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The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema - A Pilot Study
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注册号:

Registration number:

ChiCTR-TRC-09000743 

最近更新日期:

Date of Last Refreshed on:

2017-05-04 

注册时间:

Date of Registration:

2010-05-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema - A Pilot Study 

Public title:

The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema - A Pilot Study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema - A Pilot Study 

Scientific title:

The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema - A Pilot Study 

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:

CUHK_CCT00130 

申请注册联系人:

Miss Joyce Kung 

研究负责人:

Prof Dennis SC Lam 

Applicant:

Miss Joyce Kung 

Study leader:

Prof Dennis SC Lam 

申请注册联系人电话:

Applicant telephone:

+852 27623134 

研究负责人电话:

Study leader's telephone:

+852 27623134 

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:

joycekung@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

dennislam_cu_res@cuhk.edu.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00130 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00130 

申请注册联系人通讯地址:

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon 

研究负责人通讯地址:

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon 

Applicant address:

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon 

Study leader's address:

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon. 

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:

Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong 

Applicant's institution:

Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong 

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:

NA 

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:

The Chinese University of Hong Kong 

Name of the ethic committee:

The Chinese University of Hong Kong 

伦理委员会批准日期:

Date of approved by ethic committee:

2007-05-04 

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:

The Chinese University of Hong Kong 

Primary sponsor:

The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon 

Primary sponsor's address:

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

Department of Ophthalmology and Visual Sciences The Chinese University of Hong Kong 

Source(s) of funding:

Department of Ophthalmology and Visual Sciences The Chinese University of Hong Kong 

研究疾病:

Diabetic macular edema 

Target disease:

Diabetic macular edema 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema 

Objectives of Study:

The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema. 

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:

Inclusion criteria: 1. Aged 18 years or older; 2. Clinically significant macular edema (CSME) defined according to the ETDRS; 3. Macular edema of at least 250um involving the fovea, as documented on optical coherent tomogram; 4. Patients with best corrected visual acuity of better than 1.3 ETDRS logMAR units (equivalent to 20/400 on Snellen Chart); 5. Patients physically fit to receive treatment and comply with follow-up schedule; 6. Informed consent. 

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older; 2. Clinically significant macular edema (CSME) defined according to the ETDRS; 3. Macular edema of at least 250um involving the fovea, as documented on optical coherent tomogram; 4. Patients with best corrected visual acuity of better than 1.3 ETDRS logMAR units (equivalent to 20/400 on Snellen Chart); 5. Patients physically fit to receive treatment and comply with follow-up schedule; 6. Informed consent. 

排除标准:

Exclusion criteria: 1. Ocular diseases other than cataract, diabetic retinopathy and refractive error; 2. Proliferative diabetic retinopathy; 3. Media opacities which affect fundus examination or OCT measurements; 4. Previous intraocular surgery except uncomplicated cataract extraction and posterior intraocular lens insertion more than 6 months prior to enrollment; 5. History of macular laser photocoagulation, intravitreal/ subtenon injection of triamcinolone acetonide or intravitreal injection of any vascular endothelial growth factor inhibitors; 6. History of fluorescein allergy; 7. Fellow eye visual acuity worse than 20/400. 

Exclusion criteria:

Exclusion criteria: 1. Ocular diseases other than cataract, diabetic retinopathy and refractive error; 2. Proliferative diabetic retinopathy; 3. Media opacities which affect fundus examination or OCT measurements; 4. Previous intraocular surgery except uncomplicated cataract extraction and posterior intraocular lens insertion more than 6 months prior to enrollment; 5. History of macular laser photocoagulation, intravitreal/ subtenon injection of triamcinolone acetonide or intravitreal injection of any vascular endothelial growth factor inhibitors; 6. History of fluorescein allergy; 7. Fellow eye visual acuity worse than 20/400. 

研究实施时间:

Study execute time:

From2007-06-10To  

干预措施:

Interventions:

组别:

Case series

样本量:

30

Group:

Case series

Sample size:

干预措施:

Subtenon triamcinolone injection and macular photocoagulation for two months

干预措施代码:

Intervention:

Subtenon triamcinolone injection and macular photocoagulation for two months

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

The Chinese University of Hong Kong 

单位级别:

The Chinese University of Hong Kong 

Institution
hospital:

The Chinese University of Hong Kong  

Level of the institution:

The Chinese University of Hong Kong 

测量指标:

Outcomes:

指标中文名:

1. Best-corrected visual acuity

指标类型:

主要指标 

Outcome:

1. Best-corrected visual acuity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

2. Central foveal thickness measured by optical coherent tomogram

指标类型:

主要指标 

Outcome:

2. Central foveal thickness measured by optical coherent tomogram

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

3. Proportion of patients with a) moderate visual loss or b) stable/ gain in vision

指标类型:

主要指标 

Outcome:

3. Proportion of patients with a) moderate visual loss or b) stable/ gain in vision

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

1. Intraocular pressure

指标类型:

次要指标 

Outcome:

1. Intraocular pressure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

2. Changes in fluorescein angiography

指标类型:

次要指标 

Outcome:

2. Changes in fluorescein angiography

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

3. Adverse events

指标类型:

次要指标 

Outcome:

3. Adverse events

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 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):

NA

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

NA

盲法:

Blinding:

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2010-05-04
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