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Novel spectacle lenses versus single-vision spectacle lenses on the progression of myopia in children: A randomised clinical trial
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注册号:

Registration number:

ChiCTR-TRC-09000476 

最近更新日期:

Date of Last Refreshed on:

2015-05-15 

注册时间:

Date of Registration:

2009-08-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

通过比较配戴新型设计眼镜与配戴普通设计眼镜对儿童近视进展控制的随机临床研究 

Public title:

Novel spectacle lenses versus single-vision spectacle lenses on the progression of myopia in children: A randomised clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型设计眼镜控制近视研究 

Scientific title:

Novel spectacle lenses versus single-vision spectacle lenses on the progression of myopia in children: A randomised clinical trial 

研究课题代号(代码):

Study subject ID:

IER2008-021 

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:

陈翔 

研究负责人:

葛坚 

Applicant:

Xiang Chen 

Study leader:

Jian Ge 

申请注册联系人电话:

Applicant telephone:

+86 020 87330351 

研究负责人电话:

Study leader's telephone:

+86 020 87330351 

申请注册联系人传真 :

Applicant Fax:

+86 020 87333271 

研究负责人传真:

Study leader's fax:

+86 020 87333271 

申请注册联系人电子邮件:

Applicant E-mail:

chen1094@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

gejian@mail.sysu.edu.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

www.gzzoc.com 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

www.gzzoc.com 

申请注册联系人通讯地址:

广州市先烈南路54号 

研究负责人通讯地址:

广州市先烈南路54号 

Applicant address:

No.54, Xianlie Road, Guangzhou, China 

Study leader's address:

No.54, Xianlie Road, Guangzhou, China 

申请注册联系人邮政编码:

Applicant postcode:

510060 

研究负责人邮政编码:

Study leader's postcode:

510060 

申请人所在单位:

中山大学中山眼科中心 

Applicant's institution:

Zhongshan Ophthalmic Center, Sun Yat-sen 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:

2008-29 

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:

中山大学中山眼科中心医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Zhongshan Ophthalmic Center, Sun Yat-sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2008-12-06 

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:

中山大学中山眼科中心 

Primary sponsor:

Zhongshan Ophthalmic Center,Sun Yat-Sen University 

研究实施负责(组长)单位地址:

广州市先烈南路54号 

Primary sponsor's address:

No.54, Xianlie Road, Guangzhou, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

澳大利亚

省(直辖市):

NA

市(区县):

Country:

Australia

Province:

NA

City:

单位(医院):

澳大利亚眼科研究所

具体地址:

澳大利亚悉尼贝克街14号门

Institution
hospital:

Institute for Eye Research, Australia

Address:

No.14, Baker Street, Sydney, Australia

经费或物资来源:

澳大利亚眼科研究所 

Source(s) of funding:

Institute for Eye Research, Australia 

研究疾病:

近视眼 

Target disease:

Myopia 

研究疾病代码:

N/A 

Target disease code:

N/A 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

II期临床试验 

Study phase:

研究目的:

通过比较配戴普通眼镜和新型设计眼镜来观察其对近视度数进展的影响 

Objectives of Study:

To compare myopia progression in experimental groups of three different type of single-vision spectacle lenses compared with that of the control group. 

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. 6至12岁儿童; 2. 近视度数介于-0.75 D到-3.50 D间,散光少于-1.50 D; 3. 愿意依从研究的要求配戴眼镜和定时复诊; 4. 愿意只配戴研究者提供的眼镜; 5. 眼科检查正常; 6. 视力至少能矫正到6/9.5或以上。 

Inclusion criteria

1. Be male or female between 6 and 12 years old; 2. Be myopic (short-sighted) -0.75 D to -3.50 D with astigmatism no more than -1.50 D; 3. Be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator; 4. Be willing to wear only the spectacles provided by the Investigators; 5. Have ocular health findings considered to be "normal"; 6. Have vision correctable to at least 6/9.5 or better in each eye with spectacles. 

排除标准:

1. 已知对“脱品酰胺”或表麻药过敏者; 2. 屈光参差超过1.00 D者; 3. 任一眼散光超过-1.50 D者; 4. 有斜视或弱视者; 5. 过往曾经做过眼部手术者(包括斜视手术); 6. 患有任何可能影响屈光变化的全身系统性疾病(如马凡综合症、糖尿病等); 7. 患有任何可能影响屈光变化的眼科疾病(如圆锥角膜等); 8. 过往12月内配戴过双光镜或渐进镜者; 9. 过往12月内配戴过OK镜者; 10. 正在接受OK镜治疗或视觉训练者; 11. 有任何生理或解剖情况不适合配戴框架眼镜者; 12. 正在参加另外一项临床研究者. 

Exclusion criteria:

1. A known allergy to, or a history of intolerance to tropicamide or topical anaesthetics; 2. Be anisometropic by more than 1.00 D; 3. Astigmatism more than -1.50 D in either eye; 4. Had strabismus and/or amblyopia; 5. Had previous eye surgery (including strabismus surgery); 6. Any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity, diabetes; 7. Had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids; 8. Worn bifocal or progressive addition spectacles in the previous 12 months; 9. Worn orthokeratology lenses in the previous 12 months; 10. Current orthoptic treatment or vision training; 11. Any anatomical, skin or other condition that would impact on the wearing of spectacles; 12. Current enrolment in another clinical trial. 

研究实施时间:

Study execute time:

From2009-08-01To 2011-12-31 

征募观察对象时间:

Recruiting time:

From2009-08-01To 2009-09-30 

干预措施:

Interventions:

组别:

E组

样本量:

50

Group:

Group E

Sample size:

干预措施:

E型特殊设计眼镜

干预措施代码:

Intervention:

Iteration E

Intervention code:

组别:

G组

样本量:

50

Group:

Group G

Sample size:

干预措施:

G型特殊设计眼镜

干预措施代码:

Intervention:

Iteration G

Intervention code:

组别:

F组

样本量:

50

Group:

Group F

Sample size:

干预措施:

F型特殊设计眼镜

干预措施代码:

Intervention:

Iteration F

Intervention code:

组别:

H组

样本量:

50

Group:

Group H

Sample size:

干预措施:

正常设计眼镜(对照组)

干预措施代码:

Intervention:

control group

Intervention code:

组别:

总数

样本量:

200

Group:

Total

Sample size:

干预措施:

分别配戴三种新型设计眼镜和一组普通设计眼镜

干预措施代码:

Intervention:

Single-vision spectacle lenses (differing only from commercially-available lenses by slightly steeper front surface curvature) fitted to commercially-available frames

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学中山眼科中心 

单位级别:

三甲医院,眼科学国家重点实验室 

Institution
hospital:

Zhongshan Ophthalmic Center, Sun Yat-sen University  

Level of the institution:

Tertiary hospital 

测量指标:

Outcomes:

指标中文名:

睫状肌麻痹验光

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:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 6 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):

随机数字表

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

Random Number Table

盲法:

200名研究参与者 是 分为四组

Blinding:

Participants: yes

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):

中山大学中山眼科中心

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

Zhongshan Ophthalmic Center, Sun Yat-sen University

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:

澳大利亚眼科研究所

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

Institute for Eye Research, Australia

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2009-08-04
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