Topical Ice-therapy for Intravitreal Injections

Topical Ice-therapy for Pain Modulation During Intravitreal Injections: A Prospective Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Injection Site Irritation; Anesthesia; Hypothermia
• Intervention / Treatment: Other: Ice-therapy; Other: No Ice-therapy

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jade Moon, MD; Email: moon0278@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Jade Moon, M.D.; Email: moon0278@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ice-therapy; Ice therapy will be provided prior to the provision of the intravitreal injection	Other: Ice-therapy; Ice therapy will be provided prior to intravitreal injection provision
Placebo Comparator: No Ice-therapy; No ice therapy will be provided prior to the provision of the intravitreal injection	Other: No Ice-therapy; No additional intervention (i.e.) ice therapy will be provided prior to intravitreal injection provision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This will be assessed at five minutes after the conclusion of the intravitreal injection
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.	This will be assessed at five minutes after the conclusion of the intravitreal injection
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.	This will be assessed at five minutes after the conclusion of the intravitreal injection
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.	This will be assessed at five minutes after the conclusion of the intravitreal injection
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.	This will be assessed at five minutes after the conclusion of the intravitreal injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This will be assessed at 24-hours after the conclusion of the intravitreal injection
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.	This will be assessed at 24-hours after the conclusion of the intravitreal injection
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.	This will be assessed at 24-hours after the conclusion of the intravitreal injection
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.	This will be assessed at 24-hours after the conclusion of the intravitreal injection
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.	This will be assessed at 24-hours after the conclusion of the intravitreal injection

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Jade Moon, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: January 16, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: OPH-2022-30605

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No