Optical Coherence Tomography in Multiple Sclerosis Patients

NCT ID: NCT01774123

Last Updated: 2014-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-06-30

Brief 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

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy

Healthy controls

No interventions assigned to this group

MS-ON

Multiple sclerosis with optic neuritis

No interventions assigned to this group

MS-NON

Multiple sclerosis without optic neuritis

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.
• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Peter Kaiser

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter K. Kaiser, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Cole Eye Institute

Robert Bermel, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Mellen Center

Locations

Cole Eye Institute

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19043423 (View on PubMed)

Siger 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.

Reference Type: BACKGROUND

PMID: 18825432 (View on PubMed)

Other Identifiers

12-422

Identifier Type: -

Identifier Source: org_study_id