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Anesthetic and Dilating Gel for Cataract Surgery
This study has been completed.
Sponsored by: Queen's University
Information provided by: Queen's University
ClinicalTrials.gov Identifier: NCT00335400
  Purpose

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.


Condition Intervention
Cataract
Drug: Anesthetic Dilating Gel

MedlinePlus related topics: Anesthesia Cataract
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment
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.

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Pupil dilation
  • Corneal anesthesia

Secondary Outcome Measures:
  • Gel stability
  • Gel sterility
  • Patient comfort

Estimated Enrollment: 20
Study Start Date: March 2006
Study Completion Date: May 2007
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335400

Locations
Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Sherif El-Defrawy, MD PhD FRCSC Hotel Dieu Hospital, Kingston General Hospital, Queen's University
  More Information

Study ID Numbers: QUEENS-SRE-1
Study First Received: June 8, 2006
Last Updated: June 5, 2007
ClinicalTrials.gov Identifier: NCT00335400  
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Dilatation, Pathologic
Eye Diseases
Cataract
Mydriasis
Lens Diseases

ClinicalTrials.gov processed this record on January 16, 2009