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有晶体眼后房型折叠式人工晶体植入术中应用角膜松解切口矫正角膜散光的研究
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注册号:

Registration number:

ChiCTR-OOC-15005896 

最近更新日期:

Date of Last Refreshed on:

2015-01-29 

注册时间:

Date of Registration:

2014-09-03 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

有晶体眼后房型折叠式人工晶体植入术中应用角膜松解切口矫正角膜散光的研究 

Public title:

A study on using Limbal Relaxing Incisions for treatment of corneal astigmatism during the surgery of Implantable Collamer Lens Implantation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

有晶状体眼后房型人工晶体植入术后效果的观察与评估 

Scientific title:

Clinical study of Phakic Collamer Lens(ICL) Implantation 

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:

孙炜 

研究负责人:

孔珺 

Applicant:

Sun Wei 

Study leader:

Kong Jun 

申请注册联系人电话:

Applicant telephone:

+86 13234006345 

研究负责人电话:

Study leader's telephone:

+86 13066521123 

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:

sunw2007@126.com 

研究负责人电子邮件:

Study leader's E-mail:

31015460@qq.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:

沈阳市和平区新华路11号 

研究负责人通讯地址:

沈阳市和平区新华路11号 

Applicant address:

No 11 Xinhua Road, Heping District, Shenyang 

Study leader's address:

No 11 Xinhua Road, Heping District, Shenyang 

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:

中国医科大学附属第四医院 

Applicant's institution:

the Fourth Affiliated Hospital of China Medical University 

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:

2007-13 

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:

中国医科大学附属第四医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of the Fourth Affiliated Hospital of China Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2007-05-15 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

中国医科大学附属第四医院 

Primary sponsor:

the Fourth Affiliated Hospital of China Medical University 

研究实施负责(组长)单位地址:

沈阳市和平区新华路11号 

Primary sponsor's address:

No 11 Xinhua Road, Heping District, Shenyang 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

辽宁

市(区县):

Country:

China

Province:

Liaoning

City:

单位(医院):

中国医科大学附属第四医院

具体地址:

沈阳市和平区新华路11号

Institution
hospital:

the Fourth Affiliated Hospital of China Medical University

Address:

No 11 Xinhua Road, Heping District, Shenyang

经费或物资来源:

无 

Source(s) of funding:

Nil 

研究疾病:

屈光不正 

Target disease:

ametropia 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

研究在有晶体眼后房型折叠式人工晶体植入术中应用角膜松解切口来矫正角膜散光的有效性、稳定性和安全性。 

Objectives of Study:

To assess the efficiency, stability and safety of LRIs in the surgery of ICL implantation. 

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:

1.年龄≥18岁;2.常规近视,有手术治疗需求的患者;3.无其他眼科疾病 

Inclusion criteria

Over 18 years old; Patients with ametropia and treatment needs; No other eye diseases. 

排除标准:

存在其他眼科疾病,尤其是角膜疾病 

Exclusion criteria:

Patient complicated with other eye conditions. 

研究实施时间:

Study execute time:

From2007-06-01To 2012-12-31 

征募观察对象时间:

Recruiting time:

From2007-06-01To 2015-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

100

Group:

Case series

Sample size:

干预措施:

角膜松解性切口

干预措施代码:

Intervention:

Limbal Relaxing Incisions

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

中国医科大学附属第四医院 

单位级别:

三甲 

Institution
hospital:

the Fourth Affiliated Hospital of China Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

屈光

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:

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:

视觉质量

指标类型:

主要指标 

Outcome:

Visual quality

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:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 50 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):

N/A

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

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:

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-09-03
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