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Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03401879
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Optic Neuritis Device: Dynamic Vessel Analyzer (DVA) Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT) Device: Optical coherence tomography (OCT) Device: Optical coherence tomography angiography (OCTA) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with MS
Patients with Multiple Sclerosis
 Device: Dynamic Vessel Analyzer (DVA)
Retinal vessel diameters and oxygen saturation will be measured with the DVA device.

Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT)
Retinal blood flow will be assessed using FDOCT.

Device: Optical coherence tomography (OCT)
Nerve fiber layer thickness and central retinal thickness will be measured using OCT.

Device: Optical coherence tomography angiography (OCTA)
Retinal microvasculature will be assessed using OCTA.
Experimental: Healthy control subjects
Healthy age- and sex- matched control subjects
 Device: Dynamic Vessel Analyzer (DVA)
Retinal vessel diameters and oxygen saturation will be measured with the DVA device.

Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT)
Retinal blood flow will be assessed using FDOCT.

Device: Optical coherence tomography (OCT)
Nerve fiber layer thickness and central retinal thickness will be measured using OCT.

Device: Optical coherence tomography angiography (OCTA)
Retinal microvasculature will be assessed using OCTA.


Outcome Measures
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Primary Outcome Measures :
  1. Flicker induced increase in retinal blood flow [ Time Frame: 1 day ]
    Response of retinal blood flow to flicker light assessed with FDOCT


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401879


Contacts
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Contact: Gerhard Garhöfer, MD 0043140400 ext 29810 gerhard.garhoefer@medunwien.ac.at

Locations
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Austria
Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhöfer, MD    0043140400 ext 29810      
Principal Investigator: Gerhard Garhöfer, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Gerhard Garhöfer, MD Department of Clinical Pharmacology, Medical University of Vienna
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gerhard Garhofer, Section Head Ophthalmo-Pharmacology, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03401879    
Other Study ID Numbers: OPHT-210417
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Neuritis
Multiple Sclerosis, Relapsing-Remitting
Optic Neuritis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases