ChiCTR-TRC-13004032 版本V3.3 版本创建时间2025/05/08 17:14:01 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR-TRC-13004032 

最近更新日期：

Date of Last Refreshed on：

 2021-07-07 22:59:41 

注册时间：

Date of Registration：

 2013-12-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

低濃度阿托品眼藥水對近視進展控制之研究

Public title：

Low Concentration Atropine for Myopia Progression Study (LAMP)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

低濃度阿托品眼藥水對近視進展控制之研究

Scientific title：

Low Concentration Atropine for Myopia Progression Study (LAMP)

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：

CUHK_CCT00383

申请注册联系人：

Ms. Jennifer Tsoi 

研究负责人：

Dr. Yam Cheuk Sing Jason 

Applicant：

Ms. Jennifer Tsoi 

Study leader：

Dr. Yam Cheuk Sing Jason 

申请注册联系人电话：

Applicant telephone：

 +852 3943 5818

研究负责人电话：

Study leader's
telephone：

+852 39435892

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：

 jennifertsoi@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 yamcheuksing@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/222

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/222

申请注册联系人通讯地址：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, 3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

研究负责人通讯地址：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, 3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

Applicant address：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, 3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

Study leader's address：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, 3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

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：

香港中文大學

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

The Chinese University of Hong Kong

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：

 KC/KE-13-0182/FR-2

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：

Kowloon Central Cluster REC / Kowloon East Cluster REC

Name of the ethic committee：

Kowloon Central Cluster REC / Kowloon East Cluster REC

伦理委员会批准日期：

Date of approved by ethic committee：

 2013-11-19 00:00:00

伦理委员会联系人：

Ms Lyon Chan

Contact Name of the ethic committee：

Ms Lyon Chan

伦理委员会联系地址：

Kowloon Central Cluster REC / Kowloon East Cluster REC

Contact Address of the ethic committee：

Kowloon Central Cluster REC / Kowloon East Cluster REC

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：

香港中文大學眼科及視覺科學學系

Primary sponsor：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

Primary sponsor's address：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

Source(s) of funding：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

研究疾病：

Myopia  

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

不同濃度阿托品眼藥水在近視加深控制之研究  

Objectives of Study：

Evaluation of different regimen and concentration of low dose topical atropine in retarding myopia progression

药物成份或治疗方案详述：

Group 1: 0.05% atropine both eyes once daily; Group 2: 0.025% atropine both eyes once daily; Group 3: 0.01% atropine both eyes once daily Phase 1 (first year): Children in the group 4 will use 0.9% normal saline only for 1 year. Phase 2 (second year): After one year, children in this group will switch to 0.05% atropine daily treatment group. Group 1, 2 and 3 of atropine treatment will be continued for one year. The myopia progression status will be assessed at the end of this period. Phase 3 (third year): Group 1, 2, and 3 are further randomized with half to atropine-continued group (according to their original concentrations 0.05%, 0.025%, 0.01%), and half to washout group.. The myopia progression status will be assessed at the end of the washout period. If the progression is -0.5D or more during the washout period, the original treatment in the first two years will be reapplied to these children for two more years. Phase 4 (fourth and fifth year): All drops will be switched to 0.05% atropine eye drops, accordingly to the following two treatment regimens: 1) Atropine-continued group; and 2) PRN treatment group. Atropine-continued group: All subjects from the atropine-continued group 0.05%, 0.025%, and 0.01% who had completed the 3-years follow up in Phase 3 will be recruited into atropine-continued group. 0.05% atropine eye drops daily will be administered to both eyes till end of year 5, regardless of the myopia progression rate during the previous year. PRN group: All subjects from the washout group 0.05%, 0.025%, and 0.01% who had completed the 3-years follow up in Phase 3 will be recruited into the PRN group. Protocol for restart treatment: atropine 0.05% will be restarted if myopic SE progressed 0.5D or more in either eye in the past one-year period, either during the washout period, or during the follow up of year 4 and year 5. Duration for treatment: atropine 0.05% will be used for at least one year. If myopia progresses less than 0.5D during the one-year treatment period, atropine drops will be stopped. Subjects will be continued for follow up at 6-months interval till end of year 5. If myopia progresses 0.5D or more, treatment will be continued for one more year or till end of year 5. 

