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.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
-
Istanbul、七面鳥、34899
- Marmara University
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：ケースコントロール
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
角膜神経線維密度 (CNFD)
時間枠：ベースライン
|
神経線維の自動トレースプログラム - CMetrics (CCMetrics; M. A. Dabbah, ISBE、マンチェスター大学、マンチェスター、英国) を使用して CNFD を分析しました。
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ベースライン
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Corneal nerve fiber density (CNFD)
時間枠：6 Month
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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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角膜神経枝密度 (CNBD)
時間枠：ベースライン
|
神経線維の自動トレースプログラム - CMetrics (CCMetrics; M. A. Dabbah, ISBE、マンチェスター大学、マンチェスター、英国) を使用して CNBD を分析しました。
|
ベースライン
|
|
Corneal nerve branch density (CNBD)
時間枠：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)
時間枠：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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Dendritic Cells
時間枠：Baseline
|
the number of DCs counted by ImageJ's Cell Counter plug-in
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Baseline
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Dendritic Cells
時間枠：6 Months
|
the number of DCs counted by ImageJ's Cell Counter plug-in
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6 Months
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 09.2021.240
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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