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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00956462
First received: July 17, 2009
Last updated: August 7, 2009
Last verified: July 2009
History of Changes
  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: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

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

Primary Outcome Measures:
  • Intraocular pressure [ Time Frame: Six weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

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

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Dexamethasone acetate
Anti-Inflammatory Agents
Dexamethasone
Ketorolac
Anti-Inflammatory Agents, Non-Steroidal
Dexamethasone 21-phosphate
BB 1101
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Antiemetics
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013