Topical Ice-therapy for Intravitreal Injections

Study Overview
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Brief Summary
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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.

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

Conditions
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Anesthesia; Hypothermia, Injection Site Irritation

Intervention / Treatment
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* Other: Ice-therapy
* Other: No Ice-therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |