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不同飞秒激光操作平台辅助的白内障摘除术的临床研究
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注册号:

Registration number:

ChiCTR-TRC-14004977 

最近更新日期:

Date of Last Refreshed on:

2014-10-27 

注册时间:

Date of Registration:

2014-07-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

不同飞秒激光操作平台辅助的白内障摘除术的临床研究 

Public title:

Clinical study of femtosecond laser assisted cataract surgery on different operation platforms 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

不同飞秒激光操作平台辅助的白内障摘除术的临床研究 

Scientific title:

Clinical study of femtosecond laser assisted cataract surgery on different operation platforms 

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:

王静 

研究负责人:

张劲松 

Applicant:

WANG Jing 

Study leader:

ZHANG Jin-song 

申请注册联系人电话:

Applicant telephone:

+86 13840385261 

研究负责人电话:

Study leader's telephone:

+86 13066667486 

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:

wj047322@163.com 

研究负责人电子邮件:

Study leader's E-mail:

cmu4h-zjs@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:

辽宁省沈阳市和平区新华路11号 

研究负责人通讯地址:

辽宁省沈阳市和平区新华路11号 

Applicant address:

No. 11 Xinhua Road, Heping District, Shenyang city, Liaoning province 

Study leader's address:

No. 11 Xinhua Road, Heping District, Shenyang city, Liaoning province 

申请注册联系人邮政编码:

Applicant postcode:

110005 

研究负责人邮政编码:

Study leader's postcode:

110005 

申请人所在单位:

中国医科大学附属第四医院眼科 中国医科大学眼科医院 辽宁省晶状体学重点实验室 

Applicant's institution:

Department of Ophthalmology, the Fourth Affiliated Hospital of China Medical University, Eye Hospital of China Medical University, The Key Lenticular Laboratory of Liaoning Province 

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:

2014-036 

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:

中国医科大学附属第四医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of the Fourth Affiliated Hospital of China Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-07-18 

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:

中国医科大学附属第四医院眼科 中国医科大学眼科医院 辽宁省晶状体学重点实验室 

Primary sponsor:

Department of Ophthalmology, the Fourth Affiliated Hospital of China Medical University, Eye Hospital of China Medical University, The Key Lenticular Laboratory of Liaoning Province 

研究实施负责(组长)单位地址:

辽宁省沈阳市和平区新华路11号 

Primary sponsor's address:

No. 11 Xinhua Road, Heping District, Shenyang city, Liaoning province 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

辽宁

市(区县):

Country:

China

Province:

Liaoning

City:

单位(医院):

中国医科大学附属第四医院眼科 中国医科大学眼科医院 辽宁省晶状体学重点实验室

具体地址:

辽宁省沈阳市和平区新华路11号

Institution
hospital:

Department of Ophthalmology, the Fourth Affiliated Hospital of China Medical University, Eye Hospital of China Medical University, The Key Lenticular Laboratory of Liaoning Province

Address:

No. 11 Xinhua Road, Heping District, Shenyang city, Liaoning province

经费或物资来源:

自筹 

Source(s) of funding:

self-raised expenses 

研究疾病:

白内障 

Target disease:

cataract 

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:

研究目的:

白内障已成为世界性的公共健康问题。本项研究拟通过临床观察证明飞秒激光辅助的白内障超声乳化手术的安全性、稳定性及有效性,并进一步总结不同飞秒激光操作平台在白内障手术中的应用优势。 

Objectives of Study:

Cataract is a public health problem in the world. This study plans to prove the safety, stability and effectiveness of the femtosecond laser assisted cataract surgery, and further summarizes the advantages of different femtosecond laser operating platform in cataract operation 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

拟行白内障超声乳化摘除联合人工晶状体植入术的年龄相关性白内障患者 

Inclusion criteria

Patients with age-related cataract undergoing cataract ultrasound emulsification excision and intraocular lens implantation. 

排除标准:

瞳孔无法散大(<6.0mm),睑裂小,眼球震颤或眼睑明显痉挛,明显的角膜混浊白斑,过熟期白内障,青光眼,活动性的眼部炎症,合并其他眼部疾病,如虹膜新生血管、剥脱综合征、视神经萎缩、眼部肿瘤等 

Exclusion criteria:

Patients with poorly dilating pulils (less than 3.0mm), narrow palpebral fissures, nystagmus or hemofacial spasm, obvious corneal opacities, mature cataract, advanced glaucoma, active iris, a history of serious coexisting ocular disease (eg. iris nervasculization, pseudoexfoliation syndrom, optic atrophy, ocular tumor. 

研究实施时间:

Study execute time:

From2014-08-01To 2014-09-21 

干预措施:

Interventions:

组别:

1

样本量:

50

Group:

FLACS group 1

Sample size:

干预措施:

LenSX飞秒激光辅助的白内障超声乳化手术

干预措施代码:

Intervention:

LenSX femtosecond laser assisted cataract surgery

Intervention code:

组别:

2

样本量:

50

Group:

FLACS group 2

Sample size:

干预措施:

Catalys飞秒激光辅助的白内障超声乳化手术

干预措施代码:

Intervention:

Catalys femtosecond laser assisted cataract surger

Intervention code:

组别:

对照组

样本量:

50

Group:

control group

Sample size:

干预措施:

常规超声乳化白内障手术

干预措施代码:

Intervention:

conventional phacoemulsification surgery

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

中国医科大学附属第四医院 

单位级别:

三级甲等 

Institution
hospital:

The Fourth Affiliated Hospital of China 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:

visual acuity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超声时间及超声能量

指标类型:

主要指标 

Outcome:

phaco time and power

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼红分析

指标类型:

主要指标 

Outcome:

Redness analysis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

角膜厚度

指标类型:

主要指标 

Outcome:

corneal thickness

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

房水蛋白浓度

指标类型:

主要指标 

Outcome:

Flare

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

角膜内皮细胞

指标类型:

主要指标 

Outcome:

corneal endothelial cell

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

黄斑形态

指标类型:

主要指标 

Outcome:

macular morphology

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

屈光状态

指标类型:

主要指标 

Outcome:

refractive status

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

晶状体囊形态

指标类型:

主要指标 

Outcome:

anterior capsulotomy morphology

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

波前像差

指标类型:

主要指标 

Outcome:

wavefront abberation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

核分级

指标类型:

主要指标 

Outcome:

PN

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:

anterior capsule

组织:

晶状体前囊膜

Sample Name:

anterior capsule

Tissue:

anterior capsule

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 40 years
最大 Max age 80 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):

由不参与试验过程的统计人员采用区组随机化的方式进行随机分组

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

The block randomization was used for the study by a statistical personnel who was not included

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):

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):

中国医科大学附属第四医院眼科 中国医科大学眼科医院 辽宁省晶状体学重点实验室

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

Department of Ophthalmology,the Fourth Affiliated Hospital of China Medical University, Eye Hospital of China Medical University,The Key Lenticular Laboratory of Liaoning Province

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:

中国医科大学附属第四医院眼科 中国医科大学眼科医院 辽宁省晶状体学重点实验室

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

Department of Ophthalmology,the Fourth Affiliated Hospital of China Medical University, Eye Hospital of China Medical University,The Key Lenticular Laboratory of Liaoning Province

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-07-19
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