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Clinical Trials in France / NCT05300698
Recruiting Observational

MRI Versus Ocular UltraSonography for a Non Contact Evaluation of Ocular Layers

NCT05300698 · tracked via the Priya Life Science France tracker
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Phase
Observational
Started
2024-01-23
Last updated
2026-01-05

Condition(s) studied

Describe Ultrasound Matches and Disagreements Ocular and MRI

Investigational drug(s) / intervention(s)

MRI

MRI: compare between MRI and ultrasound for indirect assessment of ocular layers

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • description of concordance and discordance of ultrasound ocular and MRI — 1 DAY

Trial sites (1)

FacilityCityRegionStatus
Hopital Fondation Adolphe de Rothschild Paris Paris Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05300698 on ClinicalTrials.gov ↗ ← All trials in France