Different Intravitreal Injection Techniques and Pain Level

Injection Site Discomfort Clinical Trial

Official title:

Effect of Different Injection Techniques on Pain Level in Intravitreal Injections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02497092
• Other study ID #: 0021-15-RMC
• Status: Recruiting
• Phase: N/A
• First received: July 7, 2015
• Last updated: April 17, 2016
• Start date: August 2015

Study information

• Verified date: April 2016
• Source: Rabin Medical Center
• Contact: Amir Sternfeld, MD
• Phone: 972-50-7665980
• Email: shtery[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether certain intravitreal injection techniques cause less pain than others and would therefore be beneficial for the patient's well being.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients receiving intravitreal anti vascular endothelial growth factor (VEGF) injections

• Informed consent

Exclusion Criteria:

• Dementia or any other reason for cognitive deterioration

• Technical limitations not allowing injecting by the protocol

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Injection Site Discomfort

Intervention

Other:
• Technique of injection

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain during the injection as measured by the "Pain numeric rating scale"		Up to 2 minutes after the injection	No