今天是:2018-04-21 星期六

自体富血小板血浆治疗重度干眼的临床研究
下载XML文档

注册号:

Registration number:

ChiCTR-INR-16009161 

最近更新日期:

Date of Last Refreshed on:

2016-09-18 

注册时间:

Date of Registration:

2016-09-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

自体富血小板血浆治疗重度干眼的临床研究 

Public title:

Severe Dry Eye Treatment with Autologous Platelet-Rich Plasma 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

自体富血小板血浆治疗重度干眼的临床研究 

Scientific title:

Severe Dry Eye Treatment with Autologous Platelet-Rich Plasma 

研究课题代号(代码):

Study subject ID:

重庆卫生计生委医学科研计划项目2016MSXM145 

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:

蔡明铭 

研究负责人:

蔡明铭 

Applicant:

Cai Mingming 

Study leader:

Cai Mingming 

申请注册联系人电话:

Applicant telephone:

+86 15696107998 

研究负责人电话:

Study leader's telephone:

+86 15696107998 

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:

mm198222@126.com 

研究负责人电子邮件:

Study leader's E-mail:

mm198222@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:

重庆市北碚区嘉陵村129号5-11-3 

研究负责人通讯地址:

重庆市北碚区嘉陵村129号5-11-3 

Applicant address:

129 Jialing Road, Chongqing, China 

Study leader's address:

129 Jialing Road, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

400700 

研究负责人邮政编码:

Study leader's postcode:

400700 

申请人所在单位:

重庆市第九人民医院 

Applicant's institution:

The Ninth People's Hospital of Chongqing 

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:

20160817 

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:

重庆市第九人民医院伦理委员会 

Name of the ethic committee:

Institutional Ethics Committee of the Ninth People's Hospital of Chongqing 

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:

重庆市第九人民医院 

Primary sponsor:

The Ninth People's Hospital of Chongqing 

研究实施负责(组长)单位地址:

重庆市北碚区嘉陵村69号 

Primary sponsor's address:

69 Jialing Road, 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):

重庆市第九人民医院

具体地址:

重庆市北碚区嘉陵村69号

Institution
hospital:

The Ninth People's Hospital of Chongqing

Address:

69 Jialing Road, Chongqing, China

经费或物资来源:

重庆市卫生计生委医学科研计划项目2016MSXM145 

Source(s) of funding:

Chongqing Municipal Health Bureau 2016MSXM145 

研究疾病:

干眼 

Target disease:

Dry Eye 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

研究自体富血小板血浆治疗重度干眼的临床疗效,开辟干眼治疗的新途径。 

Objectives of Study:

Investigate the potential use of autologous platelet-rich plasma in the treatment of severe dry eye. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

符合重度干眼的诊断标准;年龄18-60岁;排除其他眼科疾病;临床症状大于6个月,使用常规治疗3月以上疗效不明显;近2周未用其他治疗方法和药物;自愿参加本临床研究,签署知情同意书。 

Inclusion criteria

A previous diagnosis of severe dry eye; aged 18-60 years; symptom duration more than 6 months; conventional treatment with poor or no response; without any other treatment more than 2 weeks; all patients signed an informed consent before beginning therapy. 

排除标准:

合并有心血管、脑血管、肝、肾和造血系统等严重全身性疾病及精神病患者;合并其他眼病者;配戴角膜接触镜;轻中度干眼患者;.治疗前2周使用其他治疗方法和药物者;不符合纳入标准,不愿意接受本疗法。 

Exclusion criteria:

Exclude severe systemic disease and psychiatric patients; complicated with other eye diseases; wear contact lens;slight to moderate dry eye; Use other treatment within 2 weeks;did not accord with the Inclusion criteria; unwilling to accept this therapy. 

研究实施时间:

Study execute time:

From2016-09-15To 2017-02-15 

干预措施:

Interventions:

组别:

治疗组

样本量:

40

Group:

Treatment Group

Sample size:

干预措施:

自体富血小板血浆眼液,每日3次,每次1滴,疗程28天。

干预措施代码:

Intervention:

platelet-rich plasma was given topically as eyedrops, 3 times a day, every time a drop, 28 days

Intervention code:

组别:

对照组

样本量:

40

Group:

Control group

Sample size:

干预措施:

人工泪液,每日3次,每次1滴,疗程28天。

干预措施代码:

Intervention:

artificial tears was given topically as eyedrops, 3 times a day, every time a drop, 28 days

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):

重庆市第九人民医院 

单位级别:

三级甲等 

Institution
hospital:

The Ninth People’s Hospital of Chongqing  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

泪膜破裂时间

指标类型:

主要指标 

Outcome:

BUT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

泪液分泌试验

指标类型:

主要指标 

Outcome:

Schirmer Test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

角膜染色评分

指标类型:

主要指标 

Outcome:

Corneal staining scores

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

干眼症状

指标类型:

主要指标 

Outcome:

Dry eye symptom

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 60 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):

同一名眼科专科医生、随机分组

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

The same ophthalmologist、Random grouping

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):

NA

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

NA

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:

NA

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

NA

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-09-05
返回列表