Clinical trial NCT05218317: Evaluation of Relapse Presence in Multiple Sclerosis
Official title: Evaluation of Relapse Presence in Multiple Sclerosis Patients by Cross-Sectional In-Vivo Corneal Confocal Microscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis Relapse
Keywords: multiple sclerosis, in-vivo corneal confocal microscopy, relapse, inflammation, neurodegeneration, neuroregeneration
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fifty-eight patients with RRMS and 30 HCs were included in the study. The RRMS patients were divided into two subgroups: 1) Thirty-one patients (MS-Control) who were followed up with the diagnosis of RRMS, 2) Twenty-seven patients (MS-Relapse) for whom the administration of intravenous corticosteroids was decided due to the diagnosis of new relapse.

Brief summary: Purpose: This study aims to investigate the demonstrability of increased inflammation and neurodegeneration in multiple sclerosis (MS) patients in relapse period compared to MS patients in remission by cross-sectional analysis of in-vivo corneal confocal microscopy (IVCM), and to evaluate the alternations with a second IVCM administered at least 6 months after the relapse period.

Methods: This prospective, non-randomized-controlled, cross-sectional study included 58 MS patients which were grouped regarding the presence of relapse (MS-Relapse group \[n=27\] and MS-Control group \[n=31\]), and age-sex matched 30 healthy controls (HC). The corneal nerve fiber density (CNFD), the corneal nerve branch density (CNBD), the corneal nerve fiber length (CNFL), and dendritic cell (DC) density were evaluated in all MS patients and HCs by IVCM. If the patients in the MS-relapse group did not have an attack within 6 months, the same parameters were evaluated with the second IVCM. The patients with a history of optic neuritis or trigeminal symptoms were excluded.


Eligibility criteria: Inclusion Criteria:

* Patients for whom the administration of intravenous corticosteroids was decided due to the diagnosis of new relapse
* Patients who were followed up with the diagnosis of RRMS
* Healthy controls

Exclusion Criteria:

* Being younger than 18 years old
* Having any other neurological or metabolic diseases
* Ophthalmological diseases
* A history of optic neuritis and trigeminal symptoms
* Ocular trauma or surgery
* Contact lens use
* The patients who had a relapse attack 6 months prior to the study

Primary outcomes:
measure: Corneal nerve fiber density (CNFD)
timeFrame: Baseline
measure: Corneal nerve fiber density (CNFD)
timeFrame: 6 Month
measure: Corneal nerve branch density (CNBD)
timeFrame: Baseline
measure: Corneal nerve branch density (CNBD)
timeFrame: 6 Month
measure: Corneal nerve fiber length (CNFL)
timeFrame: Baseline
measure: Corneal nerve fiber length (CNFL)
timeFrame: 6 Months
Secondary outcomes:
measure: Dendritic Cells
timeFrame: Baseline
measure: Dendritic Cells
timeFrame: 6 Months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
References: