Optical Coherence Tomography in Multiple Sclerosis Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01774123

Enrollment

Registered

2013-01-23

Start date

2012-08-31

Completion date

2013-06-30

Last updated

2014-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Optic Neuritis

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results