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睫状体损伤对开放性眼外伤患者预后影响的多中心前瞻性研究
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注册号:

Registration number:

ChiCTR-OCH-08000202 

最近更新日期:

Date of Last Refreshed on:

2015-05-08 

注册时间:

Date of Registration:

2008-11-28 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

睫状体损伤对开放性眼外伤患者预后影响的多中心前瞻性研究 

Public title:

Multicentre prospective study of prognosis after opening globe injuries with severely injuried ciliary body (SICB). 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

睫状体损伤对开放性眼外伤患者预后影响的多中心前瞻性研究 

Scientific title:

Multicentre prospective study of prognosis after opening globe injuries with severely injuried ciliary body (SICB). 

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:

封康 

研究负责人:

马志中 

Applicant:

Feng Kang 

Study leader:

Ma Zhizhong 

申请注册联系人电话:

Applicant telephone:

+86 0 13391688720 

研究负责人电话:

Study leader's telephone:

+86 0 13801105509 

申请注册联系人传真 :

Applicant Fax:

+86 010 82089951 

研究负责人传真:

Study leader's fax:

+86 010 82089951 

申请注册联系人电子邮件:

Applicant E-mail:

ocufeng@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

puh3_yk@bjmu.edu.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.puec.net.cn 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.puec.net.cn 

申请注册联系人通讯地址:

北京市海淀区花园北路49号 北京大学眼科中心 

研究负责人通讯地址:

北京市海淀区花园北路49号 北京大学眼科中心 

Applicant address:

49 Huayuan north Rd., Haidian District, Beijing, China. 

Study leader's address:

49 Huayuan north Rd., Haidian District, Beijing, China. 

申请注册联系人邮政编码:

Applicant postcode:

100191 

研究负责人邮政编码:

Study leader's postcode:

100191 

申请人所在单位:

北京大学眼科中心 

Applicant's institution:

Eye Center, Peking 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:

NA 

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:

北京大学第三医院伦理委员会 

Name of the ethic committee:

Research Ethics Committee of Peking University Third Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2008-10-27 

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:

北京大学第三医院 

Primary sponsor:

Peking University Eye Center 

研究实施负责(组长)单位地址:

北京市海淀区花园北路49号 

Primary sponsor's address:

No.49, North Huayuan Road, Haidian District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹 

Source(s) of funding:

Self-sponsor 

研究疾病:

眼球开放伤 

Target disease:

Open eye injuried patients, who experienced Vitrectomy or explorative Vitrectomy. 

研究疾病代码:

S05.903 

Target disease code:

S05.903 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

探讨睫状体损伤对眼球开放伤患者预后的影响。 

Objectives of Study:

To investigate the prognosis of patients with severely injuried ciliary body after opening globe injuries. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

开放性眼外伤,且经历玻璃体切除术或探查性玻璃体切除术的患者。 

Inclusion criteria

Open eye injuried patients, who experienced Vitrectomy or explorative Vitrectomy. 

排除标准:

闭合性眼损伤患者;无玻璃体切除手术适应证的开放性眼损伤患者;未经探查性玻璃体切除术而实施眼球摘除的病例。 

Exclusion criteria:

Closed eye injuries' patients; and the opened eye injuries' patients who have no indication of Vitrectomy; and the ones who experienced enucleation without explorative Vitrectomy. 

研究实施时间:

Study execute time:

From1997-01-01To 2009-06-30 

干预措施:

Interventions:

组别:

无睫状体损伤患者

样本量:

0

Group:

Opening globe injuries' patients without SICB.

Sample size:

干预措施:

根据病情需要而采取最适的救治措施,包括:玻璃体切除、视网膜复位、异物摘除(球内异物伤)及眼球内容物填充等术式。无特殊需要研究的干预措施

干预措施代码:

Intervention:

Most adapted operation type was selected. None special treatment

Intervention code:

组别:

睫状体损伤患者

样本量:

0

Group:

Opening globe injuries' patients with SICB.

Sample size:

干预措施:

根据病情需要而采取最适的救治措施,包括:玻璃体切除、视网膜复位、异物摘除(球内异物伤)及眼球内容物填充等术式。无特殊需要研究的干预措施。

干预措施代码:

Intervention:

Most adapted operation type was selected. None special treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第三医院 

单位级别:

三级甲等医院 

Institution
hospital:

The third Beijing university hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

解放军总医院 

单位级别:

三级甲等医院 

Institution
hospital:

Liberation army general hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

同仁医院 

单位级别:

三级甲等医院 

Institution
hospital:

Tongren hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

People's hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第一医院 

单位级别:

三级甲等医院 

Institution
hospital:

The first hospital, Beijing university  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

温州眼视光医院 

单位级别:

三级甲等医院 

Institution
hospital:

Wenzhou eye hospital depends on the light  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

伤后视力,伤后眼压,视网膜脱离范围,睫状体损伤程度,巩膜伤口长度,随访视力,随访眼压,解剖修复结局。

指标类型:

主要指标 

Outcome:

VA and IOP after injury, VA & IOP of follow-up, and outcome of globe.

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼外伤类型,眼外伤分区。

指标类型:

次要指标 

Outcome:

type and zone of eye injury

Type:

Secondary 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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 0 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):

方便选择

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

Convenience Selection

盲法:

符合纳入标准的眼外伤患者 无需盲法

Blinding:

none

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):

北京大学眼科中心

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

Peking University Eye Center

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:

北京大学眼科中心

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

Peking University Eye Center

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2008-11-28
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