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Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections

This study has been completed.
Sponsor:
Information provided by:
Illinois Retina Associates
ClinicalTrials.gov Identifier:
NCT01027611
First received: December 4, 2009
Last updated: May 3, 2010
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Pain
 Drug: proparacaine HCL 0.5%
Drug: proparacaine HCL 0.5% + 4% lidocaine solution
Drug: 3.5% viscous lidocaine gel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Illinois Retina Associates:

Primary Outcome Measures:
  • Injection experience "grade" [ Time Frame: Outcome data is obtained approximately 10 seconds after conclusion of procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain grades for lid speculum, needle insertion, povidone iodine burning/stinging [ Time Frame: Outcome data is obtained approximately 10 seconds after conclusion of procedure ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027611

Locations
United States, Illinois
Illinois Retina Associates
Joliet, Illinois, United States, 60435
Sponsors and Collaborators
Illinois Retina Associates
Investigators
Study Chair: John S. Pollack, MD Illinois Retina Associates
  More Information

No publications provided

Responsible Party: John S. Pollack, M.D., Illinois Retina Associates
ClinicalTrials.gov Identifier: NCT01027611     History of Changes
Other Study ID Numbers: jsp-001
Study First Received: December 4, 2009
Last Updated: May 3, 2010
Health Authority: United States: Institutional Review Board

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:
Anesthetics
Lidocaine
Proxymetacaine
Propoxycaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013