Back to results

Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting, Optic Neuritis

Status

Recruiting

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Dynamic Vessel Analyzer (DVA)

Fourier Domain Doppler Optical Coherence Tomography (FDOCT)

Optical coherence tomography (OCT)

Optical coherence tomography angiography (OCTA)

About this trial

This is an interventional basic science trial for Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Clinical Pharmacology, Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Patients with MS

Healthy control subjects

Arm Description

Patients with Multiple Sclerosis

Healthy age- and sex- matched control subjects

Outcomes

Primary Outcome Measures

Flicker induced increase in retinal blood flow

Response of retinal blood flow to flicker light assessed with FDOCT

Secondary Outcome Measures

Retinal vessel diameters

Response of retinal vessel diameters to flicker light assessed with DVA

Retinal oxygen saturation

Retinal oxygen saturation measured with DVA

Retinal nerve fiber layer thickness

Retinal nerve fiber layer thickness measured using OCT

Layer specific flow signal

Retinal layer specific blood flow signal measured using OCTA

Full Information

NCT ID

NCT03401879

First Posted

January 10, 2018

Last Updated

April 6, 2022

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT03401879

Brief Title

Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis

Official Title

Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2018 (Actual)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Relapsing-Remitting, Optic Neuritis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with MS

Arm Type

Experimental

Arm Description

Patients with Multiple Sclerosis

Arm Title

Healthy control subjects

Arm Type

Experimental

Arm Description

Healthy age- and sex- matched control subjects

Intervention Type

Device

Intervention Name(s)

Dynamic Vessel Analyzer (DVA)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Fourier Domain Doppler Optical Coherence Tomography (FDOCT)

Intervention Description

Retinal blood flow will be assessed using FDOCT.

Intervention Type

Device

Intervention Name(s)

Optical coherence tomography (OCT)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Optical coherence tomography angiography (OCTA)

Intervention Description

Retinal microvasculature will be assessed using OCTA.

Primary Outcome Measure Information:

Title

Flicker induced increase in retinal blood flow

Description

Response of retinal blood flow to flicker light assessed with FDOCT

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Retinal vessel diameters

Description

Response of retinal vessel diameters to flicker light assessed with DVA

Time Frame

1 day

Title

Retinal oxygen saturation

Description

Retinal oxygen saturation measured with DVA

Time Frame

1 day

Title

Retinal nerve fiber layer thickness

Description

Retinal nerve fiber layer thickness measured using OCT

Time Frame

1 day

Title

Layer specific flow signal

Description

Retinal layer specific blood flow signal measured using OCTA

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gerhard Garhöfer, MD

Phone

0043140400

Ext

29810

gerhard.garhoefer@medunwien.ac.at

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerhard Garhöfer, MD

Organizational Affiliation

Department of Clinical Pharmacology, Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Clinical Pharmacology, Medical University of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gerhard Garhöfer, MD

Phone

0043140400

Ext

29810

First Name & Middle Initial & Last Name & Degree

Gerhard Garhöfer, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

34712117

Citation

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.

Results Reference

derived

Learn more about this trial

Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis

We'll reach out to this number within 24 hrs