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

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ketorolac (NSAID) versus Dexamethasone (steroid)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring intraocular pressure, Ahmed valve, NSAIDS, steroids

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Graham TropeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NSAID

Steroids

Arm Description

Outcomes

Primary Outcome Measures

Intraocular pressure

Secondary Outcome Measures

Full Information

First Posted
July 17, 2009
Last Updated
August 7, 2009
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00956462
Brief Title
Steroids Versus Non-steroidal Anti-inflammatory Drugs Following Glaucoma Surgery
Official Title
Topical Steroids Versus Topical Non-steroidal Anti-inflammatory Drugs Following Ahmed Valve Glaucoma Drainage Device Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
intraocular pressure, Ahmed valve, NSAIDS, steroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NSAID
Arm Type
Experimental
Arm Title
Steroids
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ketorolac (NSAID) versus Dexamethasone (steroid)
Other Intervention Name(s)
Acular (NSAID), Maxidex (steroid)
Intervention Description
Topical NSAID versus topical steroid after implantation of glaucoma drainage device
Primary Outcome Measure Information:
Title
Intraocular pressure
Time Frame
Six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Graham E Trope, Professor
Phone
416-603-5317
Email
Graham.Trope@uhn.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham Trope, MD FRCSC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Graham Trope
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Graham Trope
Phone
416.603.5317
Email
Graham.Trope@uhn.on.ca
First Name & Middle Initial & Last Name & Degree
Tariq A Alasbali
First Name & Middle Initial & Last Name & Degree
Darana Yuen
First Name & Middle Initial & Last Name & Degree
Michael Smith
First Name & Middle Initial & Last Name & Degree
Yvonne Buys

12. IPD Sharing Statement

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

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