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白玉婧医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 评估多点近视离焦镜片(DIMS)和Apollo渐进镜片(PAL)在6-12岁儿童中近视进展控制效果:前瞻性,多中心,随机对照临床试验
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注册号:

Registration number:

ChiCTR1900025645 

最近更新日期:

Date of Last Refreshed on:

2019-09-03 

注册时间:

Date of Registration:

2019-09-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

白玉婧医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 评估多点近视离焦镜片(DIMS)和Apollo渐进镜片(PAL)在6-12岁儿童中近视进展控制效果:前瞻性,多中心,随机对照临床试验 

Public title:

Evaluating the myopia progression control efficacy of defocus-incorporated multiple segments (DIMS) lenses and Apollo progressive-addition spectacle lenses (PAL) in 6-12 years old children: a prospective, multi-center, randomized controlled trial 

注册题目简写:

评估不同近视离焦镜片的近视控制临床研究 

English Acronym:

Assessment of myopia defocus spectacle lenses in myopia progression control 

研究课题的正式科学名称:

功能性镜片对儿童青少年近视控制有效率的多中心临床对比研究 

Scientific title:

Multi-center clinical comparative study for the effectiveness of functional spectacle lenses in the treatment of myopia in children and adolescents 

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:

白玉婧 

研究负责人:

李岩 

Applicant:

Yujing Bai 

Study leader:

Yan Li 

申请注册联系人电话:

Applicant telephone:

+86 18511279718 

研究负责人电话:

Study leader's telephone:

+86 13522998100 

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:

baiyujing@pkuph.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

41379226@qq.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:

北京市西直门南大街11号 

研究负责人通讯地址:

北京市西直门南大街11号 

Applicant address:

11 Xizhimen South Street, Beijing 

Study leader's address:

11 Xizhimen South Street, Beijing 

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:

北京大学人民医院眼视光中心 

Applicant's institution:

Eye Diseases and Optometry Institute, Peking University People's Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

北京大学人民医院眼视光中心 

Primary sponsor:

Eye Diseases and Optometry Institute, Peking University People's Hospital 

研究实施负责(组长)单位地址:

北京市西直门南大街11号 

Primary sponsor's address:

11 Xizhimen South Street, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学人民医院

具体地址:

西直门南大街11号

Institution
hospital:

Peking University People's Hospital

Address:

11 Xizhimen South Street

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

屈光不正 

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 

研究目的:

该前瞻性、多中心、随机对照试验研究评估了两种临床使用近视离焦(MD)设计的眼镜镜片,即DIMS镜片和PAL镜片,在6-12岁的近视儿童中的近视进展控制效果。 主要目的是比较等效球镜屈光度(SER)和眼轴长度(AL)在基线和3年内每6个月的变化。 在研究期间还比较了其他变化,包括风险因素,眼健康,未矫正的相对周边屈光,双眼视功能(主要为聚散功能),调节(特别是调节滞后和调节幅度)评估,中央凹脉络膜厚度和视觉环境等。 

Objectives of Study:

The current prospective, multi-center randomized controlled trial study evaluated the myopia progression control efficacy of two clinically used myopia defocus (MD) designed spectacle lens, which are DIMS lenses and PAL lenses, in 6-12 years old myopia children. The primary aim is comparing changes of spherical equivalent refraction (SER) and axial length (AL) at baseline and every 6 months over 3 years. Other changes are also compared over the study period, including risk factors, ocular health, uncorrected relative peripheral refraction, binocular vision function (principally vergence), accommodation (particularly lag and amplitude) assessment, sub-foveal choroidal thickness, and visual environment. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

中国大陆人,汉族。 年龄:6-12岁。 睫状肌麻痹球面等效屈光度(SER):-1.00至-4.00屈光度(D)。 SER计算为球体加0.5 x圆柱体,以屈光度(D)计算。 (睫状肌麻痹屈光度的推荐剂量是2滴1%托吡卡胺,分别给予5分钟。在第一滴托吡卡胺滴注后30-45分钟应进行睫状肌麻痹屈光结果测量,以确保最大的睫状肌麻痹效果。) 散光:1.50 D或更低。 屈光参差:1.50 D或更低。 瞳孔直径差异:2毫米或更小。 单眼最佳矫正视力(BCVA):20/20(0.0 logMAR)或更好(LogMar图表)。 愿意定期佩戴眼镜镜片。 接受随机组分配和蒙面研究设计。 

Inclusion criteria

The following eligibility criteria exist for this trial: Mainland Chinese, the Han nationality. Age at enrolment: 6–12 years old. Cycloplegic spherical equivalent refraction (SER): -1.00 to -4.00 diopters (D). SER is calculated as the sphere plus 0.5 x the cylinder, in diopters (D). (Recommended dosage for cycloplegic refraction is 2 drops of 1% tropicamide given 5 minutes separately. Cycloplegic refraction outcome measures should be performed 30-45 minutes after the first drop of tropicamide is instilled, which ensure the maximal cycloplegic effect.) Astigmatism:1.50 D or less. Anisometropia: 1.50 D or less. The difference of pupil between eyes of 2 mm or less. Monocular best corrected visual acuity (BCVA): 20/20 (0.0 logMAR) or better (LogMar chart). Willingness to wear spectacle lenses regularly. Acceptance of random group allocation and the masked study design.  

