Exploration of Microcirculatory Alteration and Endothelial Dysfunction by Adaptive Optics in Multiple Sclerosis (MS-EYE)

April 16, 2018 updated by: Dr Dan BUCH, Versailles Hospital
It's a pilot, interventional prospective monocentric study. It aims to compare the wall / lumen ratio (WLR) of retinal arterioles (common marker of microangiopathies) between patients with multiple sclerosis and controls using the technique of adaptive optics.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Chesnay, France
        • CH de Versailles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Patient Inclusion Criteria

  • Major patient between 18 and 50 years
  • Patient with relapsing or remitting multiple sclerosis defined according to revised Mc Donald criteria 2010
  • Written, free and informed consent dated and signed
  • Patient affiliated to a social security scheme

Control Inclusion Criteria:

  • Person between the ages of 18 and 50
  • Written, free and informed consent dated and signed
  • Person affiliated to a social security scheme
  • Person with multiple sclerosis

Exclusion Criteria:

  • Contraindication to the use oxygen (O2): Acute or chronic respiratory insufficiency
  • Pregnant or lactating woman
  • Inability to see fundus (cataract), retinopathy, glaucoma
  • Use of vasoactive substances (eg nasal decongestants, triptans, alkaloids) in the last 48 hours
  • Use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, ..) and steroids (corticosteroids) in the last 48 hours
  • Known Diabetes or taking antidiabetics in the last 48 hours
  • Use of statins in the last 48 hours
  • Known hypertension or antihypertensive treatment in the last 48 hours
  • Any cardiac pathology (valvulopathy, angina, ventricular arrhythmia or atrial fibrillation), vascular (arteritis obliterating the lower limbs, stenosis of the arteries with encephalic destiny, coronary artery disease) or significant respiratory (asthma, Chronic obstructive pulmonary disease, interstitial pathology)
  • Alcohol consumption within 8 hours
  • Ophthalmoparesis or incapacitating nystagmus (impossibility of correctly evaluating the fundus)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Arm
Other: Ocular Fundus on voluntary person
Ocular Fundus on voluntary person
Active Comparator: Multiple Sclerosis Arm
Other: Ocular fundus on patient with Multiple Sclerosis
Ocular fundus on patient with Multiple Sclerosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the wall / lumen ratio (WLR) of retinal arterioles (common marker of microangiopathies) between multiple sclerosis patients and controls using the adaptive optics technique.
Time Frame: Day 0
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare between patients with multiple sclerosis and controls, retinal arteriolar gauges measured by external and internal diameter.
Time Frame: Day 0
Day 0
Correlate possible changes in arteriolar WLR with internal and external diameter, smoking, age, blood pressure, fatigue (MFIS), cognition (MDT) and disability (EDSS) scores to ambient air and normobaric oxygen.
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Versailles Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2017

Primary Completion (Actual)

October 26, 2017

Study Completion (Anticipated)

June 30, 2018

Study Registration Dates

First Submitted

March 25, 2018

First Submitted That Met QC Criteria

April 16, 2018

First Posted (Actual)

April 25, 2018

Study Record Updates

Last Update Posted (Actual)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P15/18_ MS-EYE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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