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Study for assessment of imaging of choroidopathy of diabetic choroidopathy and for the method of quantitative analysis
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注册号:

Registration number:

ChiCTR2000033074 

最近更新日期:

Date of Last Refreshed on:

2020-05-19 

注册时间:

Date of Registration:

2020-05-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

糖尿病脉络膜病变影像学评估与量化分析方法研究 

Public title:

Study for assessment of imaging of choroidopathy of diabetic choroidopathy and for the method of quantitative analysis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

糖尿病脉络膜病变影像学评估与量化分析方法研究 

Scientific title:

Study for assessment of imaging of choroidopathy of diabetic choroidopathy and for the method of quantitative analysis 

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:

沈胤忱 

研究负责人:

沈胤忱 

Applicant:

Yinchen Shen 

Study leader:

Yinchen Shen 

申请注册联系人电话:

Applicant telephone:

+86 13661459663 

研究负责人电话:

Study leader's telephone:

+86 13661459663 

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:

shen_yinchen@163.com 

研究负责人电子邮件:

Study leader's E-mail:

shen_yinchen@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:

上海市虹口区海宁路100号 

研究负责人通讯地址:

上海市虹口区海宁路100号 

Applicant address:

100 Haining Road, Hongkou District, Shanghai, China 

Study leader's address:

100 Haining Road, Hongkou District, Shanghai, 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:

上海市第一人民医院 

Applicant's institution:

Shanghai General 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:

2020SQ292 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

上海市第一人民医院人体试验伦理审查委员会 

Name of the ethic committee:

The Ethics Committee of Shanghai General Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-05-18 

伦理委员会联系人:

江一峰 

Contact Name of the ethic committee:

Yifeng Jiang 

伦理委员会联系地址:

上海市虹口区海宁路100号 

Contact Address of the ethic committee:

100 Haining Road, Hongkou District, Shanghai, 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:

上海市第一人民医院 

Primary sponsor:

Shanghai General Hospital 

研究实施负责(组长)单位地址:

上海市虹口区海宁路100号 

Primary sponsor's address:

100 Haining Road, Hongkou District, Shanghai, 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):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市第一人民医院

具体地址:

上海市虹口区海宁路100号

Institution
hospital:

Shanghai General Hospital

Address:

100 Haining Road, Hongkou District, Shanghai

经费或物资来源:

自筹经费 

Source(s) of funding:

self-financing 

研究疾病:

糖尿病脉络膜病变 

Target disease:

diabetic choroidopathy 

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:

研究目的:

本课题的主要研究目的是:通过前瞻性、观察性临床研究,寻找和DR发生发展有关的脉络膜影像学特征性生物标记物,确定预测指标及其界值。同时探索脉络膜毛细血管血流量化分析方法,建立准确、高效的糖尿病脉络膜病变评价标准与定量方法,早期预警潜在DR高危人群,为DR的预防干预提供新的方法和思路。 

Objectives of Study:

The main purpose of this study is to search for biomarkers of choroid imaging characteristics related to the occurrence and development of DR through prospective and observational clinical studies, and to determine the predictors and their boundary values. Meanwhile, the quantitative analysis method of blood flow in choroid capillaries was explored to establish an accurate and efficient evaluation standard and quantitative method for diabetic choroid lesions, so as to give early warning to potential high-risk groups of DR and provide new methods and ideas for prevention and intervention of DR. 

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)选取年龄≥18岁中国汉族人群1型或2型糖尿病患者,性别不限; 2)随机血糖≥11.1mmol/L或空腹血糖(FBG)≥7.0mmol/; 3)具有正常思维和语言沟通交流能力,能够积极配合完成检查; 4)了解本研究的背景、目的,同意参加本研究并签署知情同意书。 

Inclusion criteria

1) patients with type 1 or type 2 diabetes in Chinese han population aged >=18 years; 2) random blood glucose >=11.1mmol/L or fasting blood glucose (FBG)>=7.0mmol/L; 3) have normal thinking and language communication skills, and can actively cooperate to complete the inspection; 4) understand the background and purpose of this study, agree to participate in this study and sign the informed consent. 

排除标准:

1)合并有其他黄斑病变如黄斑前膜、玻璃体黄斑牵引、年龄相关性黄斑变性等; 2)高度近视或高度远视; 3)固视不良、严重屈光间质混浊影响脉络膜成像者; 4)妊娠状态; 5)合并眼部外伤或急性炎症等; 6)其他经研究者判断不适合参与研究的情况。 

Exclusion criteria:

1) patients with other macular lesions, such as anterior macular membrane, vitreous macular traction, age-related macular degeneration, etc. 2) high myopia or high hyperopia; 3) patients with poor fixation and severe refractive interstitium turbidity affect choroid imaging; 4) pregnancy status; 5) combined with eye trauma or acute inflammation; 6) other situations judged by the researcher to be unsuitable for the study. 

研究实施时间:

Study execute time:

From2020-05-19To 2022-05-31 

征募观察对象时间:

Recruiting time:

From2020-05-19To 2022-05-31 

干预措施:

Interventions:

组别:

糖尿病非DR组

样本量:

50

Group:

DM without retinopathy

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

组别:

轻度非增殖性糖尿病视网膜病变(NPDR)组

样本量:

50

Group:

mild NPDR

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

组别:

中度非增殖性糖尿病视网膜病变(NPDR)组

样本量:

50

Group:

moderate NPDR

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

组别:

重度非增殖性糖尿病视网膜病变(NPDR)组

样本量:

50

Group:

severe NPDR

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

组别:

增殖性糖尿病视网膜病变(PDR)组

样本量:

50

Group:

PDR

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海市 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市第一人民医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai General Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

脉络膜厚度

指标类型:

主要指标 

Outcome:

Thickness of the choroid

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 100 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):

NA

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

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:

病例记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-19
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