Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT03401879

Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis

Led by Medical University of Vienna · Updated on 2025-05-23

50

Participants Needed

1

Research Sites

421 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged over 18 years
  • Non-smokers
  • For healthy subjects: normal medical history unless minor issues deemed irrelevant by investigator
  • Normal eye exam with ametropy less than 6 diopters
  • For MS patients: diagnosis of relapsing-remitting multiple sclerosis by McDonald criteria (2010 revision)
  • History of acute optic neuritis in one eye at least one year ago
  • Adequate visual acuity for ocular blood flow measurements
  • Stable doses of all medications for at least 30 days prior to inclusion, except MS therapy
Not Eligible

You will not qualify if you...

  • Diagnosis of possible MS for healthy subjects
  • Severe medical conditions as judged by investigator
  • Untreated arterial hypertension
  • History or family history of epilepsy
  • Eye abnormalities preventing reliable measurements
  • Family history of MS, optic neuritis, neuromyelitis optica (NMO), or NMO spectrum disorders
  • History of inflammatory or infectious CNS disease
  • Best corrected visual acuity less than 0.5 Snellen
  • Ametropy equal to or greater than 6 diopters
  • Pregnancy or planned pregnancy
  • Alcoholism or substance abuse
  • History of neuromyelitis optica or NMO spectrum disorders for MS patients
  • Significant neurological disease other than MS if relevant

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria, Austria, 1090

Actively Recruiting

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Research Team

G

Gerhard Garhöfer, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis | DecenTrialz