Optical Coherence Tomography in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

Official title:

Optical Coherence Tomography in Multiple Sclerosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774123
• Other study ID #: 12-422
• Status: Completed
• Phase: N/A
• First received: September 17, 2012
• Last updated: May 30, 2014
• Start date: August 2012
• Est. completion date: June 2013

Study information

• Verified date: May 2014
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Optic Neuritis
• Sclerosis

Locations

Country	Name	City	State
United States	Cole Eye Institute	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No