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RecruitingNCT03401879Updated May 23, 2025

Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis

An interventional study of Dynamic Vessel Analyzer (DVA) and Fourier Domain Doppler Optical Coherence Tomography (FDOCT) in Multiple Sclerosis, Relapsing-Remitting and Optic Neuritis, sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-23.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Feb 2018; still recruiting 8 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Multiple Sclerosis, Relapsing-Remitting
  • Optic Neuritis
03

In context

Multiple Sclerosis, Relapsing-Remitting

618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.

This study's planned enrollment of 50 is below the median of 66 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.

Browse Multiple Sclerosis, Relapsing-Remitting studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.

Browse Medical University of Vienna studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion criteria for healthy subjects:

  • 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.

Inclusion criteria for patients with MS:

  • Men and women aged over 18 years
  • Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to clinical evaluation and McDonald criteria (revision 2010)
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Patients with MS

    Patients with Multiple Sclerosis

    Device: Dynamic Vessel Analyzer (DVA) · Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT) · Device: Optical coherence tomography (OCT) · Device: Optical coherence tomography angiography (OCTA)

  • Experimental
    Healthy control subjects

    Healthy age- and sex- matched control subjects

    Device: Dynamic Vessel Analyzer (DVA) · Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT) · Device: Optical coherence tomography (OCT) · Device: Optical coherence tomography angiography (OCTA)

Interventions

  • DeviceDynamic Vessel Analyzer (DVA)

    Retinal vessel diameters and oxygen saturation will be measured with the DVA device.

  • DeviceFourier Domain Doppler Optical Coherence Tomography (FDOCT)

    Retinal blood flow will be assessed using FDOCT.

  • DeviceOptical coherence tomography (OCT)

    Nerve fiber layer thickness and central retinal thickness will be measured using OCT.

  • DeviceOptical coherence tomography angiography (OCTA)

    Retinal microvasculature will be assessed using OCTA.

06

What researchers measure

Primary outcomes

  1. Flicker induced increase in retinal blood flow

    Response of retinal blood flow to flicker light assessed with FDOCT

    Time frame: 1 day

Secondary outcomes

  1. Retinal vessel diameters

    Response of retinal vessel diameters to flicker light assessed with DVA

    Time frame: 1 day

  2. Retinal oxygen saturation

    Retinal oxygen saturation measured with DVA

    Time frame: 1 day

  3. Retinal nerve fiber layer thickness

    Retinal nerve fiber layer thickness measured using OCT

    Time frame: 1 day

  4. Layer specific flow signal

    Retinal layer specific blood flow signal measured using OCTA

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Department of Clinical Pharmacology, Medical University of Vienna
    Vienna, 1090, Austria
    Recruiting
    • Gerhard Garhöfer, MD · Contact0043140400
    • Gerhard Garhöfer, MD · Principal investigator
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2018 (actual). Primary completion is estimated for Mar 2026, 97 months after the start.

Of 79 non-industry interventional studies with no phase under Multiple Sclerosis, Relapsing-Remitting, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 45. This study's planned 97 months is above that.

Counting every sponsor, half of 81 studies reached it within 29 months; a quarter within 15 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 10, 2018
First posted
Jan 17, 2018
StartActual
Feb 1, 2018
Primary completionEst.
Mar 2026
CompletionEst.
Mar 2026
Last update
May 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03401879
Lead sponsor
Medical University of Vienna
Responsible party
Gerhard Garhofer (Section Head Ophthalmo-Pharmacology, Medical University of Vienna) — Principal investigator
First posted
Jan 17, 2018
Start date
Feb 1, 2018
Primary completion
Mar 2026 (estimated)
Completion
Mar 2026 (estimated)
Last update
May 23, 2025

Study contacts

Gerhard Garhöfer, MD
Contact
gerhard.garhoefer@medunwien.ac.at
0043140400 ext. 29810
Gerhard Garhöfer, MD
principal investigator · Department of Clinical Pharmacology, Medical University of Vienna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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