, as compared to controls.
Measured: 1 day
Secondary outcomes (1)
Iris area
Determine the area of the iris (measured in square microns) of optic neuritis-affected eye in MS patients, as compared to controls.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startAug 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Kaiser, The Cleveland Clinic
- Investigators
- Peter K. Kaiser, MD, Principal investigator, Cleveland Clinic Cole Eye InstituteRobert Bermel, MD, Principal investigator, Cleveland Clinic Mellen Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774123
- Sponsor's protocol ID
- 12-422
- Status last verified
- May 2014
- First submitted
- 17 Sep 2012
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Frohman EM, Fujimoto JG, Frohman TC, Calabresi PA, Cutter G, Balcer LJ. Optical coherence tomography: a window into the mechanisms of multiple sclerosis. Nat Clin Pract Neurol. 2008 Dec;4(12):664-75. doi: 10.1038/ncpneuro0950.
PubMed 19043423Siger M, Dziegielewski K, Jasek L, Bieniek M, Nicpan A, Nawrocki J, Selmaj K. Optical coherence tomography in multiple sclerosis: thickness of the retinal nerve fiber layer as a potential measure of axonal loss and brain atrophy. J Neurol. 2008 Oct;255(10):1555-60. doi: 10.1007/s00415-008-0985-5. Epub 2008 Sep 25.
PubMed 18825432
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT01774123
- Acronym / sponsor ID
- 12-422
- Conditions
- Multiple Sclerosis, Optic Neuritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Jan 2013 (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.
To evaluate the ability of different spectral domain optical coherence tomography (OCT) devices, as well as different acquisition and analysis packages, to detect disease progression in patients with multiple sclerosis with and without a history of optic neuritis
Detailed description
Optical coherence tomography imaging of the retina has been shown to be an effective non invasive method to study retinal changes associated with multiple sclerosis induced optic neuritis. The retina is a unique structure in that it is an unmyelinated part of the central nervous system (CNS). However, it is uncertain which layer of the retina provides the best correlation with MS disease. The investigators propose a prospective, case-control study to compare OCT measurements from different parts of the retina of MS patients with optic neuritis, those without optic neuritis, and healthy controls. The investigators will then correlate the OCT measurements to clinical measures of disease. This will allow future studies to use OCT technology as a primary outcome in studying MS axonal and cell body injury of the CNS, as well as evaluating strategies in treating MS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –Healthy controls |
| MS-ON | – | –Multiple sclerosis with optic neuritis |
| MS-NON | – | –Multiple sclerosis without optic neuritis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective, case-control study of patients from the Mellen Center and Cole Eye Institute of the Cleveland Clinic in Cleveland Ohio. The study population will consist of MS patients with a prior history optic neuritis in one eye. The affected eye will serve as cases for the study. The contralateral, unaffected eye will be used as the control. Controls will also be recruited from MS patients without a history of optic neuritis and from healthy individuals from Cole Eye Institute.
Key inclusion criteria (11 listed)
- History of unilateral optic neuritis as a manifestation of multiple sclerosis.
- Age between 18 and 65, inclusive.
- Ability to perform adequate OCT exam.
- Able to provide informed consent to participate in study.
- History of multiple sclerosis without optic neuritis
Key exclusion criteria (5 listed)
- Refractive error greater than ±6 diopters.
- Refractive error greater than ±6 diopters.
- Prior history of neurological disease.
- First degree relative with MS.
- Refractive error greater than ±6 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
Thickness of retinal layer
Time frame: 1 day
The primary outcome is to determine the thickness of the retinal layers (measured in microns) of optic neuritis-affected eye in MS patients, as compared to controls.
1 secondary outcome
Iris area
Time frame: 1 day
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 3 Jun 2014.
- Background: PubMed 19043423Frohman EM, Fujimoto JG, Frohman TC, Calabresi PA, Cutter G, Balcer LJ. Optical coherence tomography: a window into the mechanisms of multiple sclerosis. Nat Clin Pract Neurol. 2008 Dec;4(12):664-75. doi: 10.1038/ncpneuro0950.
- Background: PubMed 18825432Siger M, Dziegielewski K, Jasek L, Bieniek M, Nicpan A, Nawrocki J, Selmaj K. Optical coherence tomography in multiple sclerosis: thickness of the retinal nerve fiber layer as a potential measure of axonal loss and brain atrophy. J Neurol. 2008 Oct;255(10):1555-60. doi: 10.1007/s00415-008-0985-5. Epub 2008 Sep 25.
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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.
Peter K. Kaiser, MD principal investigator
Cleveland Clinic Cole Eye Institute
Robert Bermel, MD principal investigator
Cleveland Clinic Mellen Center
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 and Optic Neuritis, run by The Cleveland Clinic 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 11 inclusion and 5 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 3 Jun 2014. 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?
Thickness of retinal layer (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01774123, which also lists 2 linked publications.
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 3 Jun 2014.