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NCT01272596 Clinical Trial

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

Multiple Sclerosis Clinical Trial

Official title:
Evaluation of Low Contrast Sloan Visual Charts as Method for the Assessment of Disease Progression in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01272596
Other study ID # Sloan-Study
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2009
Est. completion date November 2013

Study information
Verified date July 2021
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin Berlin

Sponsors (2)
Lead Sponsor Collaborator
Charite University, Berlin, Germany Novartis Germany GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Contrast Acuity 24 Months
Secondary Structural and Functional Changes of Optic Pathway 24 Months
Secondary Clinical Neurological Assessment 24 Months
Secondary Quality of Life 24 Months
Secondary Contrast Sensitivity 24 Months
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