间歇性外斜视患者动态深度知觉和静态立体视的研究

注册号:

Registration number:

ChiCTR2000041275 

最近更新日期:

Date of Last Refreshed on:

2021-03-06 00:05:43 

注册时间:

Date of Registration:

2020-12-23 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

间歇性外斜视患者动态深度知觉和静态立体视的研究

Public title:

The abnormalities of motion-in-depth perception and static stereopsis in patients with intermittent exotropia

注册题目简写:

English Acronym:

研究课题的正式科学名称:

间歇性外斜视患者动态深度知觉和静态立体视的研究

Scientific title:

The abnormalities of motion-in-depth perception and static stereopsis in patients with 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:

王星宇 

研究负责人:

刘陇黔 

Applicant:

Wang Xingyu 

Study leader:

Longqian Liu 

申请注册联系人电话:

Applicant telephone:

+86 18782091241

研究负责人电话:

Study leader's
telephone:

+86 18980601759

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:

515321593@qq.com

研究负责人电子邮件:

Study leader's E-mail:

liulq@scu.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:

四川省成都市武侯区国学巷37号

研究负责人通讯地址:

四川省成都市武侯区国学巷37号

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院

Applicant's institution:

West China Hospital, Sichuan University

研究负责人所在单位:

四川大学华西医院

Affiliation of the Leader:

West China Hospital, Sichuan University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2017-249

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:

四川大学华西医院生物医学伦理委员会

Name of the ethic committee:

West China Hospital of Sichuan University Biomedical Research Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2017-09-15 00:00:00

伦理委员会联系人:

李娜

Contact Name of the ethic committee:

Li Na

伦理委员会联系地址:

四川省成都市武侯区国学巷37号四川大学华西医院第八教学楼412办公室

Contact Address of the ethic committee:

Room 412, Old 8th Teaching Building, West China Hospital, Sichuan University, 37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院

Primary sponsor:

West China Hospital

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

武侯区国学巷37号

Institution
hospital:

West China Hospital

Address:

37 Guoxue Lane, Wuhou District, Chengdu

经费或物资来源:

研究生经费

Source(s) of funding:

Graduate funding

研究疾病:

立体视  

Target disease:

stereopsis

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:

其它 

Study phase:

N/A

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

研究目的:

分析间歇性外斜视患者的动态深度知觉与静态立体视的特点;寻找影响动态深度知觉获得的因素,例如刺激的参数、患者的眼位、双眼视力、发病年龄、治疗史等;研究动态深度知觉与静态立体视的关系。通过对斜视患者术前立体视的评估,观察其与斜视术后斜视复发或继发的相关性,为临床对斜视手术愈后提供理论支持。  

Objectives of Study:

The characteristics of motion-in-depth perception and static stereopsis were analyzed in patients with intermittent exotropia, factors influencing the acquisition of motion-in-depth perception, such as stimulation parameters, eye position, binocular vision, age of onset, treatment history, etc.; the relationship between motion-in-depth perception and static stereopsis was studied. The relationship between stereopsis and the recurrence or secondary of strabismus was observed by the evaluation of the patients with strabismus, which provides theoretical support for the clinical treatment of strabismus.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

排除不能配合检查操作、有眼部器质性病变或全身疾病史的患者。

Exclusion criteria:

Patients who cannot cooperate with the examination, have the history of organic lesions of the eyes or systemic diseases are excluded.

研究实施时间:

Study execute time:

From 2018-01-01 00:00:00 To 2021-04-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2020-10-08 00:00:00 To 2021-04-30 00:00:00

干预措施:

Interventions:

组别:

斜视组

样本量:

25

Group:

Strabismus group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

组别:

对照组

样本量:

25

Group:

control group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

四川 

市(区县):

成都 

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

静态立体视

指标类型:

主要指标

Outcome:

static stereopsis

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

动态深度知觉

指标类型:

主要指标

Outcome:

motion-in-depth perception

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

斜视度

指标类型:

主要指标

Outcome:

squint

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

反应时间

指标类型:

主要指标

Outcome:

response time

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:

N/A

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

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 8 years
最大 Max age 30 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):

该实验不涉及随机分组,进行测试时,不同动态深度知觉的视标移动速度由EXCEL生成的随机表决定。

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

The experiment does not involve random grouping. When performing tests, the order of the tests is random and determined by the random table generated by Excel.

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:

单盲

Blinding:

single blind

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

试验结束并在论文发表后公开,通过上传Excel/word文件共享到中国临床试验注册中心

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

After completion of the trial and finishing the paper publication, they will be shared through uploading Excel/word to the web of Chinese clinical registry

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:

原始数据记录及病例记录表由研究负责人保存,电子版采用excel及spss软件管理

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

All of the original data records and case records are preserved by study leader, and the electronic version records was managed by excel and spss.

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:

 2020-12-23 08:30:03