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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03703180

Acronym

VICTOR2

Enrollment

200

Registered

2018-10-11

Start date

2018-01-29

Completion date

2021-02-28

Last updated

2018-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Correlation between ganglion cell / inner plexiform layer (GCIPL) thickness loss and area under the log CSF curve change over two years	2 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

Secondary

Measure	Time frame	Description
Correlation between retinal nerve fibre layer (RNFL) thickness loss and area under the log CSF curve change over two years	2 years	To correlate anterior visual system integrity with contrast vision assessed with the CSF
Longitudinal correlation between visual quality of life and contrast vision	2 years	To correlate Quality of life scores from the national eye institute visual functioning questionnaire questionnaire with contrast vision assessed with the CSF

Countries

Germany

Contacts

Primary ContactJan-Patrick Stellmann, MD

j.stellmann@uke.de+4940741054076

Outcome results