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Intravitreal Injection Anesthesia - Comparison of Different Topical Agents

Primary Purpose

Age-Related Macular Degeneration (AMD)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Tetracaine
Cocaine
Lidocaine
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration (AMD) focused on measuring AMD, Intravitreal Injection, Anesthesia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ivey Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Tetracaine gtt

Tetraciane gtt + Lidocaine pledget

Cocaine gtt alone

Arm Description

Pre-Intravitreal injection - 1 gtt Tetracaine topically

1 gtt Tetracaine pre-IVT injection + application Lidocaine pledget to injection site

1 gtt pre-IVT injection

Outcomes

Primary Outcome Measures

To elucidate the most effective topical agent for intravitreal injections.
Patients will measure pain by the use of a Visual Analog Scale.

Secondary Outcome Measures

To elucidate the most effective topical agent for intravitreal injections.
Patients will measure pain by the use of a Visual Analog Scale.

Full Information

First Posted
October 6, 2010
Last Updated
April 17, 2012
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01224847
Brief Title
Intravitreal Injection Anesthesia - Comparison of Different Topical Agents
Official Title
Intravitreal Injection Anesthesia - Comparison of Different Topical Agents.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration (AMD)
Keywords
AMD, Intravitreal Injection, Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tetracaine gtt
Arm Type
Active Comparator
Arm Description
Pre-Intravitreal injection - 1 gtt Tetracaine topically
Arm Title
Tetraciane gtt + Lidocaine pledget
Arm Type
Active Comparator
Arm Description
1 gtt Tetracaine pre-IVT injection + application Lidocaine pledget to injection site
Arm Title
Cocaine gtt alone
Arm Type
Active Comparator
Arm Description
1 gtt pre-IVT injection
Intervention Type
Drug
Intervention Name(s)
Tetracaine
Intervention Description
1 gtt
Intervention Type
Drug
Intervention Name(s)
Cocaine
Intervention Description
1 gtt
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Lidocaine soaked pledget
Primary Outcome Measure Information:
Title
To elucidate the most effective topical agent for intravitreal injections.
Description
Patients will measure pain by the use of a Visual Analog Scale.
Time Frame
Pain scores reported immediately after intravitreal injection.
Secondary Outcome Measure Information:
Title
To elucidate the most effective topical agent for intravitreal injections.
Description
Patients will measure pain by the use of a Visual Analog Scale.
Time Frame
Pain scores reported 15 minutes after intravitreal injection.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas G Sheidow, MD, FRCSC
Organizational Affiliation
Ivey Eye Institute, St. Joseph's Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ivey Eye Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

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Intravitreal Injection Anesthesia - Comparison of Different Topical Agents

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