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

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ClinicalTrials.gov Identifier: NCT02573792
Recruitment Status : Active, not recruiting
First Posted : October 12, 2015
Last Update Posted : June 25, 2019
Sponsor:
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
Estimated Primary Completion Date : July 2019
Estimated 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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02573792


Locations
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France
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
ClinicalTrials.gov Identifier: NCT02573792     History of Changes
Other Study ID Numbers: RDS_2015_21
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: June 25, 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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Neuritis
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases