Anesthesia; Hypothermia, Injection Site Irritation
Conditions
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.
Interventions
OTHERIce-therapy
Ice therapy will be provided prior to intravitreal injection provision
OTHERNo Ice-therapy
No additional intervention (i.e.) ice therapy will be provided prior to intravitreal injection provision
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed