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

Primary Purpose

Sclerosis, Multiple

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ocular fundus on patient with Multiple Sclerosis
Ocular Fundus on voluntary person
Sponsored by
Versailles Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sclerosis, Multiple

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • CH de Versailles

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Control Arm

Multiple Sclerosis Arm

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Compare between patients with multiple sclerosis and controls, retinal arteriolar gauges measured by external and internal diameter.
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.

Full Information

First Posted
March 25, 2018
Last Updated
April 16, 2018
Sponsor
Versailles Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03508089
Brief Title
Exploration of Microcirculatory Alteration and Endothelial Dysfunction by Adaptive Optics in Multiple Sclerosis
Acronym
MS-EYE
Official Title
Exploration of Microcirculatory Alteration and Endothelial Dysfunction by Adaptive Optics in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2017 (Actual)
Primary Completion Date
October 26, 2017 (Actual)
Study Completion Date
June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Other
Arm Title
Multiple Sclerosis Arm
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Ocular fundus on patient with Multiple Sclerosis
Intervention Description
Ocular fundus on patient with Multiple Sclerosis
Intervention Type
Other
Intervention Name(s)
Ocular Fundus on voluntary person
Intervention Description
Ocular Fundus on voluntary person
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Compare between patients with multiple sclerosis and controls, retinal arteriolar gauges measured by external and internal diameter.
Time Frame
Day 0
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
CH de Versailles
City
Le Chesnay
Country
France

12. IPD Sharing Statement

Learn more about this trial

Exploration of Microcirculatory Alteration and Endothelial Dysfunction by Adaptive Optics in Multiple Sclerosis

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