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A clinical study for adjustable dynamic horizontal flip glasses in the prevention and control of myopia
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注册号:

Registration number:

ChiCTR2000031755 

最近更新日期:

Date of Last Refreshed on:

2020-04-09 

注册时间:

Date of Registration:

2020-04-09 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

水平可调动态翻转镜对近视防控的临床治疗研究 

Public title:

A clinical study for adjustable dynamic horizontal flip glasses in the prevention and control of myopia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

水平可调动态翻转镜对近视防控的临床治疗研究 

Scientific title:

A clinical study for adjustable dynamic horizontal flip glasses in the prevention and control of myopia 

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:

邓宏伟 

研究负责人:

邓宏伟 

Applicant:

Hongwei Deng 

Study leader:

Hongwei Deng 

申请注册联系人电话:

Applicant telephone:

+86 13510093392 

研究负责人电话:

Study leader's telephone:

+86 13510093392 

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:

dhw110@126.com 

研究负责人电子邮件:

Study leader's E-mail:

dhw110@126.com 

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:

中国广东深圳市福田区泽田路18号 

研究负责人通讯地址:

中国广东深圳市福田区泽田路18号 

Applicant address:

18 Zetian Road, Futian District, Shenzhen, Guangdong, China 

Study leader's address:

18 Zetian Road, Futian District, Shenzhen, Guangdong, China 

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:

深圳市眼科医院 

Applicant's institution:

Shenzhen Eye Hospital 

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:

深眼伦审20191021-05号 

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:

深圳市眼科医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Shenzhen Eye Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-30 

伦理委员会联系人:

陈洁 

Contact Name of the ethic committee:

Jie Chen 

伦理委员会联系地址:

深圳市福田区泽田路18号 

Contact Address of the ethic committee:

18 Zetian Road, Futian District, Shenzhen, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0755-23959627 

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:

深圳市眼科医院 

Primary sponsor:

Shenzhen Eye Hospital 

研究实施负责(组长)单位地址:

深圳市福田区泽田路18号 

Primary sponsor's address:

18 Zetian Road, Futian District, Shenzhen, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

深圳

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

深圳市眼科医院

具体地址:

深圳市福田区泽田路18号

Institution
hospital:

Shenzhen Eye Hospital

Address:

18 Zetian Road, Futian District, Shenzhen

经费或物资来源:

深圳不虚科技有限公司 

Source(s) of funding:

Shenzhen Buxu Technology Co., Ltd 

研究疾病:

近视 

Target disease:

Myopia 

研究疾病代码:

 

Target disease code:

 

研究类型:

治疗研究 

Study type:

Treatment study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

评估水平可调动态翻转镜(ADHF)对青少年近视的治疗作用 

Objectives of Study:

To evaluate the therapeutic effect of adjustable dynamic horizontal flip glasses on juvenile myopia. 

药物成份或治疗方案详述:

佩戴时两片单曲面镜以水平沿着光学中心轴相对方向位移来改变镜片组的屈光度(0.00D度到+2.00D),使得物像拉近拉远来回运动,从而改变睫状肌调节。镜片组拉近物像停留时间为10秒,拉远物像停留时间为30秒,循环工作。 

Description for medicine or protocol of treatment in detail:

During wearing, the two pieces of single curved mirrors can change the diopter (0.00D to +2.00D) of the lens group by horizontal displacement along the relative direction of the optical center axis, so that the object image can be moved back and forth by drawing close and far, so as to change the ciliary muscle regulation. The retention time of lens group for drawing object image is 10 seconds, and the retention time for drawing object image is 30 seconds. 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

1. 年龄5-14岁; 2. 单眼最佳矫正视力≥0.3; 3. 单/双眼等效球镜度数(-3.75D至+0.00D) 4. 能够配合完成复查并佩戴6个月以上。 

Inclusion criteria

1. Aged 5-14 years old; 2. The best corrected visual acuity of single eye >=0.3; 3. Single / double eye equivalent spherical lens degree (-3.75D to + 0.00D); 4. Be able to cooperate to complete reexamination and wear ADHF for more than 6 months. 

排除标准:

排除高度散光,重度弱视,斜视患者,患有其他眼部基础疾病,排除使用影响近视发生发展的药物使用史或患有全身严重疾病的患者。 

Exclusion criteria:

Exclude patients with high astigmatism, severe amblyopia, strabismus, other basic eye diseases, and patients with drug use history that affect the development of myopia or serious systemic diseases 

研究实施时间:

Study execute time:

From2019-04-01To 2020-10-21 

干预措施:

Interventions:

组别:

A组

样本量:

50

Group:

Group A

Sample size:

干预措施:

近距离用眼(1米内)时,佩戴水平可调动态翻转镜持续30分钟一次,一天佩戴2次 40天复查

干预措施代码:

Intervention:

Wear ADHF when using eyes at close range (within 1m), lasts for 30 minutes, bid, reexamine after 40days

Intervention code:

组别:

B组

样本量:

50

Group:

Group B

Sample size:

干预措施:

佩戴传统框架眼镜,40天复查

干预措施代码:

Intervention:

Wear traditional frame glasses, reexamination for 40 days

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):

深圳 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

深圳市眼科医院 

单位级别:

三级医院 

Institution
hospital:

Shenzhen Eye Hospital  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

裸视力,矫正屈光度,眼轴与角膜曲率比值,眼压

指标类型:

主要指标 

Outcome:

Naked vision, corrected diopter, axial to corneal curvature ratio, intraocular pressure

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:

标本中文名:

组织:

Sample Name:

Null

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction 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 7 years
最大 Max age 18 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):

分层随机

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

Stratified randomization

盲法:

未说明

Blinding:

Not stated

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):

每月1号,15号两次以纸质文件形式公布在深圳市眼科医院青少年近视防控中心诊室

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

The data are published twice in paper on 1st/15th of each month, in the clinic center for prevention and control of juvenile myopia of Shenzhen Eye Hospital

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:

数据采集:水平可调动态翻转镜验光单 管理:近视力验光系统V1.0

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

Data acquisition: adjustable dynamic horizontal flip glasses optometry sheet Management: near vision optometry system V1.0

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-04-09
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