Vision Assessment With the Quick Contrast Sensitivity Function (qCSF) Method in Healthy Controls and MS

NCT ID: NCT03703180

Last Updated: 2018-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-29
• Study Completion Date: 2021-02-28

Brief Summary

Victor2 is an observational cohort study over two years and is designed to investigate longitudinal changes of visual impairment in multiple sclerosis (MS). The investigators aim to recruit patients in the relapsing-remitting phase of the disease (n=50) as well as progressive MS patients (n=50). Both cohorts will be compared with age and gender matched healthy controls (HC). All participants undergo yearly clinical assessments including standard charts for visual acuity (Sloan, Snellen), a new computer adaptive test measuring the complete contrast sensitive function (CSF), optical coherence tomography and a vision related quality of life questionnaire (NEI-VFQ). The study aims to validate and extend previous finding from a cross-sectional study which found a better association between CSF and NEI-VFQ than for standard charts. Moreover, the study is designed to proof also a better association with anterior visual system integrity as assessed with OCT.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MS

representative cohort of relapsing-remitting MS (n=50) and progressive MS patients (n=50) over the typical age range of 18-65. During two years of follow-up the integrity and function of the visual system will be observed annually with optical coherence tomography, high and low contrast visual acuity and a vision related quality of life questionnaire.

No interventions assigned to this group

Controls

Age and Gender matched healthy controls (n=100) will undergo the same assessments as the MS cohort to build up a representative normative dataset.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Relapsing-remitting MS
• Expanded Disability Status Scale (EDSS) Score between 0 and 6.0
• No other major neurological or psychiatric disorder (such as major depression or schizophrenia)
• Age 18 - 65 years

• Primary or Secondary-progressive MS according to the revised McDonald criteria
• Expanded Disability Status Scale (EDSS) Score between 3.0 and 6.0
• No relapse in the last 12 months
• No other major neurological or psychiatric disorder (such as major depression or schizophrenia)
• Age 18 - 65 years

Exclusion Criteria

• Cataract and other major ophthalmological diseases (e.g. Uveitis, Glaucoma)
• Hyperopia > 5 dpt, Myopia > -7 dpt, Astigmatisms > 3 dpt
• Neuromyelitis optica spectrum diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan-Patrick Stellmann, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Neuroimmunology and MS

Locations

Institute of Neuroimmunology and MS

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Jan-Patrick Stellmann, MD

Role: CONTACT

j.stellmann@uke.de

+4940741054076

Facility Contacts

Jan-Patrick Stellmann, MD

Role: primary

multiplesklerose@uke.de

+4940741054076

Other Identifiers

inims-victor2

Identifier Type: -

Identifier Source: org_study_id