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Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01027611
Recruitment Status : Completed
First Posted : December 8, 2009
Last Update Posted : May 4, 2010
Sponsor:
Information provided by:
Illinois Retina Associates

Study Description
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Brief Summary:
There are currently several different commercially available topical eye drops and gels used to reduce eye discomfort (topical anesthetics) during and after eye injections. Dr. Pollack is performing a research study to evaluate three commercially available topical anesthetics (eye numbing treatments) to determine if individuals have a preference for one over the other. The three topical anesthetics being studied are 1) 0.5% proparacaine hydrochloride (generic, Akorn, Inc), 2) 0.5% proparacaine hydrochloride (generic, Akorn, Inc) PLUS 4% lidocaine hydrochloride topical solution (generic, Roxane Laboratories), and 3) 3.5% lidocaine hydrochloride ophthalmic gel (Akten, Akorn, Inc). These eye anesthetics are NOT experimental medications. They are all commercially available topical anesthetics currently used in our offices and their use is widespread among retina specialists throughout the United States. Dr. Pollack will randomly select one topical anesthetic to use and he will ask you to grade your level of pain associated with the injection procedure. Answering these questions should take less than one minute of your time and your identity will NOT be revealed with the results of this study. The results of this study will be used to inform doctors which eye anesthetics patients find most effective for pain control during eye injections.

Condition or disease Intervention/treatment Phase
Pain Drug: proparacaine HCL 0.5% Drug: proparacaine HCL 0.5% + 4% lidocaine solution Drug: 3.5% viscous lidocaine gel Phase 3

Detailed Description:
In this prospective study, 120 sequential patients undergoing 30 and 33 Gauge intravitreal injections were randomly assigned to receive either: proparacaine HCL 0.5% (Group 1), proparacaine HCL 0.5% + 4% lidocaine liquid drops (Group 2); or 3.5% lidocaine gel (Group 3) as topical anesthetic prior to injection. All procedures utilized a lid speculum and 5% povidone iodine. Approximately 10 seconds after injection, patients graded pain associated with the lid speculum, the needle, and with burning sensation on a pain scale of 0 to 10, with 0 representing no pain and 10 representing the patient's worst imaginable pain. They also graded their overall injection procedure experience as Excellent, Very Good, Fair, Poor, or Awful.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections
Study Start Date : October 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: proparacaine HCL 0.5% Drug: proparacaine HCL 0.5%
Experimental: proparacaine + lidocaine Drug: proparacaine HCL 0.5% + 4% lidocaine solution
Experimental: lidocaine gel Drug: 3.5% viscous lidocaine gel


Outcome Measures
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Primary Outcome Measures :
  1. Injection experience "grade" [ Time Frame: Outcome data is obtained approximately 10 seconds after conclusion of procedure ]

Secondary Outcome Measures :
  1. Pain grades for lid speculum, needle insertion, povidone iodine burning/stinging [ Time Frame: Outcome data is obtained approximately 10 seconds after conclusion of procedure ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients requiring intravitreal injection for treatment of eye disease

Exclusion Criteria:

  • Eye infection
  • Retinal detachment
  • Age less than 18 years
  • Pregnant
  • Unable or unwilling to provide informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027611


Locations
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United States, Illinois
Illinois Retina Associates
Joliet, Illinois, United States, 60435
Sponsors and Collaborators
Illinois Retina Associates
Investigators
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Study Chair: John S. Pollack, MD Illinois Retina Associates
More Information
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Responsible Party: John S. Pollack, M.D., Illinois Retina Associates
ClinicalTrials.gov Identifier: NCT01027611    
Other Study ID Numbers: jsp-001
First Posted: December 8, 2009    Key Record Dates
Last Update Posted: May 4, 2010
Last Verified: December 2009
Keywords provided by Illinois Retina Associates:
Effectiveness of topical pain medicine for control of pain associated with intravitreal injections
Eye discomfort
Additional relevant MeSH terms:
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Lidocaine
Proxymetacaine
Propoxycaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action