Today is 2019-05-24

Inference of improved cataract surgery for visual quality and complications
download

注册号:

Registration number:

ChiCTR1900022686 

最近更新日期:

Date of Last Refreshed on:

2019-04-21 

注册时间:

Date of Registration:

2019-04-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

白内障手术操作改进对于患者术后视觉质量及并发症影响 

Public title:

Inference of improved cataract surgery for visual quality and complications 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

前囊膜抛光对于白内障患者术后视觉质量及并发症的对照性研究 

Scientific title:

A comparative study for anterior capsular polishing of visual quality and complications after cataract surgery 

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:

李昕欣 

研究负责人:

张晗 

Applicant:

Li Xinxin 

Study leader:

Zhang Han 

申请注册联系人电话:

Applicant telephone:

+86 18392885341 

研究负责人电话:

Study leader's telephone:

+86 13705310696 

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:

948382845@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

13705310696@139.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:

山东省济南市天桥区山东大学第二医院文会楼 

研究负责人通讯地址:

山东省济南市天桥区山东大学第二医院 

Applicant address:

Wenhui Building, Second Hospital of Shandong University, Tianqiao District, Ji'nan, Shandong, China 

Study leader's address:

Wenhui Building, Second Hospital of Shandong University, Tianqiao District, Ji'nan, Shandong, 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:

山东大学 

Applicant's institution:

Shandong 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:

山东大学第二医院 

Primary sponsor:

Second Hospital of Shandong University 

研究实施负责(组长)单位地址:

山东省济南市天桥区山东大学第二医院 

Primary sponsor's address:

Wenhui Building, Second Hospital of Shandong University, Tianqiao District, Ji'nan, Shandong, 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):

山东省

市(区县):

济南市

Country:

China

Province:

Shandong Province

City:

Jinan City

单位(医院):

山东大学第二医院

具体地址:

天桥区北园大街

Institution
hospital:

Second Hospital of Shandong University

Address:

Beiyuan Street, Tianqiao District

经费或物资来源:

研究经费由研究者个人及张晗光明团队承担 

Source(s) of funding:

The research funds are borne by the individual researcher and Zhang Haoming's team. 

研究疾病:

老年性白内障 

Target disease:

Senile cataract 

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:

前囊膜抛光是否对于白内障患者超声乳化术后视觉质量改善及并发症的预防方面有相关临床意义 

Objectives of Study:

Whether anterior capsular polishing has clinical significance in improving visual quality and preventing complications of cataract patients after phacoemulsification 

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. 年龄18岁以上; 2. 诊断为白内障,并拟行白内障超声乳化+人工晶体植入术的患者; 3. 光定位及色觉正常; 4. 患眼核硬度为2级至4级之间,适合行超声乳化术; 5. 患眼术前或术后散光度数小于或等于1.5D; 6. 需要植入的人工晶体屈光度范围在+10.0D到+30.0D之间; 7.符合并通过白内障术前眼部检查及全身检查合格者。 

Inclusion criteria

1. Age above 18 years old; 2. Patients diagnosed as cataract and planning to undergo phacoemulsification and intraocular lens implantation; 3. Light localization and color perception are normal; 4. The hardness of the affected nucleus is between 2 and 4 grades, which is suitable for phacoemulsification; 5. The astigmatism before or after operation is less than or equal to 1.5D; 6. The refractive range of intraocular lens needed to be implanted is between + 10.0D and + 30.0D; 7. Those who conform to and pass the eye examination and general examination before cataract surgery. 

排除标准:

1. 合并严重的全身系统性疾病,如伴有严重的心/肾/肝/免疫系统等其他系统严重疾病不能行手术者; 2. 合并其他眼部疾病,有明显手术禁忌不能手术者:小眼球/低角膜上皮细胞数(<1200/cm2)/未控制的眼部感染/炎症(虹膜炎/葡萄膜炎)/高眼压/眼内出血/眼外伤等; 3. 已经确诊糖尿病或新诊断的糖尿病患者(空腹血糖>7.0mmol/L); 4. 曾行各种角膜(触及中央瞳孔区的)及内眼手术患者,如:眼底激光手术/视网膜修复术/翼状胬肉手术; 5. 患有可能术后观察期内较大程度影响患者视力变化的眼部疾病,如:控制不佳的青光眼患者/虹膜睫状体炎等易诱发后囊下浑浊的眼部疾病; 6. 患者除白内障外存在明显其他严重影响视力的因素的患者,如:弱视/青光眼(晚期视野缺损严重)/视网膜脱离/视网膜动脉或静脉阻塞并视力损毁严重; 7. 其他判定为不适合入组的情况:不能耐受手术/对于手术用药有过敏/使用可能影响视觉质量判断的/依从性差的(术后不能按时随访或失访者)/患有精神疾病等情况。 

Exclusion criteria:

1. Those with severe systemic diseases, such as heart/kidney/liver/immune system, who can not be operated on; 2. Complicated with other ocular diseases, there are obvious operative contraindications for those who can not be operated: the number of small eyeball/low corneal epithelial cells (< 1200/cm2)/uncontrolled ocular infection/inflammation (iritis/uveitis)/high intraocular pressure/intraocular hemorrhage/ocular trauma, etc. 3. Patients with diabetes or newly diagnosed diabetes mellitus (fasting blood sugar > 7.0 mmol/L); 4. All kinds of corneal (touching the central pupil) and intraocular surgery were performed, such as fundus laser surgery/retinal repair/pterygium surgery; 5. Eye diseases that may affect the visual acuity of patients to a great extent during the observation period after operation, such as glaucoma patients with poor control/iridocyclitis, which easily induce posterior subcapsular opacity; 6. In addition to cataract, there are other factors that seriously affect visual acuity, such as amblyopia/glaucoma (severe late visual field defect)/retinal detachment/retinal artery or vein occlusion and severe visual impairment; 7. Other cases judged unsuitable for enrollment: intolerance of surgery/allergy to surgical medication/use of medication that may affect visual quality judgement/poor compliance (failure to follow up on time after surgery or loss of interviewees)/mental illness, etc. 

研究实施时间:

Study execute time:

From2019-05-01To 2020-09-30 

干预措施:

Interventions:

组别:

Two groups

样本量:

140

Group:

Two groups

Sample size:

干预措施:

前囊膜抛光vs空白对照

干预措施代码:

Intervention:

Polishing of anterior capsule versus blank control

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东省 

市(区县):

济南市 

Country:

China 

Province:

Shandong Province 

City:

Jinan City 

单位(医院):

山东大学第二医院 

单位级别:

三级甲等医院 

Institution
hospital:

Second Hospital of Shandong University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

最佳矫正视力

指标类型:

主要指标 

Outcome:

Best corrected visual acuity

Type:

Primary indicator 

测量时间点:

术后6月

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

屈光度

指标类型:

主要指标 

Outcome:

Diopter

Type:

Primary indicator 

测量时间点:

术后6月

测量方法:

Measure time point of outcome:

Measure method:

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6月

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

客观散射指数

指标类型:

主要指标 

Outcome:

Objective scattering index

Type:

Primary indicator 

测量时间点:

术后6月

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

手术眼根据患者自主选择的晶体类型分为A,B两组(A组为亲水组,B组为疏水组),每组患者按照入院时间前后确定入组编号,相邻2人一对,按从001编号开始,逐次排号,根据编号在下图所示的随机数表中横向20列从左至右,从上至下勾选相应的随机数字并记录,每个随机数字对应2只术眼,直接决定编号较小者手术方式,编号较大者则为相反的手术方式(奇数为抛光组,偶数为空白对照组),后入院的1只则选择相反的手术方式。在以上条件下当1名患者双眼均符合入组条件,且决定单次进行双眼手术时,则该名患者2只术眼作为一对,编号相邻,其中若双眼视力相同,则按照对应随机数表中的数字奇偶决定哪只眼为试验组(若为奇数则左眼为试验组,若为偶数则右眼为试验组)另一只眼则作为对照组;若双眼的视力不同,则术前最佳矫正视力较低的一组为试验组;

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

Operative eyes were divided into two groups according to the type of crystals chosen by the patients independently (group A was hydrophilic group, group B was hydrophobic group). Each group was assigned a group number according to the time of admission. Two pairs of adjacent patients were paired. They w

盲法:

Open label

Blinding:

Open label

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

共享原始数据将以Excel表格的形式共享于研究项目负责人张晗主任医师医疗团队微信公众号—张晗光明团队

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

Sharing raw data will be shared in Excel form in the research project leader, Dr. Zhang Hao, Medical Team Wechat Public Number - Zhang Hao Guangming Team

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:

数据采集由实验单位固定的三位技师采用相同的检测仪器行相关的数据检测并出具报告; 源数据及其文件由研究者自报告中采集,并填写录入电子信息采集系统; 参试者个人试验期完成1周内再次核查报告,纸质病例表,电子信息采集系统中的数据的 一致性;

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

Data acquisition is carried out by three technicians fixed by the experimental unit, who use the same testing instrument to detect and report relevant data. Source data and their documents are collected by researchers from their reports and entered into the electronic information acquisition system. Within one week after the completion of the individual test period, the participants re-check the consistency of the report, the paper case sheet and the data in the electronic information acquisition system.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-21
return list