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

• Conditions: Multiple Sclerosis

• Registration Number: NCT03703180
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-29
• Status Verified: 2018-10
• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-11
• Last Update Submitted: 2018-10-18
• Last Update Posted: 2018-10-22
• Primary Completion: 2021-02
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Inclusion criteria relapsing-remitting MS

• 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

Inclusion criteria progressiveMS

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between ganglion cell / inner plexiform layer (GCIPL) thickness loss and area under the log CSF curve change over two years	2 years	GCIPL thickness represents anterior visual system integrity on neuronal level and its change over two years will be correlated with the change of the CSF

Secondary Outcome Measures

Name	Time	Method
Longitudinal correlation between visual quality of life and contrast vision	2 years	To correlate Quality of life scores from the national eye institute visual functioning questionnaire questionnaire with contrast vision assessed with the CSF
Correlation between retinal nerve fibre layer (RNFL) thickness loss and area under the log CSF curve change over two years	2 years	To correlate anterior visual system integrity with contrast vision assessed with the CSF

Trial Locations

Locations (1)

Institute of Neuroimmunology and MS; 🇩🇪 Hamburg, Germany