Topical Ice-therapy for Intravitreal Injections
- Conditions
- Injection Site IrritationAnesthesia; Hypothermia
- Interventions
- Other: Ice-therapyOther: No Ice-therapy
- Registration Number
- NCT05269823
- Lead Sponsor
- University of Minnesota
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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
- N/A
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ice-therapy Ice-therapy Ice therapy will be provided prior to the provision of the intravitreal injection No Ice-therapy No Ice-therapy No ice therapy will be provided prior to the provision of the intravitreal injection
- Primary Outcome Measures
Name Time Method 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.
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.
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.
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 Outcome Measures
Name Time Method 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.
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.
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.
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States