Ignite Creation Date:
2024-05-05 @ 10:05 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01027611
Status:
COMPLETED
Last Update Posted:
2010-05-04
First Post:
2009-12-04
Brief Title:
Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections
Sponsor:
Illinois Retina Associates
Organization:
Illinois Retina Associates
Study Overview
Official Title:
Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 proparacaine hydrochloride generic Akorn Inc 2 05 proparacaine hydrochloride generic Akorn Inc PLUS 4 lidocaine hydrochloride topical solution generic Roxane Laboratories and 3 35 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 05 Group 1 proparacaine HCL 05 4 lidocaine liquid drops Group 2 or 35 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 patients worst imaginable pain They also graded their overall injection procedure experience as Excellent Very Good Fair Poor or Awful
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None