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

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT01272596
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2011-01-07
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-10
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Contrast Acuity	24 Months

Secondary Outcome Measures

Name	Time	Method
Contrast Sensitivity	24 Months
Quality of Life	24 Months
Structural and Functional Changes of Optic Pathway	24 Months
Clinical Neurological Assessment	24 Months

Trial Locations

Locations (1)

NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin; 🇩🇪 Berlin, Germany