中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR-TRC-13004032
最近更新日期： Date of Last Refreshed on：	2026-03-02 14:11:00
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 (LAMP-1) Study
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 (LAMP-1) 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：	CUHK_CCT00383

申请注册联系人：	Ms. Jennifer Tsoi	研究负责人：	Prof. Yam Cheuk Sing Jason
Applicant：	Ms. Jennifer Tsoi	Study leader：	Prof. 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：	Room 414, Nurse Quarters, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong, 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：

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：

国家：	China	省(直辖市)：	Hong Kong SAR	市(区县)：
Country：	China	Province：	Hong Kong SAR	City：
单位(医院)：	The Chinese University of Hong Kong	具体地址：	3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon
Institution hospital：	The Chinese University of Hong Kong	Address：	3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

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; Group 4: 0.9% normal saline 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), Three groups 0.05%, 0.025%, and 0.01% atropine, each was further randomized 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. Phase 5 (sixth and seventh year), All subjects who are using atropine will be grouped and randomized to continue group and wean off group in 1:1 ratio; while those who stop using atropine will be assigned to the observation group for monitoring of long-term effect. The observation group will be monitored continuously for every 6 months at year 6 and year 7. Continue group: All subjects will be administered with 0.05% atropine eye drops to both eyes for 1 year and stopped the treatment for the next year with continuous follow up for every 6 months. Wean off group: All subjects will be administered with 0.05% atropine eye drops to both eyes for the first 6 months and 0.025% atropine eye drops to both eyes for next 6 months and stopped the treatment for the second year with continuous follow up for every 6 months. Phase 6 (eighth to tenth year), All subjects who use atropine eye drops during Phases 1-5 will be recruited for Phase 6. All participants have used low concentration atropine at various concentrations for 5 to 6 years. Treatment has been stopped at year 6 in all participants. No further treatment will be provided in this phase; instead, they will be monitored every 12 months for 3 years (Years 8, 9, and 10). For those participants’ progress more than 0.5 D per year during this phase, they will exit the study to either restart the treatment or to receive alternative intervention.

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; Group 4: 0.9% normal saline 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), Three groups 0.05%, 0.025%, and 0.01% atropine, each was further randomized 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. Phase 5 (sixth and seventh year), All subjects who are using atropine will be grouped and randomized to continue group and wean off group in 1:1 ratio; while those who stop using atropine will be assigned to the observation group for monitoring of long-term effect. The observation group will be monitored continuously for every 6 months at year 6 and year 7. Continue group: All subjects will be administered with 0.05% atropine eye drops to both eyes for 1 year and stopped the treatment for the next year with continuous follow up for every 6 months. Wean off group: All subjects will be administered with 0.05% atropine eye drops to both eyes for the first 6 months and 0.025% atropine eye drops to both eyes for next 6 months and stopped the treatment for the second year with continuous follow up for every 6 months. Phase 6 (eighth to tenth year), All subjects who use atropine eye drops during Phases 1-5 will be recruited for Phase 6. All participants have used low concentration atropine at various concentrations for 5 to 6 years. Treatment has been stopped at year 6 in all participants. No further treatment will be provided in this phase; instead, they will be monitored every 12 months for 3 years (Years 8, 9, and 10). For those participants’ progress more than 0.5 D per year during this phase, they will exit the study to either restart the treatment or to receive alternative intervention.

纳入标准：

Inclusion criteria

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 2026-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2014-01-02 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：	Group 1	样本量：	125
Group：	Group 1	Sample size：	125
干预措施：	0.05% atropine both eyes once daily	干预措施代码：
Intervention：	0.05% atropine both eyes once daily	Intervention code：

组别：	Group 2	样本量：	125
Group：	Group 2	Sample size：	125
干预措施：	0.025% atropine both eyes once daily	干预措施代码：
Intervention：	0.025% atropine both eyes once daily	Intervention code：

组别：	Group 3	样本量：	125
Group：	Group 3	Sample size：	125
干预措施：	0.01% atropine both eyes once daily	干预措施代码：
Intervention：	0.01% atropine both eyes once daily	Intervention code：

组别：	Group 4	样本量：	125
Group：	Group 4	Sample size：	125
干预措施：	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：	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：

标本中文名：	blood	组织：
Sample Name：	blood	Tissue：
人体标本去向	使用后保存	说明
Fate of sample：	Preservation after use	Note：

标本中文名：	buccal swab	组织：
Sample Name：	buccal swab	Tissue：
人体标本去向	使用后保存	说明
Fate of sample：	Preservation after use	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	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）：

1. First Randomization (conducted in Phase 1) We adopt permuted-block randomization stratified by age range of subjects. In each strata (or age group) subjects will be assigned to 4 arms (atropine 0.05% once daily, atropine 0.025% once daily, atropine 0.01%, normal saline 0.9%) based on randomization codes generated by the permuted-block randomization with random allocation within each block. SAS® is used to generate the randomization table for each age group. The block size and detailed method in generation of randomization codes is kept confidential throughout the study by statistician. 2. Second Randomization (conducted in Phase 3) In Phase 3, at completion of two-years follow up, the subjects in each atropine group (0.05%, 0.025%, and 0.01%) were randomized to either atropine-continued group or washout group for 1 year, stratified by gender and age groups (8-10,11-13,14-16): 1) Atropine-continued group: half of the subjects from atropine 0.05%, 0.025%, and 0.01% continued their original concentration of atropine eye drops; 2) Washout group: half of the subjects from atropine 0.05%, 0.025%, and 0.01% stopped the treatment but continued regular follow up for monitoring. 3.Third Randomization (conducted in Phase 5) In Phase 5, at completion of five-year follow up, the subjects who was using atropine will be grouped and then randomized to continue group and wean off group in 1:1 ratio.

