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Clinical Trials/NCT00956462
NCT00956462
Unknown
Not Applicable

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

University Health Network, Toronto1 site in 1 country36 target enrollmentJuly 2007

Overview

Phase
Not Applicable
Intervention
Ketorolac (NSAID) versus Dexamethasone (steroid)
Conditions
Glaucoma
Sponsor
University Health Network, Toronto
Enrollment
36
Locations
1
Primary Endpoint
Intraocular pressure
Last Updated
16 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 2007
End Date
June 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 18 - 85 years of age
  • Undergoing glaucoma drainage device surgery
  • Exclusion criteria
  • Unable to consent
  • Undergoing combined GDD and cataract surgery
  • Patients with conditions requiring additional anti-inflammatory medications e.g., uveitic glaucoma, previous corneal transplant
  • Patients with prior history of corneal ulceration
  • Breast-feeding (nursing) mothers
  • Pregnant or planning to become pregnant during the trial period
  • 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

Exclusion Criteria

  • Not provided

Arms & Interventions

NSAID

Intervention: Ketorolac (NSAID) versus Dexamethasone (steroid)

Steroids

Intervention: Ketorolac (NSAID) versus Dexamethasone (steroid)

Outcomes

Primary Outcomes

Intraocular pressure

Time Frame: Six weeks

Study Sites (1)

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