Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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. |
Not provided
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Inclusion criteria relapsing-remitting MS
Inclusion criteria progressiveMS
Exclusion Criteria:
Not provided
Not provided
Not provided
representative longitudinal cohort including the complete spectrum of disease course
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan-Patrick Stellmann, MD | Contact | +4940741054076 | j.stellmann@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Jan-Patrick Stellmann, MD | Institute of Neuroimmunology and MS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Neuroimmunology and MS | Recruiting | Hamburg | 20246 | Germany |
Anonymous data will be available after study completion.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
To correlate Quality of life scores from the national eye institute visual functioning questionnaire questionnaire with contrast vision assessed with the CSF |
| 2 years |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |