Back to resultsTopical Ice-therapy for Intravitreal Injections
Primary Purpose
Anesthesia; Hypothermia, Injection Site Irritation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ice-therapy
No Ice-therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Anesthesia; Hypothermia
Eligibility Criteria
Inclusion Criteria:
- All patients aged 18 or older evaluated by a single retina specialist at the University of Minnesota Department of Ophthalmology with a clinical indication necessitating an anti-VEGF intravitreal injection
Exclusion Criteria:
- N/A
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ice-therapy
No Ice-therapy
Arm Description
Ice therapy will be provided prior to the provision of the intravitreal injection
No ice therapy will be provided prior to the provision of the intravitreal injection
Outcomes
Primary Outcome Measures
Discomfort assessed by the visual analog scale
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to discomfort, while a rating of ten signifies the maximum self-reported subjective rating attributed to discomfort.
Itching assessed by the visual analog scale
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to itching, while a rating of ten signifies the maximum self-reported subjective rating attributed to itching.
Burning assessed by the visual analog scale
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to burning, while a rating of ten signifies the maximum self-reported subjective rating attributed to burning.
Overall Pain assessed by the visual analog scale
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to overall pain, while a rating of ten signifies the maximum self-reported subjective rating attributed to overall pain.
Overall Tolerability assessed by the visual analog scale
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to overall tolerability, while a rating of ten signifies the maximum self-reported subjective rating attributed to overall tolerability.
Secondary Outcome Measures
Discomfort assessed by the visual analog scale
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to discomfort, while a rating of ten signifies the maximum self-reported subjective rating attributed to discomfort.
Itching assessed by the visual analog scale
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to itching, while a rating of ten signifies the maximum self-reported subjective rating attributed to itching.
Burning assessed by the visual analog scale
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to burning, while a rating of ten signifies the maximum self-reported subjective rating attributed to burning.
Overall Pain assessed by the visual analog scale
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to overall pain, while a rating of ten signifies the maximum self-reported subjective rating attributed to overall pain.
Overall Tolerability assessed by the visual analog scale
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to overall tolerability, while a rating of ten signifies the maximum self-reported subjective rating attributed to overall tolerability.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05269823
Brief Title
Topical Ice-therapy for Intravitreal Injections
Official Title
Topical Ice-therapy for Pain Modulation During Intravitreal Injections: A Prospective Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
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
Purpose: To examine the difference in patient's pain experience in the setting of intravitreal anti-VEGF injections with pretreatment of topical ice-therapy compared with no-ice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia; Hypothermia, Injection Site Irritation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ice-therapy
Arm Type
Active Comparator
Arm Description
Ice therapy will be provided prior to the provision of the intravitreal injection
Arm Title
No Ice-therapy
Arm Type
Placebo Comparator
Arm Description
No ice therapy will be provided prior to the provision of the intravitreal injection
Intervention Type
Other
Intervention Name(s)
Ice-therapy
Intervention Description
Ice therapy will be provided prior to intravitreal injection provision
Intervention Type
Other
Intervention Name(s)
No Ice-therapy
Intervention Description
No additional intervention (i.e.) ice therapy will be provided prior to intravitreal injection provision
Primary Outcome Measure Information:
Title
Discomfort assessed by the visual analog scale
Description
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to discomfort, while a rating of ten signifies the maximum self-reported subjective rating attributed to discomfort.
Time Frame
This will be assessed at five minutes after the conclusion of the intravitreal injection
Title
Itching assessed by the visual analog scale
Description
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to itching, while a rating of ten signifies the maximum self-reported subjective rating attributed to itching.
Time Frame
This will be assessed at five minutes after the conclusion of the intravitreal injection
Title
Burning assessed by the visual analog scale
Description
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to burning, while a rating of ten signifies the maximum self-reported subjective rating attributed to burning.
Time Frame
This will be assessed at five minutes after the conclusion of the intravitreal injection
Title
Overall Pain assessed by the visual analog scale
Description
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to overall pain, while a rating of ten signifies the maximum self-reported subjective rating attributed to overall pain.
Time Frame
This will be assessed at five minutes after the conclusion of the intravitreal injection
Title
Overall Tolerability assessed by the visual analog scale
Description
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to overall tolerability, while a rating of ten signifies the maximum self-reported subjective rating attributed to overall tolerability.
Time Frame
This will be assessed at five minutes after the conclusion of the intravitreal injection
Secondary Outcome Measure Information:
Title
Discomfort assessed by the visual analog scale
Description
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to discomfort, while a rating of ten signifies the maximum self-reported subjective rating attributed to discomfort.
Time Frame
This will be assessed at 24-hours after the conclusion of the intravitreal injection
Title
Itching assessed by the visual analog scale
Description
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to itching, while a rating of ten signifies the maximum self-reported subjective rating attributed to itching.
Time Frame
This will be assessed at 24-hours after the conclusion of the intravitreal injection
Title
Burning assessed by the visual analog scale
Description
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to burning, while a rating of ten signifies the maximum self-reported subjective rating attributed to burning.
Time Frame
This will be assessed at 24-hours after the conclusion of the intravitreal injection
Title
Overall Pain assessed by the visual analog scale
Description
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to overall pain, while a rating of ten signifies the maximum self-reported subjective rating attributed to overall pain.
Time Frame
This will be assessed at 24-hours after the conclusion of the intravitreal injection
Title
Overall Tolerability assessed by the visual analog scale
Description
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to overall tolerability, while a rating of ten signifies the maximum self-reported subjective rating attributed to overall tolerability.
Time Frame
This will be assessed at 24-hours after the conclusion of the intravitreal injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients aged 18 or older evaluated by a single retina specialist at the University of Minnesota Department of Ophthalmology with a clinical indication necessitating an anti-VEGF intravitreal injection
Exclusion Criteria:
N/A
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olufemi Adams, MD
Phone
612-625-4654
Email
Adams977@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olufemi Adams, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olufemi Adams, M.D.
Phone
612-625-4654
Email
Adams977@umn.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Topical Ice-therapy for Intravitreal Injections
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