Evaluation of Relapse Presence in Multiple Sclerosis
Evaluation of Relapse Presence in Multiple Sclerosis Patients by Cross-Sectional In-Vivo Corneal Confocal Microscopy
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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-
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Istanbul, Tacchino, 34899
- Marmara University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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). |
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.
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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). |
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).
|
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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Densità delle fibre nervose corneali (CNFD)
Lasso di tempo: Linea di base
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Per analizzare il CNFD è stato utilizzato il programma di tracciamento automatizzato delle fibre nervose - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK).
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Linea di base
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Corneal nerve fiber density (CNFD)
Lasso di tempo: 6 Month
|
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFD.
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6 Month
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Densità dei rami nervosi corneali (CNBD)
Lasso di tempo: Linea di base
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Per analizzare il CNBD è stato utilizzato il programma di tracciamento automatizzato delle fibre nervose - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK).
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Linea di base
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Corneal nerve branch density (CNBD)
Lasso di tempo: 6 Month
|
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNBD.
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6 Month
|
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Corneal nerve fiber length (CNFL)
Lasso di tempo: Baseline
|
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFL.
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Baseline
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Corneal nerve fiber length (CNFL)
Lasso di tempo: 6 Months
|
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFL.
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6 Months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Dendritic Cells
Lasso di tempo: Baseline
|
the number of DCs counted by ImageJ's Cell Counter plug-in
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Baseline
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Dendritic Cells
Lasso di tempo: 6 Months
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the number of DCs counted by ImageJ's Cell Counter plug-in
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6 Months
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Collaboratori e investigatori
Sponsor
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattie del sistema nervoso
- Malattie del sistema immunitario
- Malattie autoimmuni demielinizzanti, SNC
- Malattie autoimmuni del sistema nervoso
- Malattie demielinizzanti
- Malattie autoimmuni
- Attributi della malattia
- Sclerosi multipla
- Sclerosi
- Sclerosi multipla, recidivante-remittente
- Ricorrenza
Altri numeri di identificazione dello studio
- 09.2021.240
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