MRI Versus Ocular UltraSonography for a Non Contact Evaluation of Ocular Layers (MOUSE)

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 Overview

• Status: Recruiting
• Conditions: Describe Ultrasound Matches and Disagreements Ocular and MRI
• Intervention / Treatment: Device: MRI

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Amelie YAVCHITZ, PhD; Phone Number: 0148036454; Email: ayavchitz@for.paris
• Study Contact Backup: Name: Yvonne PURCELL, PhD; Phone Number: 01 48 03 74 06; Email: ypurcell@for.paris

Study Locations

• France
  • Paris
    • Paris, Paris, France, 75019
      • Recruiting
      • Hôpital Fondation Adolphe de Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited when they are referred for imaging to performing an ocular ultrasound.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
description of concordance and discordance of ultrasound ocular and MRI	1 DAY

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: YPL_2021_29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No