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Short Term and Sustained EyePressure Changes after Intraocular injection of Bevacizumab in Diabetic Retinopathy Patients
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注册号：

Registration number：

 ChiCTR2100042595 

最近更新日期：

Date of Last Refreshed on：

 2021-05-03 14:16:50 

注册时间：

Date of Registration：

 2021-01-23 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Short Term and Sustained EyePressure Changes after Intraocular injection of Bevacizumab in Diabetic Retinopathy Patients

Public title：

Short Term and Sustained EyePressure Changes after Intraocular injection of Bevacizumab in Diabetic Retinopathy Patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Short Term and Sustained Intra-Ocular Pressure Changes after Intravitreal Injection of Bevacizumab in Diabetic Retinopathy Patients

Scientific title：

Short Term and Sustained Intra-Ocular Pressure Changes after Intravitreal Injection of Bevacizumab in Diabetic Retinopathy Patients

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：

Usama Iqbal 

研究负责人：

Irfan Qayyum Malik 

Applicant：

Usama Iqbal 

Study leader：

Irfan Qayyum Malik 

申请注册联系人电话：

Applicant telephone：

 +92 33 38255055

研究负责人电话：

Study leader's
telephone：

+92 32 30000013

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：

 usamaiqqbal@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 irfan790@yahoo.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：

House 32, Street 8, Kabul Block, DC - Colony, Gujranwala, Punjab, Pakistan

研究负责人通讯地址：

Major Eye clinic, Sethi plaza, sheikhupura moor, GT road, Gujranwala, Punjab, Pakistan

Applicant address：

House 32, Street 8, Kabul Block, DC - Colony, Gujranwala, Punjab, Pakistan

Study leader's address：

Major Eye clinic, Sethi plaza, sheikhupura moor, GT road, Gujranwala, Punjab, Pakistan

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：

巴基斯坦旁遮普省拉合尔卫生科学大学Gujranwala医学院

Applicant's institution：

Gujranwala Medical College/ University of Health Sciences

研究负责人所在单位：

巴基斯坦旁遮普省拉合尔卫生科学大学Gujranwala医学院

Affiliation of the Leader：

Gujranwala Medical College/ University of Health Sciences

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：

 admin/131/GMC

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：

Institutional Review Board Gujranwala Medical College/ Teaching Hospital

Name of the ethic committee：

Institutional Review Board Gujranwala Medical College/ Teaching Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-11-12 00:00:00

伦理委员会联系人：

Institutional Review Board Gujranwala Medical College/ Teaching Hospital

Contact Name of the ethic committee：

Institutional Review Board Gujranwala Medical College/ Teaching Hospital

伦理委员会联系地址：

Gujranwala Medical College, Alipur Chatha Rd, Gondlan Wala, Gujranwala, Punjab, Pakistan

Contact Address of the ethic committee：

Gujranwala Medical College, Alipur Chatha Rd, Gondlan Wala, Gujranwala, Punjab, Pakistan

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +92 55 4556465

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 principalgmcg@gmail.com

研究实施负责（组长）单位：

University of Health Sciences, Lahore, Pakistan

Primary sponsor：

University of Health Sciences, Lahore, Pakistan

研究实施负责（组长）单位地址：

Khayaban-e-Jamia Punjab, Block D Muslim Town, Lahore, Punjab 54600, Pakistan

Primary sponsor's address：

Khayaban-e-Jamia Punjab, Block D Muslim Town, Lahore, Punjab 54600, Pakistan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

巴基斯坦

省(直辖市)：

旁遮普省

市(区县)：

Country：

pakistan

Province：

punjab

City：

gujranwala

单位(医院)：

Gujranwala Medical College

具体地址：

Gujranwala Medical College, Alipur Chatha Rd, Gondlan Wala, Gujranwala, Punjab, Pakistan

Institution
hospital：

Gujranwala Medical College

Address：

Gujranwala Medical College, Alipur Chatha Rd, Gondlan Wala, Gujranwala, Punjab, Pakistan

经费或物资来源：

Nil

Source(s) of funding：

Nil

研究疾病：

Diabetic Retinopathy  

Target disease：

Diabetic Retinopathy

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：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

To determine the short term and sustained intra-ocular pressure (IOP) changes after intravitreal injection of bevacizumab in patients with diabetic retinopathy (DR).  

Objectives of Study：

To determine the short term and sustained intra-ocular pressure (IOP) changes after intravitreal injection of bevacizumab in patients with diabetic retinopathy (DR).

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1. Patients who had intravitreal injections of triamcinolone acetonide any time up until 6 months prior to the study.
2. Patients with active uveitis or ocular ischemic syndrome.
3. Diagnosed with any type of glaucoma or pre injection ocular hypertension.
4. History of any intraocular surgery.
5. History of use systemic steroids or beta- blockers.

Exclusion criteria：

1. Patients who had intravitreal injections of triamcinolone acetonide any time up until 6 months prior to the study.
2. Patients with active uveitis or ocular ischemic syndrome.
3. Diagnosed with any type of glaucoma or pre injection ocular hypertension.
4. History of any intraocular surgery.
5. History of use systemic steroids or beta- blockers.

