Status:
COMPLETED
5FU vs 5FU With Viscoelastic Formulation for the Prevention of Scarring Post-trabeculectomy
Lead Sponsor:
Singapore National Eye Centre
Collaborating Sponsors:
Singapore Eye Research Institute
Nanchang University
Conditions:
Glaucoma
Trabeculectomy
Eligibility:
All Genders
21-90 years
Phase:
PHASE4
Brief 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 b...
Detailed Description
Specific Aims The aim of this study is to determine whether needling of the conjunctival bleb after trabeculectomy with subconjunctival injection of a 5 Fluorouracil (5FU)/ viscoelastic formulation i...
Eligibility Criteria
Inclusion
- 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
- Active or recent bleb leak
- Known hypersensitivity to 5-FU or HA
- Only eye
- Active or recent blebitis or endophthalmitis.
- Intraocular pressure less than 10.
- Inability to give informed consent.
- Inability to safely administer a subconjunctival injection
- Uncontrolled systemic hypertension, CVA or TIA within the previous month.
- Pregnancy
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00607685
Start Date
February 1 2008
End Date
January 1 2010
Last Update
May 12 2010
Active Locations (1)
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1
Singapore National Eye Centre
Singapore, Singapore, 168751