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Trial record 8 of 2199 for:    MULTIPLE SCLEROSIS

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

Tracking Information
First Submitted Date  ICMJE March 25, 2018
First Posted Date  ICMJE April 25, 2018
Last Update Posted Date April 25, 2018
Actual Study Start Date  ICMJE August 22, 2017
Actual Primary Completion Date October 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
  • Compare between patients with multiple sclerosis and controls, retinal arteriolar gauges measured by external and internal diameter. [ Time Frame: 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. [ Time Frame: Day 0 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploration of Microcirculatory Alteration and Endothelial Dysfunction by Adaptive Optics in Multiple Sclerosis
Official Title  ICMJE Exploration of Microcirculatory Alteration and Endothelial Dysfunction by Adaptive Optics in Multiple Sclerosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Sclerosis, Multiple
Intervention  ICMJE
  • Other: Ocular fundus on patient with Multiple Sclerosis
    Ocular fundus on patient with Multiple Sclerosis
  • Other: Ocular Fundus on voluntary person
    Ocular Fundus on voluntary person
Study Arms  ICMJE
  • Control Arm
    Intervention: Other: Ocular Fundus on voluntary person
  • Active Comparator: Multiple Sclerosis Arm
    Intervention: Other: Ocular fundus on patient with Multiple Sclerosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2018
Actual Primary Completion Date October 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03508089
Other Study ID Numbers  ICMJE P15/18_ MS-EYE
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Dan BUCH, Versailles Hospital
Study Sponsor  ICMJE Versailles Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Versailles Hospital
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP