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

Not Applicable

• Conditions: Sclerosis, Multiple
• Interventions: Other: Ocular Fundus on voluntary person; Other: Ocular fundus on patient with Multiple Sclerosis

• Registration Number: NCT03508089
• Lead Sponsor: Versailles Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-22
• Primary Completion: 2017-10-26
• Study First Submitted: 2018-03-25
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-16
• Last Update Submitted: 2018-04-16
• Study First Posted: 2018-04-25
• Last Update Posted: 2018-04-25
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Ocular Fundus on voluntary person	-
Multiple Sclerosis Arm	Ocular fundus on patient with Multiple Sclerosis	-

Primary Outcome Measures

Name	Time	Method
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.	Day 0

Secondary Outcome Measures

Name	Time	Method
Compare between patients with multiple sclerosis and controls, retinal arteriolar gauges measured by external and internal diameter.	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.	Day 0

Trial Locations

Locations (1)

CH de Versailles; 🇫🇷 Le Chesnay, France