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

Tracking Information

First Received Date ^ICMJE

July 17, 2009

Last Updated Date

August 7, 2009

Start Date ^ICMJE

July 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Intraocular pressure [ Time Frame: Six weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00956462 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Glaucoma

Intervention ^ICMJE

Drug: Ketorolac (NSAID) versus Dexamethasone (steroid)

Topical NSAID versus topical steroid after implantation of glaucoma drainage device

Other Names:

Acular (NSAID)
Maxidex (steroid)

Study Arm (s)

Experimental: NSAID
Intervention: Drug: Ketorolac (NSAID) versus Dexamethasone (steroid)
Active Comparator: Steroids
Intervention: Drug: Ketorolac (NSAID) versus Dexamethasone (steroid)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Graham E Trope, Professor

416-603-5317

Graham.Trope@uhn.on.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00956462

Other Study ID Numbers ^ICMJE

Trope2009

Has Data Monitoring Committee

Yes

Responsible Party

University Health Network, Toronto, University Health Network, toronto

Study Sponsor ^ICMJE

University Health Network, Toronto

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Graham Trope, MD FRCSC

University Health Network, Toronto

Information Provided By

University Health Network, Toronto

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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