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

NCT03508089 | Unknown

• 1 other identifier: P15/18_ MS-EYE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sclerosis, Multiple

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Control Arm

OTHER

Other: Ocular Fundus on voluntary person

Multiple Sclerosis Arm

ACTIVE COMPARATOR

Other: Ocular fundus on patient with Multiple Sclerosis

Interventions

Ocular fundus on patient with Multiple Sclerosis OTHER

Ocular fundus on patient with Multiple Sclerosis

Multiple Sclerosis Arm

Ocular Fundus on voluntary person OTHER

Ocular Fundus on voluntary person

Control Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Versailles Hospital: lead

Study Sites (1)

CH de Versailles

Le Chesnay, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: April 25, 2018
• Study Start: August 22, 2017
• Primary Completion: October 26, 2017
• Study Completion: June 30, 2018
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

FR (1)