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

NCT ID: NCT05300698

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-23
• Study Completion Date: 2026-11-30

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.

Conditions

Describe Ultrasound Matches and Disagreements Ocular and MRI

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

MRI

compare between MRI and ultrasound for indirect assessment of ocular layers

Intervention Type: DEVICE

Other Intervention Names

baseline

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Fondation Adolphe de Rothschild

Paris, Paris, France

Site Status: RECRUITING

Countries

France

Central Contacts

Amélie Yavchitz, PhD

Role: CONTACT

ayavchitz@for.paris

0148036454

Yvonne PURCELL, PhD

Role: CONTACT

ypurcell@for.paris

01 48 03 74 06

Other Identifiers

YPL_2021_29

Identifier Type: -

Identifier Source: org_study_id