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Evaluation of the effectiveness and safety of bianshi moxibustion infrared dry eye therapeutic instrument in the treatment of meibomian gland dysfunction
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注册号:

Registration number:

ChiCTR1900027643 

最近更新日期:

Date of Last Refreshed on:

2019-11-24 

注册时间:

Date of Registration:

2019-11-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

砭石艾灸红外干眼治疗仪在睑板腺功能障碍治疗中的有效性和安全性研究 

Public title:

Evaluation of the effectiveness and safety of bianshi moxibustion infrared dry eye therapeutic instrument in the treatment of meibomian gland dysfunction 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

砭石艾灸红外干眼治疗仪在睑板腺功能障碍治疗中的有效性和安全性研究 

Scientific title:

Evaluation of the effectiveness and safety of bianshi moxibustion infrared dry eye therapeutic instrument in the treatment of meibomian gland dysfunction 

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:

ChiMCTR1900025363 

申请注册联系人:

郝然 

研究负责人:

李学民 

Applicant:

Ran Hao 

Study leader:

Xuemin Li 

申请注册联系人电话:

Applicant telephone:

+86 15810619836 

研究负责人电话:

Study leader's telephone:

+86 13911254862 

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:

15810619836@163.com 

研究负责人电子邮件:

Study leader's E-mail:

13911254862@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:

北京市海淀区花园北路49号 

研究负责人通讯地址:

北京市海淀区花园北路49号 

Applicant address:

49 North Huayuan Road, Beijing, Haidian District, China 

Study leader's address:

49 North Huayuan Road, Beijing, Haidian District, 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:

北京大学第三医院 

Applicant's institution:

Peking University Third Hospital 

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:

北京大学第三医院 

Primary sponsor:

Peking University Third Hospital 

研究实施负责(组长)单位地址:

北京市海淀区花园北路49号 

Primary sponsor's address:

49 North Huayuan Road, Beijing, Haidian District, 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):

北京

市(区县):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

北京大学第三医院

具体地址:

北京市海淀区花园北路49号

Institution
hospital:

Peking University Third Hospital

Address:

49 North Huayuan Road, Beijing, Haidian District, China

经费或物资来源:

首都卫生发展科研专项项目 

Source(s) of funding:

Capital’s Funds for Health Improvement and Research 

研究疾病:

睑板腺功能障碍 

Target disease:

meibomian gland dysfunction 

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:

(1)评估砭石艾灸红外干眼治疗仪治疗MGD的有效性和安全性 (2)探索砭石艾灸红外干眼治疗仪治疗MGD的最佳使用频率与使用时长 

Objectives of Study:

(1) To evaluate the effectiveness and safety of bianshi moxibustion infrared dry eye therapeutic instrument in the treatment of meibomian gland dysfunction; (2) To explore the optimal frequency and duration of bianshi moxibustion infrared dry eye therapeutic instrument in the treatment of meibomian gland dysfunction. 

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18~80岁 2 干眼症的诊断标准: (1)眼表症状: ① 持续超过3个月,且每天均出现干眼症状; ② 眼睛反复出现异物感; ③ 每天使用人工泪液超过3次; (2)体征: ① 泪液分泌试验(Schirmer I test,ST-I)(无表面麻醉)≤ 5mm / 5min; ② 角膜荧光素染色评分≥4分(根据van Bijsterveld评分标准); 干眼症的诊断需具备至少一项症状和至少一项体征。 3 睑板腺功能障碍 (1)睑板腺体缺如; (2)睑缘及睑板腺开口异常; (3)睑板腺分泌物数量和质量改变; 以上任何一种体征结合干眼症状可诊断MGD。 

Inclusion criteria

1. Aged 18~80 years old; 2. Diagnostic criteria of dry eye: (1) Ocular symptoms: 1) Feeling dry eye every day for more than 3 months; 2) Repeated foreign body sensation; 3) Using artificial tears more than 3 times one day; (2) Ocular signs: 1) Schirmer I test (ST-I)(no anesthesia) <=5mm / 5min; 2) Corneal fluorescein staining score >=4 (according to van Bijsterveld scoring standard); The diagnosis of dry eye requires at least one symptom and one sign. 3. Diagnostic criteria of meibomian gland dysfunction (1) Absence of meibomian glands; (2) Abnormal of eyelid margin and meibomian gland; (3) Changes in the quantity and quality of meibomian secretion; MGD could be diagnosed with any of these signs in combination with dry eye symptoms. 

