Anesthetic and Dilating Gel for Cataract Surgery
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Anesthetic Dilating Gel
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
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
Sites / Locations
- Hotel Dieu Hospital
Outcomes
Primary Outcome Measures
Pupil dilation
Corneal anesthesia
Secondary Outcome Measures
Gel stability
Gel sterility
Patient comfort
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00335400
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Anesthetic Dilating Gel
Primary Outcome Measure Information:
Title
Pupil dilation
Title
Corneal anesthesia
Secondary Outcome Measure Information:
Title
Gel stability
Title
Gel sterility
Title
Patient comfort
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif El-Defrawy, MD PhD FRCSC
Organizational Affiliation
Hotel Dieu Hospital, Kingston General Hospital, Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
12. IPD Sharing Statement
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Anesthetic and Dilating Gel for Cataract Surgery
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