Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2018
CompletedFirst Posted
Study publicly available on registry
January 17, 2018
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedMay 23, 2025
April 1, 2025
8.1 years
January 10, 2018
May 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Flicker induced increase in retinal blood flow
Response of retinal blood flow to flicker light assessed with FDOCT
1 day
Secondary Outcomes (4)
Retinal vessel diameters
1 day
Retinal oxygen saturation
1 day
Retinal nerve fiber layer thickness
1 day
Layer specific flow signal
1 day
Study Arms (2)
Patients with MS
EXPERIMENTALPatients with Multiple Sclerosis
Healthy control subjects
EXPERIMENTALHealthy age- and sex- matched control subjects
Interventions
Retinal vessel diameters and oxygen saturation will be measured with the DVA device.
Retinal blood flow will be assessed using FDOCT.
Nerve fiber layer thickness and central retinal thickness will be measured using OCT.
Retinal microvasculature will be assessed using OCTA.
Eligibility Criteria
You may qualify if:
- 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)
- 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
- 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
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090, Austria
Related Publications (1)
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.
PMID: 34712117DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerhard Garhöfer, MD
Department of Clinical Pharmacology, Medical University of Vienna
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Section Head Ophthalmo-Pharmacology
Study Record Dates
First Submitted
January 10, 2018
First Posted
January 17, 2018
Study Start
February 1, 2018
Primary Completion
March 1, 2026
Study Completion
March 1, 2026
Last Updated
May 23, 2025
Record last verified: 2025-04