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人工晶状体悬吊术
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注册号:

Registration number:

ChiCTR1800017436 

最近更新日期:

Date of Last Refreshed on:

2018-07-30 

注册时间:

Date of Registration:

2018-07-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

人工晶状体悬吊术 

Public title:

Intraocular lens suspension 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

25G套管辅助下无缝线的晶状体脚襻巩膜内挂钩术 

Scientific title:

Sutureless intrascleral haptic-hook lens implantation using 25-gauge trocars 

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:

林海双 

研究负责人:

吴荣瀚 

Applicant:

Hai-Shuang Lin 

Study leader:

Rong-Han Wu 

申请注册联系人电话:

Applicant telephone:

+86 15067896739 

研究负责人电话:

Study leader's telephone:

+86 13625772422 

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:

731054417@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

wuronghan@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:

浙江省温州市鹿城区学院西路270号附属眼视光医院 

研究负责人通讯地址:

浙江省温州市鹿城区学院西路附属眼视光医院 

Applicant address:

270 Xueyuan Road West, Wenzhou, Zhejiang, China 

Study leader's address:

270 Xueyuan Road West, Wenzhou, Zhejiang, 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:

温州医科大学附属眼视光医院 

Applicant's institution:

The Eye Hospital, School of Ophthalmology and Optometry, Wenzhou 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:

XY2018-013 

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:

温州医科大学附属眼视光医院伦理委员会 

Name of the ethic committee:

Ethics committee of the eye hospital of Wenzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-01-31 

伦理委员会联系人:

王晨晓 

Contact Name of the ethic committee:

Chenxiao Wang 

伦理委员会联系地址:

浙江省温州市鹿城区学院西路270号附属眼视光医院 

Contact Address of the ethic committee:

The Eye Hospital, School of Ophthalmology and Optometry, Wenzhou Medical University, 270 Xueyuan Road West, Wenzhou, Zhejiang, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0577-88075582 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

EYE_ec@126.com 

研究实施负责(组长)单位:

温州医科大学附属眼视光医院 

Primary sponsor:

The Eye Hospital, School of Ophthalmology and Optometry, Wenzhou Medical University 

研究实施负责(组长)单位地址:

浙江省温州市鹿城区学院西路270号附属眼视光医院 

Primary sponsor's address:

270 Xueyuan Road West, Wenzhou, Zhejiang, 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):

浙江

市(区县):

温州

Country:

China

Province:

Zhejiang

City:

Wenzhou

单位(医院):

温州医科大学附属眼视光医院

具体地址:

浙江省温州市鹿城区学院西路270号附属眼视光医院

Institution
hospital:

The Eye Hospital, School of Ophthalmology and Optometry, Wenzhou Medical University

Address:

270 Xueyuan Road West, Wenzhou, Zhejiang, China

经费或物资来源:

温州医科大学附属眼视光医院 

Source(s) of funding:

The Eye Hospital, School of Ophthalmology and Optometry, Wenzhou Medical University 

研究疾病:

无晶状体眼、晶状体脱位 

Target disease:

aphakia, dislocated IOL 

研究疾病代码:

 

Target disease code:

 

研究类型:

治疗研究 

Study type:

Treatment 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:

评估25G套管辅助下三片式可折叠人工晶状体的无缝线巩膜内固定术的安全性及有效性。 

Objectives of Study:

Evaluate the safety and effectiveness of sutureless intrascleral fixation if three-piece foldable intraocular lenses(IOLs) using 25-gauge trocars in the treatment of the patients with aphakia or dislocated IOL. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

晶体或人工晶体脱位、无晶体眼晶体囊袋缺失等导致视力下降的病人。 全身状况良好。 

Inclusion criteria

Patients with vision loss caused by lens dislocation, intraocular lens dislocation or absence of lens capsule. Patients whose whole body conditions are good. 

排除标准:

1. 角膜内皮细胞严重变性、角膜内皮细胞数明显减少者。2. 眼部活动性炎症者。3. 角膜浑浊者。4. 有器官移植史,如角膜移植、肾移植等.5.有出血倾向者。6.眼球先天发育异常,以及所有严重影响手术操作的其他情况。 

Exclusion criteria:

1. Patients whose corneal endothelial cells are severely denatured and number of corneal endothelial cells decreased significantly; 2. Patients with active inflammation in eyes; 3. Corneal opacity; 4. History of organ transplantation such as corneal transplantation, kidney transplantation; 5. Bleeding tendency; 6. Congenital abnormality of the eyeball and all other conditions which seriously affect the operation. 

研究实施时间:

Study execute time:

From2018-08-16To 2019-12-01 

征募观察对象时间:

Recruiting time:

From2018-08-17To 2020-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

20

Group:

Case series

Sample size:

干预措施:

25G套管辅助下无缝线的晶状体脚襻巩膜内挂钩术

干预措施代码:

Intervention:

Sutureless intrascleral haptic-hook lens implantation using 25-gauge trocars

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

温州市 

Country:

China 

Province:

Zhejiang 

City:

Wenzhou 

单位(医院):

温州医科大学附属眼视光医院 

单位级别:

三级甲等 

Institution
hospital:

The Eye Hospital, School of Ophthalmology and Optometry, Wenzhou Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

视力

指标类型:

主要指标 

Outcome:

vision

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

指标类型:

次要指标 

Outcome:

refractive diopters

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良反应事件

指标类型:

副作用指标 

Outcome:

adverse events

Type:

Adverse events 

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):

非随机

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

non-comparative study

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

论文发表见刊后,可邮箱传递

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

The data can be delivered by mail after the paper published in the journal

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:

数据采用Excel保持,采用SPSS 22.0统计

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

The data were saved by Excel and analyzed by SPSS 22.0

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-07-30
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