Reduction of Post Intravitreal Injection Bleeding and Pain by Ice

August 5, 2018 updated by: Wolfson Medical Center

Intravitreal injections are an efficient method for delivering intraocular therapeutic agents in numerous ophthalmologic diseases. However, side effects, such as pain and subconjunctival hemorrhage remain a major concern.

Prevention or alleviation of those side effects might shorten the healing duration and improve patients' quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

cooling the eye using ice patched prior to Intravitreal injections may ameliorated pain and subconjunctival hemorrhage incidences.

Study Type

Interventional

Enrollment (Actual)

40

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
      • Holon, Israel, 58100
        • The E.Wolfson Medical Center

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 injection

Exclusion Criteria:

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ice
Patients were randomly assigned to receive an ice 5 minutes prior the IViT
Other: ice pack
ice pack was placed on eyelid 5 minutes prior to IVIT
Placebo Comparator: placebo
Patients were randomly assigned to a room temperature patch (placebo) 5 minutes prior the IViT
Other: room temperature pack
room temperature pack was placed on eyelid 5 minutes prior to IVIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain
Time Frame: change between VAS pain score at baseline and 10 minutes
Visual Analogue Scale (VAS) is a Likert-type scale (1-10). The VAS is a reliable tool in evaluating and quantifying ocular discomfort
change between VAS pain score at baseline and 10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
size of subconjunctival hemorrhage
Time Frame: change between subconjunctival hemorrhage at baseline and 10 minutes
subconjunctival hemorrhage in mm
change between subconjunctival hemorrhage at baseline and 10 minutes

Collaborators and Investigators

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

Sponsor

Wolfson 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 (Actual)

January 1, 2017

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 25, 2017

Study Registration Dates

First Submitted

November 26, 2017

First Submitted That Met QC Criteria

August 5, 2018

First Posted (Actual)

August 7, 2018

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 5, 2018

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • icepreventpain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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