Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections
Information source: Illinois Retina Associates
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: proparacaine HCL 0.5% (Drug); proparacaine HCL 0.5% + 4% lidocaine solution (Drug); 3.5% viscous lidocaine gel (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Illinois Retina Associates Official(s) and/or principal investigator(s): John S. Pollack, MD, Study Chair, Affiliation: Illinois Retina Associates
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.
Clinical Details
Official title: Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Injection experience "grade"
Secondary outcome: Pain grades for lid speculum, needle insertion, povidone iodine burning/stinging
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Illinois Retina Associates, Joliet, Illinois 60435, United States
Additional Information
Starting date: October 2009
Last updated: May 3, 2010
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