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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
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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:

 

English Acronym:

 

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:

 

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:

 

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):

 

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:

 

申请人所在单位:

陆军军医大学大坪医院眼科 

Applicant's institution:

Department of Ophthalmology, Daping Hospital, Army Medical University of PLA 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

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:

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 

Name of the ethic committee:

Ethics Committee of the Third Affiliated Hospital of Army Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

王晶晶 

Contact Name of the ethic committee:

Wang JingJing 

伦理委员会联系地址:

重庆市渝中区长江支路10号 

Contact Address of the ethic committee:

10 Changjiang Branch Road, Yuzhong District, Chongqing, China  

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 

Primary sponsor:

Department of Ophthalmology, Daping Hospital, 3rd Military Medical University (army medical university) of PLA  

研究实施负责(组长)单位地址:

重庆市渝中区长江支路10号 

Primary sponsor's address:

10 Changjiang Branch Road, Yuzhong District, Chongqing, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

大坪医院

具体地址:

重庆市渝中区长江支路10号

Institution
hospital:

Daping Hospital

Address:

10 Changjiang Branch Road, Yuzhong District

经费或物资来源:

自筹 

Source(s) of funding:

Self financing 

研究疾病:

近视 

Target disease:

myopia 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

介绍一种新的屈光不正矫正方法——融合法(MCA)。 

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.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

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。 

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.  

排除标准:

除近视以外的其它眼部疾病史 

Exclusion criteria:

History of eye diseases other than myopia 

研究实施时间:

Study execute time:

From2016-08-01To 2019-06-30 

征募观察对象时间:

Recruiting time:

From2016-08-01To 2018-08-31 

干预措施:

Interventions:

组别:

Case series

样本量:

120

Group:

Case series

Sample size:

干预措施:

MCA

干预措施代码:

Intervention:

MCA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

大坪医院 

单位级别:

三甲医院 

Institution
hospital:

Daping Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

视力

指标类型:

主要指标 

Outcome:

visual acuity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

屈光状态

指标类型:

主要指标 

Outcome:

refraction

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

光学质量

指标类型:

主要指标 

Outcome:

optical quality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

对比敏感度

指标类型:

主要指标 

Outcome:

contrast sensity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

波前像差

指标类型:

主要指标 

Outcome:

Wavefront aberration

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

N

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

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):

点击下载

Calculated Results after
the Study Completed(upload file):

download

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

注册人:

Name of Registration:

 2020-02-25
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