Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections

Illinois Retina Associates

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: proparacaine HCL 0.5%; Drug: proparacaine HCL 0.5% + 4% lidocaine solution; Drug: 3.5% viscous lidocaine gel

Study type: Interventional

Funder types: Other

Identifiers

NCT01027611

jsp-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

proparacaine HCL 0.5%

Experimental group

Treatment:

Drug: proparacaine HCL 0.5%

proparacaine + lidocaine

Experimental group

Treatment:

Drug: proparacaine HCL 0.5% + 4% lidocaine solution

lidocaine gel

Experimental group

Treatment:

Drug: 3.5% viscous lidocaine gel