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

July 28, 2021 updated by: Jan-Markus Dörr, Charite University, Berlin, Germany

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

Completed

Conditions

Multiple Sclerosis

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Berlin, Germany, 10117
    - NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with Clinically Isolated Syndrome or Definite Multiple Sclerosis

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Contrast Acuity Time Frame: 24 Months	24 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Structural and Functional Changes of Optic Pathway Time Frame: 24 Months	24 Months
Clinical Neurological Assessment Time Frame: 24 Months	24 Months
Quality of Life Time Frame: 24 Months	24 Months
Contrast Sensitivity Time Frame: 24 Months	24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Novartis Germany GmbH

Investigators

Principal Investigator: Jan M Dörr, MD, NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

NeuroCure Clinical Research Center, Charité Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)