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OpenTrials
Completed

NCT Number: NCT01272596

Evaluation of Sloan-Charts for Assessment of Disease Progress 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Visual Contrast Acuity

    Time frame: 24 Months

Secondary outcomes

  1. Structural and Functional Changes of Optic Pathway

    Time frame: 24 Months

  2. Clinical Neurological Assessment

    Time frame: 24 Months

  3. Quality of Life

    Time frame: 24 Months

  4. Contrast Sensitivity

    Time frame: 24 Months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Novartis Germany GmbH

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 10, 2011
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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