Optical Coherence Tomography in Multiple Sclerosis Patients

NeuroTherapia, Inc.

Status: Completed

Conditions: Multiple Sclerosis; Optic Neuritis

Study type: Observational

Funder types: Other

Identifiers

NCT01774123

12-422

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

78 participants in 3 patient groups

Healthy

Description:

Healthy controls

MS-ON

Description:

Multiple sclerosis with optic neuritis

MS-NON

Description:

Multiple sclerosis without optic neuritis