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Anesthetic and Dilating Gel for Cataract Surgery

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ClinicalTrials.gov Identifier: NCT00335400
Recruitment Status : Completed
First Posted : June 9, 2006
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Sherif R El-Defrawy, Queen's University

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.

Condition or disease Intervention/treatment Phase
Cataract Drug: Anesthetic Dilating Gel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2006
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract




Primary Outcome Measures :
  1. Pupil dilation
  2. Corneal anesthesia

Secondary Outcome Measures :
  1. Gel stability
  2. Gel sterility
  3. Patient comfort


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335400


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

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Responsible Party: Dr. Sherif R El-Defrawy, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00335400     History of Changes
Other Study ID Numbers: QUEENS-SRE-1
First Posted: June 9, 2006    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs