Linking Optic Nerve MRI and the Retinal Axonal Loss After Optic Neuritis (IRMANO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03651362|
Recruitment Status : Unknown
Verified August 2018 by University Hospital, Lille.
Recruitment status was: Recruiting
First Posted : August 29, 2018
Last Update Posted : August 31, 2018
|Condition or disease|
Neurologists and Neuro-Ophthalmologists are in need for reliable and robust imaging biomarkers enabling to predict retinal axonal loss and visual disability after clinical episode of optic neuritis (ON). Length of optic nerve lesion measured on MRI may be one of them.
The aim of our study is to measure the association between the extent of inflammatory demyelinating process on optic nerve at the acute of ON and the retinal degenerative process following optic nerve injury.
The investigators planned to include 50 patients suffering from a recent clinical episode of ON.
Extent of demyelinating inflammatory process will be assessed by the length of optic nerve double inversion recovery (DIR) hypersignal at the acute phase of ON.
The axonal degenerative process following optic nerve demyelinating injury will be assessed by retinal atrophy measured on optical coherence tomography at 12 months after ON, by visual disability measured on low vision contrast acuity scale and by microstructural quality analysis of optic nerve measured on diffusion tensor imaging sequence of the optic nerve.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Linking Optic Nerve Lesion Length at MRI and the Retinal Axonal Loss at 12 Months From a Clinical Episode of Optic Neuritis|
|Actual Study Start Date :||February 2016|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
- Severity of retinal axonal loss around papilla after a clinical episode of optic neuritis [ Time Frame: 12 months ]peripapillary RNFL thickness decrease
- Severity of retinal axonal loss within macula after a clinical episode of optic neuritis [ Time Frame: 12 months ]macular volume decrease
- Severity of visual disability after a clinical episode of optic neuritis [ Time Frame: 12 months ]monocular low contrast (2.5%) vision
- Severity of microstructural architecture of optic nerve after a clinical episode of optic neuritis [ Time Frame: 12 months ]fractional anisotropy
- Progression of optic nerve lesion length [ Time Frame: 12 months ]lesion length in mm measured on 3D-double inversion recovery sequence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651362
|Contact: Olivier Outteryck, MD, PhDemail@example.com|
|Hôpital Roger Salengro, CHRU de Lille||Recruiting|
|Principal Investigator: Olivier Outteryck, MD|
|Principal Investigator:||Olivier Outteryck, MD, PhD||University Hospital, Lille|