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Effect of Topical NSAIDs (Diclofenac 0.1%, Nepafenac 0.1%, Nepafenac 0.3%) on Pain Management During Intravitreal Injections: A Prospective, Non-Randomized, Case-Control Trial
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注册号：

Registration number：

 ChiCTR2500110461 

最近更新日期：

Date of Last Refreshed on：

 2026-03-05 15:42:56 

注册时间：

Date of Registration：

 2025-10-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effect of Topical NSAIDs (Diclofenac 0.1%, Nepafenac 0.1%, Nepafenac 0.3%) on Pain Management During Intravitreal Injections: A Prospective, Non-Randomized, Case-Control Trial

Public title：

Effect of Topical NSAIDs (Diclofenac 0.1%, Nepafenac 0.1%, Nepafenac 0.3%) on Pain Management During Intravitreal Injections: A Prospective, Non-Randomized, Case-Control Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effect of Topical NSAIDs on Pain Management During Intravitreal Injections

Scientific title：

Effect of Topical NSAIDs on Pain Management During Intravitreal Injections

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：

Muhammad Azeem Khizer 

研究负责人：

Muhammad Azeem Khizer 

Applicant：

Muhammad Azeem Khizer 

Study leader：

Muhammad Azeem Khizer 

申请注册联系人电话：

Applicant telephone：

 +92 345 5061287

研究负责人电话：

Study leader's
telephone：

+92 345 5061287

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：

 doc.mazeemk@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 doc.mazeemk@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：

Department of Ophthalmology, Fauji Foundation Hospital, Rawalpindi, Pakistan

研究负责人通讯地址：

Department of Ophthalmology, Fauji Foundation Hospital, Rawalpindi, Pakistan

Applicant address：

Department of Ophthalmology, Fauji Foundation Hospital, Rawalpindi, Pakistan

Study leader's address：

Department of Ophthalmology, Fauji Foundation Hospital, Rawalpindi, Pakistan

申请注册联系人邮政编码：

Applicant postcode：

 44000

研究负责人邮政编码：

Study leader's postcode：

 44000

申请人所在单位：

Fauji Foundation Hospital Rawalpindi, Pakistan / Foundation University Medical College Islamabad, Pakistan

Applicant's institution：

Fauji Foundation Hospital Rawalpindi, Pakistan / Foundation University Medical College Islamabad, Pakistan

研究负责人所在单位：

Fauji Foundation Hospital Rawalpindi, Pakistan / Foundation University Medical College Islamabad, Pakistan

Affiliation of the Leader：

Fauji Foundation Hospital Rawalpindi, Pakistan / Foundation University Medical College Islamabad, Pakistan

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：

 935/RC/FFH/RWP

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：

Ethical Review Committee of Fauji Foundation Hospital Rawalpindi

Name of the ethic committee：

Ethical Review Committee of Fauji Foundation Hospital Rawalpindi

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-03-17 00:00:00

伦理委员会联系人：

Dr Shahid Ahmad Abbasi

Contact Name of the ethic committee：

Dr Shahid Ahmad Abbasi

伦理委员会联系地址：

President Ethical Committee, Fauji Foundation Hospital Rawalpindi, Pakistan

Contact Address of the ethic committee：

President Ethical Committee, Fauji Foundation Hospital Rawalpindi, Pakistan

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +92 51 5788150

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：

Fauji Foundation Hospital

Primary sponsor：

Fauji Foundation Hospital

研究实施负责（组长）单位地址：

Fauji Foundation Hospital, Jhelum Road, DHA-I, Rawalpindi, Pakistan

Primary sponsor's address：

Fauji Foundation Hospital, Jhelum Road, DHA-I, Rawalpindi, Pakistan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Pakistan

省(直辖市)：

Punjab

市(区县)：

Rawalpindi

Country：

Pakistan

Province：

Punjab

City：

Rawalpindi

单位(医院)：

Fauji Foundation Hospital

具体地址：

Fauji Foundation Hospital, Jhelum Road, DHA-I, Rawalpindi, Pakistan

Institution
hospital：

Fauji Foundation Hospital

Address：

Fauji Foundation Hospital, Jhelum Road, DHA-I, Rawalpindi, Pakistan

经费或物资来源：

Self-funded

Source(s) of funding：

Self-funded

研究疾病：

Pain associated with Intravitreal Injections  

Target disease：

Pain associated with Intravitreal Injections

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：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

