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

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

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • Institute of Neuroimmunology and MS
    • Contact: Jan-Patrick Stellmann, MD; Phone Number: +4940741054076; Email: multiplesklerose@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

representative longitudinal cohort including the complete spectrum of disease course

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Jan-Patrick Stellmann, MD, Institute of Neuroimmunology and MS

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2018
• Primary Completion (ANTICIPATED): February 1, 2021
• Study Completion (ANTICIPATED): February 1, 2021

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (ACTUAL): October 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: inims-victor2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Anonymous data will be available after study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No