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NCT Number: NCT03401879

Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria, 1090

Location status: Recruiting

Location contact

Gerhard Garhöfer, MD

CONTACT

0043140400 ext. 29810

Gerhard Garhöfer, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Flicker induced increase in retinal blood flow

    Time frame: 1 day

    Response of retinal blood flow to flicker light assessed with FDOCT

Secondary outcomes

  1. Retinal vessel diameters

    Time frame: 1 day

    Response of retinal vessel diameters to flicker light assessed with DVA

  2. Retinal oxygen saturation

    Time frame: 1 day

    Retinal oxygen saturation measured with DVA

  3. Retinal nerve fiber layer thickness

    Time frame: 1 day

    Retinal nerve fiber layer thickness measured using OCT

  4. Layer specific flow signal

    Time frame: 1 day

    Retinal layer specific blood flow signal measured using OCTA

Study contacts

Contact information is provided by the study sponsor or research team.

Gerhard Garhöfer, MD

CONTACT

[email protected]

0043140400 ext. 29810

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jan 17, 2018
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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