Evaluation of Relapse Presence in Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis Relapse
• Interventions: Diagnostic Test: in-vivo Corneal Confocal Microscopy

• Registration Number: NCT05218317
• Lead Sponsor: Marmara University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-10-01
• Status Verified: 2022-01
• Study Completion: 2022-01-01
• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-01-20
• Last Update Submitted: 2022-01-20
• Study First Posted: 2022-02-01
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MS-Relapse	in-vivo Corneal Confocal Microscopy	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).
Healthy Controls	in-vivo Corneal Confocal Microscopy	Thirty healthy age and gender similar population These subjects underwent Corneal Confocal Microscopy (IVCM).
MS-Control	in-vivo Corneal Confocal Microscopy	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).

Primary Outcome Measures

Name	Time	Method
Corneal nerve fiber density (CNFD)	6 Month	Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFD.
Corneal nerve branch density (CNBD)	6 Month	Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNBD.
Corneal nerve fiber length (CNFL)	6 Months	Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFL.

Secondary Outcome Measures

Name	Time	Method
Dendritic Cells	6 Months	the number of DCs counted by ImageJ's Cell Counter plug-in

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Turkey