Anesthetic and Dilating Gel for Cataract Surgery - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 8, 2006

Last Updated Date

June 5, 2007

Start Date ^†

March 2006

Current Primary Outcome Measures ^†

Pupil dilation
Corneal anesthesia

Original Primary Outcome Measures ^†

Pupil dilation
Corneal anesthesia

Change History

Complete list of historical versions of study NCT00335400 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Gel stability
Gel sterility
Patient comfort

Original Secondary Outcome Measures ^†

Gel stability
Gel sterility
Patient comfort

Descriptive Information

Brief Title ^†

Anesthetic and Dilating Gel for Cataract Surgery

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.

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

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment

Condition ^†

Cataract

Intervention ^†

Drug: Anesthetic Dilating Gel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

May 2007

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

scheduled for first cataract surgery (i.e., first eye)

Exclusion Criteria:

previous ocular surgery,
pseudoexfoliation syndrome,
diabetes,
herpetic eye disease,
posterior synechiae,
previous uveitis

Gender

Both

Ages

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00335400

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Queen's University

Collaborators ^††

Investigators ^†

Principal Investigator:

Sherif El-Defrawy, MD PhD FRCSC

Hotel Dieu Hospital, Kingston General Hospital, Queen's University

Information Provided By

Queen's University

Verification Date

May 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.