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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03508089
Other study ID # P15/18_ MS-EYE
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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