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Completed

NCT Number: NCT05269823

Topical Ice-therapy for Intravitreal Injections

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.

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Key information

Conditions

Anesthesia; Hypothermia Body Temperature Changes Hypothermia Injection Site Irritation Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ice-therapy

Other

Ice therapy will be provided prior to intravitreal injection provision

No Ice-therapy

Other

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

Primary outcomes

  1. Discomfort assessed by the visual analog scale

    Time frame: 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.

  2. Itching assessed by the visual analog scale

    Time frame: 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.

  3. Burning assessed by the visual analog scale

    Time frame: 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.

  4. Overall Pain assessed by the visual analog scale

    Time frame: 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.

  5. Overall Tolerability assessed by the visual analog scale

    Time frame: 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.

Secondary outcomes

  1. Discomfort assessed by the visual analog scale

    Time frame: 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.

  2. Itching assessed by the visual analog scale

    Time frame: 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.

  3. Burning assessed by the visual analog scale

    Time frame: 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.

  4. Overall Pain assessed by the visual analog scale

    Time frame: 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.

  5. Overall Tolerability assessed by the visual analog scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2022
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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