排除标准:

(1) 因全身性疾病的某些症状(疼痛、发热、咳嗽)等以及外界环境干扰因素引起者 (2) 合并其他眼部疾病(青光眼、白内障、视网膜脱离等)或曾施行眼部手术者。 (3) 全身结缔组织疾病和严重的自身免疫性疾病 (4) 合并中枢神经系统疾病或曾施行颅脑手术者。 (5) 合并有严重的心肺、肝肾、血液系统疾病者。 (6) 怀疑或确有酒精、药物滥用病史、精神病的患者。 (7) 过敏体质者。 (8) 妊娠或准备妊娠妇女,哺乳期妇女。 (9) 最近2周内使用过治疗干眼症药物的患者。 (10) 最近1个月内参加过其他临床试验或已接受过本临床试验的随机分组。 (11) 研究者认为不适合进入本临床试验者。 

Exclusion criteria:

(1) Caused by systemic diseases (pain, fever, cough) or other external environmental factors. (2) Complicated with other eye diseases (glaucoma, cataract, retinal detachment, etc.) or undergone eye surgery. (3) Systemic connective tissue disease or severe autoimmune diseases (4) Patients with central nervous system disease or craniocerebral surgery. (5) Patients with severe diseases of heart, lung, liver, kidney or blood system. (6) Patients who suspect or have a history of alcohol or drug abuse or mental illness. (7) Allergic constitution. (8) Pregnant or lactating women. (9) Patients who have taken medication for dry eye in the last 2 weeks. (10) Patients who have participated in other clinical trials within the last 1 month or have accepted the randomized group of this clinical trial. (11) The investigator considers that the participants are not suitable for this clinical trial. 

研究实施时间:

Study execute time:

From2019-11-13To 2020-12-31 

干预措施:

Interventions:

组别:

1

样本量:

50

Group:

Group 1

Sample size:

干预措施:

使用砭石艾灸红外干眼治疗仪治疗MGD(每日2次,每次30min)

干预措施代码:

Intervention:

MGD was treated with bian-stone moxibustion infrared dry eye therapeutic instrument (twice a day, 30min each time).

Intervention code:

组别:

2

样本量:

50

Group:

Group 2

Sample size:

干预措施:

使用砭石艾灸红外干眼治疗仪治疗MGD(每日2次,每次20min)

干预措施代码:

Intervention:

MGD was treated with bian-stone moxibustion infrared dry eye therapeutic instrument (twice a day, 20min each time).

Intervention code:

组别:

3

样本量:

50

Group:

Group 3

Sample size:

干预措施:

使用砭石艾灸红外干眼治疗仪治疗MGD(每日3次,每次20min)

干预措施代码:

Intervention:

MGD was treated with bian-stone moxibustion infrared dry eye therapeutic instrument (three times a day, 20min each time)

Intervention code:

组别:

4

样本量:

50

Group:

Group 4

Sample size:

干预措施:

传统红外治疗

干预措施代码:

Intervention:

Conventional infrared therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

北京大学第三医院 

单位级别:

三级甲等 

Institution
hospital:

Peking University Third Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

眼表疾病指数量表

指标类型:

主要指标 

Outcome:

Ocular Surface Disease Index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睑板腺评分

指标类型:

主要指标 

Outcome:

Meibomian gland score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睑缘评分

指标类型:

主要指标 

Outcome:

Eyelid margin score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

下睑中央泪河线高度

指标类型:

主要指标 

Outcome:

Tear meniscus height

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

泪膜破裂时间

指标类型:

主要指标 

Outcome:

Tear break up time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

泪液分泌试验

指标类型:

主要指标 

Outcome:

Schirmer I test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

角膜荧光素染色评分

指标类型:

主要指标 

Outcome:

Corneal fluorescein staining score

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:

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 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):

采用SAS 9.4软件进行随机分组

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

SAS 9.4 software.

盲法:

未说明

Blinding:

Not stated

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):

2019-12-31

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

2019-12-31

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:

研究成员进行细化分工,专人负责专项的数据采集与整理工作。在研究开始前,主要研究者组织开展系统学习以及专人专项培训学习,确保数据收集的有效性。数据采集专员定期向课题负责人汇报数据收集情况和数据分析结果。定期召开数据结果分析学习交流会,分析数据变化特征,发现数据采集过程中需要改进的地方并及时修正。

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

The researchers have been devided, and special persons are responsible for special data collection and collation. Before the beginning of the study, the main researcher organized systematic learning and specialized training to ensure the effectiveness of data collection. The data collection specialist should report the data collection and analysis results to the project leader regularly. Hold the data result analysis and learning meeting regularly, analyze the change characteristics of the data, find out the areas that need to be improved in the process of data collection and correct them in time.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-11-22
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