Diagnostic Accuracy of Optimized Diffusion-Weighted Imaging for Detecting Anterior Ischemic Optic Neuropathy

Neuro-Ophthalmology Clinical Trial

— DACODAC  

Official title:

Diagnostic Accuracy of Optimized Diffusion-Weighted Imaging for Detecting Anterior Ischemic Optic Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451265
• Other study ID #: GPN_2020_6
• Status: Recruiting
• Start date: October 26, 2022
• Est. completion date: March 2028

Study information

• Verified date: December 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Amelie YAVCHITZ
• Phone: 0148036431
• Email: ayavchitz[@]for.paris
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The patient presents to the ophthalmological emergencies and / or to the internal medicine department. NOIA clinical discovery Patient referred in radiology for brain and visual MRI. The two sequences added by the research (8 minutes) will be added to that of the treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: March 2028
• Est. primary completion date: September 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over 18 years old

• Patient with suspected NOIA, evoked after clinical examination by a specialized ophthalmologist

• For which a brain and visual MRI is planned

• Express consent to participate in the study

• Affiliate or beneficiary of a Social Security scheme

Exclusion Criteria:

• Contraindication to MRI (electrical device, metallic foreign body, claustrophobia)

• Patient benefiting from a legal protection measure

• Pregnant or breastfeeding woman

Related Conditions & MeSH terms

• Neuro-Ophthalmology
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic

Intervention

Other:
• MRI
Diffusion sequence (8 minutes long) added to the initial MRI

Locations

Country	Name	City	State
France	CHU de LILLE	Lille
France	Fondation A De Rothschild	Paris
France	Chu Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study the sensitivity of the High resolution Diffusion sequence in the detection of NOIA, evaluated by a DWI hypersignal and an ADC hyposignal of the optic nerve		basline