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

Recruiting

• Conditions: Describe Ultrasound Matches and Disagreements Ocular and MRI

• Registration Number: NCT05300698
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

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.

Study Timeline

• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-18
• Study First Posted: 2022-03-29
• Study Start: 2024-01-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2026-02
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
description of concordance and discordance of ultrasound ocular and MRI	1 DAY

Trial Locations

Locations (1)

Hopital Fondation Adolphe de Rothschild; 🇫🇷 Paris, France