今天是:2020-08-11 星期二

多中心评价眼外科生物补片安全性与有效性的临床试验
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注册号:

Registration number:

ChiCTR2000034661 

最近更新日期:

Date of Last Refreshed on:

2020-07-15 

注册时间:

Date of Registration:

2020-07-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

多中心评价眼外科生物补片安全性与有效性的临床试验 

Public title:

Clinical trial to evaluate the safety and efficacy of biologic mesh in ophthalmic surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

多中心评价眼外科生物补片安全性与有效性的临床试验 

Scientific title:

Clinical trial to evaluate the safety and efficacy of biologic mesh in ophthalmic surgery 

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:

刘金金 

研究负责人:

邓宏伟 

Applicant:

Jinjin Liu 

Study leader:

Hongwei Deng 

申请注册联系人电话:

Applicant telephone:

+86 15101149724 

研究负责人电话:

Study leader's telephone:

+86 0755-23959542 

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:

2997506733@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

dhw110@126.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:

北京市昌平区科技园东区华昌路2号 

研究负责人通讯地址:

广东省深圳市福田区泽田路18号 

Applicant address:

2 Huachang Road, East Science Park, Changping District, Beijing, China 

Study leader's address:

18 Zetian Road, Futian District, Shenzhen, Guangdong, 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:

北京佰仁医疗科技股份有限公司 

Applicant's institution:

Beijing Bairen Medical Technology Co. LTD 

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:

深眼伦审20200628-04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:

深圳市眼科医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Shenzhen Eye Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-06-28 

伦理委员会联系人:

汪涛 

Contact Name of the ethic committee:

Tao Wang 

伦理委员会联系地址:

广东省深圳市福田区泽田路18号 

Contact Address of the ethic committee:

18 Zetian Road, Futian District, Shenzhen, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0755-25959627 

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:

北京大学人民医院 

Primary sponsor:

People's Hospital of Peking University 

研究实施负责(组长)单位地址:

北京市西城区西直门南大街11号 

Primary sponsor's address:

11 Xizhimen South Street, 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):

西城区

Country:

China

Province:

Beijing

City:

Xicheng District

单位(医院):

北京大学人民医院

具体地址:

西直门南大街11号

Institution
hospital:

People's Hospital of Peking University

Address:

11 Xizhimen South Street

国家:

中国

省(直辖市):

广东

市(区县):

深圳

Country:

China

Province:

Guangdong

City:

shenzhen

单位(医院):

深圳市眼科医院

具体地址:

福田区泽田路18号

Institution
hospital:

Shenzhen Eye Hospital

Address:

18 Zetian Road, Futian District

国家:

中国

省(直辖市):

安徽

市(区县):

合肥

Country:

China

Province:

Anhui

City:

hefei

单位(医院):

安徽医科大学第二附属医院

具体地址:

经济技术开发区芙蓉路678号

Institution
hospital:

Second Affiliated Hospital of Anhui Medical University

Address:

678 Furong Road, Hefei Economic and Technological Development Zone

国家:

中国

省(直辖市):

上海

市(区县):

徐汇区

Country:

China

Province:

Shanghai

City:

xuhui District

单位(医院):

复旦大学附属眼耳鼻喉科医院

具体地址:

汾阳路83号

Institution
hospital:

Eye, Ear, Nose and Throat Hospital affiliated to Fudan University

Address:

83 Fenyang Road

国家:

中国

省(直辖市):

北京

市(区县):

海淀区

Country:

China

Province:

Beijing

City:

Haidian District

单位(医院):

中国人民解放军总医院

具体地址:

复兴路28号

Institution
hospital:

The General Hospital of the People's Liberation Army

Address:

28 Fuxing Road

国家:

中国

省(直辖市):

北京

市(区县):

东城区

Country:

China

Province:

Beijing

City:

Dongcheng District

单位(医院):

首都医科大学北京同仁医院

具体地址:

东交民巷1号

Institution
hospital:

Beijing Tongren Hospital, Capital Medical University

Address:

1 Dongjiaomin Lane

经费或物资来源:

北京佰仁医疗科技股份有限公司 

Source(s) of funding:

Beijing Bairen Medical Technology Co. LTD 

研究疾病:

病理性近视 

Target disease:

Pathological myopia 

研究疾病代码:

H52.101 

Target disease code:

H52.101 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

本临床试验的目的是评价“眼外科生物补片”应用于后巩膜加固是否具有预期的安全性和有效性。 

Objectives of Study:

The purpose of this clinical trial was to evaluate the efficacy and safety of biologic mesh for posterior scleral reinforcement. 

药物成份或治疗方案详述:

通过多中心、单组目标值设计临床试验评价眼外科生物补片应用于后巩膜加固的安全性和有效性。 

Description for medicine or protocol of treatment in detail:

To evaluate the safety and efficacy of biological mesh in posterior scleral reinforcement in ophthalmic surgery in a multi-center, single-target clinical trial. 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

a.3~5岁≥-5.00D以上,6岁≥-6.00D,7岁≥-7.00D,8岁≥-8.00D,9岁≥-9.00D,10岁及其以上者近视程度在-10.00D以上; b.20岁以下者,近视每年增加≥-1.00D,眼轴增长长度≥0.45mm以上; c.20岁以上者,除有-10.00D以上近视眼外,且每年眼轴还在继续增长; d.30岁以上者,近视在-10.00D以上,合并出现眼底视网膜后极部病变,包括黄斑出血、黄斑裂孔、黄斑变性、视网膜襞裂等; e.入院前具有三个月或三个月以上的眼部相关数据(眼轴、最佳矫正视力、轴率比等)的检查单者,且要符合a、b、c、d任意一条; f.受试者满足上述任意一条即可入组。 

Inclusion criteria

A. 3~5 years old >= -5.00D or above, 6 years old >= -6.00D, 7 years old >= -7.00D, 8 years old >= -8.00D, 9 years old >= -9.00D, 10 years old or above myopia level >= -10.00D; B. For people under 20 years old, myopia increases >= -1.00d and axial length increases >= 0.45mm per year; C. People over 20 years old have myopia of -10.00D or above, and the ocular axis continues to increase every year; D. Myopia above 30 years old is above -10.00 d, accompanied by posterior retinal pole lesions of the fundus, including macular hemorrhage, macular hole, macular degeneration, retinal plica; E. Patients who have a checklist of ocular related data (eye axis, best corrected visual acuity, axial ratio, etc.) for three months or more before admission, and they should meet any one of A, B, C, D; F. Subjects can be enrolled if they meet any of the above criteria. 

排除标准:

a.既往有明确眼外伤史和眼科手术史者; b.无法耐受麻醉者; c.早产儿、双胞胎或多胞胎、低出生体重儿及其他出生史异常者; d.合并青光眼、白内障、圆锥角膜、角膜云翳、先天性上睑下垂等眼病; e.眼球或其周围组织有急慢性炎症或肿瘤者; f.单纯性近视、非轴性近视眼及由其他综合征引起的近视者,如Marfan综合征、Stickler综合征等; g.患有全身严重疾病者,如白血病、胶原性疾病、糖尿病、肾病性视网膜病变、严重高血压等; h.三个月内参与其他临床试验者; i.研究者认为不合适入组者; 受试者满足以上任意一条皆不能入组。 

Exclusion criteria:

A. Having a definite history of eye trauma and eye surgery; B. Those who cannot tolerate anesthesia; C. Premature infants, twins or multiple births, low birth weight infants and other birth abnormalities; D. Combined glaucoma, cataract, keratoconus, corneal ptosis, congenital ptosis and other eye diseases; E. Acute or chronic inflammation or tumor in or around the eyeball; F. Simple myopia, non-axial myopia and myopia caused by other syndromes, such as Marfan syndrome and Stickler syndrome; G. Persons suffering from systemic serious diseases, such as leukaemia, collagen diseases, diabetes, nephrotic retinopathy, severe hypertension, etc.; H. Participants in other clinical trials within three months; I. Those who are considered unsuitable by the researcher; Subjects who meet any of the above criteria will not be enrolled. 

研究实施时间:

Study execute time:

From2020-05-11To 2021-12-13 

征募观察对象时间:

Recruiting time:

From2020-07-13To 2021-12-13 

干预措施:

Interventions:

组别:

试验组

样本量:

100

Group:

Experimental group

Sample size:

干预措施:

干预措施代码:

Intervention:

NA

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):

西城区 

Country:

China 

Province:

Beijing 

City:

Xicheng District 

单位(医院):

北京大学人民医院 

单位级别:

三级甲等 

Institution
hospital:

People's Hospital of Peking University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

广东 

市(区县):

深圳 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

深圳市眼科医院 

单位级别:

三级 

Institution
hospital:

Shenzhen Eye Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

安徽 

市(区县):

合肥 

Country:

China 

Province:

Anhui 

City:

Hefei 

单位(医院):

安徽医科大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

Second Affiliated Hospital of Anhui Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

上海 

市(区县):

徐汇区 

Country:

China 

Province:

Shanghai 

City:

Xuhui 

单位(医院):

上海复旦大学附属眼耳鼻喉科医院 

单位级别:

三级甲等 

Institution
hospital:

Eye, Ear, Nose and Throat Hospital affiliated to Fudan University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

海淀区 

Country:

China 

Province:

Beijing 

City:

Haidian 

单位(医院):

中国人民解放军总医院 

单位级别:

三级甲等 

Institution
hospital:

The General Hospital of the People's Liberation Army  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

东城区 

Country:

China 

Province:

Beijing 

City:

Dongcheng 

单位(医院):

首都医科大学北京同仁医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Tongren Hospital, Capital Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

眼轴

指标类型:

主要指标 

Outcome:

Ocular 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:

等效球镜度数

指标类型:

次要指标 

Outcome:

Equivalent degree of ball mirror

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

最佳矫正视力

指标类型:

次要指标 

Outcome:

UCVA

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼底病变

指标类型:

次要指标 

Outcome:

Fundus lesions

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

后极部视网膜血液循环

指标类型:

次要指标 

Outcome:

Blood circulation in the posterior polar retina

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:

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 5 years
最大 Max age 60 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):

单组目标值临床试验

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

A single target clinical trial

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

临床试验结束后,公开方式,网络平台

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

After the end of the clinical trial, the public way, network platform

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:

病例报告表

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

CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-07-13
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