Intravitreal Injection Anesthesia - Comparison of Different Topical Agents
2 other identifiers
interventional
92
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 6, 2010
CompletedFirst Posted
Study publicly available on registry
October 20, 2010
CompletedApril 19, 2012
April 1, 2012
1 month
October 6, 2010
April 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To elucidate the most effective topical agent for intravitreal injections.
Pain scores reported 15 minutes after intravitreal injection.
Study Arms (3)
Tetracaine gtt
ACTIVE COMPARATORPre-Intravitreal injection - 1 gtt Tetracaine topically
Tetraciane gtt + Lidocaine pledget
ACTIVE COMPARATOR1 gtt Tetracaine pre-IVT injection + application Lidocaine pledget to injection site
Cocaine gtt alone
ACTIVE COMPARATOR1 gtt pre-IVT injection
Interventions
Eligibility Criteria
You may qualify if:
- Age greater than 50
- Scheduled to receive Ranibizumab for neovascular AMD
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ivey Eye Institute
London, Ontario, N6A 4V2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas G Sheidow, MD, FRCSC
Ivey Eye Institute, St. Joseph's Health Care
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, FRCSC, Ophthalmologist, Vitreoretinal Surgeon
Study Record Dates
First Submitted
October 6, 2010
First Posted
October 20, 2010
Study Start
October 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
April 19, 2012
Record last verified: 2012-04