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高度近视防治与视觉质量优化的多中心临床研究
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注册号:

Registration number:

ChiCTR1800017594 

最近更新日期:

Date of Last Refreshed on:

2018-08-05 

注册时间:

Date of Registration:

2018-08-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

高度近视防治与视觉质量优化的多中心临床研究 

Public title:

Multicenter clinical study on prevention and visual quality optimization of high myopia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

高度近视防治与视觉质量优化的多中心临床研究 

Scientific title:

Multicenter clinical study on prevention and visual quality optimization of high myopia 

研究课题代号(代码):

Study subject ID:

Grant No .17411950200 & 17411950201 

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:

赵婧 

研究负责人:

周行涛 

Applicant:

Jing Zhao 

Study leader:

Xingtao Zhou 

申请注册联系人电话:

Applicant telephone:

+8615000556332 

研究负责人电话:

Study leader's telephone:

13816880725 

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:

zhaojing_med@163.com 

研究负责人电子邮件:

Study leader's E-mail:

doctzhouxingtao@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:

上海徐汇区汾阳路83号 

研究负责人通讯地址:

上海徐汇区汾阳路83号 

Applicant address:

83 Fenyang Road, Xuhui District, Shanghai, China 

Study leader's address:

83 Fenyang Road, Xuhui District, Shanghai, 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:

复旦大学附属眼耳鼻喉科医院 

Applicant's institution:

Department of Ophthalmology, Eye and ENT Hospital of Fudan University 

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:

复旦大学附属眼耳鼻喉科医院眼科 

Primary sponsor:

Department of Ophthalmology, Eye and ENT Hospital of Fudan University 

研究实施负责(组长)单位地址:

上海徐汇区汾阳路83号 

Primary sponsor's address:

83 Fenyang Road, Xuhui, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

Shanghai

单位(医院):

复旦大学附属眼耳鼻喉科医院

具体地址:

上海徐汇区汾阳路83号

Institution
hospital:

Eye and ENT hospital of Fudan University

Address:

83 Fenyang Road, Xuhui, Shanghai, China

经费或物资来源:

上海市“科技创新行动计划” 临床医学领域项目 

Source(s) of funding:

Project of Shanghai Science and Technology Grant No .17411950200 & 17411950201 

研究疾病:

近视 

Target disease:

Myopia 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

卫生服务研究 

Study phase:

Health Services Research 

研究目的:

针对高度近视及其并发症致盲,探索其视觉质量特点和危险因素,探索早期干预方案,研究关键有效的治疗技术,提高高度近视患者的视觉质量,减少高度近视致盲率;对高度近视及其并发症的干预方法包括手术(全飞秒SMILE手术及ICL手术)与非手术(光学干预)矫正对视觉质量的影响进行系统评估,建立高度近视及其并发症防治的优选方案,为制定相关行业规范标准提供科学依据、技术支撑和行业指导原则。  

Objectives of Study:

In view of the high myopia and its complications, explore its visual quality and risk factors, explore the early intervention program, investigate the key and effective treatment techniques, improve the visual quality of the patients with high myopia, reduce the rate of high myopia blindness; the intervention methods for high myopia include the operation (all femtosecond SMILE and ICL operation ) The effect of the operation on the visual quality is systematically evaluated, and the optimal scheme for the prevention and control of high myopia and its complications is established, which provides scientific basis, technical support and industry guidance for the formulation of relevant standards. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1.不同年龄、不同近视程度的近视人群2.身心健康,排除眼部其他疾病 3、愿意并遵从试验所有要求,进行所需的随访 

Inclusion criteria

1. different ages groups with myopia and different myopia levels; 2. in physical and mental health, excluding other diseases of the eye; 3. willing and complying with all the requirements of the test, to follow up the required follow-up. 

排除标准:

(1)正在使用精神科药物或治疗认知性疾病的药物;(2)在过去半年内接受过其他眼部手术 (3)本试验期内怀孕包括计划怀孕或哺乳期妇女 (4)受试者患有眼球震颤或其他疾病,影响手术或其他诊断检查中的固视 .  

