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Evaluation of Relapse Presence in Multiple Sclerosis

2022年1月20日 更新者：Marmara University

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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

观察性的

注册 (实际的)

87

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 火鸡
      • Istanbul、火鸡、34899
        • Marmara University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Fifty-eight patients with RRMS and 30 HCs were included in the study. The RRMS patients were divided into two subgroups: 1) Thirty-one patients (MS-Control) who were followed up with the diagnosis of RRMS, 2) Twenty-seven patients (MS-Relapse) for whom the administration of intravenous corticosteroids was decided due to the diagnosis of new relapse.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：病例对照
  • 时间观点：预期

队列和干预

团体/队列
干预/治疗
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).
诊断测试：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.
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).
诊断测试：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.
Healthy Controls
Thirty healthy age and gender similar population These subjects underwent Corneal Confocal Microscopy (IVCM).
诊断测试：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
角膜神经纤维密度（CNFD）
大体时间：基线
神经纤维自动追踪程序 - CCMetrics（CCMetrics；M. A. Dabbah，ISBE，曼彻斯特大学，曼彻斯特，英国）用于分析 CNFD。
基线
Corneal nerve fiber density (CNFD)
大体时间：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
角膜神经分支密度（CNBD）
大体时间：基线
神经纤维自动追踪程序 - CCMetrics（CCMetrics；M. A. Dabbah，ISBE，曼彻斯特大学，曼彻斯特，英国）用于分析 CNBD。
基线
Corneal nerve branch density (CNBD)
大体时间：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)
大体时间：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)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Dendritic Cells
大体时间：Baseline
the number of DCs counted by ImageJ's Cell Counter plug-in
Baseline
Dendritic Cells
大体时间：6 Months
the number of DCs counted by ImageJ's Cell Counter plug-in
6 Months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Marmara University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年1月1日

初级完成 (实际的)

2021年10月1日

研究完成 (实际的)

2022年1月1日

研究注册日期

首次提交

2022年1月20日

首先提交符合 QC 标准的

2022年1月20日

首次发布 (实际的)

2022年2月1日

研究记录更新

最后更新发布 (实际的)

2022年2月1日

上次提交的符合 QC 标准的更新

2022年1月20日

最后验证

2022年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 09.2021.240

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

罕见疾病

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