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

University Health Network, Toronto

Status: Unknown

Conditions: Glaucoma

Treatments: Drug: Ketorolac (NSAID) versus Dexamethasone (steroid)

Study type: Interventional

Funder types: Other

Identifiers

NCT00956462

Trope2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups

NSAID

Experimental group

Treatment:

Drug: Ketorolac (NSAID) versus Dexamethasone (steroid)

Steroids

Active Comparator group

Treatment:

Drug: Ketorolac (NSAID) versus Dexamethasone (steroid)