Topical Ice-therapy for Intravitreal Injections

NCT05269823 | Completed

• 1 other identifier: OPH-2022-30605
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Hypothermia; Injection Site Irritation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Discomfort assessed by the visual analog scale

  This will be assessed at 24-hours after the conclusion of the intravitreal injection

• Itching assessed by the visual analog scale

  This will be assessed at 24-hours after the conclusion of the intravitreal injection

• Burning assessed by the visual analog scale

  This will be assessed at 24-hours after the conclusion of the intravitreal injection

• Overall Pain assessed by the visual analog scale

  This will be assessed at 24-hours after the conclusion of the intravitreal injection

• Overall Tolerability assessed by the visual analog scale

  This will be assessed at 24-hours after the conclusion of the intravitreal injection

Study Arms (2)

Ice-therapy

ACTIVE COMPARATOR

Ice therapy will be provided prior to the provision of the intravitreal injection

Other: Ice-therapy

No Ice-therapy

PLACEBO COMPARATOR

No ice therapy will be provided prior to the provision of the intravitreal injection

Other: No Ice-therapy

Interventions

Ice-therapy OTHER

Ice therapy will be provided prior to intravitreal injection provision

Ice-therapy

No Ice-therapy OTHER

No additional intervention (i.e.) ice therapy will be provided prior to intravitreal injection provision

No Ice-therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Hypothermia

Interventions

Ice

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Study Officials

• Jade Moon, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2022
• First Posted: March 8, 2022
• Study Start: April 1, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

US (1)