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

NCT03703180 | Unknown

• 1 other identifier: inims-victor2
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Correlation between retinal nerve fibre layer (RNFL) thickness loss and area under the log CSF curve change over two years

  2 years

• Longitudinal correlation between visual quality of life and contrast vision

  2 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

representative longitudinal cohort including the complete spectrum of disease course

You may qualify if:

• 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
• 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

You may not qualify if:

• Cataract and other major ophthalmological diseases (e.g. Uveitis, Glaucoma)
• Hyperopia \> 5 dpt, Myopia \> -7 dpt, Astigmatisms \> 3 dpt
• Neuromyelitis optica spectrum diseases

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Institute of Neuroimmunology and MS

Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jan-Patrick Stellmann, MD

  Institute of Neuroimmunology and MS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan-Patrick Stellmann, MD

CONTACT

+4940741054076; j.stellmann@uke.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 11, 2018
• Study Start: January 29, 2018
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: October 22, 2018

Record last verified: 2018-10

Locations

DE (1)