Anesthesia; HypothermiaNCT05269823
Topical Ice-therapy for Intravitreal Injections
A study testing Ice-therapy and No Ice-therapy in people with Anesthesia; Hypothermia and Injection Site Irritation, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia; Hypothermia, Injection Site Irritation
- What is being tested?
- Ice-therapy and No Ice-therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Topical Ice-therapy for Pain Modulation During Intravitreal Injections: A Prospective Randomized Control Trial
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
- Being tested
- Ice-therapy, No Ice-therapy
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice-therapyOther
Ice therapy will be provided prior to intravitreal injection provision
No Ice-therapyOther
No additional intervention (i.e.) ice therapy will be provided prior to intravitreal injection provision
| Study group | Role | What they receive |
|---|---|---|
| Ice-therapy | Active comparator | Ice therapy will be provided prior to the provision of the intravitreal injection Receives: Other: Ice-therapy |
| No Ice-therapy | Placebo comparator | No ice therapy will be provided prior to the provision of the intravitreal injection Receives: Other: No Ice-therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This will be assessed at 24-hours after the conclusion of the intravitreal injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Apr 2022
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jade Moon, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269823
- Sponsor's protocol ID
- OPH-2022-30605
- Status last verified
- Aug 2025
- First submitted
- 16 Jan 2022
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Ice-therapy for Pain Modulation During Intravitreal Injections: A Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05269823
- Acronym / sponsor ID
- OPH-2022-30605
- Conditions
- Anesthesia; Hypothermia, Injection Site Irritation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ice-therapy | Active comparator | Other: Ice-therapyIce therapy will be provided prior to the provision of the intravitreal injection |
| No Ice-therapy | Placebo comparator | Other: No Ice-therapyNo ice therapy will be provided prior to the provision of the intravitreal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ice-therapyIce therapy will be provided prior to intravitreal injection provision | Other | Ice-therapy |
| No Ice-therapyNo additional intervention (i.e.) ice therapy will be provided prior to intravitreal injection provision | Other | No Ice-therapy |
Primary outcome
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.
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.
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.
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.
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.
5 secondary outcomes
Discomfort assessed by the visual analog scale
Time frame: This will be assessed at 24-hours after the conclusion of the intravitreal injection
Itching assessed by the visual analog scale
Time frame: This will be assessed at 24-hours after the conclusion of the intravitreal injection
Burning assessed by the visual analog scale
Time frame: This will be assessed at 24-hours after the conclusion of the intravitreal injection
Overall Pain assessed by the visual analog scale
Time frame: This will be assessed at 24-hours after the conclusion of the intravitreal injection
Overall Tolerability assessed by the visual analog scale
Time frame: This will be assessed at 24-hours after the conclusion of the intravitreal injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jade Moon, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice-therapy and No Ice-therapy in people with Anesthesia; Hypothermia and Injection Site Irritation, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discomfort assessed by the visual analog scale (time frame: This will be assessed at five minutes after the conclusion of the intravitreal injection). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.