Today is 2022-01-28

Effects of 1% cyclopentatrol hydrochloride on pupil diameter and reftactive error of Chinese children with dark brown iris and its associated factors
download

注册号:

Registration number:

ChiCTR1900025774 

最近更新日期:

Date of Last Refreshed on:

2019-11-03 

注册时间:

Date of Registration:

2019-09-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

1%盐酸环喷托酯对中国深棕色虹膜儿童瞳孔直径和屈光度的作用效果及其影响因素 

Public title:

Effects of 1% cyclopentatrol hydrochloride on pupil diameter and reftactive error of Chinese children with dark brown iris and its associated factors 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

1%盐酸环喷托酯对中国深棕色虹膜儿童瞳孔直径和屈光度的作用效果及其影响因素 

Scientific title:

Effects of 1% cyclopentatrol hydrochloride on pupil diameter and reftactive error of Chinese children with dark brown iris and its influencing factors 

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:

金成成 

研究负责人:

魏瑞华 

Applicant:

Chengcheng Jin 

Study leader:

Ruihua Wei 

申请注册联系人电话:

Applicant telephone:

+86 15602181249 

研究负责人电话:

Study leader's telephone:

+86 13920685016 

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:

jcc_tmu@126.com 

研究负责人电子邮件:

Study leader's E-mail:

rwei@tmu.edu.cn 

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:

天津市南开区复康路251号 

研究负责人通讯地址:

天津市南开区复康路251号 

Applicant address:

251 Fukang Road, Nankai District, Tianjin, China 

Study leader's address:

251 Fukang Road, Nankai District, Tianjin, 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:

天津医科大学眼科医院 

Applicant's institution:

Tianjin Medical University 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:

2019KY-14 

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:

天津医科大学眼科医院医学伦理委员会 

Name of the ethic committee:

Ophthalmology Ethics Committee of Tianjin Medical University Eye Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-09-17 

伦理委员会联系人:

陈卓 

Contact Name of the ethic committee:

Zhuo Chen 

伦理委员会联系地址:

天津市南开区复康路251号 

Contact Address of the ethic committee:

251 Fukang Road, Nankai District, Tianjin, 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:

天津医科大学眼科医院 

Primary sponsor:

Tianjin Medical University Eye Hospital 

研究实施负责(组长)单位地址:

天津市南开区复康路251号 

Primary sponsor's address:

251 Fukang Road, Nankai District, Tianjin, 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):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津医科大学眼科医院

具体地址:

南开区复康路251号

Institution
hospital:

Tianjin Medical University Eye Hospital

Address:

251 Fukang Road, Nankai District

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

屈光不正 

Target disease:

Refractive error 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

探究1%盐酸环喷托酯对中国深棕色虹膜儿童瞳孔直径和屈光度的作用效果及其影响因素。 

Objectives of Study:

To investigate the effect of 1% cyclopentatrol hydrochloride on pupil diameter and refractive error of children with dark brown iris in China and its associated factors. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1. 中国深棕色虹膜儿童; 2. 年龄:4-15岁; 3. 除屈光不正外无其他眼部疾病。 

Inclusion criteria

1. Chinese children with dark brown irises; 2. Aged 6 to 15 years; 3. No other eye diseases except ametropia. 

排除标准:

1. 存在显斜视,眼球震颤、上睑下垂、角膜瘢痕、白内障等影响仪器检测的眼部疾病; 2. 眼压高于25mmHg者; 3. 有影响瞳孔大小和眼部调节功能的用药史,如低浓度阿托品等; 4. 接触镜配戴史,如角膜塑形镜; 5. 眼部手术史和外伤史; 6. 无法配合检查者。 

Exclusion criteria:

1. Ocular diseases with manifest strabismus, nystagmus, ptosis, corneal scar, cataract and other diseases affecting instrument detection; 2. Iop was higher than 25mmHg; 3. Medication history that affects pupil size and accommodation, such as low concentration atropine; 4. Wearing history of contact lens, such as orthokeratology lens; 5. History of eye surgery and trauma; 6. Unable to cooperate with the inspection. 

研究实施时间:

Study execute time:

From2019-09-17To 2019-09-30 

征募观察对象时间:

Recruiting time:

From2019-09-17To 2019-09-30 

干预措施:

Interventions:

组别:

1

样本量:

150

Group:

single arm

Sample size:

干预措施:

1%盐酸环喷托酯

干预措施代码:

Intervention:

1% cyclopentatrol hydrochloride

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津医科大学眼科医院 

单位级别:

三甲医院 

Institution
hospital:

Tianjin Medical University Eye Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

瞳孔直径

指标类型:

主要指标 

Outcome:

pupil diameter

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

屈光度

指标类型:

主要指标 

Outcome:

refractive error

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:

眼压

指标类型:

次要指标 

Outcome:

IOP

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:

Lag of accommodation

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 4 years
最大 Max age 15 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):

未使用

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

Not used

盲法:

N/A

Blinding:

N/A

是否共享原始数据:

IPD sharing

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):

文章发表

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

Article published

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:

1.所有患者检查数据记录在纸质的检查记录表中; 2.通过人工录入形成电子Excel文件,使用SPSS进行统计分析。

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

1. All data shall be recorded in paper examination records; 2. Form electronic Excel files through manual input, and use SPSS for statistical analysis.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2019-09-07
return list