注册号: Registration number: |
ChiCTR2000030193 |
最近更新日期: Date of Last Refreshed on: |
2020-02-25 |
注册时间: Date of Registration: |
2020-02-25 |
注册号状态: |
补注册 |
Registration Status: |
Retrospective registration |
注册题目: |
请与我们联系上传伦理批件 应用融合法在角膜地形图引导的个性化角膜屈光手术矫正近视散光 |
Public title: |
Mutual Comparative Analysis (MCA): a new method to modify refraction using topography-guided custom ablations treatment (T-CAT) |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
应用融合法在角膜地形图引导的个性化角膜屈光手术矫正近视散光 |
Scientific title: |
Mutual Comparative Analysis (MCA): a new method to modify refraction using topography-guided custom ablations treatment (T-CAT) |
研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
申请注册联系人: |
曹开伟 |
研究负责人: |
刘莛 |
Applicant: |
Cao KaiWei |
Study leader: |
Liu Ting |
申请注册联系人电话: Applicant telephone: |
+86 17721861763 |
研究负责人电话: Study leader's telephone: |
+86 15823486785 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
ckw125@126.com |
研究负责人电子邮件: Study leader's E-mail: |
tingliu1597@126.com |
申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
重庆市渝中区长江支路10号 |
研究负责人通讯地址: |
重庆市渝中区长江支路10号 |
Applicant address: |
10 Changjiang Branch Road, Yuzhong District, Chongqing, China |
Study leader's address: |
10 Changjiang Branch Road, Yuzhong District, Chongqing, China |
申请注册联系人邮政编码: Applicant postcode: |
研究负责人邮政编码: Study leader's postcode: |
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申请人所在单位: |
陆军军医大学大坪医院眼科 |
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Applicant's institution: |
Department of Ophthalmology, Daping Hospital, Army Medical University of PLA |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
2017-48 |
伦理委员会批件附件: Approved file of Ethical Committee: |
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批准本研究的伦理委员会名称: |
陆军军医大学第三附属医院伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of the Third Affiliated Hospital of Army Medical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
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伦理委员会联系人: |
王晶晶 |
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Contact Name of the ethic committee: |
Wang JingJing |
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伦理委员会联系地址: |
重庆市渝中区长江支路10号 |
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Contact Address of the ethic committee: |
10 Changjiang Branch Road, Yuzhong District, Chongqing, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
研究实施负责(组长)单位: |
陆军军医大学大坪医院眼科 |
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Primary sponsor: |
Department of Ophthalmology, Daping Hospital, 3rd Military Medical University (army medical university) of PLA |
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研究实施负责(组长)单位地址: |
重庆市渝中区长江支路10号 |
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Primary sponsor's address: |
10 Changjiang Branch Road, Yuzhong District, Chongqing, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自筹 |
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Source(s) of funding: |
Self financing |
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研究疾病: |
近视 |
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Target disease: |
myopia |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
Study phase: |
N/A |
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研究目的: |
介绍一种新的屈光不正矫正方法——融合法(MCA)。 |
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Objectives of Study: |
To demonstrate a new method called Mutual Comparative Analysis (MCA) for correcting ametropia, which is based on manifest refraction and corneal topographic data and combined with the patient's subjective perception. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
单臂 |
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Study design: |
Single arm |
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纳入标准: |
近视手术患者,年龄大于18岁小于35岁,中央角膜厚度500-600微米,非接触眼压大于10小于21mmHg,术前两年内屈光度变化小于0.5D,术前显然验光与角膜地形图测得的散光在量和轴位上存在较大差异(量大于0.75D或轴位大于10度),超过了FDA法的应用条件,有通过角膜屈光手术治疗近视的愿望。 |
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Inclusion criteria |
The power or axis (or both) of the astigmatism between manifest refraction and corneal topographic data were different (power>0.75D or/and axis>10degrees) in these eyes preoperatively. |
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排除标准: |
除近视以外的其它眼部疾病史 |
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Exclusion criteria: |
History of eye diseases other than myopia |
研究实施时间: Study execute time: |
从From2016-08-01至To 2019-06-30 |
征募观察对象时间: Recruiting time: |
从From2016-08-01至To 2018-08-31 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
结束 Completed |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
None |
盲法: |
N/A |
Blinding: |
N/A |
试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
是Yes |
共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
通过ResMan提供原始数据查询 |
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
IPD will be public accessable via ResMan |
数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
病例记录表、电子数据采集和管理系统 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Case Record Form、Electronic Data Capture |
数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |