- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01272596
Evaluation of Sloan-Charts for Assessment of Disease Progress in Multiple Sclerosis
Evaluation of Low Contrast Sloan Visual Charts as Method for the Assessment of Disease Progression in Multiple Sclerosis
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Berlin, Germany, 10117
- NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Multiple Sclerosis Patients
Patients with Clinically Isolated Syndrome or definite Multiple Sclerosis (either relapsing-remitting or secondary progressive)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Visual Contrast Acuity
Time Frame: 24 Months
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24 Months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Structural and Functional Changes of Optic Pathway
Time Frame: 24 Months
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24 Months
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Clinical Neurological Assessment
Time Frame: 24 Months
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24 Months
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Quality of Life
Time Frame: 24 Months
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24 Months
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Contrast Sensitivity
Time Frame: 24 Months
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24 Months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jan M Dörr, MD, NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sloan-Study
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