Intravitreal Injection Anesthesia - Comparison of Different Topical Agents

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intravitreal Injection Anesthesia - Comparison of Different Topical Agents.

Conditions
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Age-Related Macular Degeneration (AMD)

Intervention / Treatment
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* Drug: Tetracaine
* Drug: Cocaine
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 50 Scheduled to receive Ranibizumab for neovascular AMD Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tetracaine gtt<br>Pre-Intravitreal injection - 1 gtt Tetracaine topically | Drug: Tetracaine<br>* 1 gtt<br>|
| Active Comparator: Tetraciane gtt + Lidocaine pledget<br>1 gtt Tetracaine pre-IVT injection + application Lidocaine pledget to injection site | Drug: Lidocaine<br>* Lidocaine soaked pledget<br>|
| Active Comparator: Cocaine gtt alone<br>1 gtt pre-IVT injection | Drug: Cocaine<br>* 1 gtt<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To elucidate the most effective topical agent for intravitreal injections. | Patients will measure pain by the use of a Visual Analog Scale. | Pain scores reported immediately after intravitreal injection. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To elucidate the most effective topical agent for intravitreal injections. | Patients will measure pain by the use of a Visual Analog Scale. | Pain scores reported 15 minutes after intravitreal injection. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, Intravitreal Injection, Anesthesia