5FU vs 5FU With Viscoelastic Formulation for the Prevention of Scarring Post-trabeculectomy

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Trabeculectomy is the most effective method of lowering intraocular pressure in glaucoma that is not well controlled with drop medication. The post-operative wound healing response remains the major barrier in surgical success. Scar tissue formation results in occlusion of the surgical drainage site created. As a consequence, the intraocular pressure rises once again. The current use of anti-scarring agents such as 5 Fluorouracil (5FU), is a well established method employed by ophthalmologists to clinically reduce the postoperative scarring response. However, in patients with a high risk of bleb failure, repeated subconjunctival injections of 5FU following bleb needling is often required resulting in increased clinical load and patient inconvenience. A slow release formulation of 5FU would be of benefit by releasing the 5FU into the subconjunctival space over an extended period thereby providing a prolonged therapeutic effect. In addition, hyaluronic acid is known to possess antifibrotic properties and from its gel-like physical state, would potentially act as a physical tissue spacer that may further limit active subconjunctival scarring at the site where it is injected. We hypothesise that injecting a mixture of 5FU with hyaluronic acid would give better outcomes than injecting 5FU alone.

The aim of this study is to determine whether bleb needling with subconjunctival injection of Viscoelastic/5FU formulation is an effective method for prolonged drug delivery in preventing the post-operative scarring response. This will be a prospective case-controlled study involving patients who have already undergone trabeculectomy and who require bleb needling and subconjunctival 5FU injections.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Singapore National Eye Centre
• Collaborators: Nanchang University; Singapore Eye Research Institute
• Treatments: Fluorouracil; Hyaluronic Acid

Criteria

Inclusion Criteria:

Glaucoma patients within 1 year of the primary (first) trabeculectomy who are deemed on clinical grounds (increased bleb vascularity, bleb contraction or encapsulation or IOP elevation) to require a subconjunctival 5-FU injection.

Exclusion Criteria:

1. Active or recent bleb leak

2. Known hypersensitivity to 5-FU or HA

3. Only eye

4. Active or recent blebitis or endophthalmitis.

5. Intraocular pressure less than 10.

6. Inability to give informed consent.

7. Inability to safely administer a subconjunctival injection

8. Uncontrolled systemic hypertension, CVA or TIA within the previous month.

9. Pregnancy