Multiple SclerosisVICTOR2NCT03703180
Vision Assessment With the Quick Contrast Sensitivity Function (qCSF) Method in Healthy Controls and MS
An observational study of Multiple Sclerosis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 29 Jan 2018to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: representative longitudinal cohort including the complete spectrum of disease course
Who may be able to join
- 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
Show all 9Show fewer
- No relapse in the last 12 months
- No other major neurological or psychiatric disorder (such as major depression or schizophrenia)
- Age 18 - 65 years
Who cannot join
- Cataract and other major ophthalmological diseases (e.g. Uveitis, Glaucoma)
- Hyperopia > 5 dpt, Myopia > -7 dpt, Astigmatisms > 3 dpt
- Neuromyelitis optica spectrum diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Institute of Neuroimmunology and MS
Hamburg, 20246
Jan-Patrick Stellmann, MD, +4940741054076, multiplesklerose@uke.de
About this study
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
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
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
To correlate anterior visual system integrity with contrast vision assessed with the CSF
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start29 Jan 2018
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan-Patrick Stellmann, MD, Principal investigator, Institute of Neuroimmunology and MS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703180
- Sponsor's protocol ID
- inims-victor2
- Acronym
- VICTOR2
- Status last verified
- Oct 2018
- First submitted
- 4 Oct 2018
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymous data will be available after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03703180
- Acronym / sponsor ID
- VICTOR2 / inims-victor2
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 11 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- representative longitudinal cohort including the complete spectrum of disease course
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Cataract and other major ophthalmological diseases (e.g. Uveitis, Glaucoma)
- Hyperopia > 5 dpt, Myopia > -7 dpt, Astigmatisms > 3 dpt
- Neuromyelitis optica spectrum diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between ganglion cell / inner plexiform layer (GCIPL) thickness loss and area under the log CSF curve change over two years
Time frame: 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
2 secondary outcomes
Correlation between retinal nerve fibre layer (RNFL) thickness loss and area under the log CSF curve change over two years
Time frame: 2 years
Longitudinal correlation between visual quality of life and contrast vision
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Individual participant dataSharing planned: Undecided. Anonymous data will be available after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan-Patrick Stellmann, MD principal investigator
Institute of Neuroimmunology and MS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan-Patrick Stellmann, MD (+4940741054076, j.stellmann@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between ganglion cell / inner plexiform layer (GCIPL) thickness loss and area under the log CSF curve change over two years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.