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

Study Overview
=================
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.

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

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Ketorolac (NSAID) versus Dexamethasone (steroid)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NSAID<br> | Drug: Ketorolac (NSAID) versus Dexamethasone (steroid)<br>* Topical NSAID versus topical steroid after implantation of glaucoma drainage device<br>* Other names: Maxidex (steroid);|
| Active Comparator: Steroids<br> | Drug: Ketorolac (NSAID) versus Dexamethasone (steroid)<br>* Topical NSAID versus topical steroid after implantation of glaucoma drainage device<br>* Other names: Maxidex (steroid);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure |  | Six weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraocular pressure, Ahmed valve, NSAIDS, steroids