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

Sclerosis, Multiple Clinical Trial

— MS-EYE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03508089
• Other study ID #: P15/18_ MS-EYE
• Status: Active, not recruiting
• Phase: N/A
• First received: March 25, 2018
• Last updated: April 16, 2018
• Start date: August 22, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: April 2018
• Source: Versailles Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 30, 2018
• Est. primary completion date: October 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Sclerosis, Multiple

Intervention

Other:
• Ocular fundus on patient with Multiple Sclerosis
Ocular fundus on patient with Multiple Sclerosis
• Ocular Fundus on voluntary person
Ocular Fundus on voluntary person

Locations

Country	Name	City	State
France	CH de Versailles	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare between patients with multiple sclerosis and controls, retinal arteriolar gauges measured by external and internal diameter.		Day 0
Secondary	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