Age-Related Macular Degeneration (AMD)NCT01224847
Intravitreal Injection Anesthesia - Comparison of Different Topical Agents
A study testing Tetracaine, Cocaine and Lidocaine in people with Age-Related Macular Degeneration (AMD), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients with neovascular age-related macular degeneration (AMD) scheduled to receive intravitreal (IVT) Ranibizumab injection will be randomized to receive one of three topical anesthetics: (1) tetracaine drop (gtt) + lidocaine pledget to the injection site for 10 seconds (2) tetracaine gtt alone and (3) cocaine gtt… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration (AMD)
- What is being tested?
- Tetracaine, Cocaine and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Nov 2009
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 50
- Scheduled to receive Ranibizumab for neovascular AMD
Who cannot join
- History of pars plana vitrectomy
- Any major surgery within the prior 28 days, or one planned within next 6 months
- History of thromboembolic event
- Previous known allergic response to topical anesthetic(s) (lidocaine, tetracaine, cocaine)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravitreal Injection Anesthesia - Comparison of Different Topical Agents.
Patients with neovascular age-related macular degeneration (AMD) scheduled to receive intravitreal (IVT) Ranibizumab injection will be randomized to receive one of three topical anesthetics: (1) tetracaine drop (gtt) + lidocaine pledget to the injection site for 10 seconds (2) tetracaine gtt alone and (3) cocaine gtt alone. A questionnaire will be conducted immediately after and 15 minutes after the injection, to assess for pain.
Read the detailed description
All patients scheduled to receive intravitreal Ranibizumab for the treatment of neovascular AMD will be evaluated for inclusion into the study. After a positive evaluation, the study will be explained to the patient, the Letter of Explanation reviewed with the patient and informed consent approved if patient agrees to participate. Demographic data of sex and age will be recorded. As well the number of previous intravitreal injections will be recorded ( none, 2 - 5 and > 5 ). A nurse will then proceed to select an opaque envelope from a box of identical envelopes. The envelope will contain the topical anesthetic agent to be used. The randomization code linking each patient to their anesthetic will be stored in a secure location, and only accessed at the completion of the trial. The anesthetic procedure will be performed by someone other than the surgeon who will perform the IVT injection. After a minute of the anesthetic application, the surgeon, blinded to the anesthetic intervention, will perform the IVT injection of Ranibizumab. Immediately following the injection, a blinded observer will first explain the Pain Questionnaire, and then conduct it. Also at this time, the physician who performed the injection will complete the Wong-Baker Pain Questionnaire. The patient will then be asked to wait in a room for an additional 15 minutes, where the same observer will return and the Pain Questionnaire will be conducted a second time.
- Conditions
- Age-Related Macular Degeneration (AMD)
- Being tested
- Tetracaine, Cocaine, Lidocaine
- Keywords
- AMD, Intravitreal Injection, Anesthesia
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetracaineDrug
1 gtt
CocaineDrug
1 gtt
LidocaineDrug
Lidocaine soaked pledget
| Study group | Role | What they receive |
|---|---|---|
| Tetracaine gtt | Active comparator | Pre-Intravitreal injection - 1 gtt Tetracaine topically Receives: Drug: Tetracaine |
| Tetraciane gtt + Lidocaine pledget | Active comparator | 1 gtt Tetracaine pre-IVT injection + application Lidocaine pledget to injection site Receives: Drug: Lidocaine |
| Cocaine gtt alone | Active comparator | 1 gtt pre-IVT injection Receives: Drug: Cocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To elucidate the most effective topical agent for intravitreal injections.
Patients will measure pain by the use of a Visual Analog Scale.
Measured: Pain scores reported immediately after intravitreal injection.
Secondary outcomes (1)
To elucidate the most effective topical agent for intravitreal injections.
Patients will measure pain by the use of a Visual Analog Scale.
