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Evaluation of Sloan-Charts for Assessment of Disease Progress in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01272596
Recruitment Status : Completed
First Posted : January 10, 2011
Last Update Posted : April 15, 2020
Novartis Germany GmbH
Information provided by (Responsible Party):
Jan-Markus Dörr, Charite University, Berlin, Germany

Brief Summary:

Impairment of visual deficits, in particular contrast acuity and contrast impairment are frequent symptoms in MS. However, visual function is not appropriately covered by the standard tools for clinical assessment, namely, the EDSS and the MSFC.

The primary aim of this study is to investigate, whether in MS patients contrast acuity and sensitivity change over a period of two years.

Secondary aims are the correlation of visual contrast parameters with structural retinal changes and quality of life.

Condition or disease
Multiple Sclerosis

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Low Contrast Sloan Visual Charts as Method for the Assessment of Disease Progression in Multiple Sclerosis
Study Start Date : December 2009
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Multiple Sclerosis Patients
Patients with Clinically Isolated Syndrome or definite Multiple Sclerosis (either relapsing-remitting or secondary progressive)

Primary Outcome Measures :
  1. Visual Contrast Acuity [ Time Frame: 24 Months ]

Secondary Outcome Measures :
  1. Structural and Functional Changes of Optic Pathway [ Time Frame: 24 Months ]
  2. Clinical Neurological Assessment [ Time Frame: 24 Months ]
  3. Quality of Life [ Time Frame: 24 Months ]
  4. Contrast Sensitivity [ Time Frame: 24 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Clinically Isolated Syndrome or Definite Multiple Sclerosis

Inclusion Criteria:

  • Clinically Isolated Syndrome or definite MS (relapsing-remitting or secondary progressive course)
  • Written Informed Consent

Exclusion Criteria:

  • Relapse within the last 30 Days
  • Significant Cognitive Impairment
  • Severely Decreased Visual Acuity
  • Preexisting Severe Retinal Pathology

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01272596

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NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Novartis Germany GmbH
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Principal Investigator: Jan M Dörr, MD NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin
Additional Information:
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Responsible Party: Jan-Markus Dörr, PI, Charite University, Berlin, Germany Identifier: NCT01272596    
Other Study ID Numbers: Sloan-Study
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Keywords provided by Jan-Markus Dörr, Charite University, Berlin, Germany:
Multiple Sclerosis
Visual Contrast Acuity
Visual Contrast Sensitivity
Sloan Charts
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases