Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion (POLAR)

Lille Catholic University

Status: Completed

Conditions: Multiple Sclerosis; Clinically Isolated Syndrome

Treatments: Procedure: tears and cerebrospinal fluid sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT02043964

RC-P0021

Details and patient eligibility

About

This is a multicentric and prospective study for the validation of a diagnostic method in multiple sclerosis. Our hypothesis is that there is a characteristic profile of tears that can be recognized in order to help in the diagnosis of this pathology and that could possibly replace the lumbar punction which is an invasive method. Semi-automatic and automatic techniques of isoelectric focusing will be developed for analyzing data from tears. These results will help in the identification of markers of this disease.

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years old or more
• Clinically isolated syndrome of less than 3 months of onset
• Informed consent to participate

Exclusion criteria

• Progressive primary multiple sclerosis
• Relapsing remitting multiple sclerosis
• Persons wearing contact lenses
• Ocular Infection
• Corticoid treatment at least 30 days before sampling
• Immunosuppressive or immunomodulatory treatment at least 3 months before sampling
• Pregnancy or breast feeding
• No coverage by the Social Insurance

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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165 participants in 1 patient group

tears and cerebro-spinal fluid sampling

Experimental group

Treatment:

Procedure: tears and cerebrospinal fluid sampling