Today is 2019-12-12

Lhasa Childhood Eye Study
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注册号:

Registration number:

ChiCTR1900026693 

最近更新日期:

Date of Last Refreshed on:

2019-10-19 

注册时间:

Date of Registration:

2019-10-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

拉萨儿童眼病研究 

Public title:

Lhasa Childhood Eye Study 

注册题目简写:

LCES 

English Acronym:

LCES 

研究课题的正式科学名称:

拉萨儿童眼病研究 

Scientific title:

Lhasa Childhood Eye Study 

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:

陈伟伟 

研究负责人:

付晶 

Applicant:

Weiwei Chen 

Study leader:

Jing Fu 

申请注册联系人电话:

Applicant telephone:

+86 18888852990 

研究负责人电话:

Study leader's telephone:

+86 13801218591 

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:

wuren508@163.com 

研究负责人电子邮件:

Study leader's E-mail:

fu_jing@126.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:

北京市东城区东郊民巷1号 

研究负责人通讯地址:

北京市东城区东郊民巷1号 

Applicant address:

1 Dong-Jiao-Min-Xiang, Dongcheng District, Beijing, China 

Study leader's address:

1 Dong-Jiao-Min-Xiang, Dongcheng District, Beijing, 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:

首都医科大学附属北京同仁医院,北京同仁眼科中心,北京市眼科研究所;眼科学与视觉科学北京市重点实验室 

Applicant's institution:

Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University; Beijing Ophthalmology & Visual Sciences Key Laboratory 

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:

等待正式批号中 

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:

首都医科大学附属北京同仁医院伦理委员会 

Name of the ethic committee:

Ethics committee of Beijing tongren hospital affiliated to capital medical university 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-10 

伦理委员会联系人:

常灏 

Contact Name of the ethic committee:

Chang Hao 

伦理委员会联系地址:

北京市东城区东郊民巷1号 

Contact Address of the ethic committee:

1 Dong-Jiao-Min-Xiang, Dongcheng District, Beijing, 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:

首都医科大学附属北京同仁医院 

Primary sponsor:

Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市东城区东郊民巷1号 

Primary sponsor's address:

1 Dong-Jiao-Min-Xiang, Dongcheng District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京同仁医院

具体地址:

北京市东城区东郊民巷1号

Institution
hospital:

Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University

Address:

1 Dong-Jiao-Min-Xiang, Dongcheng District, Beijing, China

经费或物资来源:

北京后生基金会 

Source(s) of funding:

Beijing Hoson Foundation 

研究疾病:

儿童眼病,近视眼 

Target disease:

childhood eye disease, myopia 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health Services Research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

利用五年队列研究探索位于中国西南青藏高原地区的拉萨市儿童近视及其他儿童眼病的患病率、发病率及危险因素 

Objectives of Study:

To explore the prevalence, incidence and risk factors of myopia and other ocular diseases in children in the Tibetan plateau region of southwest China by a five year cohort study 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1.拉萨市城区小学1年级学生; 2.在拉萨市居住半年以上并长期居住者; 3.自愿参加本研究。 

Inclusion criteria

1. Grade 1 students in urban primary school of Lhasa; 2. Those who have lived in Lhasa for more than half a year and will live there for a long time; 3. Voluntary participation in this study. 

排除标准:

1.患有精神疾病,不能配合完成基线资料调查及随访者; 2.迁入拉萨市居住不足半年,流动性人口; 3.因某种原因不能签署知情同意书者。 

Exclusion criteria:

1. Suffering from mental illness and unable to cooperate with the completion of baseline data survey and follow-up; 2. Live in Lhasa for less than half a year, with floating population; 3. The informed consent cannot be signed for any reason. 

研究实施时间:

Study execute time:

From2019-10-16To 2024-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

1855

Group:

Case series

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):

西藏自治区 

市(区县):

拉萨 

Country:

China 

Province:

Tibet Tibetan Autonomous Region 

City:

Lhasa 

单位(医院):

拉萨市妇幼保健院 

单位级别:

二级甲等医院 

Institution
hospital:

Lhasa maternal and child health care center  

Level of the institution:

Second A Hospital 

测量指标:

Outcomes:

指标中文名:

问卷

指标类型:

主要指标 

Outcome:

questionnaire

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

远视力

指标类型:

主要指标 

Outcome:

distant visual accuity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

近视力

指标类型:

主要指标 

Outcome:

near visual accuity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼生物学指标

指标类型:

主要指标 

Outcome:

ocular biometry

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

散瞳后电脑验光

指标类型:

主要指标 

Outcome:

cycloplegic autorefraction

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

调节力检查

指标类型:

主要指标 

Outcome:

accommodative response

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

OCT 检查

指标类型:

次要指标 

Outcome:

OCT test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼底照相

指标类型:

次要指标 

Outcome:

retinal photography

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

斜视专科检查

指标类型:

次要指标 

Outcome:

identification of amblyopia and strabismus

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身高

指标类型:

次要指标 

Outcome:

height

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重

指标类型:

次要指标 

Outcome:

weight

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:

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):

由统计师李蕾,采用SAS 9.4软件产生随机序列,将拉萨地区3个区27所学校共计6274小学一年级人群中进行随机整群抽样,最后7所学校入选,基线样本量为1855例。

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

By statistician li lei, SAS 9.4 software was used to generate a random sequence, and random cluster sampling was conducted among the first-grade population of 6274 primary schools from 27 schools in 3 districts in Lhasa area. Finally, 7 schools were selected, with a baseline sample size of 1,855 cases.

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):

杂志论文发表

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

Scientific paper

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,EPIDATA电子录入

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

CRF, electronic data input by EPIDATA

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-10-19
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