Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections - Full Text View

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:

Drug Information available for: Lidocaine hydrochloride Lidocaine Proparacaine Proparacaine hydrochloride

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 (Adult, Senior)
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

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: 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


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:


Lidocaine Proxymetacaine Propoxycaine Anesthetics Anesthetics, Local 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

ClinicalTrials.gov processed this record on September 28, 2016