Topical Ice-therapy for Intravitreal Injections

Not Applicable

Recruiting

• Conditions: Injection Site Irritation; Anesthesia; Hypothermia

• Registration Number: NCT05269823
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-16
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-08
• Study Start: 2022-04-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-05-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall Tolerability assessed by the visual analog scale	This will be assessed at five minutes after the conclusion of the intravitreal injection	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.
Itching assessed by the visual analog scale	This will be assessed at five minutes after the conclusion of the intravitreal injection	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.
Discomfort assessed by the visual analog scale	This will be assessed at five minutes after the conclusion of the intravitreal injection	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.
Burning assessed by the visual analog scale	This will be assessed at five minutes after the conclusion of the intravitreal injection	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 will be assessed at five minutes after the conclusion of the intravitreal injection	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.

Secondary Outcome Measures

Name	Time	Method
Burning assessed by the visual analog scale	This will be assessed at 24-hours after the conclusion of the intravitreal injection	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.
Discomfort assessed by the visual analog scale	This will be assessed at 24-hours after the conclusion of the intravitreal injection	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 will be assessed at 24-hours after the conclusion of the intravitreal injection	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.
Overall Pain assessed by the visual analog scale	This will be assessed at 24-hours after the conclusion of the intravitreal injection	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 will be assessed at 24-hours after the conclusion of the intravitreal injection	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States