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

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05300698
Collaborator
(none)
30
21

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
MRI Versus Ocular UltraSonography for a Non Contact Evaluation of Ocular Layers
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Outcome Measures

Primary Outcome Measures

  1. description of concordance and discordance of ultrasound ocular and MRI [1 DAY]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT05300698
Other Study ID Numbers:
  • YPL_2021_29
First Posted:
Mar 29, 2022
Last Update Posted:
Jul 28, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 28, 2022