Clinical trial NCT01027611: Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections
Official title: Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Effectiveness of topical pain medicine for control of pain associated with intravitreal injections
Eye discomfort
Lead sponsor: Illinois Retina Associates
Sponsor class: OTHER
First posted: 2009-12-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Injection experience "grade"
timeFrame: Outcome data is obtained approximately 10 seconds after conclusion of procedure
Secondary outcomes:
measure: Pain grades for lid speculum, needle insertion, povidone iodine burning/stinging
timeFrame: Outcome data is obtained approximately 10 seconds after conclusion of procedure
Other outcomes:
Locations:
city: Joliet
country: United States
facility: Illinois Retina Associates
state: Illinois
Study officials:
affiliation: Illinois Retina Associates
name: John S. Pollack, MD
role: STUDY_CHAIR
References: