Steroids Versus Non-steroidal Anti-inflammatory Drugs Following Glaucoma Surgery

August 7, 2009 updated by: University Health Network, Toronto

Topical Steroids Versus Topical Non-steroidal Anti-inflammatory Drugs Following Ahmed Valve Glaucoma Drainage Device Surgery

This study aims to evaluate the eye pressure response to non-steroidal anti-inflammatory eye drops as compared to steroid eye drops following glaucoma surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Glaucoma is a chronic disease of the eye which results in gradual loss of nerve fibres, resulting in visual loss. The mainstay of treatment is reduction of intraocular pressure (IOP), which has been shown to preserve vision, and glaucoma surgery aims to achieve this. One type of surgery involves insertion of a glaucoma drainage device (GDD). Following surgery steroid eye drops are commonly used in order to reduce the inflammation that occurs as a result of the surgery. However, a common side effect of steroid eye drops is a rise in eye pressure. Non-steroidal anti-inflammatory drugs (NSAID) eye drops do not have this side effect and are used as an alternative to steroids following other types of eye surgery. Use of NSAID drops following GDD surgery may result in improved eye pressure. This study aims to evaluate the eye pressure response to NSAID eye drops following GDD surgery.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • Graham Trope
        • Contact:
        • Sub-Investigator:
          • Tariq A Alasbali
        • Sub-Investigator:
          • Darana Yuen
        • Sub-Investigator:
          • Michael Smith
        • Sub-Investigator:
          • Yvonne Buys

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 - 85 years of age
  2. Undergoing glaucoma drainage device surgery

Exclusion criteria

  1. Unable to consent
  2. Undergoing combined GDD and cataract surgery
  3. Patients with conditions requiring additional anti-inflammatory medications e.g., uveitic glaucoma, previous corneal transplant
  4. Patients with prior history of corneal ulceration
  5. Breast-feeding (nursing) mothers
  6. Pregnant or planning to become pregnant during the trial period
  7. Allergic to Ketorolac Tromethamine, or had an allergic-type reaction to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs used for pain relief or arthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NSAID
Drug: Ketorolac (NSAID) versus Dexamethasone (steroid)
Topical NSAID versus topical steroid after implantation of glaucoma drainage device
Other Names:
  • Acular (NSAID)
  • Maxidex (steroid)
Active Comparator: Steroids
Drug: Ketorolac (NSAID) versus Dexamethasone (steroid)
Topical NSAID versus topical steroid after implantation of glaucoma drainage device
Other Names:
  • Acular (NSAID)
  • Maxidex (steroid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular pressure
Time Frame: Six weeks
Six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Graham Trope, MD FRCSC, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

July 17, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (Estimate)

August 11, 2009

Study Record Updates

Last Update Posted (Estimate)

August 11, 2009

Last Update Submitted That Met QC Criteria

August 7, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Trope2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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