今天是:2019-11-15 星期五

不同非球面设计人工晶状体植入术后的视觉质量对比观察
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注册号:

Registration number:

ChiCTR1800015638 

最近更新日期:

Date of Last Refreshed on:

2018-04-12 

注册时间:

Date of Registration:

2018-04-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

不同非球面设计人工晶状体植入术后的视觉质量对比观察 

Public title:

Comparison of visual outcomes of different design aspheric intraocular lens implatation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

不同非球面设计人工晶状体植入术后的视觉质量对比观察 

Scientific title:

Comparison of visual outcomes of different design aspheric intraocular lens implatation 

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:

Jing Wang 

Study leader:

Jinsong Zhang 

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 18900916888 

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):

www.cmu4h.cn 

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:

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:

EC-2018-KS-003 

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:

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:

2018-02-12 

伦理委员会联系人:

李嵚 

Contact Name of the ethic committee:

Qin Li 

伦理委员会联系地址:

辽宁省沈阳市皇姑区崇山东路4号 

Contact Address of the ethic committee:

4 Chongshan Road, HuangGu District, Shenyang, Liaoning, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 18900916689 

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:

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):

沈阳

Country:

China

Province:

Liaoning

City:

Shenyang

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:

11 Xinhua Road, HePing District, Shenyang, Liaoning, China

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:

观察性研究 

Study type:

Observational study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

本研究的目的是评估不同非球面设计人工晶状体(非球面平衡曲线设计、负球差非球面等)植入术后的视觉质量,进一步评估不同非球面设计的IOL在白内障手术中的临床应用价值,指导患者的IOL选择方案 

Objectives of Study:

The purpose of this study is to evaluate the visual outcomes of different aspherical designs intraocular lenses implantation(aspherical balance curve design, negative spherical aspherical design)  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

年龄40周岁以上,男女不限; 单纯性白内障患者,需行白内障超声乳化吸除术 能够理解试验的目的,自愿参加并由患者本人或其法律监护人签署知情同意书 

Inclusion criteria

Patients more than 40 years old needing cataract phacoemulsification and intraocular lens implantation and understanding the purpose of the study and be voluntary to sign the informed consent.  

排除标准:

合并严重影响术后视力的眼部疾病,如角膜变性、青光眼、年龄相关性黄斑变性、糖尿病视网膜病变、晶状体脱位、葡萄膜炎等 伴有严重的或不稳定的心、肝、肾、肺、内分泌(包括甲状腺功能不全)、血液、精神神经功能障碍等疾病可能影响研究结果及不能配合随访者 存在眼部外伤史、晶状体悬韧带异常、瞳孔异常、瞳孔无法散大<6mm、既往行角膜屈光手术史等患者 同时参加其他药物或医疗器械临床试验者 研究者判断患者不适合入选的其它情况 

Exclusion criteria:

Patients with other serious coexisting ocular disease, and a history of trauma, zonular weakness, abnormal pupil, previous corneal refractive surgery and other researchers judged excluded patients  

研究实施时间:

Study execute time:

From2018-04-15To 2018-12-31 

干预措施:

Interventions:

组别:

观察组1

样本量:

20

Group:

observation group 1

Sample size:

干预措施:

植入ABC设计IOL(iSert? 251,HOYA)

干预措施代码:

Intervention:

ABC design IOL implantation (iSert 251, HOYA)

Intervention code:

组别:

观察组2

样本量:

20

Group:

observation group 2

Sample size:

干预措施:

ABC设计IOL(Vivinex,HOYA)

干预措施代码:

Intervention:

ABC design IOL implantation (Vivinex, HOYA)

Intervention code:

组别:

对照组1

样本量:

20

Group:

Control group 1

Sample size:

干预措施:

植入负球差非球面设计IOL(SN60WF,Alcon)

干预措施代码:

Intervention:

aspheric IOL implatation (SN60WF)

Intervention code:

组别:

对照组2

样本量:

20

Group:

Control group 2

Sample size:

干预措施:

植入负球差非球面设计IOL(ZCB00,AMO)

干预措施代码:

Intervention:

aspheric IOL implatation (ZCB00)

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眼科 中国医科大学眼科医院 辽宁省晶状体学重点实验室 

单位级别:

三级甲等 

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  

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:

术后1周、1个月、3个月

测量方法:

视力表测量

Measure time point of outcome:

1 week, 1 month and 3 months after operation

Measure method:

visual chart

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:

术后1周、1个月、3个月

测量方法:

OPD / i-trace

Measure time point of outcome:

1 week, 1 month and 3 months after operation

Measure method:

OPD / i-trace

指标中文名:

IOL偏心值及倾斜度

指标类型:

主要指标 

Outcome:

IOL decentration and tilt degree

Type:

Primary indicator 

测量时间点:

术后1周、1个月、3个月

测量方法:

Pentacam

Measure time point of outcome:

1 week, 1 month and 3 months after operation

Measure method:

Pentacam

指标中文名:

客观视觉质量

指标类型:

次要指标 

Outcome:

Objective visual quality

Type:

Secondary indicator 

测量时间点:

术后1周、1个月、3个月

测量方法:

C-Quant and OQAS

Measure time point of outcome:

1 week, 1 month and 3 months after operation

Measure method:

C-Quant and OQAS

指标中文名:

对比敏感度

指标类型:

次要指标 

Outcome:

Contrast sensitivity

Type:

Secondary indicator 

测量时间点:

术后1周、1个月、3个月

测量方法:

OPTEC 6500

Measure time point of outcome:

1 week, 1 month and 3 months after operation

Measure method:

OPTEC 6500

指标中文名:

客观视觉质量 调制传递函数

指标类型:

次要指标 

Outcome:

MTF

Type:

Secondary indicator 

测量时间点:

术后1周、1个月、3个月

测量方法:

OPD/itrace

Measure time point of outcome:

1 week, 1 month and 3 months after operation

Measure method:

OPD /itrace

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):

非随机对照实验 以患者意愿选择植入晶状体类型分组

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

Non random controlled trial Dividing into groups according to patients intention for differernt types of intraocular lens implantation

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:

病例记录表(Case Record Form, CRF)

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-04-12
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