MRI Versus Ocular UltraSonography for a Non Contact Evaluation of Ocular Layers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondation Ophtalmologique Adolphe de Rothschild
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
Patients will be recruited when they are referred for imaging to performing an ocular ultrasound.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MRI
Devicecompare between MRI and ultrasound for indirect assessment of ocular layers
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
description of concordance and discordance of ultrasound ocular and MRI
Time frame
1 DAYSponsors and contacts
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Source ClinicalTrials.gov