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MRI Versus Ocular UltraSonography for a Non Contact Evaluation of Ocular Layers (MOUSE)

F

Fondation Ophtalmologique Adolphe de Rothschild

Status

Enrolling

Conditions

Describe Ultrasound Matches and Disagreements Ocular and MRI

Treatments

Device: MRI

Study type

Observational

Funder types

NETWORK

Identifiers

NCT05300698
YPL_2021_29

Details and patient eligibility

About

D0: inclusion visit

  • information
  • Realization of the ocular ultrasound (care)
  • Collection of consent
  • Realization of high resolution MRI with injection of contrast product (duration of 30 minutes) For the realization of the MRI, the contrast product used is the gadobutrol. The dose, the lowest allowing an enhancement of sufficient contrast for diagnostic purposes (0.1 mmol/kg body mass body), is administered as a bolus intravenously in the lying patient. The MRI examination can begin immediately after injection. The patient should be monitored for at least half an hour after this, the majority of undesirable effects occurring at the during this period. The indication of ocular ultrasound and ophthalmological follow-up of the patient up to 1 month after inclusion will be collected at from their medical records.

Full description

D0: inclusion visit

  • information
  • Realization of the ocular ultrasound (care)
  • Collection of consent
  • Realization of high resolution MRI with injection of contrast product (duration of 30 minutes) For the realization of the MRI, the contrast product used is the gadobutrol. The dose, the lowest allowing an enhancement of sufficient contrast for diagnostic purposes (0.1 mmol/kg body mass body), is administered as a bolus intravenously in the lying patient. The MRI examination can begin immediately after injection. The patient should be monitored for at least half an hour after this, the majority of undesirable effects occurring at the during this period. The indication of ocular ultrasound and ophthalmological follow-up of the patient up to 1 month after inclusion will be collected at from their medical records.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient over 18 years old
  • Addressed in imaging for the realization of an ultrasound diagnostic eye
  • Express consent to participate in the study
  • Member of or beneficiary of a social security scheme

Exclusion criteria

  • Patient with an absolute or relative contraindication to MRI (pacemaker or neurosensory stimulator or defibrillator implantable; ocular or cerebral ferromagnetic foreign body; claustrophobia)
  • Absolute or relative contraindication to the injection of gadolinium (history of an allergic reaction to a product of contrast, bronchial asthma, allergic terrain, renal failure with serum creatinine clearance <30 mL/min)
  • Patient benefiting from a legal protection measure
  • Pregnant or breastfeeding woman: a pregnancy test in the woman of childbearing age is to be carried out before inclusion

Trial contacts and locations

2

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Central trial contact

Yvonne PURCELL, PhD; Amélie Yavchitz, PhD

Data sourced from clinicaltrials.gov

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