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

Not Applicable

• Conditions: Glaucoma
• Interventions: Drug: Ketorolac (NSAID) versus Dexamethasone (steroid)

• Registration Number: NCT00956462
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study Start: 2007-07
• Status Verified: 2009-07
• Study First Submitted: 2009-07-17
• Study First Submitted QC: 2009-08-07
• Last Update Submitted: 2009-08-07
• Study First Posted: 2009-08-11
• Last Update Posted: 2009-08-11
• Primary Completion: 2009-12
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSAID	Ketorolac (NSAID) versus Dexamethasone (steroid)	-
Steroids	Ketorolac (NSAID) versus Dexamethasone (steroid)	-

Primary Outcome Measures

Name	Time	Method
Intraocular pressure	Six weeks

Trial Locations

Locations (1)

Graham Trope; 🇨🇦 Toronto, Ontario, Canada