Evaluation of Relapse Presence in Multiple Sclerosis

Marmara University

Status: Completed

Conditions: Multiple Sclerosis Relapse; Multiple Sclerosis, Relapsing-Remitting

Treatments: Diagnostic Test: in-vivo Corneal Confocal Microscopy

Study type: Observational

Funder types: Other

Identifiers

NCT05218317

09.2021.240

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

87 participants in 3 patient groups

MS-Relapse

Description:

Twenty-seven patients (MS-Relapse) for whom the administration of intravenous corticosteroids was decided due to the diagnosis of new relapse. The diagnosis of RRMS and the new relapse was confirmed and decided by a senior neurologist (K.A) of Marmara University Department of Neurology, according to the revised McDonald criteria, based on clinical and radiological findings These subjects underwent Corneal Confocal Microscopy (IVCM).

Treatment:

Diagnostic Test: in-vivo Corneal Confocal Microscopy

MS-Control

Description:

Thirty-one patients (MS-Control) who were followed up with the diagnosis of RRMS The diagnosis of RRMS and the new relapse was confirmed and decided by a senior neurologist (K.A) of Marmara University Department of Neurology, according to the revised McDonald criteria, based on clinical and radiological findings. These subjects underwent Corneal Confocal Microscopy (IVCM).

Treatment:

Diagnostic Test: in-vivo Corneal Confocal Microscopy

Healthy Controls

Description:

Thirty healthy age and gender similar population These subjects underwent Corneal Confocal Microscopy (IVCM).

Treatment:

Diagnostic Test: in-vivo Corneal Confocal Microscopy