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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00956462
First Posted: August 11, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Health Network, Toronto
  Purpose
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
Glaucoma Drug: Ketorolac (NSAID) versus Dexamethasone (steroid)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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.
  Eligibility

Information from the National Library of Medicine

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

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
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): NCT00956462


Contacts
Contact: Graham E Trope, Professor 416-603-5317 Graham.Trope@uhn.on.ca

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

Responsible Party: University Health Network, Toronto, University Health Network, toronto
ClinicalTrials.gov Identifier: NCT00956462     History of Changes
Other Study ID Numbers: Trope2009
First Submitted: July 17, 2009
First Posted: August 11, 2009
Last Update Posted: October 12, 2017
Last Verified: July 2009

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

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Dexamethasone
Ketorolac
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action