Multiple Sclerosis, Relapsing-RemittingNCT03401879
Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis
A study testing Dynamic Vessel Analyzer (DVA), Fourier Domain Doppler Optical Coherence Tomography (FDOCT) and Optical coherence tomography (OCT) in people with Multiple Sclerosis, Relapsing-Remitting and Optic Neuritis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Multiple sclerosis (MS) affects approximately 2.3 million patients worldwide, with a global median prevalence of 33 per 100,000. MS is diagnosed at an average of 30 years and affects twice as many women as men. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting, Optic Neuritis
- What is being tested?
- Dynamic Vessel Analyzer (DVA), Fourier Domain Doppler Optical Coherence Tomography (FDOCT) and Optical coherence tomography (OCT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2018to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged over 18 years
- Non-smokers
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropy < 6 Dpt.
- Men and women aged over 18 years
- Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to clinical evaluation and McDonald criteria (revision 2010)
Show all 35Show fewer
- History of AON in one eye at least one year ago
- Non-smokers
- Normal ophthalmic findings, ametropy < 6 Dpt.
- Adequate visual acuity to allow participation in the ocular blood flow measurements
- A potential participant has to be on stable doses of all medications he/she is taking because of consisting illnesses according to medical history (except MS therapy itself which will be recorded separately) for at least 30 days prior inclusion, if considered relevant by the investigator.
- Any of the following will exclude a healthy subject from the study:
- Diagnosis of "possible MS" according to the McDonald criteria (revision 2010)
- Presence or history of a severe medical condition as judged by the clinical investigator
- Untreated Arterial hypertension
- History or family history of epilepsy
- Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
- Family history of MS, optic neuritis, neuromyelitis optica (NMO, Devic disease) or NMO spectrum disorders
- History of inflammatory or infectious disease of central nervous system
- Best corrected visual acuity < 0.5 Snellen
- Ametropy ≥ 6Dpt
- Pregnancy or planned pregnancy
- Alcoholism or substance abuse
- Any of the following will exclude a patient from the study:
- Presence or history of a severe medical condition other than MS as judged by the clinical investigator
- History of neuromyelitis optica (NMO, Devic disease) or NMO spectrum disorders
- History of inflammatory or infectious disease of central nervous system other than MS
- Untreated Arterial hypertension
- History or family history of epilepsy
- Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
- Best corrected visual acuity < 0.5 Snellen
- Ametropy ≥ 6 Dpt
- Pregnancy, planned pregnancy
- Significant neurological disease other than MS, if considered relevant by the investigator
- Alcoholism or substance abuse
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Gerhard Garhöfer, MD, 0043140400 ext. 29810
Gerhard Garhöfer, MD
About this study
Multiple sclerosis (MS) affects approximately 2.3 million patients worldwide, with a global median prevalence of 33 per 100,000. MS is diagnosed at an average of 30 years and affects twice as many women as men. MS is traditionally diagnosed by the presentation of lesions of the central nervous system, disseminated in time and in space, proven by clinical examination and magnetic resonance imaging. Several anatomical parameters in the eye, both vascular and neural, have been found to be altered in MS patients.
Because of its unique optical properties, the eye offers the possibility of the non-invasive assessment of both structural and functional alterations in neuronal tissue. As the neuro-retina is part of the brain, it does not come as a surprise that neuro-degenerative changes in the brain are accompanied by structural and possibly also functional changes in the neuro-retina and the ocular vasculature.
The current study seeks to test the hypothesis that beside the known anatomical changes, also functional changes can be detected in the retina of patients with MS. For this purpose, flicker light induced hyperemia will be measured in the retina as a functional test to assess the coupling between neural activity and blood flow. Further, structural parameters such as retinal nerve fiber layer thickness and function parameters such as ocular blood flow and retinal oxygenation will be assessed and compared to age and sex matched controls.
- Being tested
- Dynamic Vessel Analyzer (DVA), Fourier Domain Doppler Optical Coherence Tomography (FDOCT), Optical coherence tomography (OCT), Optical coherence tomography angiography (OCTA)
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Vessel Analyzer (DVA)Device
Retinal vessel diameters and oxygen saturation will be measured with the DVA device.
Fourier Domain Doppler Optical Coherence Tomography (FDOCT)Device
Retinal blood flow will be assessed using FDOCT.
Optical coherence tomography (OCT)Device
Nerve fiber layer thickness and central retinal thickness will be measured using OCT.
