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眼前节超声生物显微镜对眼前节相关疾病的观察及开发研究
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注册号:

Registration number:

ChiCTR-DOD-15007603 

最近更新日期:

Date of Last Refreshed on:

2015-12-18 

注册时间:

Date of Registration:

2015-12-17 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

眼前节超声生物显微镜对眼前节相关疾病的观察及开发研究 

Public title:

Observation Research and Development on the Anterior Segment and It Related Diseases Using Anterior Segment Ultrasound Biomicroscopy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

眼前节超声生物显微镜对眼前节相关疾病的观察研究及开发研究 

Scientific title:

Observation Research and Development on the Anterior Segment and It Related Diseases Using Anterior Segment Ultrasound Biomicroscopy 

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:

史铭宇 

研究负责人:

史铭宇 

Applicant:

Mingyu Shi 

Study leader:

Mingyu Shi 

申请注册联系人电话:

Applicant telephone:

+86 18900913663 

研究负责人电话:

Study leader's telephone:

+86 18900913663 

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:

xm5788@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xm5788@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:

沈阳市和平区新华路11号 

研究负责人通讯地址:

沈阳市和平区新华路11号 

Applicant address:

11 Xinhua Road, HePing District, Shenyang, Liaoning, China  

Study leader's address:

11 Xinhua Road, HePing District, Shenyang, Liaoning, China 

申请注册联系人邮政编码:

Applicant postcode:

110005 

研究负责人邮政编码:

Study leader's postcode:

110005 

申请人所在单位:

中国医科大学附属第四医院 

Applicant's institution:

The Fourth Affiliated Hospital of China 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:

2015-029 

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:

中国医科大学附属第四医院医学伦理委员会 

Name of the ethic committee:

The Ethics Committee of the The Fourth Affiliated Hospital of China Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2015-01-05 

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:

中国医科大学附属第四医院 

Primary sponsor:

The Fourth Affiliated Hospital of China Medical University  

研究实施负责(组长)单位地址:

沈阳市皇姑区崇山东路4号 

Primary sponsor's address:

4 Chong-shan Road East, Shenyang, 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):

辽宁

市(区县):

Country:

China

Province:

Liaoning

City:

单位(医院):

中国医科大学附属第四医院

具体地址:

沈阳市皇姑区崇山东路4号

Institution
hospital:

The Fourth Affiliated Hospital of China Medical University

Address:

4 Chong-shan Road East, Shenyang, China

经费或物资来源:

无 

Source(s) of funding:

N/A 

研究疾病:

眼前节相关疾病 

Target disease:

Anterior Segment Related Diseases 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

通过与其他眼前节检查设备比较,探讨眼前节超声生物显微镜在眼科的使用范围和应用价值,为眼前节疾病提供可供参考的术前指导。 

Objectives of Study:

Comparison with other anterior segment examination equipments, discuss the application value of anterior segment ultrasound biomicroscopy in ophthalmology, and provide useful guidance for the preoperative ocular anterior segment diseases. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

诊断性病例对照试验 

Study design:

Diagnostic test: case-control 

纳入标准:

部分正常人群及患有各类眼前节疾病的患者,全身状态良好,能够配合检查者。 

Inclusion criteria

Part of the normal persons, patients with anterior segments diseases in good body conditions and coordinating examination well 

排除标准:

严重眼前节炎症,开放性眼外伤,年龄太小或太大,无法配合检查者 

Exclusion criteria:

Severe ocular anterior segment inflammation, open ocular trauma, patients'age too small or too large to fit examination. 

研究实施时间:

Study execute time:

From2014-10-08To 2017-03-01 

征募观察对象时间:

Recruiting time:

From2014-10-08To 2016-12-31 

诊断试验:

Diagnostic Tests:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

Index test:

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

例数:

Sample size:

0

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

中国医科大学附属第四医院 

单位级别:

三甲 

Institution
hospital:

The Fourth Affiliated Hospital of China Medical University  

Level of the institution:

tertiary A hospital. 

测量指标:

Outcomes:

指标中文名:

图像,眼前节参数

指标类型:

主要指标 

Outcome:

image, Anterior segment parameters

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:

眼球

组织:

Sample Name:

eye

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 5 years
最大 Max age 89 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):

眼科医生明确诊断为眼前节疾病,能够配合检查者即纳入检查序列

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

patients diagnosed as anterior segment diseases by ophthalmologist clearly and coping with the examination well.

盲法:

Blinding:

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:

即时公开/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):

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

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:

Data collection and Management (A standard data collection and management system include a 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:

 2015-12-17
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