Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome
Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion Among Patients With or Without Lesions at the Magnetic Resonance Imaging (Oligoclonal Profile of Tears)
What it found
We found no results in the registry or in papers.
This trial finished 8 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- tears and cerebrospinal fluid sampling
What it measured
Main measures
Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid
two years after
Blood or spinal fluid markers
Other measures (5)
Diagnostic performance of isoelectric focusing of tears
inclusion, two years after
Concordance between visual and automatic reading of electrophoretic profiles
two years
Calculation of sensitivity/specificity
two years
Calculation of positive/negative predictive value
two years
Calculation of efficiency odds ratio
two years
Who could take part
Early (CIS/RIS) · 18 and over
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Oct 2012
Main results due
Jun 2018
Finished
Dec 2018