Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: proparacaine HCL 0.5%; Drug: proparacaine HCL 0.5% + 4% lidocaine solution; 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Illinois Retina Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Injection experience "grade"	Outcome data is obtained approximately 10 seconds after conclusion of procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain grades for lid speculum, needle insertion, povidone iodine burning/stinging	Outcome data is obtained approximately 10 seconds after conclusion of procedure

Collaborators and Investigators

• Sponsor: Illinois Retina Associates
• Investigators: Study Chair: John S. Pollack, MD, Illinois Retina Associates

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: December 4, 2009
• First Submitted That Met QC Criteria: December 7, 2009
• First Posted (Estimate): December 8, 2009

Study Record Updates

• Last Update Posted (Estimate): May 4, 2010
• Last Update Submitted That Met QC Criteria: May 3, 2010
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Effectiveness of topical pain medicine for control of pain associated with intravitreal injections; Eye discomfort
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Proxymetacaine; Propoxycaine
• Other Study ID Numbers: jsp-001