Clinical trial NCT03703180: Vision Assessment With the Quick Contrast Sensitivity Function (qCSF) Method in Healthy Controls and MS
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: representative longitudinal cohort including the complete spectrum of disease course

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.


Eligibility criteria: 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

Primary outcomes:
measure: Correlation between ganglion cell / inner plexiform layer (GCIPL) thickness loss and area under the log CSF curve change over two years
timeFrame: 2 years
Secondary outcomes:
measure: Correlation between retinal nerve fibre layer (RNFL) thickness loss and area under the log CSF curve change over two years
timeFrame: 2 years
measure: Longitudinal correlation between visual quality of life and contrast vision
timeFrame: 2 years
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Institute of Neuroimmunology and MS
Study officials:
affiliation: Institute of Neuroimmunology and MS
name: Jan-Patrick Stellmann, MD
role: PRINCIPAL_INVESTIGATOR
References: