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Completed

NCT Number: NCT00335400

Anesthetic and Dilating Gel for Cataract Surgery

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anesthetic Dilating Gel

Drug

Primary outcomes

  1. Pupil dilation

  2. Corneal anesthesia

Secondary outcomes

  1. Gel stability

  2. Gel sterility

  3. Patient comfort

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study 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.

Important dates

Study start
2006
Study completion
2007
First posted
Jun 9, 2006
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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