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-10000902
最近更新日期： Date of Last Refreshed on：	2015-06-14 10:24:41
注册时间： Date of Registration：	2010-05-13 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	A randomized controlled trial comparing the treatment effects of patching versus acupuncture plus patching on amblyopia in patients of 7 to <13 years old
Public title：	A randomized controlled trial comparing the treatment effects of patching versus acupuncture plus patching on amblyopia in patients of 7 to <13 years old
注册题目简写：
English Acronym：
研究课题的正式科学名称：	A randomized controlled trial comparing the treatment effects of patching versus acupuncture plus patching on amblyopia in patients of 7 to <13 years old
Scientific title：	A randomized controlled trial comparing the treatment effects of patching versus acupuncture plus patching on amblyopia in patients of 7 to <13 years old
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_CCT00262

申请注册联系人：	Zheng Chongren	研究负责人：	Prof. Dennis Shun Chiu Lam
Applicant：	Zheng Chongren	Study leader：	Prof. Dennis Shun Chiu Lam
申请注册联系人电话： Applicant telephone：	+852 2762 3126	研究负责人电话： Study leader's telephone：	+852 2762 3157
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：	iriszheng@cuhk.edu.hk	研究负责人电子邮件： Study leader's E-mail：	dennislam_cu_res@cuhk.edu.hk
申请单位网址(自愿提供)： Applicant website(voluntary supply)：	http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00262	研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：	http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00262
申请注册联系人通讯地址：	3/F Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong	研究负责人通讯地址：	3/F Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong
Applicant address：	3/F Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong	Study leader's address：	3/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：	3/F Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong
Applicant's institution：	3/F Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong
研究负责人所在单位：
Affiliation of the Leader：

