5FU vs 5FU With Viscoelastic Formulation for the Prevention of Scarring Post-trabeculectomy
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.
|Glaucoma Trabeculectomy Wound Healing||Drug: 5 Fluorouracil with hyaluronic acid Drug: 5 Fluorouracil||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- intraocular pressure [ Time Frame: 12 weeks ]
- bleb morphology [ Time Frame: 12 weeks ]
|Study Start Date:||February 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
The participants will receive a subconjunctival injection of a mixture of 5FU with hyaluronic acid.
Drug: 5 Fluorouracil with hyaluronic acid
Participants will receive a subconjunctival injection of 0.1ml of a mixure of 5 Fluorouracil (50mg/ml) with hyaluronic acid (23mg/ml) once at enrollment into the study.
Other Name: Healon 5 - hyaluronic acid 23mg/ml
Active Comparator: 2
Participants will receive a subconjunctival injection of 5 Fluorouracil only.
Drug: 5 Fluorouracil
Pariticpants will receive a subconjunctival injection of 0.1ml of 5 Fluorouracil 50mg/ml once at enrollment
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00607685
|Singapore National Eye Centre|
|Singapore, Singapore, 168751|
|Study Chair:||Tina TL Wong, PhD||Singapore National Eye Centre|