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

Status unknownNot a drug-phase studyMS (type not specified)NCT03508089

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

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

What it measured

Main measures

  • 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

Other measures (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

    Disability progressionThinking and memoryFatigue

Who could take part

MS (type not specified) · 18 to 50

Show the full criteria

Inclusion criteria

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)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Aug 2017

    2. Main results due

      Oct 2017

    3. Finished

      Jun 2018

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