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

V

Versailles Hospital

Status

Unknown

Conditions

Sclerosis, Multiple

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03508089
P15/18_ MS-EYE

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Control Arm
Other group
Treatment:
Other: Ocular Fundus on voluntary person
Multiple Sclerosis Arm
Active Comparator group
Treatment:
Other: Ocular fundus on patient with Multiple Sclerosis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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