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：	NA	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：	Chinese University of Hong Kong
Name of the ethic committee：	Chinese University of Hong Kong
伦理委员会批准日期： Date of approved by ethic committee：	2009-05-29 00:00:00
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：	Hong Kong Eye Hospital
Primary sponsor：	Hong Kong Eye Hospital
研究实施负责（组长）单位地址：	3/F Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong
Primary sponsor's address：	3/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：
经费或物资来源：	Yan Ai Eye Foundation, DOVS, Hong Kong, China.
Source(s) of funding：	Yan Ai Eye Foundation, DOVS, Hong Kong, China.
研究疾病：	Amblyopia
Target disease：	Amblyopia
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：	I期临床试验
Study phase：	1
研究设计：	随机平行对照
Study design：	Parallel
研究目的：	To assess the effects of patching versus acupuncture plus patching on amblyopia in patients of 7 to <13 years old
Objectives of Study：	To assess the effects of patching versus acupuncture plus patching on amblyopia in patients of 7 to <13 years old
药物成份或治疗方案详述：
Description for medicine or protocol of treatment in detail：
纳入标准：	1. Age: 7 to <13; 2. Amblyopia associated with strabismus (concomitant or inconcomitant), anisometropia, or both a. Criteria for strabismus: At least one of the following criteria must be met: (1) Heterotropia at distance and/or near fixation on examination (with or without spectacles); (2) History of strabismus surgery (or botulinum); (3) Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia). b. Criteria for anisometropia: At least one of the following criteria must be met: (1) >0.50 D difference between eyes in spherical equivalent; (2) >1.50 D difference between eyes in astigmatism in any meridian; c. Criteria for combined mechanism amblyopia: Both of the following criteria must be met: (1) Criteria for strabismus are met (see above); (2) >1.00 D difference between eyes in spherical equivalent OR >1.50 D difference between eyes in astigmatism in any meridian. Note: the spherical equivalent requirement differs from that in the definition for refractive/anisometropic amblyopia. 3. Visual acuity, measured in each eye without cycloplegia within 7 days prior to randomization using the E-ETDRS protocol on Electronic Visual Acuity Tester, as follows: (1) Visual acuity in the amblyopic eye between 19 to 71 letters inclusive (20/40 to 20/400 inclusive); (2) Visual acuity in the sound eye >=79 letters (20/25 or better); (3) Interocular acuity difference >=10 letters (i.e., amblyopic eye acuity at least 2 lines worse than sound eye acuity). 4. No amblyopia treatment (other than spectacles) in the last 6 months (any treatment more than 6 months prior to enrollment is acceptable); 5. No current vision therapy or orthoptics; 6. Ocular examination within 6 months prior to enrollment showing no ocular cause for reduced visual acuity; 7. Cycloplegic refraction within 6 months prior to enrollment; 8. Myopia no more than -6.0 D spherical equivalent in either eye; 9. Spectacle correction for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction that is no more than 6 months old (refractive error must be corrected with spectacles and not contact lenses): a. Requirements for spectacle correction: (1) For patients meeting criteria for strabismus (see 2.a above); (2) Hypermetropia if corrected must not be undercorrected by more than +1.50 D spherical equivalent, and the reduction in plus sphere must be symmetric in the two eyes. Otherwise, spectacle correction is at investigator discretion; (3) For patients meeting criteria for anisometropia or combined-mechanism (see #2. b, c above); (4) Spherical equivalent must be within 0.50 D of fully correcting the anisometropia; (5) Hypermetropia must not be undercorrected by more than +1.50 D spherical equivalent, and reduction in plus must be symmetric in the two eyes; (6) Cylinder power in both eyes must be within 0.50 D of fully correcting the astigmatism; (7) Cylinder axis in the spectacle lenses in both eyes must be within 6 degrees of the axis of the cycloplegic refraction when cylinder power is > 1.00 D. b. Spectacles meeting above criteria must be worn either: (1) for at least 16 weeks immediately prior to enrollment; or (2) until visual acuity in amblyopic eye is stable (defined as two consecutive visual acuity measurements by the same testing method at least 4 weeks apart with no improvement of one logMAR line or more); (3) An acuity measurement done any of the following ways may be considered the first of two consecutive measurements: 1) in current glasses; 2) in trial frames with full correction of hypermetropia with cycloplegia; or 3) by having the patient return in new glasses for first measurement. The second acuity measure does not have to be made through the same prescription as the first, if the second measure is made through a more accurate prescription. Note: since this determination is a pre-study procedure, the method of measuring visual acuity is not mandated although E-ETDRS testing is preferred if done as part of usual care. 10. No prior intraocular or refractive surgery; 11. No known reaction to or development of systemic side effects (e.g., confused mental state, somnolence, skin flushing, exacerbation of asthma) with prior use of cycloplegics and no known skin allergy to patch or bandage adhesives; 12. Parent willing to accept randomized treatment, available for at least 6 months of follow-up, and willing to be contacted by DOVS staff; 13. Informed parental consent.
