Intravitreal Injection Anesthesia - Comparison of Different Topical Agents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas G. Sheidow, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01224847
First received: October 6, 2010
Last updated: April 17, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Age-Related Macular Degeneration (AMD)
Drug: Tetracaine
Drug: Cocaine
Drug: Lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Intravitreal Injection Anesthesia - Comparison of Different Topical Agents.

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • To elucidate the most effective topical agent for intravitreal injections. [ Time Frame: Pain scores reported immediately after intravitreal injection. ] [ Designated as safety issue: No ]
    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. [ Time Frame: Pain scores reported 15 minutes after intravitreal injection. ] [ Designated as safety issue: No ]
    Patients will measure pain by the use of a Visual Analog Scale.


Enrollment: 92
Study Start Date: October 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tetracaine gtt
Pre-Intravitreal injection - 1 gtt Tetracaine topically
Drug: Tetracaine
1 gtt
Active Comparator: Tetraciane gtt + Lidocaine pledget
1 gtt Tetracaine pre-IVT injection + application Lidocaine pledget to injection site
Drug: Lidocaine
Lidocaine soaked pledget
Active Comparator: Cocaine gtt alone
1 gtt pre-IVT injection
Drug: Cocaine
1 gtt

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224847

Locations
Canada, Ontario
Ivey Eye Institute
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Thomas G Sheidow, MD, FRCSC Ivey Eye Institute, St. Joseph's Health Care
  More Information

No publications provided

Responsible Party: Thomas G. Sheidow, MD, FRCSC, Ophthalmologist, Vitreoretinal Surgeon, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01224847     History of Changes
Other Study ID Numbers: R-09-415, 16454
Study First Received: October 6, 2010
Last Updated: April 17, 2012
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
AMD
Intravitreal Injection
Anesthesia

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Anesthetics
Cocaine
Tetracaine
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on August 21, 2014