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
ConditionsSclerosis, Multiple
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.
Investigators
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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