Inclusion criteria	1. Age: 7 to <13; 2. Amblyopia associated with strabismus (concomitant or inconcomitant), anisometropia, or both a. Criteria for strabismus: At least one of the following criteria must be met: (1) Heterotropia at distance and/or near fixation on examination (with or without spectacles); (2) History of strabismus surgery (or botulinum); (3) Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia). b. Criteria for anisometropia: At least one of the following criteria must be met: (1) >0.50 D difference between eyes in spherical equivalent; (2) >1.50 D difference between eyes in astigmatism in any meridian; c. Criteria for combined mechanism amblyopia: Both of the following criteria must be met: (1) Criteria for strabismus are met (see above); (2) >1.00 D difference between eyes in spherical equivalent OR >1.50 D difference between eyes in astigmatism in any meridian. Note: the spherical equivalent requirement differs from that in the definition for refractive/anisometropic amblyopia. 3. Visual acuity, measured in each eye without cycloplegia within 7 days prior to randomization using the E-ETDRS protocol on Electronic Visual Acuity Tester, as follows: (1) Visual acuity in the amblyopic eye between 19 to 71 letters inclusive (20/40 to 20/400 inclusive); (2) Visual acuity in the sound eye >=79 letters (20/25 or better); (3) Interocular acuity difference >=10 letters (i.e., amblyopic eye acuity at least 2 lines worse than sound eye acuity). 4. No amblyopia treatment (other than spectacles) in the last 6 months (any treatment more than 6 months prior to enrollment is acceptable); 5. No current vision therapy or orthoptics; 6. Ocular examination within 6 months prior to enrollment showing no ocular cause for reduced visual acuity; 7. Cycloplegic refraction within 6 months prior to enrollment; 8. Myopia no more than -6.0 D spherical equivalent in either eye; 9. Spectacle correction for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction that is no more than 6 months old (refractive error must be corrected with spectacles and not contact lenses): a. Requirements for spectacle correction: (1) For patients meeting criteria for strabismus (see 2.a above); (2) Hypermetropia if corrected must not be undercorrected by more than +1.50 D spherical equivalent, and the reduction in plus sphere must be symmetric in the two eyes. Otherwise, spectacle correction is at investigator discretion; (3) For patients meeting criteria for anisometropia or combined-mechanism (see #2. b, c above); (4) Spherical equivalent must be within 0.50 D of fully correcting the anisometropia; (5) Hypermetropia must not be undercorrected by more than +1.50 D spherical equivalent, and reduction in plus must be symmetric in the two eyes; (6) Cylinder power in both eyes must be within 0.50 D of fully correcting the astigmatism; (7) Cylinder axis in the spectacle lenses in both eyes must be within 6 degrees of the axis of the cycloplegic refraction when cylinder power is > 1.00 D. b. Spectacles meeting above criteria must be worn either: (1) for at least 16 weeks immediately prior to enrollment; or (2) until visual acuity in amblyopic eye is stable (defined as two consecutive visual acuity measurements by the same testing method at least 4 weeks apart with no improvement of one logMAR line or more); (3) An acuity measurement done any of the following ways may be considered the first of two consecutive measurements: 1) in current glasses; 2) in trial frames with full correction of hypermetropia with cycloplegia; or 3) by having the patient return in new glasses for first measurement. The second acuity measure does not have to be made through the same prescription as the first, if the second measure is made through a more accurate prescription. Note: since this determination is a pre-study procedure, the method of measuring visual acuity is not mandated although E-ETDRS testing is preferred if done as part of usual care. 10. No prior intraocular or refractive surgery; 11. No known reaction to or development of systemic side effects (e.g., confused mental state, somnolence, skin flushing, exacerbation of asthma) with prior use of cycloplegics and no known skin allergy to patch or bandage adhesives; 12. Parent willing to accept randomized treatment, available for at least 6 months of follow-up, and willing to be contacted by DOVS staff; 13. Informed parental consent.
排除标准：	1. Patients with ocular diseases other than refractive error, strabismus (including microtropia) and amblyopia; 2. Systemic diseases that require chronic or regular intermittent medication (e.g. Down Syndrome, asthma, allergy, epilepsy and so on); 3. Allergy to cycloplegics; 4. Inability to attend follow-up assessment; 5. Inability to tolerate and cooperate with acupuncture procedure; 6. Myopia more than -6.0D SE in the amblyopic eye.
Exclusion criteria：	1. Patients with ocular diseases other than refractive error, strabismus (including microtropia) and amblyopia; 2. Systemic diseases that require chronic or regular intermittent medication (e.g. Down Syndrome, asthma, allergy, epilepsy and so on); 3. Allergy to cycloplegics; 4. Inability to attend follow-up assessment; 5. Inability to tolerate and cooperate with acupuncture procedure; 6. Myopia more than -6.0D SE in the amblyopic eye.

