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Recruiting

NCT Number: NCT05300698

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

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Fondation Adolphe de Rothschild

Paris, 75019, France

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Device

compare between MRI and ultrasound for indirect assessment of ocular layers

Other names: baseline

Primary outcomes

  1. description of concordance and discordance of ultrasound ocular and MRI

    Time frame: 1 DAY

Study contacts

Contact information is provided by the study sponsor or research team.

Amélie Yavchitz, PhD

CONTACT

[email protected]

0148036454

Yvonne PURCELL, PhD

CONTACT

[email protected]

01 48 03 74 06

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: MOUSE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 29, 2022
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.