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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by University Health Network, Toronto.
Recruitment status was:  Recruiting
Information provided by:
University Health Network, Toronto Identifier:
First received: July 17, 2009
Last updated: August 7, 2009
Last verified: July 2009
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.

Condition Intervention
Drug: Ketorolac (NSAID) versus Dexamethasone (steroid)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical Steroids Versus Topical Non-steroidal Anti-inflammatory Drugs Following Ahmed Valve Glaucoma Drainage Device Surgery

Resource links provided by NLM:

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Intraocular pressure [ Time Frame: Six weeks ]

Estimated Enrollment: 36
Study Start Date: July 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00956462

Contact: Graham E Trope, Professor 416-603-5317

Canada, Ontario
Graham Trope Recruiting
Toronto, Ontario, Canada
Contact: Graham Trope    416.603.5317   
Sub-Investigator: Tariq A Alasbali         
Sub-Investigator: Darana Yuen         
Sub-Investigator: Michael Smith         
Sub-Investigator: Yvonne Buys         
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Graham Trope, MD FRCSC University Health Network, Toronto
  More Information

Responsible Party: University Health Network, Toronto, University Health Network, toronto Identifier: NCT00956462     History of Changes
Other Study ID Numbers: Trope2009
Study First Received: July 17, 2009
Last Updated: August 7, 2009

Keywords provided by University Health Network, Toronto:
intraocular pressure
Ahmed valve

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017