Informations générales (source: ClinicalTrials.gov)

NCT05300698 En recrutement IDF
MRI Versus Ocular UltraSonography for a Non Contact Evaluation of Ocular Layers (MOUSE)
Observational
Fondation Ophtalmologique Adolphe de Rothschild (Voir sur ClinicalTrials)
janvier 2024
novembre 2026
29 juin 2024
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.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL FONDATION A. DE ROTHSCHILD Yvonne PURCELL En recrutement IDF 21/06/2024 13:34:23  Contacter

Critères

Tous
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



- 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