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

Multiple Sclerosis Clinical Trial

— VICTOR2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03703180
• Other study ID #: inims-victor2
• Status: Recruiting
• Start date: January 29, 2018
• Est. completion date: February 2021

Study information

• Verified date: October 2018
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Jan-Patrick Stellmann, MD
• Phone: +4940741054076
• Email: j.stellmann[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis

Locations

Country	Name	City	State
Germany	Institute of Neuroimmunology and MS	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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