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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Istanbul, Kalkon, 34899
- Marmara University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Control
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Korneal nervfiberdensitet (CNFD)
Tidsram: Baslinje
|
Program för automatiserad spårning av nervfibrer - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, Storbritannien) användes för att analysera CNFD.
|
Baslinje
|
|
Corneal nerve fiber density (CNFD)
Tidsram: 6 Month
|
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFD.
|
6 Month
|
|
Hornhinnas nervgrendensitet (CNBD)
Tidsram: Baslinje
|
Automatiserad spårning av nervtrådsprogram - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, Storbritannien) användes för att analysera CNBD.
|
Baslinje
|
|
Corneal nerve branch density (CNBD)
Tidsram: 6 Month
|
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNBD.
|
6 Month
|
|
Corneal nerve fiber length (CNFL)
Tidsram: Baseline
|
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFL.
|
Baseline
|
|
Corneal nerve fiber length (CNFL)
Tidsram: 6 Months
|
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFL.
|
6 Months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Dendritic Cells
Tidsram: Baseline
|
the number of DCs counted by ImageJ's Cell Counter plug-in
|
Baseline
|
|
Dendritic Cells
Tidsram: 6 Months
|
the number of DCs counted by ImageJ's Cell Counter plug-in
|
6 Months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 09.2021.240
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .