NCT00538590

Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Pro Top & Mediking Company Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.

Detailed description

To compare the safety and effectiveness in between oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) for glaucoma surgery. The surgery is performed by the gold standard of trabeculectomy. Mitomycin-C(MMC) is applied for those who not collagen matrix implanted.

Conditions

• Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	Collagen Matrix in Glaucoma Filtering Surgery	Collagen Matrix implantation in Glaucoma Filtering Surgery
DRUG	Mitomycin-C(MMC) and glaucoma filtering surgery	If mitomycin -C is applied, a single cellulose sponge soaked with Mitomycin-C(MMC) (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2007-10-02
• Last updated: 2012-04-25
• Results posted: 2012-04-25

Locations

1 site across 1 country: Germany