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客观视觉质量参数的测量对后发性白内障诊治的临床意义
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注册号:

Registration number:

ChiCTR1800018842 

最近更新日期:

Date of Last Refreshed on:

2018-10-13 

注册时间:

Date of Registration:

2018-10-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

客观视觉质量参数的测量对后发性白内障诊治的临床意义 

Public title:

The clinical application of optical quality parameters in Patients with posterior capsule opacification 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

客观视觉质量参数的测量对后发性白内障诊治的临床意义 

Scientific title:

The clinical application of optical quality parameters in Patients with posterior capsule opacification 

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:

陆博 

研究负责人:

马立威 

Applicant:

LU BO 

Study leader:

MA LIWEI 

申请注册联系人电话:

Applicant telephone:

+86 18900913651 

研究负责人电话:

Study leader's telephone:

+86 18900913588 

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:

lubocmu@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

18900913588@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:

辽宁省沈阳市和平区新华路11号 眼科 

研究负责人通讯地址:

辽宁省沈阳市和平区新华路11号 眼科 

Applicant address:

11 Xinhua Road, Heping District, Shenyang, China 

Study leader's address:

11 Xinhua Road, Heping District, Shenyang, China 

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 

Applicant's institution:

Department of Ophthalmology, The Fourth Affiliated Hospital of China Medical 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:

中国医科大学附属第四医院 

Primary sponsor:

the Fourth Affiliated Hospital of China Medical University 

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 眼科 

Primary sponsor's address:

Department of Ophthalmology, The Fourth Affiliated Hospital of China Medical University, 11 Xinhua Road, Heping District, Shenyang, 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):

辽宁

市(区县):

沈阳

Country:

China

Province:

Liaoning

City:

Shenyang

单位(医院):

中国医科大学附属第四医院

具体地址:

辽宁省沈阳市和平区新华路11号 眼科

Institution
hospital:

the Fourth Affiliated Hospital of China Medical University

Address:

11 Xinhua Road, Heping District, Shenyang, China

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

后发性白内障 

Target disease:

posterior capsule opacificatio 

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:

其它 

Study phase:

N/A 

研究目的:

应用双通道视觉质量分析系统(OQASⅡ)测量后发性白内障患者行Nd:YAG激光后囊膜切开术前后视觉质量参数的变化,为后发性白内障的诊治提供客观依据。 

Objectives of Study:

To evaluate the changes in visual quality parameters before and after neodymiumyttrium aluminum garnet(NdYAG)laser posterior capsulotomy in pseudophakic eyes by using double—pass optical quality analysis system (OQASⅡ)and provide an objective criterion for the diagnosis and treatment of posterior capsule opacification. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

后发性白内障患者 

Inclusion criteria

patients with posterior capsule opacification 

排除标准:

排除患者患有糖尿病、青光眼、眼表疾病、高度近视、眼部肿瘤或有其他眼部手术史。 

Exclusion criteria:

Patients with diabetes, glaucoma, ocular surface disease, high myopia, trauma, and previous eye surgery that affects visual acuity were excluded.  

研究实施时间:

Study execute time:

From2018-10-13To 2019-06-30 

征募观察对象时间:

Recruiting time:

From2018-10-13To 2019-06-30 

干预措施:

Interventions:

组别:

实验组

样本量:

100

Group:

Case series

Sample size:

干预措施:

YAG后囊截开

干预措施代码:

Intervention:

YAG laser posterior capsulotomy

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):

沈阳 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

中国医科大学附属第四医院 

单位级别:

三甲 

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:

客观散射指数

指标类型:

主要指标 

Outcome:

objective scatter 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:

最佳矫正视力

指标类型:

主要指标 

Outcome:

best correct 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:

调制传递函数

指标类型:

主要指标 

Outcome:

modulation transfer function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

OQAS值

指标类型:

主要指标 

Outcome:

OQAS value

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:

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 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):

非随机入组,按术前视力分组

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

It is not Randomization Procedure

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):

ResMan

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

ResMan

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:

基于互联网的EDC

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

electronic data capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-10-13
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