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Effects of atropine of low concentration on myopia development for children
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注册号:

Registration number:

ChiCTR-IOR-17013898 

最近更新日期:

Date of Last Refreshed on:

2017-12-14 

注册时间:

Date of Registration:

2017-12-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

低浓度阿托品对学龄儿童近视进展影响的多中心随机对照试验 

Public title:

Effects of atropine of low concentration on myopia development for children 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

低浓度阿托品对学龄儿童近视进展影响的多中心随机对照试验 

Scientific title:

Effects of atropine of low concentration on myopia development for children 

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:

孙芸芸 

研究负责人:

王宁利 

Applicant:

Sun Yunyun 

Study leader:

Wang Ningli 

申请注册联系人电话:

Applicant telephone:

+86 1510037760 

研究负责人电话:

Study leader's telephone:

+86 13511026669 

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:

2008sunshinesyy@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wningli@vip.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:

北京市东城区东交民巷1号 

研究负责人通讯地址:

北京市东城区东交民巷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,北京市眼科研究所 

Applicant's institution:

Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

首都医科大学附属北京同仁医院,北京市眼科研究所 

Primary sponsor:

Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

首都医科大学附属北京同仁医院,北京市眼科研究所 

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,北京市眼科研究所

具体地址:

北京市东城区东交民巷1号

Institution
hospital:

Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University

Address:

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

经费或物资来源:

眼科技术的集成转化与研发 

Source(s) of funding:

Integration, translation and development on Ophthalmic technology 

研究疾病:

近视 

Target disease:

myopia 

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:

其它 

Study phase:

N/A 

研究目的:

明确0.01%低浓度阿托品滴眼液在我国学龄儿童中的有效性、安全性等问题。 

Objectives of Study:

To explore the effects of atropine of low concentration on myopia development for myopic children 

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 

Study design:

Parallel 

纳入标准:

(1). 年龄7-12周岁; (2). 散瞳后验光,双眼等效球镜为-2.0D至-6.00D; (3). 近视进展活跃者(过去一年中屈光度进展至少-0.5D) (4). 双眼中任何一眼最佳矫正视力均大于或等于1.0; (5). 双眼中任何一眼散光小于1.5D; (6). 双眼的屈光参差小于1.00D; (7). 双眼眼内压正常(非接触眼压计CT-80, Topcon, Japan); (8). 双眼无斜视、弱视或其他任何眼球病理性改变; (9). 全身无影响视觉发育或屈光发育的疾病,如糖尿病、纤维组织病变; (10). 过去一年中未规律用哮喘类药物; (11). 已签署本研究的知情同意书  

Inclusion criteria

Aged 7-12 years old; cycloplegic SE: -6.0D to -2.0D; myopia progresses fast(≥0.5D last year); distance corrected visual acuity: greater than or equal to 1.0; astigmatism:less than 1.5D; anisometropia: less than 1.0D; normal ocular pressure; without significantly strabismus or other eye diseases; no systemic diseases which may affecting visual development, such as diabetes; without the use of asthma drugs during the last year; having signed the informed consent.  

排除标准:

(1). 不能配合进行眼科检查; (2). 阿托品用药禁忌者; (3). 双眼视功能缺陷或立体视缺陷者; (4). 之前或目前正在使用阿托品或哌仑西平者; (5). 无法自愿参与本研究或积极性不高; (6). 对阿托品、环戊通、丙美卡因或苯扎氯铵过敏者  

Exclusion criteria:

Those who can't tolerate eye examinations; those with contraindication to atroppine; those with eyes visual function defects or stereo visual defects; those with the applying history of atropine or pirenzepine; those who are unable to voluntarily participate in this study; those who are allergic to atropie, cyclopentanone, proxymetacaine or benzalkonium chloride.  

研究实施时间:

Study execute time:

From2018-01-01To 2023-10-31 

征募观察对象时间:

Recruiting time:

From2018-01-01To 2018-08-31 

干预措施:

Interventions:

组别:

病例组

样本量:

100

Group:

case group

Sample size:

干预措施:

0.01%低浓度阿托品

干预措施代码:

Intervention:

0.01% atropine

Intervention code:

组别:

对照组

样本量:

100

Group:

control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

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,北京市眼科研究所 

单位级别:

三甲医院 

Institution
hospital:

Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

安阳 

Country:

China 

Province:

Henan 

City:

Anyang 

单位(医院):

安阳市眼科医院 

单位级别:

眼科专科医院 

Institution
hospital:

Anyang Eye Hospital  

Level of the institution:

Ophthalmology hospital 

测量指标:

Outcomes:

指标中文名:

屈光度进展

指标类型:

主要指标 

Outcome:

myopia development

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼轴长度进展

指标类型:

主要指标 

Outcome:

development of axial length

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:

组织:

Sample Name:

none

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

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 7 years
最大 Max age 12 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):

根据入组编号,通过SAS统计软件PROC PLAN过程语句,随机分成两组,进行分配观察,并作登记

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

According to the serial number of subjects included, children should be randomly divided into two groups by the PROC PLAN process

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):

是否共享原始数据:

IPD sharing

Yes

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):

本系统

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

this database

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:

CRF, EDC

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

CRF, EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2017-12-13
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