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

This study has been completed.
Sponsor:
Collaborator:
Novartis Germany GmbH
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01272596
First received: January 7, 2011
Last updated: November 26, 2013
Last verified: November 2013
  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 Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Visual Contrast Acuity [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Structural and Functional Changes of Optic Pathway [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Clinical Neurological Assessment [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Contrast Sensitivity [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Jan Dörr, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01272596     History of Changes
Other Study ID Numbers: Sloan-Study
Study First Received: January 7, 2011
Last Updated: November 26, 2013
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014