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Exploration of Microcirculatory Alteration and Endothelial Dysfunction by Adaptive Optics in Multiple Sclerosis (MS-EYE)

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ClinicalTrials.gov Identifier: NCT03508089
Recruitment Status : Active, not recruiting
First Posted : April 25, 2018
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Dan BUCH, Versailles Hospital

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.

Condition or disease Intervention/treatment Phase
Sclerosis, Multiple Other: Ocular fundus on patient with Multiple Sclerosis Other: Ocular Fundus on voluntary person Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exploration of Microcirculatory Alteration and Endothelial Dysfunction by Adaptive Optics in Multiple Sclerosis
Actual Study Start Date : August 22, 2017
Actual Primary Completion Date : October 26, 2017
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control Arm Other: Ocular Fundus on voluntary person
Ocular Fundus on voluntary person

Active Comparator: Multiple Sclerosis Arm Other: Ocular fundus on patient with Multiple Sclerosis
Ocular fundus on patient with Multiple Sclerosis




Primary Outcome Measures :
  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. [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. Compare between patients with multiple sclerosis and controls, retinal arteriolar gauges measured by external and internal diameter. [ Time Frame: Day 0 ]
  2. 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. [ Time Frame: Day 0 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508089


Locations
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France
CH de Versailles
Le Chesnay, France
Sponsors and Collaborators
Versailles Hospital

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Responsible Party: Dr Dan BUCH, Principal Investigator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT03508089     History of Changes
Other Study ID Numbers: P15/18_ MS-EYE
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases