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The effect of optimized pulsed light technology assisted therapy for moderate and severe blepharitis associated keratoconjunctivitis
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注册号:

Registration number:

ChiCTR-ONN-17013864 

最近更新日期:

Date of Last Refreshed on:

2018-09-15 

注册时间:

Date of Registration:

2017-12-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

优化强脉冲光辅助治疗中重度睑缘炎相关角结膜病变的临床效果研究 

Public title:

The effect of optimized pulsed light technology assisted therapy for moderate and severe blepharitis associated keratoconjunctivitis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

优化强脉冲光辅助治疗中重度睑缘炎相关角结膜病变的临床效果研究 

Scientific title:

The effect of optimized pulsed light technology assisted therapy for moderate and severe blepharitis associated keratoconjunctivitis 

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:

阮方 

研究负责人:

接英 

Applicant:

Ruan Fang 

Study leader:

Jie Ying 

申请注册联系人电话:

Applicant telephone:

+86 15201475215 

研究负责人电话:

Study leader's telephone:

+86 18811612079 

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:

ruanfang0515@163.com 

研究负责人电子邮件:

Study leader's E-mail:

jie_yingcn@aliyun.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:

北京市东城区东交民巷1号 

研究负责人通讯地址:

北京市东城区东交民巷1号 

Applicant address:

1 Dong Jiao Min Xiang, Dongcheng District, Beijing, China 

Study leader's address:

1 Dong Jiao Min Xiang, Dongcheng District, Beijing, 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:

首都医科大学附属北京同仁医院 

Applicant's institution:

Beijing Tongren Hospital, Capital Medical University 

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:

TRECKY2017-063 

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:

首都医科大学附属北京同仁医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Beijing Tongren Hospital , Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-12-28 

伦理委员会联系人:

常灏 

Contact Name of the ethic committee:

Chang Hao 

伦理委员会联系地址:

北京市东城区东交民巷1号 

Contact Address of the ethic committee:

1 Dong Jiao Min Xiang, Dongcheng District, Beijing, 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:

首都医科大学附属北京同仁医院 

Primary sponsor:

Beijing Tongren Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市东城区东交民巷1号 

Primary sponsor's address:

1 Dong Jiao Min Xiang, Dongcheng District, Beijing, 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):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京同仁医院

具体地址:

北京市东城区东交民巷1号

Institution
hospital:

Beijing Tongren Hospital, Capital Medical University

Address:

1 Dong Jiao Min Xiang, Dongcheng District, Beijing, China

经费或物资来源:

同仁医院院内基金 

Source(s) of funding:

Tongren hospital internal fund 

研究疾病:

睑缘炎相关角结膜病变 

Target disease:

blepharitis associated keratoconjunctivitis 

研究疾病代码:

 

Target disease code:

 

研究类型:

治疗研究 

Study type:

Treatment study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

观察优化强脉冲光辅助治疗中重度睑缘炎相关角结膜病变的有效性和安全性。 

Objectives of Study:

This study aims to explore the efficacy and safety of optimized pulsed light technology in treating moderate to severe blepharokeratoconjunctivitis as an assisted method. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

患者需同时满足以下条件。(1)年满18周岁;(2)双眼发病;(3)满足睑缘炎体征:睑缘充血或毛细血管扩张,睫毛根部鳞屑、结痂或溃疡,睑缘形态改变(包括睑板腺开口)或睑酯质和量改变;(4)伴随结膜及角膜病变:结膜充血、乳头增生、滤泡形成或泡性结膜炎,同时有角膜周边点状糜烂、浸润、溃疡形成,或角膜浅层新生血管形成,伴不同程度的角膜混浊。 

Inclusion criteria

(1) at least 18 years old of age; (2) both eyes were affected; (3) with signs of blepharitis including eyelid hyperemia or capillary dilation, scale, scab or ulcer of eyelash root, morphologic changes of Meibomian gland; (4) concomitant conjunctival and corneal lesions: conjunctival congestion, papillary hyperplasiafollicular formation or blister conjunctivitis; and corneal peripheral punctate erosions, infiltration or ulceration, or corneal opacity with neovascularization. 

排除标准:

具有以下情况之一者即可排除入组。(1)眼部或眼周皮肤有急性炎症或过敏的患者;(2)同时患有560nm到1200nm波长的光可能激发的疾病,比如单纯复发性疱疹、系统全身性红斑狼疮、紫质症的患者;(3)怀孕及哺乳期的患者;(4)最近1年接受过放射治疗或化疗的患者或者IPL治疗后2个月内计划进行放射治疗或化疗的患者。 

Exclusion criteria:

(1) acute inflammation or allergies of the eye or periocular skin; (2) diseases that can be triggered by light wave from 560nm to 1200nm in length, such as recurrent herpes simplex infection, systemic lupus erythematosus and Porphyria; (3) pregnant or lactating; (4) treated with radiotherapy or chemotherapy within 1 year prior to the study or scheduled to undergo radiotherapy or chemotherapy within 2 months after OPT treatment. 

研究实施时间:

Study execute time:

From2018-01-01To 2018-06-30 

征募观察对象时间:

Recruiting time:

From2018-01-01To 2018-02-28 

干预措施:

Interventions:

组别:

OPT组

样本量:

20

Group:

OPT group

Sample size:

干预措施:

优化强脉冲光

干预措施代码:

Intervention:

optimized pulsed light technology

Intervention code:

组别:

对照组

样本量:

20

Group:

Control group

Sample size:

干预措施:

睑板腺按摩

干预措施代码:

Intervention:

Meibomian gland expression

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):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京同仁医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Tongren Hospital, Capital Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

睑板腺分泌物性状评分

指标类型:

主要指标 

Outcome:

quality of meibum scoring

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睑板腺脂质排出难易度评分

指标类型:

主要指标 

Outcome:

expressility of meibum scoring

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睑缘改变评分

指标类型:

主要指标 

Outcome:

changes of eyelid margin scoring

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:

次要指标 

Outcome:

corneal fluorescein staining scoring

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼表疾病指数问卷评分

指标类型:

次要指标 

Outcome:

ocular surface disease index scoring

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

非侵入式泪膜破裂时间

指标类型:

次要指标 

Outcome:

noninvasive keratography break-up time

Type:

Secondary 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:

附加指标 

Outcome:

Schirmer I test

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

泪液脂质层分级

指标类型:

附加指标 

Outcome:

classification of tear film lipid layer

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睑板腺面积缺失分级

指标类型:

附加指标 

Outcome:

classification of Meibomian gland dropout

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视力

指标类型:

副作用指标 

Outcome:

vision

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼压

指标类型:

副作用指标 

Outcome:

intraocular pressure

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼部结构情况

指标类型:

副作用指标 

Outcome:

condition of eye structure

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

面部皮肤情况

指标类型:

副作用指标 

Outcome:

condition of facial skin

Type:

Adverse events 

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:

泪液

组织:

Sample Name:

tear

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:

结束

Completed

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):

非随机对照试验

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

non-randomized controlled trial

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

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):

网络平台

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

web-bassed public database

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:

病历记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2017-12-12
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