5FU vs 5FU With Viscoelastic Formulation for the Prevention of Scarring Post-trabeculectomy
Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Singapore National Eye Centre
Collaborators:
Nanchang University Singapore Eye Research Institute