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

NCT05300698 | Recruiting

• 1 other identifier: YPL_2021_29
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Describe Ultrasound Matches and Disagreements Ocular and MRI

Outcome Measures

Primary Outcomes (1)

• description of concordance and discordance of ultrasound ocular and MRI

  1 DAY

Interventions

MRI DEVICE

compare between MRI and ultrasound for indirect assessment of ocular layers

Also known as: baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hopital Fondation Adolphe de Rothschild

Paris, Paris, 75019, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Amélie Yavchitz, PhD

CONTACT

0148036454; ayavchitz@for.paris

Yvonne PURCELL, PhD

CONTACT

01 48 03 74 06; ypurcell@for.paris

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 29, 2022
• Study Start: January 23, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)