ChiCTR2300067255 版本V1.1 版本创建时间2023/01/02 00:10:51 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：

 ChiCTR2300067255 

最近更新日期：

Date of Last Refreshed on：

 2023-01-01 21:22:16 

注册时间：

Date of Registration：

 2023-01-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

低強度紅光—阿托品眼藥水混合療法在近視加深控制之研究

Public title：

Low-level RED Light-Low Concentration Atropine for Myopia Progression Study (RED-LAMP)

注册题目简写：

RED-LAMP

English Acronym：

RED-LAMP

研究课题的正式科学名称：

低強度紅光—阿托品眼藥水混合療法在近視加深控制之研究

Scientific title：

Low-level RED Light-Low Concentration Atropine for Myopia Progression Study (RED-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：

申请注册联系人：

Jennifer Tsoi 

研究负责人：

任卓昇 

Applicant：

Jennifer Tsoi 

Study leader：

Yam Cheuk Sing Jason 

申请注册联系人电话：

Applicant telephone：

 +852 39435818

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)：

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：

香港九龍亞皆老街147K號香港眼科醫院3樓

研究负责人通讯地址：

香港九龍亞皆老街147K號香港眼科醫院4樓

Applicant address：

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

Study leader's address：

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

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：

香港中文大學眼科及視覺科學學系

Applicant's institution：

Department of Ophthalmology and Visual Sciences, CUHK

研究负责人所在单位：

香港中文大學眼科及視覺科學學系

Affiliation of the Leader：

Department of Ophthalmology and Visual Sciences, CUHK

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：

 2021.534-T

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-10-22 00:00:00

伦理委员会联系人：

Ms Envy Lee

Contact Name of the ethic committee：

Ms Envy Lee

伦理委员会联系地址：

香港新界沙田銀城街30-32號威爾士親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

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, CUHK

研究实施负责（组长）单位地址：

香港九龍亞皆老街147K號香港眼科醫院4樓

Primary sponsor's address：

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

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

香港

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

香港中文大學眼科及視覺科學學系

具体地址：

九龍亞皆老街147K號香港眼科醫院4樓

Institution
hospital：

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

Address：

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

经费或物资来源：

香港中文大學眼科及視覺科學學系

Source(s) of funding：

Department of Ophthalmology and Visual Sciences, CUHK

研究疾病：

近視  

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：

1. To compare the treatment efficacy of 0.05% atropine, low-level red light and 0.05% atropine combined with low-level red light 2. To identify the factor associated with treatment response 3. To identify the genetic correlation with the treatment response 4. To investigate the OCT imaging in myopic patient treated with 0.05% atropine, low-level red light and 0.05% atropine combined with low-level red light  

Objectives of Study：

1. To compare the treatment efficacy of 0.05% atropine, low-level red light and 0.05% atropine combined with low-level red light 2. To identify the factor associated with treatment response 3. To identify the genetic correlation with the treatment response 4. To investigate the OCT imaging in myopic patient treated with 0.05% atropine, low-level red light and 0.05% atropine combined with low-level red light

药物成份或治疗方案详述：

3-year follow up of a double-blinded, randomized control trial. Eligible children will be randomized into 4 groups: - Group 1 will use 0.05% atropine eyedrop daily; - Group 2 will use low-level red light therapy for 3 minutes twice per school day at home with interval of at least 4 hours; - Group 3 will use 0.05% atropine eyedrop once daily and low-level light therapy for three minutes twice per school day at home with interval of at least 4 hours; - Group 4 will receive the placebo eyedrop. Children will be offered photochromatic glasses if they experienced glare or their parents were worried of excessive light exposure, or progressive glasses if children experienced difficulty with near vision.  

Description for medicine or protocol of treatment in detail：

3-year follow up of a double-blinded, randomized control trial. Eligible children will be randomized into 4 groups: - Group 1 will use 0.05% atropine eyedrop daily; - Group 2 will use low-level red light therapy for 3 minutes twice per school day at home with interval of at least 4 hours; - Group 3 will use 0.05% atropine eyedrop once daily and low-level light therapy for three minutes twice per school day at home with interval of at least 4 hours; - Group 4 will receive the placebo eyedrop. Children will be offered photochromatic glasses if they experienced glare or their parents were worried of excessive light exposure, or progressive glasses if children experienced difficulty with near vision.  