研究实施时间：

Study execute time：

从 From 2020-01-15 00:00:00至 To 2021-01-23 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-01-15 00:00:00 至 To 2020-12-31 00:00:00

干预措施：

Interventions：

组别：

case series

样本量：

 42

Group：

Case series

Sample size：

干预措施：

intravitreal bevacisumab

干预措施代码：

Intervention：

intravitreal bevacisumab

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 巴基斯坦

省(直辖市)：

 旁遮普 

市(区县)：

  

Country：

Pakistan

Province：

Punjab

City：

单位(医院)：

 GMC 

单位级别：

 三级 

Institution
hospital：

GMC

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

IOP

指标类型：

主要指标

Outcome：

IOP

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：

nil

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 40 岁 years
最大 Max age 60 岁 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）：

No randomization. Single group / Quasi Experimental study

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

No randomization. Single group / Quasi Experimental study

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

N/A

Blinding：

N/A

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

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）：

as per ICMJE criteria https://research.wustl.edu/wp-content/uploads/2019/04/Data-Sharing-Statement-for-IPD.pdf

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

as per ICMJE criteria https://research.wustl.edu/wp-content/uploads/2019/04/Data-Sharing-Statement-for-IPD.pdf

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：

Methodology (Data Collection Procedure): After approval from the institutional review board and taking written informed consent, 42 patients who fulfilled the inclusion criteria will be enrolled in the study from Department of Ophthalmology/DHQ Teaching Hospital, Gujranwala. Basic demographic information of each patient (name, age, sex) will be noted. After admission to hospital detailed history and thorough clinical examinations will be carried out to reach the provisional diagnosis. Patients will be prepared in a standard fashion and positioned supine for the procedure. A solution of 10% povidone-iodine will be used for skin and eyelashes disinfection. After draping the patient, a wire lid speculum will be applied for lid control. Topical 0.5% proparacaine drops will be instilled. Before injection, 5% povidone-iodine solution will be instilled into the conjunctival sac. The intravitreal bevacizumab injection supplied in 1ml insulin syringe will be used. The needle will be inserted through pars-plana at a distance of 3.5-4mm from the limbus. Patients will be examined by slit-lamp, and an IOP measurement will be performed at 5, 10, and 30 minutes after injection using Goldmann applanation tonometry. Tonometer applanation prism will be disinfected by 1:10 dilute bleach (sodium hypochlorite) as recommended by Centre for Disease Control (CDC) and tonometer manufacturers (Junk A.K., et al 2017). Patients will be followed up on outdoor basis for IOP check at 1 week interval for 4 weeks (one month). On each visit IOP will be checked with Goldmann applanation tonometer. If any rise in IOP on two connective visits, it will be managed accordingly. 13 Statistical Analysis: Data will be analyzed by using SPSS v23.0. Mean±S.D will be computed for numerical variables like age, number of injections and IOP. Frequency and percentages will be employed to assess the categorical variables like gender, eye side and glaucoma. The mean of IOP at different points of follow-up, will be compared by ANOVA test. Statistical significance will be taken at p<0.05.

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

Methodology (Data Collection Procedure): After approval from the institutional review board and taking written informed consent, 42 patients who fulfilled the inclusion criteria will be enrolled in the study from Department of Ophthalmology/DHQ Teaching Hospital, Gujranwala. Basic demographic information of each patient (name, age, sex) will be noted. After admission to hospital detailed history and thorough clinical examinations will be carried out to reach the provisional diagnosis. Patients will be prepared in a standard fashion and positioned supine for the procedure. A solution of 10% povidone-iodine will be used for skin and eyelashes disinfection. After draping the patient, a wire lid speculum will be applied for lid control. Topical 0.5% proparacaine drops will be instilled. Before injection, 5% povidone-iodine solution will be instilled into the conjunctival sac. The intravitreal bevacizumab injection supplied in 1ml insulin syringe will be used. The needle will be inserted through pars-plana at a distance of 3.5-4mm from the limbus. Patients will be examined by slit-lamp, and an IOP measurement will be performed at 5, 10, and 30 minutes after injection using Goldmann applanation tonometry. Tonometer applanation prism will be disinfected by 1:10 dilute bleach (sodium hypochlorite) as recommended by Centre for Disease Control (CDC) and tonometer manufacturers (Junk A.K., et al 2017). Patients will be followed up on outdoor basis for IOP check at 1 week interval for 4 weeks (one month). On each visit IOP will be checked with Goldmann applanation tonometer. If any rise in IOP on two connective visits, it will be managed accordingly. 13 Statistical Analysis: Data will be analyzed by using SPSS v23.0. Mean±S.D will be computed for numerical variables like age, number of injections and IOP. Frequency and percentages will be employed to assess the categorical variables like gender, eye side and glaucoma. The mean of IOP at different points of follow-up, will be compared by ANOVA test. Statistical significance will be taken at p<0.05.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-01-23 23:59:38
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