研究实施时间：

Study execute time：

从 From 2010-05-15 00:00:00至 To 2013-05-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2010-05-15 00:00:00 至 To 2013-05-31 00:00:00

干预措施：

Interventions：

组别：	Three groups	样本量：	150
Group：	Three groups	Sample size：	150
干预措施：	Refractive correction plus acupuncture plus near activities: full time spectacle correction is prescribed to each subject. The subjects are guided to have at least 1 hour of near activities on top of patching every day. Total 60 weeks	干预措施代码：
Intervention：	Refractive correction plus acupuncture plus near activities: full time spectacle correction is prescribed to each subject. The subjects are guided to have at least 1 hour of near activities on top of patching every day. Total 60 weeks	Intervention code：

组别：	Three groups	样本量：	150
Group：	Three groups	Sample size：	150
干预措施：	Acupuncture treatment is given one time per day for 15 minutes each time, 5 days per week. Five acupoints are selected, including “Baihui” (GV20), “Taiyang” (EX-HN5), “Cuanzhu” (BL2), “Hegu” (LI4) and “Fuyang” (BL59)	干预措施代码：
Intervention：	Acupuncture treatment is given one time per day for 15 minutes each time, 5 days per week. Five acupoints are selected, including “Baihui” (GV20), “Taiyang” (EX-HN5), “Cuanzhu” (BL2), “Hegu” (LI4) and “Fuyang” (BL59)	Intervention code：

组别：	Groups	样本量：	50
Group：	Group 1	Sample size：	50
干预措施：	Optical correction with spectacles plus acupoint acupuncture plus daily patching of the sound eye for 2-6 hours per day depends on the severity of amblyopia plus near activities for at least 1 hour while patching every day	干预措施代码：
Intervention：	Optical correction with spectacles plus acupoint acupuncture plus daily patching of the sound eye for 2-6 hours per day depends on the severity of amblyopia plus near activities for at least 1 hour while patching every day	Intervention code：

组别：	Group 2	样本量：	50
Group：	Group 2	Sample size：	50
干预措施：	optical correction with spectacles plus non-acupoint acupuncture plus daily patching of the sound eye for 2-6 hours per day (depends on the severity of amblyopia) plus near activities for at least 1 hour while patching	干预措施代码：
Intervention：	optical correction with spectacles plus non-acupoint acupuncture plus daily patching of the sound eye for 2-6 hours per day (depends on the severity of amblyopia) plus near activities for at least 1 hour while patching	Intervention code：

组别：	Group 3	样本量：	50
Group：	Group 3	Sample size：	50
干预措施：	optical correction with spectacles plus patching of the sound eye for 2 hours per day plus near activities for 1 hour while patching	干预措施代码：
Intervention：	optical correction with spectacles plus patching of the sound eye for 2 hours per day plus near activities for 1 hour while patching	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	China	省(直辖市)：	香港	市(区县)：
Country：	China	Province：	Hong Kong	City：
单位(医院)：	Chinese University of Hong Kong	单位级别：	H
Institution hospital：	Chinese University of Hong Kong	Level of the institution：	H

测量指标：

Outcomes：

指标中文名：	Best-corrected visual acuity (BCVA) in the amblyop	指标类型：	主要指标
Outcome：	Best-corrected visual acuity (BCVA) in the amblyop	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	BCVA in the sound eye. The proportion of patients with resolved amblyopia and responder rate. Other parameters, e.g., stereoacuity, axial length, RNFL and macular thickness measurements, weight, height measurement, where appropriate.	指标类型：	次要指标
Outcome：	BCVA in the sound eye. The proportion of patients with resolved amblyopia and responder rate. Other parameters, e.g., stereoacuity, axial length, RNFL and macular thickness measurements, weight, height measurement, where appropriate.	Type：	Secondary 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	7	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）：

Random, active control, parallel groups

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

Random, active control, parallel groups

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：	Single-blind
Blinding：	Single-blind
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing
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）：
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：
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：
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：
数据与安全监察委员会： Data and Safety Monitoring Committee：
注册人： Name of Registration：	2015-06-14 10:24:41