Clinical trial NCT03508089: Exploration of Microcirculatory Alteration and Endothelial Dysfunction by Adaptive Optics in Multiple Sclerosis
Official title: Exploration of Microcirculatory Alteration and Endothelial Dysfunction by Adaptive Optics in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sclerosis, Multiple
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: 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.
timeFrame: Day 0
Secondary outcomes:
measure: Compare between patients with multiple sclerosis and controls, retinal arteriolar gauges measured by external and internal diameter.
timeFrame: Day 0
measure: 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.
timeFrame: Day 0
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: CH de Versailles
Study officials:
References: