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

NCT ID: NCT01272596

Last Updated: 2021-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-11-30

Brief Summary

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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

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Multiple Sclerosis Patients

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Germany GmbH

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Jan-Markus Dörr

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan M Dörr, MD

Role: PRINCIPAL_INVESTIGATOR

NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin

Locations

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NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin

Berlin, , Germany

Site Status

Countries

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Germany

Related Links

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https://neurocure.de/ncrc/ueber-uns.html

NeuroCure Clinical Research Center, Charité Berlin, Germany

Other Identifiers

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Sloan-Study

Identifier Type: -

Identifier Source: org_study_id

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