今天是:2019-12-10 星期二

Back eye layer thickness in COPD patients
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注册号:

Registration number:

ChiCTR1800016016 

最近更新日期:

Date of Last Refreshed on:

2018-05-07 

注册时间:

Date of Registration:

2018-05-07 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

Back eye layer thickness in COPD patients 

Public title:

Back eye layer thickness in COPD patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

CHOROIDAL THICKNESS IN COPD EXACERBATION 

Scientific title:

CHOROIDAL THICKNESS IN COPD EXACERBATION 

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:

ozkan kocamis 

研究负责人:

ozkan kocamis 

Applicant:

ozkan kocamis 

Study leader:

ozkan kocamis 

申请注册联系人电话:

Applicant telephone:

+90 38 62803900 

研究负责人电话:

Study leader's telephone:

+90 53 05521796 

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:

okocamis77@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

okocamis77@gmail.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:

No. 9 Asikpasa Streetn, Kirsehir, Turkey 

研究负责人通讯地址:

No. 9 Asikpasa Streetn, Kirsehir, Turkey 

Applicant address:

No. 9 Asikpasa Streetn, Kirsehir, Turkey 

Study leader's address:

No. 9 Asikpasa Streetn, Kirsehir, Turkey 

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:

Ahi Evran University 

Applicant's institution:

Ahi Evran 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:

2017-17/207 

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:

Ahi Evran University Clinical Research Ethics Committee 

Name of the ethic committee:

Ahi Evran University Clinical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

Ahi Evran University Clinical Research Ethics Committee 

Contact Name of the ethic committee:

Ahi Evran University Clinical Research Ethics Committee 

伦理委员会联系地址:

No.1 Bagbasi Street, Kirsehir, Turkey 

Contact Address of the ethic committee:

No.1 Bagbasi Street, Kirsehir, Turkey 

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:

Ahi Evran University 

Primary sponsor:

Ahi Evran University 

研究实施负责(组长)单位地址:

No.1 Bagbasi Street, Kirsehir, Turkey 

Primary sponsor's address:

No.1 Bagbasi Street, Kirsehir, Turkey 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

Turkey

省(直辖市):

Kirsehir

市(区县):

Country:

Turkey

Province:

Kirsehir

City:

单位(医院):

Ahi Evran University

具体地址:

No.1 Bagbasi Street, Kirsehir, Turkey

Institution
hospital:

Ahi Evran University

Address:

No.1 Bagbasi Street, Kirsehir, Turkey

经费或物资来源:

Ahi Evran University scientific research project coordinator 

Source(s) of funding:

Ahi Evran University scientific research project coordinator 

研究疾病:

CHRONIC OBSTRUCTIVE PULMONARY DISEASE 

Target disease:

CHRONIC OBSTRUCTIVE PULMONARY DISEASE 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

We aimed to measure the choroidal thickness with optic coherence tomography (OPT) in patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD). 

Objectives of Study:

We aimed to measure the choroidal thickness with optic coherence tomography (OPT) in patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD). 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

COPD exacerbation patients,Patients with visual acuity of 0.8 and above, spherical refraction defect spherical 3 D', cylindrical 3 D' small patients, intraocular pressure under 21 mmHHG were included, whose axial length was below 24 mm. 

Inclusion criteria

COPD exacerbation patients,Patients with visual acuity of 0.8 and above, spherical refraction defect spherical 3 D', cylindrical 3 D' small patients, intraocular pressure under 21 mmHHG were included, whose axial length was below 24 mm. 

排除标准:

pregnancy dm and hypertension cataract adult macular degeneration 

Exclusion criteria:

pregnancy dm and hypertension cataract adult macular degeneration 

研究实施时间:

Study execute time:

From2018-02-05To 2018-03-05 

干预措施:

Interventions:

组别:

Case series

样本量:

45

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

Turkey 

省(直辖市):

Kirsehir 

市(区县):

 

Country:

Turkey 

Province:

Kirsehir 

City:

 

单位(医院):

Ahi Evran University Medical school department of ophthalmology 

单位级别:

University 

Institution
hospital:

Ahi Evran University Medical school department of ophthalmology  

Level of the institution:

Universty 

测量指标:

Outcomes:

指标中文名:

choroidal thickness

指标类型:

主要指标 

Outcome:

choroidal thickness

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:

标本中文名:

No

组织:

Sample Name:

No

Tissue:

eye

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

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 70 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):

N/A

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

N/A

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

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):

https://mts.hindawi.com/submit/journals/joph/

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

https://mts.hindawi.com/submit/journals/joph/

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:

It is composed of COPD patients who are followed up in the chest disease clinic and referred to the eye clinic. Optic Coherence Tomography will measure the thickness of the choroidal layer in COPD patients who are referred to. The data will be evaluated in the SPSS 22.0 program. The normal distribution suitability will be assessed by the Komogorov Smirnov test. Descriptive statistics for age and gender will be used. Comparisons between choroidal thicknesses should be made by paired T-test. The results will be considered statistically significant when p value is less than 0.05.

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

It is composed of COPD patients who are followed up in the chest disease clinic and referred to the eye clinic. Optic Coherence Tomography will measure the thickness of the choroidal layer in COPD patients who are referred to. The data will be evaluated in the SPSS 22.0 program. The normal distribution suitability will be assessed by the Komogorov Smirnov test. Descriptive statistics for age and gender will be used. Comparisons between choroidal thicknesses should be made by paired T-test. The results will be considered statistically significant when p value is less than 0.05.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-05-07
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