Optical Coherence Tomography and Optic Neuritis (OCTON)

Optical Neuritis Clinical Trial

— OCTON  

Official title:

Optical Coherence Tomography for the Etiological Diagnosis of Inflammatory Optic Neuritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573792
• Other study ID #: RDS_2015_21
• Status: Completed
• Start date: October 5, 2015
• Est. completion date: July 2019

Study information

• Verified date: June 2021
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Neuritis
• Optic Neuritis
• Optical Neuritis

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the OCT, expressed as a percentage, for the etiological diagnosis of optical neuritis		One year