Injection Site DiscomfortNCT02497092
Different Intravitreal Injection Techniques and Pain Level
A study testing Technique of injection in people with Injection Site Discomfort, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether certain intravitreal injection techniques cause less pain than others and would therefore be beneficial for the patient's well being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injection Site Discomfort
- What is being tested?
- Technique of injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2015to Aug 2016
- 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 anti vascular endothelial growth factor (VEGF) injections
- Informed consent
Who cannot join
- Dementia or any other reason for cognitive deterioration
- Technical limitations not allowing injecting by the protocol
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
Amir Sternfeld, MD, 972-50-7665980, shtery@gmail.com
About this study
Official title: Effect of Different Injection Techniques on Pain Level in Intravitreal Injections
The purpose of this study is to determine whether certain intravitreal injection techniques cause less pain than others and would therefore be beneficial for the patient's well being.
- Conditions
- Injection Site Discomfort
- Being tested
- Technique of injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technique of injectionOther
| Study group | Role | What they receive |
|---|---|---|
| Slow angled injection | Active comparator | Slow and angled insertion of the needle through the sclera Receives: Other: Technique of injection |
| Slow straight injection | Active comparator | Slow and straight insertion of the needle through the sclera Receives: Other: Technique of injection |
| Fast angled injection | Active comparator | fast and angled insertion of the needle through the sclera Receives: Other: Technique of injection |
| Fast straight injection | Active comparator | fast and straight insertion of the needle through the sclera Receives: Other: Technique of injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during the injection as measured by the "Pain numeric rating scale"
Measured: Up to 2 minutes after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection Site DiscomfortStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Sternfeld, Rabin Medical Center
- Investigators
- Amir Sternfeld, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497092
- Sponsor's protocol ID
- 0021-15-RMC
- Status last verified
- Apr 2016
- First submitted
- 7 Jul 2015
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Injection Techniques on Pain Level in Intravitreal Injections
- ClinicalTrials.gov ID
- NCT02497092
- Acronym / sponsor ID
- 0021-15-RMC
- Conditions
- Injection Site Discomfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- First posted
- 14 Jul 2015 (estimated)
- 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.
The purpose of this study is to determine whether certain intravitreal injection techniques cause less pain than others and would therefore be beneficial for the patient's well being.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Slow angled injection | Active comparator | Other: Technique of injectionSlow and angled insertion of the needle through the sclera |
| Slow straight injection | Active comparator | Other: Technique of injectionSlow and straight insertion of the needle through the sclera |
| Fast angled injection | Active comparator | Other: Technique of injectionfast and angled insertion of the needle through the sclera |
| Fast straight injection | Active comparator | Other: Technique of injectionfast and straight insertion of the needle through the sclera |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients receiving intravitreal anti vascular endothelial growth factor (VEGF) injections
- Informed consent
Key exclusion criteria (2 listed)
- Dementia or any other reason for cognitive deterioration
- Technical limitations not allowing injecting by the protocol
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 |
|---|---|---|
| Technique of injection | Other | Fast angled injection, Fast straight injection, Slow angled injection, Slow straight injection |
Primary outcome
Pain during the injection as measured by the "Pain numeric rating scale"
Time frame: Up to 2 minutes after the injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
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.
Amir Sternfeld, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technique of injection in people with Injection Site Discomfort, run by Rabin 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Apr 2016. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Sternfeld, MD (972-50-7665980, shtery@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during the injection as measured by the "Pain numeric rating scale" (time frame: Up to 2 minutes after the injection). 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 19 Apr 2016.