Today is 2022-07-07

A medical records based study for conjunctival sac fluid drainage into the anterior chamber after phakic intraocular lens implantation by horizontal and superior clear corneal incision:a comparison
download

注册号:

Registration number:

ChiCTR2200056108 

最近更新日期:

Date of Last Refreshed on:

2022-02-01 

注册时间:

Date of Registration:

2022-02-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

观察有晶体人工晶体植入手术结束时结膜囊液体通过不同位置角膜缘切口倒吸入前房的比较分析:基于病历记录的研究 

Public title:

A medical records based study for conjunctival sac fluid drainage into the anterior chamber after phakic intraocular lens implantation by horizontal and superior clear corneal incision:a comparison 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

有晶体眼人工植入术后结膜囊液体经水平和上方透明角膜切口倒吸入前房的研究  

Scientific title:

Conjunctival sac fluid drainage into the anterior chamber after phakic intraocular lens implantation by horizontal and superior clear corneal incisions 

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:

万欢 

研究负责人:

王琳 

Applicant:

Huan Wan 

Study leader:

Lin Wang 

申请注册联系人电话:

Applicant telephone:

18909039041 

研究负责人电话:

Study leader's telephone:

18980601745 

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:

381964006@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

18980601745@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:

四川省眉山市人民医院 

研究负责人通讯地址:

四川大学华西医院 

Applicant address:

Sichuan Meishan City People's Hospital 

Study leader's address:

Sichuan University West China Hospital, Chengdu 

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:

四川省眉山市人民医院 

Applicant's institution:

Sichuan Meishan City People's Hospital 

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:

2022年审(53)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:

四川大学华西医院生物医学伦理审查委员会 

Name of the ethic committee:

Biomedical Ethics Review Committee of West China Hospital of Sichuan University  

伦理委员会批准日期:

Date of approved by ethic committee:

2022-01-18 

伦理委员会联系人:

李娜 

Contact Name of the ethic committee:

Na Li 

伦理委员会联系地址:

四川省成都市武侯区国学巷37号四川大学华西医院  

Contact Address of the ethic committee:

West China Hospital of Sichuan University, 37 Guoxue Lane, Wuhou District, Chengdu, Sichuan Province  

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:

四川大学华西医院 

Primary sponsor:

Sichuan University West China Hospital 

研究实施负责(组长)单位地址:

中国四川省成都市国学巷37号 

Primary sponsor's address:

37, Guoxue Lane, Chengdu, Sichuan, 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):

四川

市(区县):

Country:

China

Province:

SIchuan

City:

单位(医院):

四川大学华西医院

具体地址:

四川省成都市国学巷37号

Institution
hospital:

Sichuan University West China Hospital

Address:

37, Guoxue Lane, Chengdu, Sichuan,

经费或物资来源:

NA 

Source(s) of funding:

NA 

研究疾病:

屈光不正 

Target disease:

ametropia 

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

研究水平位角膜缘透明切口与上方角膜缘透明切口在有晶体后房型人工晶体植入手术结束去除开睑器时结膜囊液体倒吸入前房的比较分析。 

Objectives of Study:

To compare conjunctival sac fluid drainage into the anterior chamber using horizontal and superior clear corneal incisions (CCIs) after removal of the blepharostat during ICL implantation 

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:

年龄21岁以上40岁以下,中高度近视或散光,前房深度>2.8mm,前房角30~40°,角膜直径>10.6mm。 

Inclusion criteria

The inclusion criteria included age over 18 and under 40 years, moderate to high myopia or astigmatism, anterior chamber depth >2.8 mm, anterior chamber angle 30° to 40°, and corneal diameter >10.6 mm. 

排除标准:

角膜病变、先天性白内障、陈旧性葡萄膜炎、葡萄膜炎、眼部外伤史、青光眼、眼底疾病。 

Exclusion criteria:

The exclusion criteria were keratopathy, congenital cataract, old uveitis, uveitis, history of ocular trauma, glaucoma, and fundus diseases. 

研究实施时间:

Study execute time:

From2022-02-01To 2022-04-01 

征募观察对象时间:

Recruiting time:

From2022-02-01To 2022-02-28 

干预措施:

Interventions:

组别:

水平角膜缘切口组

样本量:

70

Group:

horizontal clear corneal incision

Sample size:

干预措施:

有晶体眼人工晶体植入手术时行水平位角膜缘透明切口行角膜缘透明切口

干预措施代码:

Intervention:

phakic intraocular lens implantation by horizontal clear corneal incision

Intervention code:

组别:

上方角膜缘切口组

样本量:

70

Group:

superior clear corneal incision

Sample size:

干预措施:

有晶体眼人工晶体植入手术时行上方角膜缘透明切口

干预措施代码:

Intervention:

phakic intraocular lens implantation by superior clear corneal incision

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

 

Country:

China 

Province:

SIchuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等医院 

Institution
hospital:

Sichuan University West China Hospital  

Level of the institution:

Grade 3, Class A hospital 

测量指标:

Outcomes:

指标中文名:

结膜囊液体倒吸入前房情况

指标类型:

主要指标 

Outcome:

Conjunctival sac fluid drainage into the anterior chamber

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:

NA

组织:

Sample Name:

NA

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 40 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):

NA

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

NA

盲法:

Blinding:

是否共享原始数据:

IPD sharing

No

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):

NA

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

NA

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:

NA

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

NA

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2022-02-01
return list