排除标准:

斜视:在远处和附近通过覆盖测试检查。 任何眼部和全身性疾病,包括异常都可能影响视功能或屈光发育。 以往的近视控制经验,包括角膜塑形术,渐进镜片,双焦镜片,药物治疗(如阿托品)等。 

Exclusion criteria:

Strabismus: checked by cover test at far and near. Any ocular and systemic diseases, including abnormalities might affect visual functions or refractive development. Previous experience of myopia control, including orthokeratology, progressive addition lenses, bifocal lenses, pharmaceutical treatment (e.g. atropine), etc. 

研究实施时间:

Study execute time:

From2019-10-14To 2022-12-30 

征募观察对象时间:

Recruiting time:

From2019-10-31To 2022-12-30 

干预措施:

Interventions:

组别:

DIMS 组

样本量:

300

Group:

DIMS group

Sample size:

干预措施:

DIMS框架眼镜

干预措施代码:

Intervention:

DIMS spectacle lenses

Intervention code:

组别:

APL 组

样本量:

300

Group:

APL group

Sample size:

干预措施:

APL框架眼镜

干预措施代码:

Intervention:

APL spectacle lenses

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学人民医院 

单位级别:

三甲 

Institution
hospital:

Peking University People's Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学国际医院 

单位级别:

三甲 

Institution
hospital:

Peking University International Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

云南 

市(区县):

 

Country:

China 

Province:

Yunnan 

City:

 

单位(医院):

昆明市妇幼保健院 

单位级别:

三级 

Institution
hospital:

Kunming City Maternal and Child Health Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市海淀区妇幼保健院眼保健中心 

单位级别:

三甲 

Institution
hospital:

Beijing Haidian Maternal and Child Health Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

清华大学附属垂杨柳医院 

单位级别:

三甲 

Institution
hospital:

ChuiYang Liu Hospital affiliated to Tsinghua University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

散瞳验光

指标类型:

主要指标 

Outcome:

Cycloplegic subjective refraction

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼轴长度

指标类型:

次要指标 

Outcome:

Axial length

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免散瞳验光

指标类型:

次要指标 

Outcome:

Non-cycloplegic autorefraction

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

周边屈光度

指标类型:

次要指标 

Outcome:

Peripheral refraction

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

最佳矫正视力

指标类型:

次要指标 

Outcome:

Best-corrected VA (BCVA

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

戴镜视力

指标类型:

次要指标 

Outcome:

Habitual spectacle VA

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

调节滞后

指标类型:

次要指标 

Outcome:

Accommodation lag

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

调节幅度

指标类型:

次要指标 

Outcome:

Accommodation amplitude

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

裂隙灯眼前节检查

指标类型:

次要指标 

Outcome:

Slit-lamp exam, external ocular health check

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

非接触眼压计眼压检查

指标类型:

次要指标 

Outcome:

IOP measurement

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

瞳孔大小

指标类型:

次要指标 

Outcome:

Pupil size

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

角膜曲率

指标类型:

次要指标 

Outcome:

Keratometry

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

对比敏感度

指标类型:

次要指标 

Outcome:

Contrast sensitivity

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

立体视

指标类型:

次要指标 

Outcome:

Stereopsis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脉络膜厚度

指标类型:

次要指标 

Outcome:

Choroidal thickness measurement

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼底检查

指标类型:

次要指标 

Outcome:

Fundus exam

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉习惯

指标类型:

次要指标 

Outcome:

Visual habits

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

父母近视情况

指标类型:

次要指标 

Outcome:

Parental myopia status

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:

标本中文名:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

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 6 years
最大 Max age 12 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):

协调员使用随机表进行随机分组

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

Coordinator uses random table for random grouping

盲法:

未说明

Blinding:

Not stated

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

是Yes

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):

2023年12月,通过百度网盘进行公开

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

In December 2023, through the Baidu network disk for public

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:

所有数据的采集及管理都是由研究中心课题组内专职人员进行,不适用电子病历系统,采用纸质病历系统

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

The collection and management of all data is carried out by a full-time staff member of the research center's research group. It is not applicable to the electronic medical record system and uses a paper medical record system.

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:

 2019-09-03
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