视野缺损的青光眼患者眼动和步态关系的行为学研究

注册号:

Registration number:

ChiCTR2500104199 

最近更新日期:

Date of Last Refreshed on:

2026-05-29 17:42:20 

注册时间:

Date of Registration:

2025-06-12 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

视野缺损的青光眼患者眼动和步态关系的行为学研究

Public title:

Behavioral study on the relationship between eye movement and gait in glaucoma patients with visual field defects

注册题目简写:

English Acronym:

研究课题的正式科学名称:

视野缺损的青光眼患者眼动和步态关系的行为学研究

Scientific title:

Behavioral study on the relationship between eye movement and gait in glaucoma patients with visual field defects

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:

王大江 

研究负责人:

王大江 

Applicant:

Wang Dajiang 

Study leader:

Wang Dajiang 

申请注册联系人电话:

Applicant telephone:

+86 137 1818 0877

研究负责人电话:

Study leader's
telephone:

+86 137 1818 0877

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:

wangdajiang301@163.com

研究负责人电子邮件:

Study leader's E-mail:

wangdajiang301@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:

永定路69号

研究负责人通讯地址:

永定路69号

Applicant address:

69 Yongding Raod, Haidian District, Beijing

Study leader's address:

69 Yongding Raod, Haidian District, Beijing

申请注册联系人邮政编码:

Applicant postcode:

100039

研究负责人邮政编码:

Study leader's postcode:

100039

申请人所在单位:

中国人民解放军总医院第三医学中心

Applicant's institution:

The Third Medical Center of Chinese PLA General Hospital

研究负责人所在单位:

中国人民解放军总医院第三医学中心

Affiliation of the Leader:

The Third Medical Center of Chinese PLA General Hospital

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:

伦审科研第(KY2022-003)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:

中国人民解放军总医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Chinese PLA General Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2022-01-25 00:00:00

伦理委员会联系人:

陈金宏

Contact Name of the ethic committee:

Chen Jinhong

伦理委员会联系地址:

北京市复兴路28号

Contact Address of the ethic committee:

28 Fuxing Raod, Haidian District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 139 1086 3311

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:

中国人民解放军总医院第三医学中心

Primary sponsor:

The Third Medical Center of Chinese PLA General Hospital

研究实施负责(组长)单位地址:

北京市海淀区永定路69号

Primary sponsor's address:

69 Yongding Raod, Haidian District, 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):

北京

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军总医院第三医学中心

具体地址:

永定路69号

Institution
hospital:

The Third Medical Center of Chinese PLA General Hospital

Address:

69 Yongding Raod

经费或物资来源:

首都医学发展科研基金

Source(s) of funding:

Capital Medical Science Development Foundation

研究疾病:

青光眼  

Target disease:

Glaucoma

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:

探索性研究/预试验 

Study phase:

0

研究设计:

非随机对照试验 

Study design:

Non randomized control 

研究目的:

制定青光眼患者跌倒风险的因素制定眼动-步态训练方案,减少跌倒风险。  

Objectives of Study:

Develop factors for the risk of falls in glaucoma patients and develop eye movement gait training programs to reduce the risk of falls.

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:

1.高度近视,角膜病,葡萄膜炎,黄斑病变,糖尿病性视网膜病和其他眼底疾病; 2.视网膜视神经疾病; 3.中枢神经系统可能导致的视神经变性性疾病; 4.颅内占位和其他神经系统疾病疾病; 5.肢体活动受限或其他原因不能配合眼科检查及步态检查。

Exclusion criteria:

1. High myopia, keratopathy, uveitis, macular degeneration, diabetic retinopathy and other fundus diseases; 2. Retinal optic nerve disease; 3. Optic nerve degenerative diseases that may be caused by the central nervous system; 4. Intracranial mass and other neurological diseases. 5.Limited limb movement or other reasons prevent cooperation with ophthalmic examination and gait examination.

研究实施时间:

Study execute time:

From 2023-11-01 00:00:00 To 2025-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2023-12-28 00:00:00 To 2025-12-31 00:00:00

干预措施:

Interventions:

组别:

训练组

样本量:

34

Group:

Training group

Sample size:

干预措施:

眼动训练;步态训练

干预措施代码:

Intervention:

Eye movement training; gait training

Intervention code:

组别:

对照组

样本量:

34

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):

北京 

市(区县):

海淀 

Country:

China

Province:

Beijing

City:

Haidian

单位(医院):

中国人民解放军总医院第三医学中心 

单位级别:

三级甲等 

Institution
hospital:

The Third Medical Center of Chinese PLA General Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

眼动

指标类型:

次要指标

Outcome:

Eye-movement

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

步态

指标类型:

次要指标

Outcome:

Gait

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

跌倒风险评估

指标类型:

主要指标

Outcome:

Fall Risk Assessment

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:

None

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 18 years
最大 Max age 70 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):

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

None

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:

Blinding:

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

否No

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):

试验完成后6个月内,国家生物信息中心 https://ngdc.cncb.ac.cn/gsub/

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

Within six months after the trial complete by China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)

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:

临床数据采集采用病历记录表(Case Record Form,CRF)

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

Clinical data collection uses Case Record Form (CRF)

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:

 2025-06-12 11:32:04