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Optical Coherence Tomography and Optic Neuritis (OCTON) (OCTON)

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. Read our disclaimer for details. Identifier: NCT02573792
Recruitment Status : Completed
First Posted : October 12, 2015
Last Update Posted : August 30, 2019
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief 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

Condition or disease
Optical Neuritis

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optical Coherence Tomography for the Etiological Diagnosis of Inflammatory Optic Neuritis
Actual Study Start Date : October 5, 2015
Actual Primary Completion Date : July 2019
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Sensitivity of the OCT, expressed as a percentage, for the etiological diagnosis of optical neuritis [ Time Frame: One 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 ophthalmological foundation for the first onset of an optical neuritis

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

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 identifier (NCT number): NCT02573792

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Fondation Ophtalmologique Adolphe de Rothschild
Paris, Ile De France, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild Identifier: NCT02573792    
Other Study ID Numbers: RDS_2015_21
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: June 2019
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
First onset of optical neuritis
Additional relevant MeSH terms:
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Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases