Tear Analysis in the Diagnosis of Multiple Sclerosis
Tear Analysis in the Diagnosis of Primary Progressive Forms of Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: Difficulties encountered in recruiting patients
This trial finished 10 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- tears sampling
What it measured
Main measures
Concordance between the quantification of oligoclonal IgG bands by isoelectric focusing in tears and in the cerebrospinal fluid in patients with primary progressive multiple sclerosis
at baseline and two years after (+/- 2 months)
Blood or spinal fluid markers
Other measures (2)
Isoelectrophoretic profile of tears
Baseline and two years after inclusion
Isoelectrophoretic profiles of tears by digital recording and analysis of images
Baseline and two years after
Who could take part
Progressive MS · 18 and over
Show the full criteria
Inclusion criteria
* 18 years old or more * Progressive neurological deficit after 12 months * At least 9 T2 brain lesions of minimum 3 mm evidenced by MRI and/or four or more T2 lesions of minimum 3 mm with positive Visual Evoked Potential and/or positive spinal cord MRI (at least two focal T2 lesions)
Exclusion criteria
* Asiatic persons * recurrent forms of the disease * Persons wearing contact lenses * Ocular Infection * Corticoid treatment at least 30 days before sampling * immunosuppressive or immunomodulatory treatment 3 months before sampling
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
In the primary progressive multiple sclerosis, the detection of oligoclonal bands in cerebrospinal fluid is critical for the diagnosis. However, lumbar puncture for cerebrospinal fluid collection is considered relatively invasive. Our hypothesis is that oligoclonal bands detection in tears is possible and useful for the diagnosis of multiple sclerosis.
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History
Started
Apr 2011
Main results due
Mar 2016
Finished
Mar 2016