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

This study has been completed.
Novartis Germany GmbH
Information provided by (Responsible Party):
Jan-Markus Dörr, Charite University, Berlin, Germany Identifier:
First received: January 7, 2011
Last updated: August 1, 2017
Last verified: August 2017

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.

Multiple Sclerosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Jan-Markus Dörr, Charite University, Berlin, Germany:

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

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

Enrollment: 100
Study Start Date: December 2009
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Multiple Sclerosis Patients
Patients with Clinically Isolated Syndrome or definite Multiple Sclerosis (either relapsing-remitting or secondary progressive)


Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01272596

NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Novartis Germany GmbH
Principal Investigator: Jan M Dörr, MD NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin
  More Information

Responsible Party: Jan-Markus Dörr, PI, Charite University, Berlin, Germany Identifier: NCT01272596     History of Changes
Other Study ID Numbers: Sloan-Study
Study First Received: January 7, 2011
Last Updated: August 1, 2017

Keywords provided by Jan-Markus Dörr, Charite University, Berlin, Germany:
Multiple Sclerosis
Visual Contrast Acuity
Visual Contrast Sensitivity
Sloan Charts

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases processed this record on August 16, 2017