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Optical Coherence Tomography and Optic Neuritis Not Related to Multiple Sclerosis (OCTON2)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03963310
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.


Condition or disease
Optic Neuritis

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation and Follow-up of Optic Neuritis Not Related to Multiple Sclerosis
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Visual acuity (ETDRS scale) [ Time Frame: 1 year ]
    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

  2. Thickness of the layers of the retina with Optical Coherent Tomography(OCT), [ Time Frame: 1 year ]
  3. Standard Humphrey Visual Field Test [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen at the Adolphe de Rothschild Foundation for the first onset of an optic neuritis not related to multiple sclerosis and clinically isolated syndrome
Criteria

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

Information from the National Library of Medicine

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): NCT03963310


Contacts
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Contact: Laurence SALOMON, MD PhD +33 1 48 03 64 31 lsalomon@for.paris
Contact: Amélie YAVCHITZ, MD +33 1 48 03 64 54 ayavchitz@for.paris

Locations
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France
Fondation A. de Rothschild Not yet recruiting
Paris, France, 75019
Contact: Romain DESCHAMPS, MD       rdeschamps@for.paris   
Principal Investigator: Romain DESCHAMPS         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Romain DESCHAMPS, MD Fondation A. de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03963310     History of Changes
Other Study ID Numbers: RDS_2019_8
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Neuritis
Optic Neuritis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases