针刺干预下白内障术后人工晶体眼视觉质量变化的临床研究

注册号:

Registration number:

AMCTR-IOR-18000231 

注册号获得时间:

Date of releasing the registration number:

2018/12/20 9:44:23 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺干预下白内障术后人工晶体眼视觉质量变化的临床研究 

Public title:

Clinical study for the visual outcomes alterations of patients with IOL implantation after cataract surgery under the intervention of acupuncture 

研究课题的正式科学名称:

针刺干预下白内障术后人工晶体眼视觉质量变化的临床研究 

Scientific title:

Clinical study for the visual outcomes alterations of patients with IOL implantation after cataract surgery under the intervention of acupuncture 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR1800020132 

申请注册联系人:

孔谐和 

研究负责人:

邹月兰 

Applicant:

Xie-he Kong 

Study leader:

Yue-lan Zou 

申请注册联系人电话:

Applicant telephone:

+86 13621775647 

研究负责人电话:

Study leader's telephone:

+86 13817027150 

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:

2293638073@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

yuelan123000@sina.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:

中国上海市静安区康定路380号 

研究负责人通讯地址:

中国上海市静安区康定路380号 

Applicant address:

380 Kangding Road, Jing-an District, Shanghai, China 

Study leader's address:

380 Kangding Road, Jing-an District, Shanghai, 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:

上海市针灸经络研究所 

Applicant's institution:

Shanghai Institute of Acupuncture-moxibustion and Meridian 

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:

[2018]74 

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:

上海市第一人民医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Shanghai General Hospital (2 Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai Key Laboratory of ocular fundus diseases) 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-21 

研究实施负责(组长)单位:

上海市眼病防治中心,上海市眼科医院,上海市第一人民医院眼科 

Primary sponsor:

Shanghai Eye Disease Prevention and Treatment Center, Shanghai Eye Hospital, Shanghai General Hospital ophthalmology 

研究实施负责(组长)单位地址:

中国上海市静安区康定路380号 

Primary sponsor's address:

380 Kangding Road, Jing-an District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市眼病防治中心

具体地址:

中国上海市静安区康定路380号

Institution
hospital:

Shanghai Eye Disease Prevention and Treatment Center, Shanghai Eye Hospital, Shanghai General Hospital ophthalmology

Address:

380 Kangding Road, Jing-an District, Shanghai, China

经费或物资来源:

上海市眼病防治中心,上海市眼科医院,上海市第一人民医院眼科 

Source(s) of funding:

Shanghai Eye Disease Prevention and Treatment Center, Shanghai Eye Hospital, Shanghai General Hospital ophthalmology 

研究疾病:

白内障 

Target disease:

Cataract 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

通过观察针刺人工晶体眼患者前后伪调节力、波前像差、泪膜破裂时间(BUT)、泪液分泌实验(SIT)的变化,探讨针刺改善人工晶体眼视觉质量的效果及机理,为白内障术后人工晶体眼视觉质量不良的患者寻求新的临床思路和方法。 

Objectives of Study:

By observing the changes of pseudo-accommodation, wavefront aberrations, break up time (BUT) and Schimer test I (SIT) before and after acupuncture in patients with intraocular lens, we investigate the effect and mechanism of acupuncture to improve the visual quality of intraocular lens and provide new clinical ideas and methods for patients with poor visual quality with intraocular lens after cataract surgery. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1.年龄相关性白内障术后植入单焦人工晶体的患者; 2.白内障术后3个月到1年; 3.视觉功能调查问卷(NEI-VFQ-25)中文版评分在85分以下。 4.签订知情同意书,依从性良好的患者。 

Inclusion criteria

1. Patients with age-related cataract after implantation of single-focal intraocular lens; 2. 3 months-1 year after cataract surgery; 3. The score of visual function questionnaire (NEI-VFQ-25) is below 85; 4. Volunteer participant with fine compliance and having signed the informed consent. 

排除标准:

1.排除其他影响泪液分泌的疾病,如甲状腺功能亢进、干燥综合征、类风湿性关节炎、强直性脊柱炎、系统性红斑狼疮、糖尿病性肾病、鼻泪道阻塞等; 2.应用人工泪液或其它眼部用药者; 3.存在青光眼或眼压≥21mmHg(1mmHg=0.133KPa)、眼底病、内眼手术史、角膜病及眼外伤等严重影响术后视力恢复病史的患者; 4.术中术后发生后囊膜破裂、严重炎症反应、角膜内皮失代偿、IOL 明显移位、偏心,IOL 后囊膜过渡纤维化、行后囊膜激光截开术等。 

Exclusion criteria:

1. Exclude other diseases affecting tear secretion, such as hyperthyroidism, sjogren's syndrome, rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, diabetic nephropathy, nasolacrimal duct obstruction, etc.; 2. Apply artificial tears or other drugs for the eye disease; 3. Patients with glaucoma or intraocular pressure ≥ 21mmHg (1mmHg=0.133KPa), fundus disease, history of internal eye surgery, keratopathy, eye trauma and other diseases which have serious effects on the recovery postoperative visual acuity; 4. Intraoperative and postoperative posterior capsule rupture, severe inflammation, corneal endothelial decompensation, obvious displacement and eccentricity of IOL, excessive fibrosis of IOL posterior capsule, laser resection of posterior capsule, etc. 

研究实施时间:

Study execute time:

From2019-01-01To 2020-05-01 

干预措施:

Interventions:

组别:

屈光不正矫正组(试验二)

样本量:

36

Group:

Group 1(Experiment 2)

Sample size:

干预措施:

佩戴眼镜

干预措施代码:

Intervention:

wearing refractive lenses

Intervention code:

组别:

针刺+屈光不正矫正组(试验二)

样本量:

36

Group:

Group 2(Experiment 2)

Sample size:

干预措施:

针刺+佩戴眼镜

干预措施代码:

Intervention:

acupuncture and wearing refractive lenses

Intervention code:

组别:

假针刺+屈光不正矫正组(试验一)

样本量:

30

Group:

Group 1(Experiment 1)

Sample size:

干预措施:

假针刺+佩戴眼镜

干预措施代码:

Intervention:

sham acupuncture and wearing refractive lenses

Intervention code:

组别:

针刺+屈光不正矫正组(试验一)

样本量:

30

Group:

Group 2(Experiment 1)

Sample size:

干预措施:

针刺+佩戴眼镜

干预措施代码:

Intervention:

acupuncture and wearing refractive lenses

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市眼病防治中心 

单位级别:

三级 

Institution
hospital:

Shanghai Eye Disease Prevention & Treatment Center  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

NEI—VFQ一25视功能量表

指标类型:

主要指标 

Outcome:

25 item National Eye Institute Visual Function Questionnaire, NEI-VFQ-25

Type:

Primary indicator 

指标中文名:

高阶像差

指标类型:

主要指标 

Outcome:

Higher-order abberations

Type:

Primary indicator 

指标中文名:

伪调节力

指标类型:

主要指标 

Outcome:

pseudo-accommodation

Type:

Primary indicator 

指标中文名:

泪膜破裂时间

指标类型:

主要指标 

Outcome:

Break up time

Type:

Primary indicator 

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

Pending

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 0 years

随机方法(请说明由何人用什么方法产生随机序列):

将全部入选患者按就诊顺序编号,采用SPSS 20.0统计软件产生随机数字及随机分配表,按顺序将患者随机分入屈光不正矫正组和针刺+屈光不正矫正组。

性别:

男女均可

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

All enrolled patients will be numbered according to the order of treatment. SPSS 20.0 statistical software was used to generate random numbers and random assignment tables. Patients were randomly assigned to refractive error correction group and manual acupuncture + refractive error correction group.

Gender:

Both

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

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):

研究数据将形成论著进行发表

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

Our research team will authored paper on our results.

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

数据采集采用病例记录表,管理采用电子采集和管理系统

The repository and management of the data(Please specify what repository will be used for management of the metadata):

We use case record form to adopt data and electronic data capture to manage data.

创建人:

Creater Name:

 2018-12-17
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