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Sponsors and Collaborators: |
Singapore National Eye Centre Singapore Eye Research Institute Nanchang University |
Information provided by: | Singapore National Eye Centre |
ClinicalTrials.gov Identifier: | NCT00607685 |
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.
Condition | Intervention | Phase |
Glaucoma Trabeculectomy Wound Healing |
Drug: 5 Fluorouracil with hyaluronic acid Drug: 5 Fluorouracil |
Phase IV |
Genetics Home Reference related topics: | early-onset glaucoma |
MedlinePlus related topics: | Glaucoma Scars |
Drug Information available for: | Fluorouracil Hyaluronate Sodium Hyaluronic acid |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
The participants will receive a subconjunctival injection of a mixture of 5FU with hyaluronic acid.
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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.
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2: Active Comparator
Participants will receive a subconjunctival injection of 5 Fluorouracil only.
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Drug: 5 Fluorouracil
Pariticpants will receive a subconjunctival injection of 0.1ml of 5 Fluorouracil 50mg/ml once at enrollment
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Show Detailed Description |
Ages Eligible for Study: | 21 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Contact: Chye Fong Peck, SRN | +65-62277255 ext 4500 | peck.chye.fong@seri.com.sg |
Singapore | |||||
Singapore National Eye Centre | |||||
Singapore, Singapore, 168751 |
Singapore National Eye Centre |
Singapore Eye Research Institute |
Nanchang University |
Study Chair: | Tina TL Wong, PhD | Singapore National Eye Centre |
Responsible Party: | Singapore National Eye Centre ( Dr Tina Wong ) |
Study ID Numbers: | R554/42/2007 |
First Received: | January 23, 2008 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00607685 |
Health Authority: | Singapore: Health Sciences Authority |
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