Optical Coherence Tomography in Multiple Sclerosis Patients

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; 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 Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cole Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Healthy; Healthy controls
MS-ON; Multiple sclerosis with optic neuritis
MS-NON; Multiple sclerosis without optic neuritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iris area	Determine the area of the iris (measured in square microns) of optic neuritis-affected eye in MS patients, as compared to controls.	1 day

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Peter K. Kaiser, MD, Cleveland Clinic Cole Eye Institute; Principal Investigator: Robert Bermel, MD, Cleveland Clinic Mellen Center

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: September 17, 2012
• First Submitted That Met QC Criteria: January 19, 2013
• First Posted (ESTIMATE): January 23, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 3, 2014
• Last Update Submitted That Met QC Criteria: May 30, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Eye Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Multiple Sclerosis; Sclerosis; Neuritis; Optic Neuritis
• Other Study ID Numbers: 12-422