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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01272596
First Posted: January 10, 2011
Last Update Posted: August 2, 2017
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.
Collaborator:
Novartis Germany GmbH
Information provided by (Responsible Party):
Jan-Markus Dörr, Charite University, Berlin, Germany
  Purpose

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

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01272596


Locations
Germany
NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Novartis Germany GmbH
Investigators
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
ClinicalTrials.gov Identifier: NCT01272596     History of Changes
Other Study ID Numbers: Sloan-Study
First Submitted: January 7, 2011
First Posted: January 10, 2011
Last Update Posted: August 2, 2017
Last Verified: August 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:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases