今天是:2019-05-24 星期五

玻璃体切除术治疗糖尿病视网膜病变
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注册号:

Registration number:

ChiCTR1900023182 

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:

玻璃体切除术治疗糖尿病视网膜病变 

Public title:

Surgical Treatment for proliferative Diabetic Retinopathy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

玻璃体切除术治疗糖尿病视网膜病变 

Scientific title:

Surgical Treatment for proliferative Diabetic Retinopathy 

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:

梁旭 

研究负责人:

张悦 

Applicant:

Xu Liang 

Study leader:

Yue Zhang 

申请注册联系人电话:

Applicant telephone:

+86 15822357231 

研究负责人电话:

Study leader's telephone:

+86 15602061989 

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:

zhongguol985@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhongguol985@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:

天津市和平区甘肃路4号 

研究负责人通讯地址:

天津市和平区甘肃路4号 

Applicant address:

4 Gansu Road, Heping District, Tianjin, China 

Study leader's address:

4 Gansu Road, Heping 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:

天津市眼科医院 

Applicant's institution:

Tianjin Eye Hospital 

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:

TJYYLL-2018-01 

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:

天津眼科医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Tianjin Eye Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

湛宝民 

Contact Name of the ethic committee:

Bao-min Zhan 

伦理委员会联系地址:

天津市和平区甘肃路4号 

Contact Address of the ethic committee:

4 Gansu Road, Heping District, Tianjin, China 

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:

天津市眼科医院 

Primary sponsor:

Tianjin Eye Hospital 

研究实施负责(组长)单位地址:

天津市和平区甘肃路4号 

Primary sponsor's address:

4 Gansu Road, Heping 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):

和平

Country:

China

Province:

Tianjin

City:

Heping

单位(医院):

天津市眼科医院

具体地址:

天津市和平区甘肃路4号

Institution
hospital:

Tianjin Eye Hospital

Address:

4 Gansu Road, Heping District, Tianjin, China

经费或物资来源:

国家自然基金 

Source(s) of funding:

National Natural Science Foundation of China  

研究疾病:

糖尿病视网膜病变 

Target disease:

Diabetic Retinopathy 

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:

研究糖尿病视网膜病手术治疗的预后及相关并发症 

Objectives of Study:

The purpose of this study is to evaluate the prevalence of NVG and other complications after modern vitrectomy techniques, investigate how variables assessed before and after vitrectomy are associated with the BCVAof patients after PDR 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:

连续入组 

Study design:

Sequential 

纳入标准:

大于18岁,根据DR分期标准确诊为Ⅴ~Ⅵ期的严重PDR、符合手术指征者 

Inclusion criteria

1. aged ≥ 18 years; 2. patients who had diabetic vitrectomy due to PDR, including non-clearing vitreous hemorrhage more than 3 months, fibrovascular membranes of the retina, or traction retinal detachment (TRD) 

排除标准:

(1)曾接受过玻切手术、玻璃体腔抗VEGF药物注射及其他眼内手术者;(2)除年龄相关性白内障及屈光不正外,有其他合并眼部疾患者;(3)严重心脏疾病、脑血管疾病、肝肾功能不全及其他手术禁忌证的PDR患者。 

Exclusion criteria:

1. Eyes with a history of glaucoma, neovascularization of the iris (NVI), ocular trauma, uveitis, intraocular injection or vitrectomy, or evidence of other vitreoretinal disease; 2. patients which is not satisfied with glycemic or blood pressure control before surgery. 

研究实施时间:

Study execute time:

From2019-05-13To 2022-05-31 

干预措施:

Interventions:

组别:

Case series

样本量:

500

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):

天津 

市(区县):

和平 

Country:

China 

Province:

Tianjin 

City:

Hepin 

单位(医院):

天津市眼科医院 

单位级别:

三级甲等 

Institution
hospital:

Tianjin Eye Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

最佳矫正视力

指标类型:

主要指标 

Outcome:

Best correct visual acuity

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:

标本中文名:

组织:

Sample Name:

blood

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 18 years
最大 Max age 75 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

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

non-randomization

盲法:

N/A

Blinding:

N/A

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:

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):

http://www.chictr.org.cn/addproject2.aspx

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

http://www.chictr.org.cn/addproject2.aspx

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:

利用Epidata数据库管理数据

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

Epidata software

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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