RecruitingPhase 4ACTRN12611000336987

Prospective study into the effect of an intraocular injection of a steroid in the prevention of Glaucoma drainage surgery failure after cataract surgery

Prospective randomised trial of intravitreal triamcinolone in the prevention of trabeculectomy failure after cataract surgery


Sponsor

Royal Victorian Eye and Ear

Enrollment

110 participants

Start Date

Jun 1, 2011

Study Type

Interventional

Conditions

Summary

Trabeculectomy surgery for Glaucoma establishes a connection between the inside of the eye and the subconjunctival space which lies just below the surface of the eye. Flow of fluid through this connection forms a subconjunctival blister known as a bleb. Aqueous humor (fluid inside the front of the eye )is absorbed from the bleb into the blood stream. A significant casue of failure of trabeculectomy is scarring of the bleb. If the bleb develops an excessive amount of scar tissue then fluid is prevented from exiting and the eye pressure is increased. Cataract surgery has been shown in research trials to increase the risk of trabeculectomy failure. Control of postoperative scar formation after cataract surgery is a significant challenge in the surgical management of glaucoma in patients who have had previous Trabeculectomy surgery. Current practice is to use topical steroids and antiscarring agents such as 5-fluorouracil (5-FU). Although the use of 5-FU is widespread, scar tissue remains a problem in many patients and treatment is associated with side effects including wound leaks and disruption of the ocular surface. Active scarring is associated with inflammation. Triamcinolone is a synthetic corticosteroid that inhibits the inflammatory process and may therefore reduce scar formation. Injection of triamcinolone into the vitreous jelly of the eye has been widely used as a treatment for various diabetic and inflammatory conditions which are unresponsive to topical corticosteroids. It has been used as a mono-therapy and co-therapy for various back of eye conditions, and is also indicated for visualisation during vitrectomy.


Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 100 Yearss

Inclusion Criteria1

  • Patients with a functioning glaucoma filtration bleb who are due to undergo cataract surgery with intra-ocular lens implantation.

Exclusion Criteria1

  • Active or recent bleb leak, known hypersensitivity to 5-FU or Triamcinolone, only eye, active or recent blebitis or endophthalmitis.Previous vitrectomy. Previous retinal detachment or tear. Inability to give informed consent. Inability to be safely administeedr an intravitreal injection.

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Interventions

A single injection of intravitreal injection of Triamcinolone acetonide (4mg in 0.1ml) in conjunction with 5-Fluorouracil (5mg in 0.1ml) injected superior to the Glaucoma filtration bleb

A single injection of intravitreal injection of Triamcinolone acetonide (4mg in 0.1ml) in conjunction with 5-Fluorouracil (5mg in 0.1ml) injected superior to the Glaucoma filtration bleb


Locations(1)

Australia

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ACTRN12611000336987


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