请与我们联系上传伦理审查文件,研究计划书,知情同意书模板。 研究青光眼治疗前后眼部血管血流变化

注册号:

Registration number:

ChiCTR2200059048 

最近更新日期:

Date of Last Refreshed on:

2023-01-08 21:04:27 

注册时间:

Date of Registration:

2022-04-23 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

请与我们联系上传伦理审查文件,研究计划书,知情同意书模板。 研究青光眼治疗前后眼部血管血流变化

Public title:

Study on the changes of ocular vascular blood flow before and after glaucoma treatment

注册题目简写:

English Acronym:

研究课题的正式科学名称:

研究青光眼治疗前后眼部血管血流变化

Scientific title:

Study on the changes of ocular vascular blood flow before and after glaucoma treatment

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:

王芷晴 

研究负责人:

王婷 

Applicant:

Zhiqing Wang 

Study leader:

Ting Wang 

申请注册联系人电话:

Applicant telephone:

+86 17616778007

研究负责人电话:

Study leader's
telephone:

+86 13869182795

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:

wangzhiqing8007@163.com

研究负责人电子邮件:

Study leader's E-mail:

wt-ting@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:

山东省济南市市中区经四路372号

研究负责人通讯地址:

山东省济南市市中区经四路372号

Applicant address:

372 Jingsi Road, Shizhong District, Jinan, Shandong

Study leader's address:

372 Jingsi Road, Shizhong District, Jinan, Shandong

申请注册联系人邮政编码:

Applicant postcode:

250021

研究负责人邮政编码:

Study leader's postcode:

250021

申请人所在单位:

山东省眼科医院

Applicant's institution:

Shandong Eye Hospital

研究负责人所在单位:

山东省眼科医院

Affiliation of the Leader:

Shandong Eye Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

202205

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:

山东省眼科医院

Name of the ethic committee:

Shandong Eye Hospital Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

1990-01-01 00:00:00

伦理委员会联系人:

亓晓琳

Contact Name of the ethic committee:

Xiaolin Qi

伦理委员会联系地址:

山东省济南市市中区经四路372号

Contact Address of the ethic committee:

372 Jingsi Road, Shizhong District, Jinan, Shandong

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:

山东省眼科医院

Primary sponsor:

Shandong Eye Hospital

研究实施负责(组长)单位地址:

山东省济南市市中区经四路372号

Primary sponsor's address:

372 Jingsi Road, Shizhong District, Jinan, Shandong

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山东

市(区县):

济南

Country:

China

Province:

Shandong

City:

Jinan

单位(医院):

山东省眼科医院

具体地址:

山东省济南市市中区经四路372号

Institution
hospital:

Shandong Eye Hospital

Address:

372 Jingsi Road, Shizhong District, Jinan, Shandong

经费或物资来源:

泰山学者;山东省自然科学基金项目

Source(s) of funding:

20150215, ZR2019MH135

研究疾病:

青光眼  

Target disease:

Glaucoma

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:

探索性研究/预试验 

Study phase:

0

研究设计:

病例对照研究 

Study design:

Case-Control study 

研究目的:

研究青光眼治疗前后眼部血管血流变化  

Objectives of Study:

To study the changes of ocular vascular blood flow before and after glaucoma treatment

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1. 眼底病变致血流变化者。

Exclusion criteria:

1. Changes in blood flow caused by fundus lesions.

研究实施时间:

Study execute time:

From 2022-06-01 00:00:00 To 2024-06-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2022-05-01 00:00:00 To 2024-05-01 00:00:00

干预措施:

Interventions:

组别:

Case series

样本量:

100

Group:

Case series

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

山东 

市(区县):

济南 

Country:

China

Province:

Shandong

City:

Jinan

单位(医院):

山东省眼科医院 

单位级别:

三甲 

Institution
hospital:

Shandong Eye Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

视力

指标类型:

主要指标

Outcome:

Vision

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼压

指标类型:

主要指标

Outcome:

Intraocular pressure, IOP

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼动脉血流参数

指标类型:

主要指标

Outcome:

Ophthalmic artery blood flow parameters

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 10 years
最大 Max age 80 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):

非随机对照实验

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

Non-randomized controlled trial

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法:

Blinding:

是否共享原始数据:

IPD sharing

否No

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,http://www.medresman.org.cn

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, http://www.medresman.org.cn

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:

山东第一医科大学附属眼科医院-山东省眼科医院

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

Eye hospital of Shandong first medical universtiy-Shandong Eye hospital

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-04-23 13:21:20