Primary objective of the study is to measure the effect of the addition of pre-operative topical NSAID on perceived pain during intravitreal injection procedures  

Objectives of Study：

Primary objective of the study is to measure the effect of the addition of pre-operative topical NSAID on perceived pain during intravitreal injection procedures

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. Known hypersensitivity or allergy to proparacaine, diclofenac, nepafenac, or any other NSAID; 2. Presence of active or severe ocular surface disease (e.g., keratitis, severe dry eye); 3. History of ocular surgery within the past 3 months; 4. Concurrent use of any systemic or topical NSAIDs for any other medical reason; 5. A diagnosed anxiety disorder, severe needle phobia, or inability to comprehend the study protocol.

Exclusion criteria：

1. Known hypersensitivity or allergy to proparacaine, diclofenac, nepafenac, or any other NSAID; 2. Presence of active or severe ocular surface disease (e.g., keratitis, severe dry eye); 3. History of ocular surgery within the past 3 months; 4. Concurrent use of any systemic or topical NSAIDs for any other medical reason; 5. A diagnosed anxiety disorder, severe needle phobia, or inability to comprehend the study protocol.

研究实施时间：

Study execute time：

从 From 2025-10-17 00:00:00至 To 2026-02-20 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-10-31 00:00:00 至 To 2026-02-06 00:00:00

干预措施：

Interventions：

组别：

Group 1

样本量：

 100

Group：

Group 1

Sample size：

干预措施：

No intervention (Control)

干预措施代码：

Intervention：

No intervention (Control)

Intervention code：

组别：

Group 2

样本量：

 100

Group：

Group 2

Sample size：

干预措施：

Topical Diclofenac 0.1% 20-30 minutes prior to intervention

干预措施代码：

Intervention：

Topical Diclofenac 0.1% 20-30 minutes prior to intervention

Intervention code：

组别：

Group 3

样本量：

 100

Group：

Group 3

Sample size：

干预措施：

Topical Nepafenac 0.1% 20-30 minutes prior to intervention

干预措施代码：

Intervention：

Topical Nepafenac 0.1% 20-30 minutes prior to intervention

Intervention code：

组别：

Group 4

样本量：

 100

Group：

Group 4

Sample size：

干预措施：

Topical Nepafenac 0.3% 20-30 minutes prior to intervention

干预措施代码：

Intervention：

Topical Nepafenac 0.3% 20-30 minutes prior to intervention

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Pakistan

省(直辖市)：

 Punjab 

市(区县)：

 Rawalpindi 

Country：

Pakistan

Province：

Punjab

City：

Rawalpindi

单位(医院)：

 Fauji Foundation Hospital Rawalpindi 

单位级别：

  

Institution
hospital：

Fauji Foundation Hospital Rawalpindi

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Mean patient-reported pain score

指标类型：

主要指标

Outcome：

Mean patient-reported pain score

Type：

Primary indicator

测量时间点：

Measured once, immediately following the completion of the intravitreal injection procedure

测量方法：

10-cm (100-mm) Visual Analog Scale (VAS)

Measure time point of outcome：

Measured once, immediately following the completion of the intravitreal injection procedure

Measure method：

10-cm (100-mm) Visual Analog Scale (VAS)

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 岁 years
最大 Max age 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）：

None

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

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）：

None

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

None

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：

Patient demographic data (age, gender) and clinical data (diagnosis requiring IVI) will be collected at baseline. The primary outcome (VAS score) will be collected by a blinded clinical assistant immediately post-procedure. All data will be recorded on a standardized case report form and then entered into a secure, password-protected database.

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

Patient demographic data (age, gender) and clinical data (diagnosis requiring IVI) will be collected at baseline. The primary outcome (VAS score) will be collected by a blinded clinical assistant immediately post-procedure. All data will be recorded on a standardized case report form and then entered into a secure, password-protected database.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-10-14 15:03:11
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