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NCT00956462 Clinical Trial

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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00956462
Other study ID # Trope2009
Secondary ID
Status Unknown status
Phase N/A
First received July 17, 2009
Last updated August 7, 2009
Start date July 2007
Est. completion date June 2010

Study information
Verified date July 2009
Source University Health Network, Toronto
Contact Graham E Trope, Professor
Phone 416-603-5317
Email Graham.Trope@uhn.on.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Unknown status
Enrollment 36
Est. completion date June 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 30 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ketorolac (NSAID) versus Dexamethasone (steroid)
Topical NSAID versus topical steroid after implantation of glaucoma drainage device

Locations
Country Name City State
Canada Graham Trope Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular pressure Six weeks
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