Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335400
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2006-06-08
Brief Title:
Anesthetic and Dilating Gel for Cataract Surgery
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
Comparison of an Anesthetic and Dilating Gel Cocktail Versus the Standard Pre-operative Pharmacologic Regimen for Cataract Surgery on Corneal Anesthesia and Pupil Dilation
Status:
COMPLETED
Status Verified Date:
2016-01
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:
To prepare the eye for cataract surgery drugs must be given to the eye to allow for surgery to take place Traditionally dilating drops and drops containing NSAIDs to control inflammation are given to the patient well in advance of surgery at repeated time intervals As well a gel containing lidocaine is applied to the eye just prior to surgery to anesthetize reduce pain and feeling in the area of the eye Although effective the procedure is time-consuming and costly for nursing staff Recently a few hospitals have reported success in mixing the pupil-dilating and NSAID drops with the lidocaine gel creating an anesthetic dilating gel Although success has been reported there have been no studies to clearly demonstrate that the anesthetic dilating gel is as effective at dilating the pupil and reducing sensitivity of the cornea during surgery than the traditional methods of drops and gel It is possible that the dilating gel is less effective due to slower diffusion of drugs into the eye The study will compare the effectiveness of the anesthetic dilating gel with the standard pre-operative pharmacologic regimen for cataract surgery Stability maintaining effectiveness over time and contamination of the study gel will also be assessed If the dilating gel is shown to be as effective in regards to pupil dilation and corneal anesthesia while maintaining stability and sterility over time hospitals can be encouraged to use such a anesthetic dilating gel routinely during pre-operative procedures before cataract surgery
Detailed Description:
None
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