Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections

NCT ID: NCT01027611

Last Updated: 2010-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2009-12-31

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.

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

proparacaine HCL 0.5%

Group Type: EXPERIMENTAL

proparacaine HCL 0.5%

Intervention Type: DRUG

proparacaine + lidocaine

Group Type: EXPERIMENTAL

proparacaine HCL 0.5% + 4% lidocaine solution

Intervention Type: DRUG

lidocaine gel

Group Type: EXPERIMENTAL

3.5% viscous lidocaine gel

Intervention Type: DRUG

Interventions

proparacaine HCL 0.5%

Intervention Type: DRUG

proparacaine HCL 0.5% + 4% lidocaine solution

Intervention Type: DRUG

3.5% viscous lidocaine gel

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Illinois Retina Associates

OTHER

Sponsor Role: lead

Responsible Party

Illinois Retina Associates

Principal Investigators

John S. Pollack, MD

Role: STUDY_CHAIR

Illinois Retina Associates

Locations

Illinois Retina Associates

Joliet, Illinois, United States

Countries

United States

Other Identifiers

jsp-001

Identifier Type: -

Identifier Source: org_study_id