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出境医 / 临床实验 / Optical Coherence Tomography and Optic Neuritis Not Related to Multiple Sclerosis (OCTON2)
Optical Coherence Tomography and Optic Neuritis Not Related to Multiple Sclerosis (OCTON2)
Study Description
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 |
Study Design
| 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 |
| Actual Study Start Date : | September 14, 2020 |
| Estimated Primary Completion Date : | September 14, 2024 |
| Estimated Study Completion Date : | September 14, 2024 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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
- Thickness of the layers of the retina with Optical Coherent Tomography(OCT), [ Time Frame: 1 year ]
- Standard Humphrey Visual Field Test [ Time Frame: 1 year ]
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| 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
| France | |
| Fondation A. de Rothschild | Recruiting |
| Paris, France, 75019 | |
| Contact: Romain DESCHAMPS, MD rdeschamps@for.paris | |
| Principal Investigator: Romain DESCHAMPS | |
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
| Principal Investigator: | Romain DESCHAMPS, MD | Fondation A. de Rothschild |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 20, 2019 | ||||||||
| First Posted Date | May 24, 2019 | ||||||||
| Last Update Posted Date | September 16, 2020 | ||||||||
| Actual Study Start Date | September 14, 2020 | ||||||||
| Estimated Primary Completion Date | September 14, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Optical Coherence Tomography and Optic Neuritis Not Related to Multiple Sclerosis | ||||||||
| Official Title | Evaluation and Follow-up of Optic Neuritis Not Related to Multiple Sclerosis | ||||||||
| 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. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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 | ||||||||
| Condition | Optic Neuritis | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
60 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | September 14, 2024 | ||||||||
| Estimated Primary Completion Date | September 14, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03963310 | ||||||||
| Other Study ID Numbers | RDS_2019_8 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Fondation Ophtalmologique Adolphe de Rothschild | ||||||||
| Study Sponsor | Fondation Ophtalmologique Adolphe de Rothschild | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Fondation Ophtalmologique Adolphe de Rothschild | ||||||||
| Verification Date | September 2020 | ||||||||
