Evaluation of Relapse Presence in Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

Evaluation of Relapse Presence in Multiple Sclerosis Patients by Cross-Sectional In-Vivo Corneal Confocal Microscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05218317
• Other study ID #: 09.2021.240
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2022
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis Relapse
• Multiple Sclerosis, Relapsing-Remitting
• Recurrence
• Sclerosis

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal nerve fiber density (CNFD)	Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFD.	Baseline
Primary	Corneal nerve fiber density (CNFD)	Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFD.	6 Month
Primary	Corneal nerve branch density (CNBD)	Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNBD.	Baseline
Primary	Corneal nerve branch density (CNBD)	Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNBD.	6 Month
Primary	Corneal nerve fiber length (CNFL)	Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFL.	Baseline
Primary	Corneal nerve fiber length (CNFL)	Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFL.	6 Months
Secondary	Dendritic Cells	the number of DCs counted by ImageJ's Cell Counter plug-in	Baseline
Secondary	Dendritic Cells	the number of DCs counted by ImageJ's Cell Counter plug-in	6 Months