Different Intravitreal Injection Techniques and Pain Level

April 17, 2016 updated by: Amir Sternfeld, Rabin Medical Center

Effect of Different Injection Techniques on Pain Level in Intravitreal Injections

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah Tikva, Israel
        • Recruiting
        • Rabin Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Slow angled injection
Slow and angled insertion of the needle through the sclera
Other: Technique of injection
Active Comparator: Slow straight injection
Slow and straight insertion of the needle through the sclera
Other: Technique of injection
Active Comparator: Fast angled injection
fast and angled insertion of the needle through the sclera
Other: Technique of injection
Active Comparator: Fast straight injection
fast and straight insertion of the needle through the sclera
Other: Technique of injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain during the injection as measured by the "Pain numeric rating scale"
Time Frame: Up to 2 minutes after the injection
Up to 2 minutes after the injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Amir Sternfeld, MD, Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

July 7, 2015

First Submitted That Met QC Criteria

July 13, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 17, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 0021-15-RMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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