Optical NeuritisOCTONNCT02573792
Optical Coherence Tomography and Optic Neuritis (OCTON)
An observational study of Optical Neuritis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Optic neuritis (ON) can remain isolated or reveal a widespread and chronic disease of the central nervous system (CNS), a multiple sclerosis (MS) or, more rarely, a Devic's neuromyelitis optica (NMO) or a systemic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Optical Neuritis
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2015to Jul 2019
- 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 ophthalmological foundation for the first onset of an optical neuritis
Who may be able to join
- first onset of an optical neuritis lasting for less than 3 months
Who cannot join
- Contra-indication to MRI
- Patient opposed to participation in the study
- Pregnant or lactating woman
- Patient under a measure of legal protection
- Absence of affiliation to social security or universal health coverage (CMU)
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation Ophtalmologique Adolphe de Rothschild
Paris, Île-de-France Region, 75019
About this study
Official title: Optical Coherence Tomography for the Etiological Diagnosis of Inflammatory Optic Neuritis
Optic neuritis (ON) can remain isolated or reveal a widespread and chronic disease of the central nervous system (CNS), a multiple sclerosis (MS) or, more rarely, a Devic's neuromyelitis optica (NMO) or a systemic disease.
The optical coherence tomography (OCT) is a retinal imaging technique to measure the thickness of the retina and its different layers with an accuracy of 4-6 µM.
Read more
Costello et al have shown that approximately 75% of 54 MS patients have developed within 3 to 6 months after a ON a loss of 10 to 40 µM in the thickness of the peripapillary retinal nerve fiber layer (RNFL).
The etiologic diagnosis of ON has been transformed in recent years. MS can now be diagnosed by McDonald's MRI criteria and NMO by the AQP4 antibodies (anti-aquaporin- 4) antibodies and the anti-MOG (myelin-oligodendrocyte glycoprotein) antibodies.
The diagnosis and prognosis value of the OCT in patients with ON is not well known
- Conditions
- Optical Neuritis
- Keywords
- First onset of optical neuritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the OCT, expressed as a percentage, for the etiological diagnosis of optical neuritis
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study start5 Oct 2015
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optical NeuritisStudies of the same condition, open and under way.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573792
- Sponsor's protocol ID
- RDS_2015_21
- Acronym
- OCTON
- Status last verified
- Jun 2021
- First submitted
- 9 Oct 2015
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography for the Etiological Diagnosis of Inflammatory Optic Neuritis
- ClinicalTrials.gov ID
- NCT02573792
- Acronym / sponsor ID
- OCTON / RDS_2015_21
- Conditions
- Optical Neuritis
- Keywords
- First onset of optical neuritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 5 Oct 2015 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 12 Oct 2015 (estimated)
- 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.
Optic neuritis (ON) can remain isolated or reveal a widespread and chronic disease of the central nervous system (CNS), a multiple sclerosis (MS) or, more rarely, a Devic's neuromyelitis optica (NMO) or a systemic disease.
The optical coherence tomography (OCT) is a retinal imaging technique to measure the thickness of the retina and its different layers with an accuracy of 4-6 µM.
Costello et al have shown that approximately 75% of 54 MS patients have developed within 3 to 6 months after a ON a loss of 10 to 40 µM in the thickness of the peripapillary retinal nerve fiber layer (RNFL).
The etiologic diagnosis of ON has been transformed in recent years. MS can now be diagnosed by McDonald's MRI criteria and NMO by the AQP4 antibodies (anti-aquaporin- 4) antibodies and the anti-MOG (myelin-oligodendrocyte glycoprotein) antibodies.
The diagnosis and prognosis value of the OCT in patients with ON is not well known
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 ophthalmological foundation for the first onset of an optical neuritis
Key inclusion criteria (1 listed)
- first onset of an optical neuritis lasting for less than 3 months
Key exclusion criteria (5 listed)
- Contra-indication to MRI
- Patient opposed to participation in the study
- Pregnant or lactating woman
- Patient under a measure of legal protection
- Absence of affiliation to social security or universal health coverage (CMU)
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
Sensitivity of the OCT, expressed as a percentage, for the etiological diagnosis of optical neuritis
Time frame: One 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 22 Jun 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Optical 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 1 inclusion and 5 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 22 Jun 2021. 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?
Sensitivity of the OCT, expressed as a percentage, for the etiological diagnosis of optical neuritis (time frame: One year). 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 22 Jun 2021; AzTrials last refreshed its copy on 30 Oct 2026.