Intravitreal Injection Anesthesia - Comparison of Different Topical Agents

Age-Related Macular Degeneration (AMD) Clinical Trial

Official title:

Intravitreal Injection Anesthesia - Comparison of Different Topical Agents.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224847
• Other study ID #: R-09-415
• Secondary ID: 16454
• Status: Completed
• Phase: N/A
• First received: October 6, 2010
• Last updated: April 17, 2012
• Start date: October 2009
• Est. completion date: November 2009

Study information

• Verified date: April 2012
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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 alone. A questionnaire will be conducted immediately after and 15 minutes after the injection, to assess for pain.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Age greater than 50

2. Scheduled to receive Ranibizumab for neovascular AMD

Exclusion Criteria:

1. History of pars plana vitrectomy

2. Any major surgery within the prior 28 days, or one planned within next 6 months

3. History of thromboembolic event

4. Previous known allergic response to topical anesthetic(s) (lidocaine, tetracaine, cocaine)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration (AMD)
• Macular Degeneration

Intervention

Drug:
• Tetracaine
1 gtt
• Cocaine
1 gtt
• Lidocaine
Lidocaine soaked pledget

Locations

Country	Name	City	State
Canada	Ivey Eye Institute	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No