Back to resultsReduction of Post Intravitreal Injection Bleeding and Pain by Ice
Primary Purpose
Pain
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ice pack
room temperature pack
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
Inclusion Criteria:
patients receiving intravitreal injection
Exclusion Criteria:
Sites / Locations
- The E.Wolfson Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ice
placebo
Arm Description
Patients were randomly assigned to receive an ice 5 minutes prior the IViT
Patients were randomly assigned to a room temperature patch (placebo) 5 minutes prior the IViT
Outcomes
Primary Outcome Measures
pain
Visual Analogue Scale (VAS) is a Likert-type scale (1-10). The VAS is a reliable tool in evaluating and quantifying ocular discomfort
Secondary Outcome Measures
size of subconjunctival hemorrhage
subconjunctival hemorrhage in mm
Full Information
NCT ID
NCT03618875
First Posted
November 26, 2017
Last Updated
August 5, 2018
Sponsor
Wolfson Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03618875
Brief Title
Reduction of Post Intravitreal Injection Bleeding and Pain by Ice
Official Title
Reduction of Post Intravitreal Injection Bleeding and Pain by Ice
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
November 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
cooling the eye using ice patched prior to Intravitreal injections may ameliorated pain and subconjunctival hemorrhage incidences.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ice
Arm Type
Active Comparator
Arm Description
Patients were randomly assigned to receive an ice 5 minutes prior the IViT
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Patients were randomly assigned to a room temperature patch (placebo) 5 minutes prior the IViT
Intervention Type
Other
Intervention Name(s)
ice pack
Intervention Description
ice pack was placed on eyelid 5 minutes prior to IVIT
Intervention Type
Other
Intervention Name(s)
room temperature pack
Intervention Description
room temperature pack was placed on eyelid 5 minutes prior to IVIT
Primary Outcome Measure Information:
Title
pain
Description
Visual Analogue Scale (VAS) is a Likert-type scale (1-10). The VAS is a reliable tool in evaluating and quantifying ocular discomfort
Time Frame
change between VAS pain score at baseline and 10 minutes
Secondary Outcome Measure Information:
Title
size of subconjunctival hemorrhage
Description
subconjunctival hemorrhage in mm
Time Frame
change between subconjunctival hemorrhage at baseline and 10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients receiving intravitreal injection
Exclusion Criteria:
Facility Information:
Facility Name
The E.Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no plan
Learn more about this trial
Reduction of Post Intravitreal Injection Bleeding and Pain by Ice
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