Optical Coherence Tomography in Multiple Sclerosis Patients

Completed

• Conditions: Multiple Sclerosis; Optic Neuritis

• Registration Number: NCT01774123
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2013-01-19
• Study First Posted: 2013-01-23
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-30
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thickness of retinal layer	1 day	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

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

Trial Locations

Locations (1)

Cole Eye Institute; 🇺🇸 Cleveland, Ohio, United States