Evaluation of Relapse Presence in Multiple Sclerosis

NCT ID: NCT05218317

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 87 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-01-01

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis Relapse

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

MS-Relapse

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).

in-vivo Corneal Confocal Microscopy

Intervention Type: DIAGNOSTIC_TEST

All study subjects underwent IVCM (Rostock Cornea Module, Heidelberg Retinal Tomograph III; Heidelberg Engineering, Germany). Before the examination, two drops of topical anesthetic with proparacaine hydrochloride (Alcaine 0.5%, Alcon-Couvreur, Belgium) were applied to both eyes. A carbomer-based gel (Viscotears 0.2%; Dr. Gerhard Mann, Chem.- Pharm. Fabrik, Germany) was used as the coupling agent between the cornea and the applanating cap of IVCM. For correctly positioning the central cornea, all subjects were asked to fixate a determined fixation point and controlled with the device camera. All scans were performed in approximately 5 minutes for each eye by a single experienced ophthalmologist, masked from the subject's disease status.

MS-Control

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).

in-vivo Corneal Confocal Microscopy

Intervention Type: DIAGNOSTIC_TEST

All study subjects underwent IVCM (Rostock Cornea Module, Heidelberg Retinal Tomograph III; Heidelberg Engineering, Germany). Before the examination, two drops of topical anesthetic with proparacaine hydrochloride (Alcaine 0.5%, Alcon-Couvreur, Belgium) were applied to both eyes. A carbomer-based gel (Viscotears 0.2%; Dr. Gerhard Mann, Chem.- Pharm. Fabrik, Germany) was used as the coupling agent between the cornea and the applanating cap of IVCM. For correctly positioning the central cornea, all subjects were asked to fixate a determined fixation point and controlled with the device camera. All scans were performed in approximately 5 minutes for each eye by a single experienced ophthalmologist, masked from the subject's disease status.

Healthy Controls

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

in-vivo Corneal Confocal Microscopy

Intervention Type: DIAGNOSTIC_TEST

All study subjects underwent IVCM (Rostock Cornea Module, Heidelberg Retinal Tomograph III; Heidelberg Engineering, Germany). Before the examination, two drops of topical anesthetic with proparacaine hydrochloride (Alcaine 0.5%, Alcon-Couvreur, Belgium) were applied to both eyes. A carbomer-based gel (Viscotears 0.2%; Dr. Gerhard Mann, Chem.- Pharm. Fabrik, Germany) was used as the coupling agent between the cornea and the applanating cap of IVCM. For correctly positioning the central cornea, all subjects were asked to fixate a determined fixation point and controlled with the device camera. All scans were performed in approximately 5 minutes for each eye by a single experienced ophthalmologist, masked from the subject's disease status.

Interventions

in-vivo Corneal Confocal Microscopy

All study subjects underwent IVCM (Rostock Cornea Module, Heidelberg Retinal Tomograph III; Heidelberg Engineering, Germany). Before the examination, two drops of topical anesthetic with proparacaine hydrochloride (Alcaine 0.5%, Alcon-Couvreur, Belgium) were applied to both eyes. A carbomer-based gel (Viscotears 0.2%; Dr. Gerhard Mann, Chem.- Pharm. Fabrik, Germany) was used as the coupling agent between the cornea and the applanating cap of IVCM. For correctly positioning the central cornea, all subjects were asked to fixate a determined fixation point and controlled with the device camera. All scans were performed in approximately 5 minutes for each eye by a single experienced ophthalmologist, masked from the subject's disease status.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Marmara University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

09.2021.240

Identifier Type: -

Identifier Source: org_study_id