Today is 2017-12-19

Clinical treatment and analysis of risk factors of central serous chorioretinopathy
download

注册号:

Registration number:

ChiCTR-IPR-16008428 

最近更新日期:

Date of Last Refreshed on:

2016-05-06 

注册时间:

Date of Registration:

2016-05-06 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

心性浆液性脉络膜视网膜病变患者临床治疗及危险因素分析 

Public title:

Clinical treatment and analysis of risk factors of central serous chorioretinopathy 

研究课题的正式科学名称:

中心性浆液性脉络膜视网膜病变患者临床治疗及危险因素分析 

Scientific title:

Clinical treatment and analysis of risk factors of central serous chorioretinopathy 

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:

袁松涛 

研究负责人:

刘庆淮 

Applicant:

Songtao Yuan 

Study leader:

Qinghuai Liu 

申请注册联系人电话:

Applicant telephone:

+86 15951088899 

研究负责人电话:

Study leader's telephone:

+86 13901585755 

申请注册联系人传真 :

Applicant Fax:

+86 025-68136470 

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:

yuansongtao@vip.sina.com 

研究负责人电子邮件:

Study leader's E-mail:

liuqh@njmu.edu.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:

南京市广州路300号 

研究负责人通讯地址:

南京市广州路300号 

Applicant address:

300 Guangzhou road, Nanjing, Jiangsu, China 

Study leader's address:

300 Guangzhou road, Nanjing, Jiangsu, 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:

南京医科大学第一附属医院 

Applicant's institution:

The First Affiliated Hospital of Nanjing 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:

2014-SR-176 

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:

南京医科大学第一附属医院伦理委员会 

Name of the ethic committee:

The First Affiliated Hospital of Nanjing Medical University ethic committee 

伦理委员会批准日期:

Date of approved by ethic committee:

 

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:

南京医科大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital of Nanjing Medical University 

研究实施负责(组长)单位地址:

南京市广州路300号 

Primary sponsor's address:

300 Guangzhou road, Nanjing, Jiangsu, 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):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

南京医科大学第一附属医院

具体地址:

南京市广州路300号

Institution
hospital:

The First Affiliated Hospital of Nanjing Medical University

Address:

300 Guangzhou road, Nanjing, Jiangsu, China

经费或物资来源:

省市级科研课题 

Source(s) of funding:

Provincial and municipal scientific research projects  

研究疾病:

中心性浆液性脉络膜视网膜病变 

Target disease:

central serous chorioretinopathy 

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:

预试验 

Study phase:

Pilot study 

研究目的:

1. 主要目的:研究CSC患者血浆激素水平,判断其与疾病预后的关系。 2. 次要目的:使用拮抗醛固酮受体拮抗剂螺内酯治疗CSC,监测其效果。 

Objectives of Study:

main purpose:To study the level of plasm hormone of CSC and judge the relationship between aldosterone and the prognosis of CSC. secondary purpose:To use spironolactone(aldosterone receptor antagonist) to treat CSC and monitor its effects. 

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:

1.光学相干断层扫描显示:视网膜神经上皮层与RPE层之间有局限性浆液性脱离。眼底荧光血管造影显示:RPE水平有局限性荧光渗漏。 2.年龄大于18岁。 3.有视网膜下积液存在并且伴随主观症状例如视力下降或者视物变形。 

Inclusion criteria

1.FFA showing a focal leak at the level of the RPE,a subretinal detachment of the retinal photoreceptors from the RPE layer was demonstrated by spectral-domain OCT; 2.patients aged >=18 years; 3.existence of subretinal fluid (SRF) with subjective symptoms such as decreased vision or metamorphopsia. 

排除标准:

1.妊娠或哺乳的女性,螺内酯可能会对此类患者有不良作用。 2.伴随服用糖皮质激素或者相关药物。 3.库欣综合征,糖尿病等其他系统性疾病 4.伴有其他眼病:CNV,PCV,AMD,高度近视等。 5.经过治疗的CSC:激光治疗、光动力治疗、抗VEGF等。 6.高血压、糖尿病、高血脂等全身病变,以上病变本身会影响血管生成相关细胞因子表达,可能会干扰实验结果; 

Exclusion criteria:

1. current pregnancy; 2. history of taking corticosteroids or related drugs; 3. systemic diseases such as endogenous hypercortisolism, and diabetic; 4. Macular disorders such as idiopathic choroidal neovascularization, polypoidal choroidal vasculopathy, and age-related macular degeneration were excluded from the study; 5. eyes with a history of previous treatment, including macular photocoagulation, photodynamic therapy, or intravitrealantivascular endothelial growth factor injection, also were excluded; 6. High blood pressure, diabetes, hyperlipidemia and other systemic diseases. 

研究实施时间:

Study execute time:

From2013-07-01To 2018-12-31 

干预措施:

Interventions:

组别:

I(急性中浆)

样本量:

100

Group:

I(acute CSC)

Sample size:

干预措施:

观察

干预措施代码:

Intervention:

observation

Intervention code:

组别:

II(急性中浆)

样本量:

100

Group:

II(acute CSC)

Sample size:

干预措施:

口服螺内酯

干预措施代码:

Intervention:

oral spironolactone

Intervention code:

组别:

III(慢性中浆)

样本量:

100

Group:

III(chronic CSC)

Sample size:

干预措施:

口服螺内酯

干预措施代码:

Intervention:

oral spironolactone

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

南京医科大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Nanjing Medical University  

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:

BCVA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

光学相干断层扫描

指标类型:

主要指标 

Outcome:

OCT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

醛固酮水平

指标类型:

主要指标 

Outcome:

aldosterone level

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:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

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 years
最大 Max age 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):

实验者用软件产生随机数

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

Experimenters used software to generate random numbe

盲法:

Blinding:

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:

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):

计划研究对象试验和随访完成后,将原始数据公开于ResMan平台以便公众查询

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

we will share the individual participant date in ResMan research manager untill the all the trial and follow-up finished.

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:

计划采用ResMan临床试验公共管理平台进行数据保存和管理

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

we plan to use ResMan research manager to manage the individual participant data.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-05-06
返回列表