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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NSAID

Group Type EXPERIMENTAL

Ketorolac (NSAID) versus Dexamethasone (steroid)

Intervention Type DRUG

Topical NSAID versus topical steroid after implantation of glaucoma drainage device

Steroids

Group Type ACTIVE_COMPARATOR

Ketorolac (NSAID) versus Dexamethasone (steroid)

Intervention Type DRUG

Topical NSAID versus topical steroid after implantation of glaucoma drainage device

Interventions

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Ketorolac (NSAID) versus Dexamethasone (steroid)

Topical NSAID versus topical steroid after implantation of glaucoma drainage device

Intervention Type DRUG

Other Intervention Names

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Acular (NSAID) Maxidex (steroid)

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No