MRI Versus Ocular UltraSonography for a Non Contact Evaluation of Ocular Layers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI.
- Who it may be relevant to
- Registry conditions: Describe Ultrasound Matches and Disagreements Ocular and MRI. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Device MRI
compare between MRI and ultrasound for indirect assessment of ocular layers
Primary outcome measures
- description of concordance and discordance of ultrasound ocular and MRI [Time frame: 1 DAY]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hopital Fondation Adolphe de Rothschild — Paris
Identifiers
NCT: NCT05300698 · YPL_2021_29