Vision Assessment With the Quick Contrast Sensitivity Function (qCSF) Method in Healthy Controls and MS (VICTOR2)

Universitätsklinikum Hamburg-Eppendorf

Status: Unknown

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Other

Identifiers

NCT03703180

inims-victor2

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

MS

Description:

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

Description:

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