Glaucoma Clinical Trial
Official title:
Prospective Case-controlled Study Comparing 5-Fluorouracil vs 5-Fluorouracil With Viscoelastic (Hyaluronic Acid) Formulation for the Prevention of Subconjunctival Scarring Post-trabeculectomy
Verified date | May 2010 |
Source | Singapore National Eye Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | Singapore: Health Sciences Authority |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 90 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Singapore | Singapore National Eye Centre | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore National Eye Centre | Nanchang University, Singapore Eye Research Institute |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | intraocular pressure | 12 weeks | No | |
Secondary | bleb morphology | 12 weeks | No |
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