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

1. First Randomization (conducted in Phase 1) We adopt permuted-block randomization stratified by age range of subjects. In each strata (or age group) subjects will be assigned to 4 arms (atropine 0.05% once daily, atropine 0.025% once daily, atropine 0.01%, normal saline 0.9%) based on randomization codes generated by the permuted-block randomization with random allocation within each block. SAS® is used to generate the randomization table for each age group. The block size and detailed method in generation of randomization codes is kept confidential throughout the study by statistician. 2. Second Randomization (conducted in Phase 3) In Phase 3, at completion of two-years follow up, the subjects in each atropine group (0.05%, 0.025%, and 0.01%) were randomized to either atropine-continued group or washout group for 1 year, stratified by gender and age groups (8-10,11-13,14-16): 1) Atropine-continued group: half of the subjects from atropine 0.05%, 0.025%, and 0.01% continued their original concentration of atropine eye drops; 2) Washout group: half of the subjects from atropine 0.05%, 0.025%, and 0.01% stopped the treatment but continued regular follow up for monitoring. 3.Third Randomization (conducted in Phase 5) In Phase 5, at completion of five-year follow up, the subjects who was using atropine will be grouped and then randomized to continue group and wean off group in 1:1 ratio.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

1.The study is designed as a double blinded clinical trial. The assignment of groups will not be disclosed to the subjects and investigators. 2.All types of eye drops (atropine 0.05%, atropine 0.025%, atropine 0.01% and normal saline 0.9%) are contained in the same type of bottle and are delivered to the investigator and subjects by project coordinator. 3.All the optometrists responsible for assessing the study outcomes are not informed about the treatment that the children having. 4.We ensure the statisticians are unaware of treatment assignment.

Blinding：

1.The study is designed as a double blinded clinical trial. The assignment of groups will not be disclosed to the subjects and investigators. 2.All types of eye drops (atropine 0.05%, atropine 0.025%, atropine 0.01% and normal saline 0.9%) are contained in the same type of bottle and are delivered to the investigator and subjects by project coordinator. 3.All the optometrists responsible for assessing the study outcomes are not informed about the treatment that the children having. 4.We ensure the statisticians are unaware of treatment assignment.

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）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	None
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：	Patient data would be handled with utmost care taking care not to breach patient's privacy in any form. Personal data is kept anonymous with unidentifiable code on study document and will follow the HA policy on handling of patient data privacy. To protect patient privacy, all research data would be handled in line with HA/Hospital’s policy in handling/storage/destruction of patients’ medical records. They would be locked in cabinets where the department/ward keeps patients' confidential information. Electronic data would be saved in secured computer of the hospital with restricted access. USB Device would not be used for patient information nor personal data. The HKID number is only for the follow-up of health condition and review the medical records from Hospital Authority when necessary. All personal data collected will be kept strictly confidential and for research purpose only. A study code would be used instead. The document of electronic file containing the linkage information between the study code and the identity of the patient would not contain any other information and would be kept separate from the study data files or data sheets with the same stringent security as the medical record. Any documents or electronic files containing personal identifiable information would be considered as part of the medical record and would be dealt with the same stringent regulations of security according to the hospital policies. All the investigators would be responsible for data handling and protection. All identifiable personal data will be anonymised and encrypted and will follow the HA policy on handling of patient data privacy.
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Patient data would be handled with utmost care taking care not to breach patient's privacy in any form. Personal data is kept anonymous with unidentifiable code on study document and will follow the HA policy on handling of patient data privacy. To protect patient privacy, all research data would be handled in line with HA/Hospital’s policy in handling/storage/destruction of patients’ medical records. They would be locked in cabinets where the department/ward keeps patients' confidential information. Electronic data would be saved in secured computer of the hospital with restricted access. USB Device would not be used for patient information nor personal data. The HKID number is only for the follow-up of health condition and review the medical records from Hospital Authority when necessary. All personal data collected will be kept strictly confidential and for research purpose only. A study code would be used instead. The document of electronic file containing the linkage information between the study code and the identity of the patient would not contain any other information and would be kept separate from the study data files or data sheets with the same stringent security as the medical record. Any documents or electronic files containing personal identifiable information would be considered as part of the medical record and would be dealt with the same stringent regulations of security according to the hospital policies. All the investigators would be responsible for data handling and protection. All identifiable personal data will be anonymised and encrypted and will follow the HA policy on handling of patient data privacy.
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