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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05300698
Acronym
MOUSE
Enrollment
30
Registered
2022-03-29
Start date
2024-01-23
Completion date
2026-11-30
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Describe Ultrasound Matches and Disagreements Ocular and MRI

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.

Interventions

DEVICEMRI

compare between MRI and ultrasound for indirect assessment of ocular layers

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
description of concordance and discordance of ultrasound ocular and MRI1 DAY

Countries

France

Contacts

Primary ContactAmélie Yavchitz, PhD
ayavchitz@for.paris0148036454
Backup ContactYvonne PURCELL, PhD
ypurcell@for.paris01 48 03 74 06

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026