今天是:2019-08-22 星期四

于笛医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 TNF-α、IL-1β、PGE2、缓激肽对第二眼白内障手术痛觉过敏的调控机理研究
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注册号:

Registration number:

ChiCTR1900023178 

最近更新日期:

Date of Last Refreshed on:

2019-05-15 

注册时间:

Date of Registration:

2019-05-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

于笛医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 TNF-α、IL-1β、PGE2、缓激肽对第二眼白内障手术痛觉过敏的调控机理研究 

Public title:

Regulation mechanism of TNF-alpha, IL-1beta, PGE2 and bradykinin on hyperalgesia in second eye cataract surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

TNF-α、IL-1β、PGE2、缓激肽对第二眼白内障手术痛觉过敏的调控机理研究 

Scientific title:

Regulation mechanism of TNF-alpha, IL-1beta, PGE2 and bradykinin on hyperalgesia in second eye cataract surgery 

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:

于笛 

研究负责人:

杨瑞波 

Applicant:

Yu Di 

Study leader:

Yang Ruibo 

申请注册联系人电话:

Applicant telephone:

+86 18624354326 

研究负责人电话:

Study leader's telephone:

+86 18802295667 

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:

yud1997@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

yangruibo771@163.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:

天津市南开区复康路251号 

研究负责人通讯地址:

天津市南开区复康路251号 

Applicant address:

251 Fukan Road, Nankai District, Tianjin, China 

Study leader's address:

251 Fukan Road, Nankai District, Tianjin, 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:

天津医科大学眼科医院 

Applicant's institution:

Tianjin Medical University Eye Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

天津医科大学眼科医院 

Primary sponsor:

Tianjin Medical University Eye Hospital 

研究实施负责(组长)单位地址:

天津市南开区复康路251号 

Primary sponsor's address:

251 Fukan Road, Nankai District, Tianjin, 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):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津医科大学眼科医院

具体地址:

南开区复康路251号

Institution
hospital:

Tianjin Medical University Eye Hospital

Address:

251 Fukan Road, Nankai District

经费或物资来源:

天津市高等学校科技发展基金计划项目资助 

Source(s) of funding:

Tianjin University Science and Technology Development Fund Project Subsidy 

研究疾病:

第二眼白内障术后痛觉过敏 

Target disease:

Postoperative hyperalgesia of the second eye after cataract surgery 

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:

探索性研究/预试验 

Study phase:

研究目的:

TNF-α及IL-1β对第二眼白内障手术痛觉过敏的调控机理。 

Objectives of Study:

Regulation mechanism of TNF-alpha and IL-1beta on hyperalgesia in second eye cataract surgery. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)神志清楚表达清晰;(2)两只眼在一个月之内均有意向做白内障手术;(3)两只眼白内障程度相近(保证两只眼术中时间相近);(4)两只眼白内障手术均由同一名经验丰富的医生来做。 

Inclusion criteria

(1) clear expression of mind; (2) both eyes intend to perform cataract surgery within a month; (3) the degree of cataract in both eyes is similar (to ensure that the operation time in both eyes is similar); (4) cataract surgery in both eyes is performed by the same experienced doctor. 

排除标准:

(1)术中有并发症的患者;(2)合并糖尿病或全身免疫性疾病;(3)长期服用精神类药物以及非甾体类抗炎药。 

Exclusion criteria:

(1) patients with intraoperative complications; (2) combined with diabetes or systemic immune disease; (3) long-term use of psychotropic drugs and non-steroidal anti-inflammatory drugs. 

研究实施时间:

Study execute time:

From2019-06-30To 2021-06-30 

干预措施:

Interventions:

组别:

试验组

样本量:

45

Group:

test group

Sample size:

干预措施:

两只眼不同时间做白内障手术

干预措施代码:

Intervention:

Cataract surgery in two eyes at different times

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津医科大学眼科医院 

单位级别:

三级甲等 

Institution
hospital:

Tianjin Medical University Eye Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

肿瘤坏死因子α

指标类型:

主要指标 

Outcome:

TNF-α

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白介素1β

指标类型:

主要指标 

Outcome:

IL-1β

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

前列腺素E2

指标类型:

次要指标 

Outcome:

PGE2

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

缓激肽

指标类型:

次要指标 

Outcome:

bradykinin

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:

标本中文名:

房水

组织:

Sample Name:

Aqueous humor

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 60 years
最大 Max age 90 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):

统计学专家利用统计软件产生随机编号。

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

A statistical expert use statistical software to generate randomized numbers.

盲法:

open

Blinding:

open

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

试验完成后6个月内

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

With six months after the trial complete

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

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-05-15
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