Description for medicine or protocol of treatment in detail：

Group 1: 0.05% atropine both eyes once daily; Group 2: 0.025% atropine both eyes once daily; Group 3: 0.01% atropine both eyes once daily Phase 1 (first year): Children in the group 4 will use 0.9% normal saline only for 1 year. Phase 2 (second year): After one year, children in this group will switch to 0.05% atropine daily treatment group. Group 1, 2 and 3 of atropine treatment will be continued for one year. The myopia progression status will be assessed at the end of this period. Phase 3 (third year): Group 1, 2, and 3 are further randomized with half to atropine-continued group (according to their original concentrations 0.05%, 0.025%, 0.01%), and half to washout group.. The myopia progression status will be assessed at the end of the washout period. If the progression is -0.5D or more during the washout period, the original treatment in the first two years will be reapplied to these children for two more years. Phase 4 (fourth and fifth year): All drops will be switched to 0.05% atropine eye drops, accordingly to the following two treatment regimens: 1) Atropine-continued group; and 2) PRN treatment group. Atropine-continued group: All subjects from the atropine-continued group 0.05%, 0.025%, and 0.01% who had completed the 3-years follow up in Phase 3 will be recruited into atropine-continued group. 0.05% atropine eye drops daily will be administered to both eyes till end of year 5, regardless of the myopia progression rate during the previous year. PRN group: All subjects from the washout group 0.05%, 0.025%, and 0.01% who had completed the 3-years follow up in Phase 3 will be recruited into the PRN group. Protocol for restart treatment: atropine 0.05% will be restarted if myopic SE progressed 0.5D or more in either eye in the past one-year period, either during the washout period, or during the follow up of year 4 and year 5. Duration for treatment: atropine 0.05% will be used for at least one year. If myopia progresses less than 0.5D during the one-year treatment period, atropine drops will be stopped. Subjects will be continued for follow up at 6-months interval till end of year 5. If myopia progresses 0.5D or more, treatment will be continued for one more year or till end of year 5. 

纳入标准：

1. Aged 4 to 12 years;
2. Myopia : SE -1 to -10 D;
3. Astigmatism: < 2.5 D;
4. Anisometropia: < 2.0 D;
5. History of myopia progression > 0.5 D for both eye in one year;
6. Informed parental consent.

Inclusion criteria

1. Aged 4 to 12 years;
2. Myopia : SE -1 to -10 D;
3. Astigmatism: < 2.5 D;
4. Anisometropia: < 2.0 D;
5. History of myopia progression > 0.5 D for both eye in one year;
6. Informed parental consent.

排除标准：

1. Ophthalmic diseases other than refractive errors;
2. Previous use of treatment of atropine;
3. Allergy or intolerance to atropine;
4. Inability to attend regular follow up assessment.

Exclusion criteria：

1. Ophthalmic diseases other than refractive errors;
2. Previous use of treatment of atropine;
3. Allergy or intolerance to atropine;
4. Inability to attend regular follow up assessment.

研究实施时间：

Study execute time：

从 From 2014-01-02 00:00:00至 To 2022-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2014-01-02 00:00:00 至 To 2019-01-31 00:00:00

干预措施：

Interventions：

组别：

Four groups

样本量：

 500

Group：

Four groups

Sample size：

干预措施：

Group 1: 0.05% atropine both eyes once daily; Group 2: 0.025% atropine both eyes once daily; Group 3: 0.01% atropine both eyes once daily; Group 4 will use 0.9% normal saline (placebo) both eyes once daily (to be switched to Group 1 after one year)

干预措施代码：

Intervention：

Group 1: 0.05% atropine both eyes once daily; Group 2: 0.025% atropine both eyes once daily; Group 3: 0.01% atropine both eyes once daily; Group 4 will use 0.9% normal saline (placebo) both eyes once daily (to be switched to Group 1 after one year)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 The Chinese University of Hong Kong 

单位级别：

 The Chinese University of Hong Kong 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

The Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

Change in spherical equivalent refraction (cycloplegic refraction)

指标类型：

主要指标

Outcome：

Change in spherical equivalent refraction (cycloplegic refraction)

Type：

Primary indicator

测量时间点：

测量方法：

Autorefractometer

Measure time point of outcome：

Measure method：

Autorefractometer

指标中文名：

Change in axial length

指标类型：

主要指标

Outcome：

Change in axial length

Type：

Primary indicator

测量时间点：

测量方法：

IOL master

Measure time point of outcome：

Measure method：

IOL master

指标中文名：

Safety variables: Self-reported visual function, best corrected visual acuity, pupil size, intraocular pressure, ocular and systemic symptoms, ocular signs , heart rate and blood pressure

指标类型：

次要指标

Outcome：

Safety variables: Self-reported visual function, best corrected visual acuity, pupil size, intraocular pressure, ocular and systemic symptoms, ocular signs , heart rate and blood pressure

Type：

Secondary indicator

测量时间点：

测量方法：

Questionnaire, ETDRS chart, applanation, pupilometer, slit lamp biomicroscopy and binocular indirect ophthalmoscopy

Measure time point of outcome：

Measure method：

Questionnaire, ETDRS chart, applanation, pupilometer, slit lamp biomicroscopy and binocular indirect ophthalmoscopy

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 4 岁 years
最大 Max age 12 岁 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）：

RCT, Subjects will be assigned to 4 arms

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

RCT, Subjects will be assigned to 4 arms

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Double-blind

Blinding：

Double-blind

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

Not stated

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

Not stated

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：

Not stated

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2013-12-24 00:00:00