Exclusion criteria:

1. current use of any medication due to a psychiatric disorder or cognitive impairment that might affect the psychological assessment; 2. subjects who had undergone ocular surgery within the last 6 months; 3. Pregnancy (including plans to become pregnant) or lactation during the course of the study; 4. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests.  

研究实施时间:

Study execute time:

From2018-09-01To 2021-09-30 

征募观察对象时间:

Recruiting time:

From2018-09-01To 2020-09-30 

干预措施:

Interventions:

组别:

1

样本量:

250

Group:

1

Sample size:

干预措施:

框架眼镜

干预措施代码:

Intervention:

Glass

Intervention code:

组别:

2

样本量:

100

Group:

2

Sample size:

干预措施:

OK镜

干预措施代码:

Intervention:

Otho-K

Intervention code:

组别:

3

样本量:

100

Group:

3

Sample size:

干预措施:

软性隐形眼镜

干预措施代码:

Intervention:

soft lens

Intervention code:

组别:

4

样本量:

150

Group:

4

Sample size:

干预措施:

全飞秒手术

干预措施代码:

Intervention:

SMILE procedure

Intervention code:

组别:

5

样本量:

100

Group:

5

Sample size:

干预措施:

ICL手术

干预措施代码:

Intervention:

ICL procedure

Intervention code:

组别:

6

样本量:

100

Group:

6

Sample size:

干预措施:

RGP

干预措施代码:

Intervention:

RGP

Intervention code:

组别:

7

样本量:

50

Group:

7

Sample size:

干预措施:

多焦软镜

干预措施代码:

Intervention:

Mutifocus soft lens( MFSCL)

Intervention code:

组别:

8

样本量:

150

Group:

8

Sample size:

干预措施:

对照组

干预措施代码:

Intervention:

Corntrol

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

复旦大学附属眼耳鼻喉科医院眼科 

单位级别:

三甲 

Institution
hospital:

Department of Ophthalmology, Eye and ENT Hospital of Fudan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属儿科医院 

单位级别:

三甲 

Institution
hospital:

Paediatrics Hospital Affiliated to Fudan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属金山医院(上海市金山区眼病防治所、上海市金山区核化伤害应急救治中心) 

单位级别:

三甲 

Institution
hospital:

Jin Shan hospital of Fudan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

上海市第一人民医院 

单位级别:

三甲 

Institution
hospital:

Shanghai First People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

上海交通大学医学院附属仁济医院 

单位级别:

三甲 

Institution
hospital:

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属新华医院 

单位级别:

三甲 

Institution
hospital:

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

上海市第十人民医院 

单位级别:

三甲 

Institution
hospital:

Shanghai Tenth People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

上海市静安区中心医院(复旦大学附属华山医院静安分院) 

单位级别:

二甲 

Institution
hospital:

Central Hospital of Shanghai Jingan District (Jingan branch)  

Level of the institution:

Tertiary B hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海爱尔眼科医院有限公司 

单位级别:

民营医院 

Institution
hospital:

Shanghai Ai'er Eye Hospital  

Level of the institution:

Private hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海和平眼科医院有限公司 

单位级别:

民营医院 

Institution
hospital:

Shanghai Heping Ophthalmological Hospital  

Level of the institution:

Private hospital 

测量指标:

Outcomes:

指标中文名:

有效指数

指标类型:

主要指标 

Outcome:

efficacy index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全指数

指标类型:

主要指标 

Outcome:

safety index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

裂隙灯观察

指标类型:

主要指标 

Outcome:

slit lamp observation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

屈光度检测

指标类型:

主要指标 

Outcome:

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

指标类型:

主要指标 

Outcome:

axial length

Type:

Primary 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:

主要指标 

Outcome:

Corneal curvature

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼压

指标类型:

主要指标 

Outcome:

Intraocular pressure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼底检查

指标类型:

主要指标 

Outcome:

Fundus examination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉质量

指标类型:

主要指标 

Outcome:

optical quality

Type:

Primary 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:

主要指标 

Outcome:

contrast sensitivity

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:

not applicable

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 6 years
最大 Max age 45 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):

not applicable

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):

论文公开发表

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

original data will be published in paper after this study is finished

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:

Excel数据库

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

Excel metadata

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-08-05
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