今天是:2020-09-23 星期三

应用OCTA分析特发性黄斑前膜玻璃体切除术后黄斑微血管系统的特点
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注册号:

Registration number:

ChiCTR2000031289 

最近更新日期:

Date of Last Refreshed on:

2020-03-26 

注册时间:

Date of Registration:

2020-03-26 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

应用OCTA分析特发性黄斑前膜玻璃体切除术后黄斑微血管系统的特点 

Public title:

A study analyzing macular microvasculature features after vitrectomy using OCT angiography in patients with idiopathic macular epiretinal membrane  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

应用血流成像OCT对黄斑前膜患者术前血流改变与 术后视功能恢复的相关性研究 

Scientific title:

Study on the correlation between preoperative macular microvasculature features changes and postoperative vision in patients with idiopathic macular epiretinal membrane by OCTA 

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:

劳吉梦 

研究负责人:

沈丽君 

Applicant:

Jimeng Lao 

Study leader:

Lijun Shen 

申请注册联系人电话:

Applicant telephone:

+86 15067895750 

研究负责人电话:

Study leader's telephone:

+86 13868302929 

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:

475811835@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

slj@mail.eye.ac.cn 

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:

浙江省杭州市江干区凤起东路618号 

研究负责人通讯地址:

浙江省杭州市江干区凤起东路618号 

Applicant address:

618 Fengqi Road East, Jianggan District, Hangzhou, Zhejiang, China 

Study leader's address:

618 Fengqi Road East, Jianggan District, Hangzhou, Zhejiang, 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:

温州医科大学附属眼视光医院 

Applicant's institution:

Eye hospital of Wenzhou Medical 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:

2019168K160 

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:

温州医科大学附属眼视光医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Eye Hospital of Wenzhou medical university 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-09-17 

伦理委员会联系人:

俞阿勇 

Contact Name of the ethic committee:

Ayong Yu 

伦理委员会联系地址:

浙江省温州市鹿城区学院西路270号 

Contact Address of the ethic committee:

270 Xueyuan Road West, Lucheng District, Wenzhou, Zhejiang, 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:

温州医科大学附属眼视光医院 

Primary sponsor:

Eye Hospital of Wenzhou Medical University 

研究实施负责(组长)单位地址:

浙江省杭州市江干区凤起东路618号 

Primary sponsor's address:

618 Fengqi Road East, Jianggan District, Hangzhou, Zhejiang, 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):

浙江

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

温州医科大学附属眼视光医院

具体地址:

浙江省杭州市江干区凤起东路618号

Institution
hospital:

Eye Hospital of Wenzhou Medical University

Address:

618 Fengqi Road East, Jianggan District, Hangzhou

经费或物资来源:

温州市基础研究项目 

Source(s) of funding:

Wenzhou basic scientific research project 

研究疾病:

特发性黄斑 

Target disease:

idiopathic macular epiretinal membrane 

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

To evaluate postoperative changes in retinal capillary plexus and to assess contributing factors in postoperative visual improvement using optical coherence tomography angiography (OCT-A) in patients with idiopathic epiretinal membrane (iERM) post membrane removal. 

Objectives of Study:

To evaluate postoperative changes in retinal capillary plexus and to assess contributing factors in postoperative visual improvement using optical coherence tomography angiography (OCT-A) in patients with idiopathic epiretinal membrane (iERM) post membrane removal. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1. Patients with iERM scheduled for vitrectomy between March 2016 and December 2017; 2. Patients were followed for six months after surgery. 

Inclusion criteria

1. Patients with iERM scheduled for vitrectomy between March 2016 and December 2017; 2. Patients were followed for six months after surgery. 

排除标准:

(1) any previous ocular surgery in the study and fellow eyes; (2) any vitreoretinopathy secondary to causes other than iERM in the study and fellow eyes; (3) opacification of the refractive medium caused by any factors such as severe cataract. 

Exclusion criteria:

(1) any previous ocular surgery in the study and fellow eyes; (2) any vitreoretinopathy secondary to causes other than iERM in the study and fellow eyes; (3) opacification of the refractive medium caused by any factors such as severe cataract. 

研究实施时间:

Study execute time:

From2019-08-01To 2019-12-31 

征募观察对象时间:

Recruiting time:

From2019-08-01To 2019-12-31 

干预措施:

Interventions:

组别:

iERM group

样本量:

35

Group:

iERM group

Sample size:

干预措施:

vitrectomy

干预措施代码:

Intervention:

vitrectomy

Intervention code:

组别:

正常对照组(对侧健眼)

样本量:

25

Group:

Normal control group

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

温州医科大学附属眼视光医院 

单位级别:

三甲医院 

Institution
hospital:

Eye Hospital of Wenzhou Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

FAZ parameters

指标类型:

主要指标 

Outcome:

FAZ parameters

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

vessel density

指标类型:

主要指标 

Outcome:

vessel density

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

best corrected visual acuity

指标类型:

主要指标 

Outcome:

best corrected 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:

No

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 47 years
最大 Max age 78 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):

Patients with iERM scheduled for vitrectomy were enrolled at the Eye Hospital of Wenzhou Medical University between March 2016 and December 2017. Patients were followed for six months after surgery.

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

Patients with iERM scheduled for vitrectomy were enrolled at the Eye Hospital of Wenzhou Medical University between March 2016 and December 2017. Patients were followed for six months after surgery.

盲法:

N/A

Blinding:

N/A

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):

ResMan临床试验公共管理平台

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

The datasets are available from the study leader on reasonable request. ResMan

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:

CRF and an electronic data capture

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

CRF and an electronic data capture

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-03-26
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