Optical Coherence Tomography in Multiple Sclerosis Patients

NCT01774123 | Completed

• 1 other identifier: 12-422
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis; Optic Neuritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Iris area

  1 day

Study Arms (3)

Healthy

Healthy controls

MS-ON

Multiple sclerosis with optic neuritis

MS-NON

Multiple sclerosis without optic neuritis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- Refractive error greater than ±6 diopters.
• 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.
• \- Refractive error greater than ±6 diopters.
• Age between 18 and 65, inclusive.
• Ability to perform adequate OCT exam.
• Able to provide informed consent to participate in the study.
• Prior history of neurological disease.
• First degree relative with MS.
• Refractive error greater than ±6 diopters.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cole Eye Institute

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

• 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.

  PMID: 19043423 BACKGROUND

• 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.

  PMID: 18825432 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Optic Neuritis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases

Study Officials

• Peter K. Kaiser, MD

  Cleveland Clinic Cole Eye Institute

  PRINCIPAL INVESTIGATOR

• Robert Bermel, MD

  Cleveland Clinic Mellen Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: January 23, 2013
• Study Start: August 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 3, 2014

Record last verified: 2014-05

Locations

US (1)