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CompletedNCT02573792OCTONUpdated Jun 22, 2021

Optical Coherence Tomography and Optic Neuritis (OCTON)

An observational study in Optical Neuritis, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-22.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
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Study 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.

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

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Conditions studied

  • Optical Neuritis

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Keywords

  • First onset of optical neuritis
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In context

Neuritis

73 studies on the registry are indexed under Neuritis; 20 are open to participants now.

This study's enrollment of 120 is close to the median of 123 across 20 observational studies indexed under Neuritis.

Browse Neuritis studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients seen at the Adolphe de Rothschild ophthalmological foundation for the first onset of an optical neuritis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • first onset of an optical neuritis lasting for less than 3 months

Exclusion criteria

Exclusion Criteria:

  • 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Sensitivity of the OCT, expressed as a percentage, for the etiological diagnosis of optical neuritis

    Time frame: One year

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Study locations

1 site
  • Fondation Ophtalmologique Adolphe de Rothschild
    Paris, Ile De France 75019, France
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2015 to primary completion in Jul 2019, 45 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2015
First posted
Oct 12, 2015
StartActual
Oct 5, 2015
Primary completionActual
Jul 2019
CompletionActual
Jul 2019
Last update
Jun 22, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02573792
Responsible party
Sponsor
First posted
Oct 12, 2015
Start date
Oct 5, 2015
Primary completion
Jul 2019
Completion
Jul 2019
Last update
Jun 22, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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