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Optical Coherence Tomography in Multiple Sclerosis Patients

This study is currently recruiting participants.
Verified January 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
Peter Kaiser, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01774123
First received: September 17, 2012
Last updated: January 19, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition
Multiple Sclerosis
Optic Neuritis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Optical Coherence Tomography in Multiple Sclerosis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Thickness of retinal layer [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Iris area [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Determine the area of the iris (measured in square microns) of optic neuritis-affected eye in MS patients, as compared to controls.


Estimated Enrollment: 75
Study Start Date: August 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy
Healthy controls
MS-ON
Multiple sclerosis with optic neuritis
MS-NON
Multiple sclerosis without 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion criteria (MS with acute optic neuritis group):

  • 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.

Exclusion criteria (MS with acute optic neuritis group):

- Refractive error greater than ±6 diopters.

Inclusion criteria (MS without acute optic neuritis group):

  • History of multiple sclerosis without optic neuritis
  • Age between 18 and 65, inclusive.
  • Ability to perform adequate OCT exam.
  • Able to provide informed consent to participate in study.

Exclusion criteria (MS without acute optic neuritis group):

- Refractive error greater than ±6 diopters.

Inclusion criteria (healthy controls):

  • Age between 18 and 65, inclusive.
  • Ability to perform adequate OCT exam.
  • Able to provide informed consent to participate in the study.

Exclusion criteria (healthy controls):

  • Prior history of neurological disease.
  • First degree relative with MS.
  • Refractive error greater than ±6 diopters.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774123

Contacts
Contact: Lucy Xu, BSc. 414-292-6036 xut@ccf.org

Locations
United States, Ohio
Cole Eye Institute Recruiting
Cleveland, Ohio, United States, 44195
Contact: Lucy Xu, BSc.     414-292-6036     xut@ccf.org    
Principal Investigator: Peter K Kaiser, MD            
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Peter K. Kaiser, MD Cleveland Clinic Cole Eye Institute
Principal Investigator: Robert Bermel, MD Cleveland Clinic Mellen Center
  More Information

Publications:

Responsible Party: Peter Kaiser, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01774123     History of Changes
Other Study ID Numbers: 12-422
Study First Received: September 17, 2012
Last Updated: January 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Sclerosis
Neuritis
Optic Neuritis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013