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.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Istanbul, 칠면조, 34899
- Marmara University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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각막 신경 섬유 밀도(CNFD)
기간: 기준선
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신경 섬유 자동 추적 프로그램 - CCMetrics(CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK)를 사용하여 CNFD를 분석했습니다.
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기준선
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Corneal nerve fiber density (CNFD)
기간: 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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각막 신경 분지 밀도(CNBD)
기간: 기준선
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신경 섬유 자동 추적 프로그램 - CCMetrics(CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK)를 사용하여 CNBD를 분석했습니다.
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기준선
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Corneal nerve branch density (CNBD)
기간: 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 CNBD.
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6 Month
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Corneal nerve fiber length (CNFL)
기간: Baseline
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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 CNFL.
|
Baseline
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Corneal nerve fiber length (CNFL)
기간: 6 Months
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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 CNFL.
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6 Months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dendritic Cells
기간: Baseline
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the number of DCs counted by ImageJ's Cell Counter plug-in
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Baseline
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Dendritic Cells
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 09.2021.240
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