Recruiting

Steroids vs. NSAIDs

Sponsor:

University Health Network, Toronto

Code:

NCT00956462

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Ketorolac (NSAID) versus Dexamethasone (steroid)

Study Details

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.

Conditions

Glaucoma

Study ID

NCT00956462

Start date

Jul, 2007

Status verified date

Jul, 2009

Completion date

Jun, 2010

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NSAID

active comparator: Steroids

Interventions

Ketorolac (NSAID) versus Dexamethasone (steroid)

Topical NSAID versus topical steroid after implantation of glaucoma drainage device

Primary outcome measure

  • Intraocular pressure [ Time Frame: Six weeks ]

Central Contacts and Locations

Central contacts

Graham E Trope, Professor

416-603-5317Graham.Trope@uhn.on.ca

Locations

Graham Trope

Recruiting

Toronto, Ontario, Canada

Contacts

Graham Trope

416.603.5317Graham.Trope@uhn.on.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Aug 11, 2009

Last verified

Jul, 2009

Keywords

  • intraocular pressure
  • Ahmed valve
  • NSAIDS
  • steroids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2009-08-11.