成人coats病的一例病例报道

注册号:

Registration number:

ChiCTR2500115842 

最近更新日期:

Date of Last Refreshed on:

2025-12-31 16:27:49 

注册时间:

Date of Registration:

2025-12-31 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

成人coats病的一例病例报道

Public title:

Adult-Onset Coats Disease in a 61-Year-Old Woman: A Case Report

注册题目简写:

English Acronym:

研究课题的正式科学名称:

成人coats病的一例病例报道

Scientific title:

Adult-Onset Coats Disease in a 61-Year-Old Woman: A Case Report

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:

李娜 

研究负责人:

李娜 

Applicant:

Na Li 

Study leader:

Na Li 

申请注册联系人电话:

Applicant telephone:

+86 191 1259 7969

研究负责人电话:

Study leader's
telephone:

+86 23 5810 3168

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:

928802338@qq.com

研究负责人电子邮件:

Study leader's E-mail:

928802338@qq.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:

重庆市万州区新城路165号

研究负责人通讯地址:

新城路165号

Applicant address:

No.165,xincheng Road,Wanzhou Distict,Chongqing

Study leader's address:

165 Xincheng Road, Wanzhou District, Chongqing

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:

重庆大学附属三峡医院

Applicant's institution:

Chongqing University Three Gorges Hospital

研究负责人所在单位:

重庆大学附属三峡医院(重庆三峡中心医院)

Affiliation of the Leader:

Chongqing University Three Gorges Hospital(Chongqing Three Gorges Central 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:

2025年科伦审第(151)号

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:

重庆大学附属三峡医院伦理委员会

Name of the ethic committee:

Ethics Committee of Three Gorges Hospital affiliated to Chongqing University

伦理委员会批准日期:

Date of approved by ethic committee:

2025-12-23 00:00:00

伦理委员会联系人:

陈利

Contact Name of the ethic committee:

Chen Li

伦理委员会联系地址:

新城路165号

Contact Address of the ethic committee:

165 Xincheng Road, Wanzhou District, Chongqing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 23 5810 3788

伦理委员会联系人邮箱:

Contact email of the ethic committee:

690692361@qq.com

研究实施负责(组长)单位:

重庆大学附属三峡医院(重庆三峡中心医院)

Primary sponsor:

Chongqing University Three Gorges Hospital(Chongqing Three Gorges Central Hospital)

研究实施负责(组长)单位地址:

新城路165号

Primary sponsor's address:

165 Xincheng Road, Wanzhou District, Chongqing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆市

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆大学附属三峡医院(重庆三峡中心医院)

具体地址:

新城路165号

Institution
hospital:

Chongqing University Three Gorges Hospital(Chongqing Three Gorges Central Hospital)

Address:

165 Xincheng Road, Wanzhou District, Chongqing

经费或物资来源:

自选课题(自筹)

Source(s) of funding:

Self-funded

研究疾病:

成人Coats  

Target disease:

Adult Coats

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

研究设计:

病例研究 

Study design:

Case study 

研究目的:

分析少见病的治疗方案,探讨联合治疗方案的优势与预后  

Objectives of Study:

Analyze the treatment plans for rare diseases and explore the advantages and prognosis of combined treatment plans

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:

诊断为其他疾病的视网膜渗出。

Exclusion criteria:

Retinal exudation diagnosed as another disease.

研究实施时间:

Study execute time:

From 2025-12-15 00:00:00 To 2026-06-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-01-01 00:00:00 To 2026-03-01 00:00:00

干预措施:

Interventions:

组别:

成人Coats病

样本量:

1

Group:

Adult Coats disease

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):

重庆市 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆大学附属三峡医院(重庆三峡中心医院) 

单位级别:

三级甲等 

Institution
hospital:

Chongqing University Three Gorges Hospital(Chongqing Three Gorges Central Hospital)

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

眼底照相、视网膜厚度

指标类型:

主要指标

Outcome:

Fundus photography, retinal thickness

Type:

Primary indicator

测量时间点:

术前、术后1月、术后3月、术后6月

测量方法:

眼底照相、OCT

Measure time point of outcome:

Before the operation, 1 month after the operation, 3 months after the operation, 6 months after the

Measure method:

Fundus photography, OCT

指标中文名:

视力

指标类型:

次要指标

Outcome:

Vision

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压

指标类型:

次要指标

Outcome:

Blood pressure

Type:

Secondary 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:

NA

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

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 61 years
最大 Max age 61 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

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

None

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:

None

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):

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

none

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2025-12-31 16:23:44