NCT01272596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

3.9 years

First QC Date

January 7, 2011

Last Update Submit

July 28, 2021

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisVisual Contrast AcuityVisual Contrast SensitivitySloan Charts

Outcome Measures

Primary Outcomes (1)

  • Visual Contrast Acuity

    24 Months

Secondary Outcomes (4)

  • Structural and Functional Changes of Optic Pathway

    24 Months

  • Clinical Neurological Assessment

    24 Months

  • Quality of Life

    24 Months

  • Contrast Sensitivity

    24 Months

Study Arms (1)

Multiple Sclerosis Patients

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Clinically Isolated Syndrome or Definite Multiple Sclerosis

You may qualify if:

  • Clinically Isolated Syndrome or definite MS (relapsing-remitting or secondary progressive course)
  • Written Informed Consent

You may not qualify if:

  • Relapse within the last 30 Days
  • Significant Cognitive Impairment
  • Severely Decreased Visual Acuity
  • Preexisting Severe Retinal Pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin

Berlin, 10117, Germany

Location

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jan M Dörr, MD

    NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 7, 2011

First Posted

January 10, 2011

Study Start

December 1, 2009

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

July 29, 2021

Record last verified: 2021-07

Locations

DE(1)