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

NCT ID: NCT03508089

Last Updated: 2018-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-22

Study Completion Date

2018-06-30

Brief Summary

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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

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Conditions

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Sclerosis, Multiple

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control Arm

Group Type OTHER

Ocular Fundus on voluntary person

Intervention Type OTHER

Ocular Fundus on voluntary person

Multiple Sclerosis Arm

Group Type ACTIVE_COMPARATOR

Ocular fundus on patient with Multiple Sclerosis

Intervention Type OTHER

Ocular fundus on patient with Multiple Sclerosis

Interventions

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Ocular fundus on patient with Multiple Sclerosis

Ocular fundus on patient with Multiple Sclerosis

Intervention Type OTHER

Ocular Fundus on voluntary person

Ocular Fundus on voluntary person

Intervention Type OTHER

Eligibility Criteria

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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


* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Versailles Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Dan BUCH

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CH de Versailles

Le Chesnay, , France

Site Status

Countries

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France

Other Identifiers

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P15/18_ MS-EYE

Identifier Type: -

Identifier Source: org_study_id

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