Optic NeuritisOCTON2NCT03963310
Optical Coherence Tomography and Optic Neuritis Not Related to Multiple Sclerosis
An observational study of Optic Neuritis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Optic Neuritis
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2020to 23 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- First onset of an optic neuritis lasting for less than 1 month
- With a brain MRI that does not meet the MS criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation and Follow-up of Optic Neuritis Not Related to Multiple Sclerosis
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.
- Conditions
- Optic Neuritis
- Medical subject headings
- Optic Neuritis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Thickness of the layers of the retina with Optical Coherent Tomography(OCT),
Measured: 1 year
Standard Humphrey Visual Field Test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start14 Sep 2020
- Primary completion23 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Romain DESCHAMPS, MD, Principal investigator, Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963310
- Sponsor's protocol ID
- RDS_2019_8
- Acronym
- OCTON2
- Status last verified
- Jun 2025
- First submitted
- 20 May 2019
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Follow-up of Optic Neuritis Not Related to Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03963310
- Acronym / sponsor ID
- OCTON2 / RDS_2019_8
- Conditions
- Optic Neuritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- First onset of an optic neuritis lasting for less than 1 month
- With a brain MRI that does not meet the MS criteria
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain DESCHAMPS, MD principal investigator
Fondation A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optic Neuritis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (ETDRS scale) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.