Topical Ice-therapy for Intravitreal Injections

Injection Site Irritation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05269823
• Other study ID #: OPH-2022-30605
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: Jade Moon, MD
• Email: moon0278[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia; Hypothermia
• Hypothermia
• Injection Site Irritation

Intervention

Other:
• Ice-therapy
Ice therapy will be provided prior to intravitreal injection provision
• No Ice-therapy
No additional intervention (i.e.) ice therapy will be provided prior to intravitreal injection provision

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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