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该研究尚未获得伦理委员会批准。请于批准后才开始纳入参试者,并与我们联系上传批件。 Nd:YAG后囊切开术对玻切术后后囊混浊患者前房参数的影响
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注册号:

Registration number:

ChiCTR1900023102 

最近更新日期:

Date of Last Refreshed on:

2019-05-11 

注册时间:

Date of Registration:

2019-05-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

该研究尚未获得伦理委员会批准。请于批准后才开始纳入参试者,并与我们联系上传批件。 Nd:YAG后囊切开术对玻切术后后囊混浊患者前房参数的影响 

Public title:

The effects of Nd:YAG laser capsulotomy on anterior segment parameters in patients with PCO after Combined Phacoemulsification and 23-Gauge Pars Plana Vitrectomy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Nd:YAG后囊切开术对玻切术后后囊混浊患者前房参数的影响 

Scientific title:

The effects of Nd:YAG laser capsulotomy on anterior segment parameters in patients with PCO after Combined Phacoemulsification and 23-Gauge Pars Plana Vitrectomy 

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:

Bo Lu 

Study leader:

Liwei Ma 

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, Liaoning, China  

Study leader's address:

11 Xinhua Road, Heping District, Shenyang, Liaoning, 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:

中国辽宁省沈阳市和平区新华路11号 

Primary sponsor's address:

11 Xinhua Road, Heping District, Shenyang, Liaoning, 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):

Country:

China

Province:

Liaoning

City:

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

Institution
hospital:

the Fourth Affiliated Hospital of China Medical University

Address:

11 Xinhua Road, Heping District, Shenyang

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 capsular opacification 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本研究借助Pentacam通过对23G玻璃体切割联合超声乳化白内障摘除联合人工晶体植入术后后发性白内障患者的前房深度、房角的测量研究,探究不同种人工晶体在行23G玻璃体切割患者眼中的前段稳定性。 

Objectives of Study:

The aim was to investigate the effects of neodymium-dopedyttrium aluminum garnet laser capsulotomy on the main numerical parameters of the anterior segment with Pentacam in patients with opacification of the posterior capsule after . 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

拟收集就诊于我院眼科,行23G玻璃体切割联合白内障超声乳化吸除联合人工晶体植入术后,门诊诊断为后发性白内障的患者。 

Inclusion criteria

All of the patients had undergone previous combined phacoemulsification and 23-Gauge pars plana vitrectomy with intraocular lens implantation at least six months earlier. All patients had significant visual loss (at least two lines compared to the last visit) and hazy fundus appearance. 

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:

corneal pathology, glaucoma, uveitis, trauma. None ofthe individuals had any history of contact lens use for any reasons (refractive, cosmetic et cetera). 

研究实施时间:

Study execute time:

From2019-05-03To 2020-05-03 

征募观察对象时间:

Recruiting time:

From2019-05-03To 2020-05-03 

干预措施:

Interventions:

组别:

509M

样本量:

50

Group:

509M

Sample size:

干预措施:

后囊切开

干预措施代码:

Intervention:

capsulotomy

Intervention code:

组别:

HOYA

样本量:

50

Group:

HOYA

Sample size:

干预措施:

后囊切开

干预措施代码:

Intervention:

capsulotomy

Intervention code:

组别:

HOYA251

样本量:

50

Group:

HOYA251

Sample size:

干预措施:

后囊切开

干预措施代码:

Intervention:

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:

前房深度

指标类型:

主要指标 

Outcome:

anterior chamber depth

Type:

Primary indicator 

测量时间点:

术后1个月

测量方法:

Pentacam

Measure time point of outcome:

1 month after capsulotomy

Measure method:

Pentacam

指标中文名:

视力

指标类型:

次要指标 

Outcome:

visual acuity

Type:

Secondary indicator 

测量时间点:

术后1个月

测量方法:

Pentacam

Measure time point of outcome:

1 month after capsulotomy

Measure method:

Pentacam

指标中文名:

球镜

指标类型:

主要指标 

Outcome:

sphericaland powers

Type:

Primary indicator 

测量时间点:

术后1个月

测量方法:

Pentacam

Measure time point of outcome:

1 month after capsulotomy

Measure method:

Pentacam

指标中文名:

柱镜

指标类型:

主要指标 

Outcome:

cylindrical powers

Type:

Primary indicator 

测量时间点:

术后1个月

测量方法:

Pentacam

Measure time point of outcome:

1 month after capsulotomy

Measure method:

Pentacam

指标中文名:

前房角

指标类型:

主要指标 

Outcome:

anterior chamber angle

Type:

Primary indicator 

测量时间点:

术后1个月

测量方法:

Pentacam

Measure time point of outcome:

1 month after capsulotomy

Measure method:

Pentacam

指标中文名:

中央角膜厚度

指标类型:

次要指标 

Outcome:

central corneal thickness

Type:

Secondary indicator 

测量时间点:

术后1个月

测量方法:

Pentacam

Measure time point of outcome:

1 month after capsulotomy

Measure method:

Pentacam

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

no

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 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):

非随机试验

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

N/A

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:

an electronic data capture

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-05-11
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