纳入标准：

- Age 4 to 12
- Myopia: SE -1 to -10 D
- Astigmatism: < 2.5 D
- Anisometropia: < 2.0 D
- Informed parental consent

Inclusion criteria

- Age 4 to 12
- Myopia: SE -1 to -10 D
- Astigmatism: < 2.5 D
- Anisometropia: < 2.0 D
- Informed parental consent

排除标准：

- Ophthalmic diseases other than refractive errors
- Previous use of treatment of atropine
- Allergy or intolerance to atropine
- Inability to attend regular follow up assessment

Exclusion criteria：

- Ophthalmic diseases other than refractive errors
- Previous use of treatment of atropine
- Allergy or intolerance to atropine
- Inability to attend regular follow up assessment

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-01-01 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：

1组

样本量：

 112

Group：

Group 1

Sample size：

干预措施：

雙眼每天一次0.05% 阿托品眼藥水

干预措施代码：

Intervention：

0.05% atropine: both eyes once daily

Intervention code：

组别：

2组

样本量：

 112

Group：

Group 2

Sample size：

干预措施：

雙眼每天一次0.9%生理鹽水；低強度紅光治療：在家每上學日兩次，相隔最少4小時，每次3分鐘

干预措施代码：

Intervention：

0.9% normal saline once daily and low-level red light therapy for 3 minutes twice per school day at home with interval of at least 4 hours

Intervention code：

组别：

3组

样本量：

 112

Group：

Group 3

Sample size：

干预措施：

雙眼每天一次0.05% 阿托品眼藥水；低強度紅光治療：在家每上學日兩次，相隔最少4小時，每次3分鐘

干预措施代码：

Intervention：

0.05% atropine both eyes once daily and low-level red light therapy twice per school day at home with an interval of at least 4 hours; each treatment lasts for 3 minutes

Intervention code：

组别：

4组

样本量：

 112

Group：

Group 4

Sample size：

干预措施：

雙眼每天一次0.9%生理鹽水

干预措施代码：

Intervention：

0.9% normal saline: both eyes once daily

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 香港 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 香港中文大學眼科中心 

单位级别：

  

Institution
hospital：

Chinese University of Hong Kong Eye Centre

Level of the institution：

测量指标：

Outcomes：

指标中文名：

近视进展:球面等效屈光度变化

指标类型：

主要指标

Outcome：

Myopic progression: change in spherical equivalent refraction

Type：

Primary indicator

测量时间点：

第4, 8, 12, 16, 20, 24, 28, 32, 36個月

测量方法：

散瞳後電腦驗眼

Measure time point of outcome：

Month 4, 8, 12, 16, 20, 24, 28, 32, 36

Measure method：

Cycloplegic refraction is assessed by autorefractometer

指标中文名：

眼軸長度變化

指标类型：

主要指标

Outcome：

Eyeball growth: change in axial length

Type：

Primary indicator

测量时间点：

第4, 8, 12, 16, 20, 24, 28, 32, 36個月

测量方法：

IOL Master眼參數

Measure time point of outcome：

Month 4, 8, 12, 16, 20, 24, 28, 32, 36

Measure method：

IOL Master eye parameters

指标中文名：

安全性

指标类型：

次要指标

Outcome：

Safety

Type：

Secondary indicator

测量时间点：

第4, 8, 12, 16, 20, 24, 28, 32, 36個月

测量方法：

問卷、視力檢查、眼壓、瞳孔大小、眼部及系統性疾病、裂隙燈檢查

Measure time point of outcome：

Month 4, 8, 12, 16, 20, 24, 28, 32, 36

Measure method：

Questionnaire, visual acuity examination, intraocular pressure, pupil size, ocular and systemic diseases, slit lamp examination

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后保存  

说明

保存5年

Fate of sample：

Preservation after use  

Note：

5 years

标本中文名：

腮抹試

组织：

Sample Name：

Buccal swab

Tissue：

人体标本去向

 使用后保存  

说明

保存5年

Fate of sample：

Preservation after use  

Note：

5 years

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 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）：

We adopt permuted-block randomization stratified by age range of subjects. In each stratum (or age group) subjects will be assigned to 4 arms (atropine group, low-level red light therapy group, atropine and low-level red light therapy group, and normal saline 0.9%) based on randomization codes generated by the&

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

We adopt permuted-block randomization stratified by age range of subjects. In each stratum (or age group) subjects will be assigned to 4 arms (atropine group, low-level red light therapy group, atropine and low-level red light therapy group, and normal saline 0.9%) based on randomization codes generated by the&

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：

Blinding：

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）：

N/A

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

N/A

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：

The coordinator is the only person has access to the randomization table. Subjects who meet the inclusion and exclusion criteria will receive their corresponding random treatment assignment via investigator according to the randomization table sequentially. The table will be filed securely by coordinator to maintain adequate blindness throughout the study. Nobody is allowed to open the sealed table without permission from project PI.

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

The coordinator is the only person has access to the randomization table. Subjects who meet the inclusion and exclusion criteria will receive their corresponding random treatment assignment via investigator according to the randomization table sequentially. The table will be filed securely by coordinator to maintain adequate blindness throughout the study. Nobody is allowed to open the sealed table without permission from project PI.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-01-01 21:22:04