NCT05300698 MRI Versus Ocular UltraSonography for a Non Contact Evaluation of Ocular Layers
| NCT ID | NCT05300698 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
| Condition | Describe Ultrasound Matches and Disagreements Ocular and MRI |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-01-23 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-01-23 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05300698 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Describe Ultrasound Matches and Disagreements Ocular and MRI. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05300698 currently recruiting?
Yes, NCT05300698 is actively recruiting participants. Contact the research team at ayavchitz@for.paris for enrollment information.
Where is the NCT05300698 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05300698 clinical trial?
NCT05300698 is sponsored by Fondation Ophtalmologique Adolphe de Rothschild. The trial plans to enroll 30 participants.