PainNCT03618875
Reduction of Post Intravitreal Injection Bleeding and Pain by Ice
A study testing ice pack and room temperature pack in people with Pain, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
Intravitreal injections are an efficient method for delivering intraocular therapeutic agents in numerous ophthalmologic diseases. However, side effects, such as pain and subconjunctival hemorrhage remain a major concern. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- ice pack and room temperature pack
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2017to 25 Nov 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients receiving intravitreal injection
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Intravitreal injections are an efficient method for delivering intraocular therapeutic agents in numerous ophthalmologic diseases. However, side effects, such as pain and subconjunctival hemorrhage remain a major concern.
Prevention or alleviation of those side effects might shorten the healing duration and improve patients' quality of life.
Read the detailed description
cooling the eye using ice patched prior to Intravitreal injections may ameliorated pain and subconjunctival hemorrhage incidences.
- Conditions
- Pain
- Being tested
- ice pack, room temperature pack
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ice packOther
ice pack was placed on eyelid 5 minutes prior to IVIT
room temperature packOther
room temperature pack was placed on eyelid 5 minutes prior to IVIT
| Study group | Role | What they receive |
|---|---|---|
| ice | Active comparator | Patients were randomly assigned to receive an ice 5 minutes prior the IViT Receives: Other: ice pack |
| placebo | Placebo comparator | Patients were randomly assigned to a room temperature patch (placebo) 5 minutes prior the IViT Receives: Other: room temperature pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Visual Analogue Scale (VAS) is a Likert-type scale (1-10). The VAS is a reliable tool in evaluating and quantifying ocular discomfort
Measured: change between VAS pain score at baseline and 10 minutes
Secondary outcomes (1)
size of subconjunctival hemorrhage
subconjunctival hemorrhage in mm
Measured: change between subconjunctival hemorrhage at baseline and 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Jan 2017
- Primary completion1 Nov 2017
- Study completion25 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618875
- Sponsor's protocol ID
- icepreventpain
- Status last verified
- Nov 2016
- First submitted
- 26 Nov 2017
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Post Intravitreal Injection Bleeding and Pain by Ice
- ClinicalTrials.gov ID
- NCT03618875
- Acronym / sponsor ID
- icepreventpain
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 25 Nov 2017 (actual)
- First posted
- 7 Aug 2018 (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.
Intravitreal injections are an efficient method for delivering intraocular therapeutic agents in numerous ophthalmologic diseases. However, side effects, such as pain and subconjunctival hemorrhage remain a major concern.
Prevention or alleviation of those side effects might shorten the healing duration and improve patients' quality of life.
Detailed description
cooling the eye using ice patched prior to Intravitreal injections may ameliorated pain and subconjunctival hemorrhage incidences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ice | Active comparator | Other: ice packPatients were randomly assigned to receive an ice 5 minutes prior the IViT |
| placebo | Placebo comparator | Other: room temperature packPatients were randomly assigned to a room temperature patch (placebo) 5 minutes prior the IViT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients receiving intravitreal injection
Key exclusion criteria (0 listed)
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 packice pack was placed on eyelid 5 minutes prior to IVIT | Other | ice |
| room temperature packroom temperature pack was placed on eyelid 5 minutes prior to IVIT | Other | placebo |
Primary outcome
pain
Time frame: change between VAS pain score at baseline and 10 minutes
Visual Analogue Scale (VAS) is a Likert-type scale (1-10). The VAS is a reliable tool in evaluating and quantifying ocular discomfort
1 secondary outcome
size of subconjunctival hemorrhage
Time frame: change between subconjunctival hemorrhage at baseline and 10 minutes
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 7 Aug 2018.
- Individual participant dataSharing planned: No. no plan
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 pack and room temperature pack in people with Pain, run by Wolfson Medical Center at 1 site in Israel.
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 0 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 7 Aug 2018. 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 Israel. 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?
pain (time frame: change between VAS pain score at baseline and 10 minutes). 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 7 Aug 2018.