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单盲、随机、单中心研究评估新型光固化玻璃酸钠凝胶应用于翼状胬肉手术的有效性与安全性
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注册号:

Registration number:

ChiCTR1900027923 

最近更新日期:

Date of Last Refreshed on:

2019-12-04 

注册时间:

Date of Registration:

2019-12-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

单盲、随机、单中心研究评估新型光固化玻璃酸钠凝胶应用于翼状胬肉手术的有效性与安全性 

Public title:

Photocuring sodium hyaluronate gel versus sutures for attaching the conjunctival autograft in pterygium surgery: an observer masked, single-center, randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

单盲、随机、单中心研究评估新型光固化玻璃酸钠凝胶应用于翼状胬肉手术的有效性与安全性 

Scientific title:

Photocuring sodium hyaluronate gel versus sutures for attaching the conjunctival autograft in pterygium surgery: an observer masked, single-center, randomized controlled trial 

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:

张依晴 

研究负责人:

戴琦 

Applicant:

Yiqing Zhang 

Study leader:

Qi Dai 

申请注册联系人电话:

Applicant telephone:

+86 15102113907 

研究负责人电话:

Study leader's telephone:

+86 18667127070 

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:

2764813251@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

day1004@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:

上海市徐汇区梅陇路130号 

研究负责人通讯地址:

中国浙江杭州市江干区凤起东路618号 

Applicant address:

130 Meilong Road, Xuhui District, Shanghai, China 

Study leader's address:

618 East Fengqi Road, Jianggan District, Hangzhou, Zhejiang, China 

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:

华东理工大学 

Applicant's institution:

East China University Of Science and Technology 

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:

2019-169-K-161 

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:

温州医科大学附属眼视光医院伦理委员会 

Name of the ethic committee:

Ethics Committee of WenZhou Medical University Affiliated Eye Optometry Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-11-05 

伦理委员会联系人:

俞阿勇 

Contact Name of the ethic committee:

Ayong Yu 

伦理委员会联系地址:

中国浙江杭州市江干区凤起东路618号温州医科大学附属眼视光医院杭州院区 

Contact Address of the ethic committee:

WenZhou Medical University Affiliated Eye Optometry Hospital HangZhou Branch, 618 East Fengqi Road, Jianggan District, Hangzhou, Zhejiang, China 

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:

温州医科大学附属眼视光医院杭州院区 

Primary sponsor:

Wenzhou Medical University Affiliated Eye Optometry Hospital Hangzhou Branch 

研究实施负责(组长)单位地址:

中国浙江省杭州市江干区凤起东路618号(钱潮路口) 

Primary sponsor's address:

618 East Fengqi Road, Jianggan District, Hangzhou, Zhejiang, 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):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

温州医科大学附属眼视光医院杭州院区

具体地址:

杭州市江干区凤起东路618号

Institution
hospital:

WenZhou Medical University Affiliated Eye Optometry Hospital HangZhou Branch

Address:

618 East Fengqi Road, Jianggan District

经费或物资来源:

自筹 

Source(s) of funding:

self-collected funds 

研究疾病:

翼状胬肉 

Target disease:

pterygium 

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:

观察对比我方研制的光固化玻璃酸钠凝胶与传统翼状胬肉术中缝线在手术时间、患者术中及术后不适感、术后并发症方面的区别。 

Objectives of Study:

The difference of operation time, intraoperative and postoperative discomfort and postoperative complications between the photocuring sodium hyaluronate gel developed by our company and the traditional suture method applied in pterygium were observed and compared. 

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:

1.静止期翼状胬肉侵入角膜缘>2mm; 2.年龄位于50-65周岁的原发性翼状胬肉患者。 3.具有完全民事行为能力 

Inclusion criteria

1. Stationary pterygium invaded corneal margin >2mm; 2. Patients aged 50-65 with primary pterygium; 3. Having full capacity for civil conduct. 

排除标准:

1、复发性翼状胬肉; 2、离温州医科大学附属眼视光医院杭州分院较远,不方便复查; 3、有青光眼病史或家族史;有糖尿病病史或全身免疫系统疾病病史; 4、翼状胬肉侵入角膜缘<2mm; 5、眼外伤术后或接受其他内眼术后。 

Exclusion criteria:

1. Recurrent pterygium; 2. It is far away from the affiliated ophthalmology hospital of Wenzhou Medical University in Hangzhou, so it is not convenient for re-examination; 3. With history of glaucoma or family history; history of diabetes or systemic immune system diseases; 4. Pterygium invaded the corneal margin <2mm; 5. After ocular trauma or other internal eye surgery. 

研究实施时间:

Study execute time:

From2019-11-30To 2020-11-01 

征募观察对象时间:

Recruiting time:

From2019-11-30To 2020-02-29 

干预措施:

Interventions:

组别:

研究组

样本量:

5

Group:

experimental group

Sample size:

干预措施:

光固化玻璃酸钠凝胶

干预措施代码:

Intervention:

photocuring sodium hyaluronate gel

Intervention code:

组别:

对照组

样本量:

5

Group:

control group

Sample size:

干预措施:

术中缝线

干预措施代码:

Intervention:

suture in the surgery

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

温州医科大学附属眼视光医院杭州院区 

单位级别:

三级甲等 

Institution
hospital:

Wenzhou Medical University Affiliated Eye Optometry Hospital HangZhou Branch  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

2周后两组游离球结膜瓣脱落率比较

指标类型:

主要指标 

Outcome:

the failure rate of free conjunctival flap between the two groups after 2 weeks

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

两组手术时间比较

指标类型:

次要指标 

Outcome:

The operation time of the two groups

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后患者满意度比较(OSDI评分表)

指标类型:

次要指标 

Outcome:

Postoperative patient satisfaction (OSDI scale)

Type:

Secondary 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:

组织:

Sample Name:

none

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 50 years
最大 Max age 65 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):

本试验计划采用动态随机的方法将筛选成功的受试者分配到光固化玻璃酸钠凝胶组(实验组)或传统缝线组(对照组),试验组与对照组的比例为1:1,每组各5例。

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

In this study, dynamic random method will be adopted to assign the successfully screened subjects to the photocuring sodium hyaluronate gel group (experimental group) and the traditional suture group (control group) with 5 patients in each group.

盲法:

未说明

Blinding:

Not stated

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):

2021-09-01,温州医科大学附属眼视光医院杭州院区

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

2021-09-01,WenZhou Medical University Affiliated Eye Optometry Hospital HangZhou Branch

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:

EXCEL,WORD,保存成纸质文档和CD,及温州医科大学附属眼视光医院杭州院区病历系统

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

EXCEL,WORD,kept as paper doucuments and CD,and eCRF of WenZhou Medical University Affiliated Eye Optometry Hospital HangZhou Branch

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-12-04
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