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

Study Overview
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Brief Summary
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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.

Official Title
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Vision Assessment With the qCSF Method in Healthy Controls and MS: Investigating the Association Between Optical Coherence Tomography (OCT) and qCSF Dynamics Over Two Years and Set-up of a Representative Normative Data-set

Conditions
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Multiple Sclerosis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MS<br>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. | |
| Controls<br>Age and Gender matched healthy controls (n=100) will undergo the same assessments as the MS cohort to build up a representative normative dataset. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between ganglion cell / inner plexiform layer (GCIPL) thickness loss and area under the log CSF curve change over two 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 | 2 years | 

Secondary Outcome Measures

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