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NCT03963310 Clinical Trial

Optical Coherence Tomography and Optic Neuritis Not Related to Multiple Sclerosis

Optic Neuritis Clinical Trial

— OCTON2  

Official title:
Evaluation and Follow-up of Optic Neuritis Not Related to Multiple Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03963310
Other study ID # RDS_2019_8
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 14, 2020
Est. completion date September 14, 2024

Study information
Verified date June 2024
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The visual prognosis of optic neuritis not related to multiple sclerosis is unknown, both in terms of functional recovery and evolution. This prospective cohort study aim to assess the ophthalmological evolution of patients presenting an episode of optic neuritis (NO) not related to a multiple sclerosis or to a clinically isolated syndrome.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date September 14, 2024
Est. primary completion date September 14, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - First onset of an optic neuritis lasting for less than 1 month - With a brain MRI that does not meet the MS criteria Exclusion Criteria: - Contra-indication to MRI - Pregnant or lactating woman - History of known ipsilateral optic neuritis - Ophthalmologic comorbidity in the ipsilateral eye that may interfere with the interpretation of the examinations

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Fondation A. de Rothschild Paris

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 Visual acuity (ETDRS scale) Evolution over 1 year of the ophthalmological parameters of patients treated for an episode of optic neuritis not related to multiple sclerosis or a clinically isolated syndrome 1 year
Primary Thickness of the layers of the retina with Optical Coherent Tomography(OCT), 1 year
Primary Standard Humphrey Visual Field Test 1 year
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