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OpenTrials
Completed

NCT Number: NCT01774123

Optical Coherence Tomography in Multiple Sclerosis Patients

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cole Eye Institute

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Thickness of retinal layer

    Time frame: 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 outcomes

  1. Iris area

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2013
Registry last updated
Jun 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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