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过矫负镜联合棱镜治疗间歇性外斜视的作用评估
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注册号:

Registration number:

ChiCTR1900025243 

最近更新日期:

Date of Last Refreshed on:

2019-08-17 

注册时间:

Date of Registration:

2019-08-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

过矫负镜联合棱镜治疗间歇性外斜视的作用评估 

Public title:

Evaluating effectiveness of overminus combined with prism lenses in Children with intermittent exotropia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

间歇性外斜视的保守治疗 

Scientific title:

Conservative treatment of intermittent exotropia 

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:

冯月兰 

研究负责人:

李宁东 

Applicant:

Yuelan Feng 

Study leader:

Ningdong Li 

申请注册联系人电话:

Applicant telephone:

+86 15044973994 

研究负责人电话:

Study leader's telephone:

+86 13621083618 

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:

fyl-2006-ky@163.com 

研究负责人电子邮件:

Study leader's E-mail:

lnd30@163.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:

北京市西城区南礼士路56号 

研究负责人通讯地址:

北京市西城区南礼士路56号 

Applicant address:

56 South Lishi Road, Xicheng District, Beijing, China 

Study leader's address:

56 South Lishi Road, Xicheng District, Beijing, 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:

首都医科大学附属北京儿童医院 

Applicant's institution:

Beijing Children's Hospital, Capital Medical University 

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:

2019-k-225 

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:

首都医科大学附属北京儿童医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Beijing Children's Hospital Affiliated to Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-06-18 

伦理委员会联系人:

李志刚 

Contact Name of the ethic committee:

Zhigang Li 

伦理委员会联系地址:

北京市西城区南礼士路56号 

Contact Address of the ethic committee:

56 South Lishi Road, Xicheng District, Beijing, 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:

首都医科大学附属北京儿童医院 

Primary sponsor:

Beijing Children's Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市西城区南礼士路56号 

Primary sponsor's address:

56 South Lishi Road, Xicheng District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京儿童医院

具体地址:

北京市西城区南礼士路56号

Institution
hospital:

Beijing Children's Hospital,Capital Medical University

Address:

56 South Lishi Road, Xicheng District, Beijing, China

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

间歇性外斜视 

Target disease:

intermittent exotropia 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

评价过矫负镜联合棱镜治疗间歇性外斜视的疗效 

Objectives of Study:

To evaluate the effectiveness of overminus combined with prism spectacles as a primary treatment option for childhood with Intermittent Exotropia  

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:

3-7岁间歇性外斜视患儿; 交替遮盖看远斜视度大于15棱镜度; 看近的斜视度不大于看远10个棱镜度 

Inclusion criteria

1. Children aged 3 to <7 years with previously untreated IXT; 2. distance exodeviation at least 15 prism diopters (PD) measured by prism and alternate cover test (PACT); 3. near deviation not exceeding the distance deviation by > 10 PD by PACT. 

排除标准:

眼部和神经系统疾病; 大于2D的屈光参差; 除间歇性外斜伴有大于5个棱镜度的垂直斜视; 其他眼部疾病导致的眼位偏斜; 以前做过斜视手术或有A/V型斜视 

Exclusion criteria:

1. children with any neurological or ocular pathology; 2. >2D of anisometropia or >5PD of vertical deviation in addition to the IXT; 3. any other ophthalmological problem leading to specific ocular deviation, or had prior ocular muscle surgery or significant A or V patterns.  

研究实施时间:

Study execute time:

From2019-09-01To 2020-09-01 

征募观察对象时间:

Recruiting time:

From2019-09-01To 2020-09-01 

干预措施:

Interventions:

组别:

治疗组

样本量:

60

Group:

Case series

Sample size:

干预措施:

过矫负镜联合三棱镜

干预措施代码:

Intervention:

overminus combined with prism 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):

首都医科大学附属北京儿童医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Children's Hospital,Capital Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

斜视度

指标类型:

主要指标 

Outcome:

deviation angle

Type:

Primary 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:

主要指标 

Outcome:

Stereopsis

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:

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 years
最大 Max age 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

2021.01.01

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

2021.01.01

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:

病例记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-08-17
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