Optical coherence tomography angiography (OCTA)Device
Retinal microvasculature will be assessed using OCTA.
| Study group | Role | What they receive |
|---|---|---|
| Patients with MS | Experimental | Patients with Multiple Sclerosis Receives: Device: Dynamic Vessel Analyzer (DVA); Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT); Device: Optical coherence tomography (OCT); Device: Optical coherence tomography angiography (OCTA) |
| Healthy control subjects | Experimental | Healthy age- and sex- matched control subjects Receives: Device: Dynamic Vessel Analyzer (DVA); Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT); Device: Optical coherence tomography (OCT); Device: Optical coherence tomography angiography (OCTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flicker induced increase in retinal blood flow
Response of retinal blood flow to flicker light assessed with FDOCT
Measured: 1 day
Secondary outcomes (4)
Retinal vessel diameters
Response of retinal vessel diameters to flicker light assessed with DVA
Measured: 1 day
Retinal oxygen saturation
Retinal oxygen saturation measured with DVA
Measured: 1 day
Retinal nerve fiber layer thickness
Retinal nerve fiber layer thickness measured using OCT
Measured: 1 day
Layer specific flow signal
Retinal layer specific blood flow signal measured using OCTA
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Feb 2018
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
- Investigators
- Gerhard Garhöfer, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401879
- Sponsor's protocol ID
- OPHT-210417
- Status last verified
- Apr 2025
- First submitted
- 10 Jan 2018
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kallab M, Hommer N, Schlatter A, Bsteh G, Altmann P, Popa-Cherecheanu A, Pfister M, Werkmeister RM, Schmidl D, Schmetterer L, Garhofer G. Retinal Oxygen Metabolism and Haemodynamics in Patients With Multiple Sclerosis and History of Optic Neuritis. Front Neurosci. 2021 Oct 12;15:761654. doi: 10.3389/fnins.2021.761654. eCollection 2021.
PubMed 34712117
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03401879
- Acronym / sponsor ID
- OPHT-210417
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 17 Jan 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.
Multiple sclerosis (MS) affects approximately 2.3 million patients worldwide, with a global median prevalence of 33 per 100,000. MS is diagnosed at an average of 30 years and affects twice as many women as men. MS is traditionally diagnosed by the presentation of lesions of the central nervous system, disseminated in time and in space, proven by clinical examination and magnetic resonance imaging. Several anatomical parameters in the eye, both vascular and neural, have been found to be altered in MS patients.
Because of its unique optical properties, the eye offers the possibility of the non-invasive assessment of both structural and functional alterations in neuronal tissue. As the neuro-retina is part of the brain, it does not come as a surprise that neuro-degenerative changes in the brain are accompanied by structural and possibly also functional changes in the neuro-retina and the ocular vasculature.
The current study seeks to test the hypothesis that beside the known anatomical changes, also functional changes can be detected in the retina of patients with MS. For this purpose, flicker light induced hyperemia will be measured in the retina as a functional test to assess the coupling between neural activity and blood flow. Further, structural parameters such as retinal nerve fiber layer thickness and function parameters such as ocular blood flow and retinal oxygenation will be assessed and compared to age and sex matched controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with MS | Experimental | Device: Dynamic Vessel Analyzer (DVA), Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT), Device: Optical coherence tomography (OCT), Device: Optical coherence tomography angiography (OCTA)Patients with Multiple Sclerosis |
| Healthy control subjects | Experimental | Device: Dynamic Vessel Analyzer (DVA), Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT), Device: Optical coherence tomography (OCT), Device: Optical coherence tomography angiography (OCTA)Healthy age- and sex- matched control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- Men and women aged over 18 years
- Non-smokers
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropy < 6 Dpt.
- Men and women aged over 18 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Vessel Analyzer (DVA)Retinal vessel diameters and oxygen saturation will be measured with the DVA device. | Device | Healthy control subjects, Patients with MS |
| Fourier Domain Doppler Optical Coherence Tomography (FDOCT)Retinal blood flow will be assessed using FDOCT. | Device | Healthy control subjects, Patients with MS |
| Optical coherence tomography (OCT)Nerve fiber layer thickness and central retinal thickness will be measured using OCT. | Device | Healthy control subjects, Patients with MS |
| Optical coherence tomography angiography (OCTA)Retinal microvasculature will be assessed using OCTA. | Device | Healthy control subjects, Patients with MS |
Primary outcome
Flicker induced increase in retinal blood flow
Time frame: 1 day
Response of retinal blood flow to flicker light assessed with FDOCT
4 secondary outcomes
Retinal vessel diameters
Time frame: 1 day
Retinal oxygen saturation
Time frame: 1 day
Retinal nerve fiber layer thickness
Time frame: 1 day
Layer specific flow signal
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Derived from this study: PubMed 34712117Kallab M, Hommer N, Schlatter A, Bsteh G, Altmann P, Popa-Cherecheanu A, Pfister M, Werkmeister RM, Schmidl D, Schmetterer L, Garhofer G. Retinal Oxygen Metabolism and Haemodynamics in Patients With Multiple Sclerosis and History of Optic Neuritis. Front Neurosci. 2021 Oct 12;15:761654. doi: 10.3389/fnins.2021.761654. eCollection 2021.
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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.
Gerhard Garhöfer, MD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Vessel Analyzer (DVA), Fourier Domain Doppler Optical Coherence Tomography (FDOCT) and Optical coherence tomography (OCT) in people with Multiple Sclerosis, Relapsing-Remitting and Optic Neuritis, run by Medical University of Vienna at 1 site in Austria.
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 35 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 23 May 2025. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Garhöfer, MD (0043140400 ext. 29810, gerhard.garhoefer@medunwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flicker induced increase in retinal blood flow (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03401879, which also lists 1 linked publication.
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 23 May 2025.