Measured: Pain scores reported 15 minutes after intravitreal injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startOct 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas G. Sheidow, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Thomas G Sheidow, MD, FRCSC, Principal investigator, Ivey Eye Institute, St. Joseph's Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224847
- Sponsor's protocol ID
- R-09-415
- Other IDs
- 16454
- Status last verified
- Apr 2012
- First submitted
- 6 Oct 2010
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Injection Anesthesia - Comparison of Different Topical Agents.
- ClinicalTrials.gov ID
- NCT01224847
- Acronym / sponsor ID
- R-09-415
- Conditions
- Age-Related Macular Degeneration (AMD)
- Keywords
- AMD, Intravitreal Injection, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Oct 2010 (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.
Patients with neovascular age-related macular degeneration (AMD) scheduled to receive intravitreal (IVT) Ranibizumab injection will be randomized to receive one of three topical anesthetics: (1) tetracaine drop (gtt) + lidocaine pledget to the injection site for 10 seconds (2) tetracaine gtt alone and (3) cocaine gtt alone. A questionnaire will be conducted immediately after and 15 minutes after the injection, to assess for pain.
Detailed description
All patients scheduled to receive intravitreal Ranibizumab for the treatment of neovascular AMD will be evaluated for inclusion into the study. After a positive evaluation, the study will be explained to the patient, the Letter of Explanation reviewed with the patient and informed consent approved if patient agrees to participate. Demographic data of sex and age will be recorded. As well the number of previous intravitreal injections will be recorded ( none, 2 - 5 and > 5 ). A nurse will then proceed to select an opaque envelope from a box of identical envelopes. The envelope will contain the topical anesthetic agent to be used. The randomization code linking each patient to their anesthetic will be stored in a secure location, and only accessed at the completion of the trial. The anesthetic procedure will be performed by someone other than the surgeon who will perform the IVT injection. After a minute of the anesthetic application, the surgeon, blinded to the anesthetic intervention, will perform the IVT injection of Ranibizumab. Immediately following the injection, a blinded observer will first explain the Pain Questionnaire, and then conduct it. Also at this time, the physician who performed the injection will complete the Wong-Baker Pain Questionnaire. The patient will then be asked to wait in a room for an additional 15 minutes, where the same observer will return and the Pain Questionnaire will be conducted a second time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tetracaine gtt | Active comparator | Drug: TetracainePre-Intravitreal injection - 1 gtt Tetracaine topically |
| Tetraciane gtt + Lidocaine pledget | Active comparator | Drug: Lidocaine1 gtt Tetracaine pre-IVT injection + application Lidocaine pledget to injection site |
| Cocaine gtt alone | Active comparator | Drug: Cocaine1 gtt pre-IVT injection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than 50
- Scheduled to receive Ranibizumab for neovascular AMD
Key exclusion criteria (4 listed)
- History of pars plana vitrectomy
- Any major surgery within the prior 28 days, or one planned within next 6 months
- History of thromboembolic event
- Previous known allergic response to topical anesthetic(s) (lidocaine, tetracaine, cocaine)
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 |
|---|---|---|
| Tetracaine1 gtt | Drug | Tetracaine gtt |
| Cocaine1 gtt | Drug | Cocaine gtt alone |
| LidocaineLidocaine soaked pledget | Drug | Tetraciane gtt + Lidocaine pledget |
Primary outcome
To elucidate the most effective topical agent for intravitreal injections.
Time frame: Pain scores reported immediately after intravitreal injection.
Patients will measure pain by the use of a Visual Analog Scale.
1 secondary outcome
To elucidate the most effective topical agent for intravitreal injections.
Time frame: Pain scores reported 15 minutes after 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 19 Apr 2012.
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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.
Thomas G Sheidow, MD, FRCSC principal investigator
Ivey Eye Institute, St. Joseph's Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetracaine, Cocaine and Lidocaine in people with Age-Related Macular Degeneration (AMD), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 4 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 19 Apr 2012. 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 Canada. 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?
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?
To elucidate the most effective topical agent for intravitreal injections. (time frame: Pain scores reported immediately after intravitreal 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 2012.