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Clinical Trials/NCT03508089
NCT03508089
Unknown
Not Applicable

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

Versailles Hospital1 site in 1 country60 target enrollmentAugust 22, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sclerosis, Multiple
Sponsor
Versailles Hospital
Enrollment
60
Locations
1
Primary Endpoint
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.
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 22, 2017
End Date
June 30, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Versailles Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Dan BUCH

Principal Investigator

Versailles Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • 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.(Day 0)
  • Compare between patients with multiple sclerosis and controls, retinal arteriolar gauges measured by external and internal diameter.(Day 0)

Study Sites (1)

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