NCT00524758

Oculusgen (Ologen) Glaucoma MMC Control in Estonia

Comprative Study of the Safety and Effectiveness Between Oculusgen (Ologen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Pro Top & Mediking Company Limited · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

To compare the safety and effectiveness between ologen collagen matrix and mitomycin-C (MMC) in glaucoma surgery. The ologen collagen matrix implantation procedure is same as traditional trabeculectomy except implant the ologen collagen matrix on the top of sclera flap after one loose stich the sclera flap. The MMC application is as the standard.

Detailed description

Ologen collagen matrix is implanted on the top of sclera flap after the loose stich sclera flap is done for the filtering surgery. The concept of ologen collagen matrix is to creat the subconjunctiva bleb and modulate the wound healing for the surgery. By implanting ologen collagen matrix in the place, subconjuctival and trabdoor scars might be prevented. This is because the ologen collagen matrix is a 3-D scaffold porous structure that can guide fibroblast to grow randomly, instead of linear alignment. This can reduce the scar formation. Doctors apply MMC for the glaucoma surgery is also trying to inhibite the scar formation. But MMC has been long time used and glaucoma specialists have not found anything to replace it. Ologen collagen matrix concept is not INHIBITION, it is guiding and creating a physiological tissue. The successful of ologen collagen matrix may be on par with MMC but the safety and side effects will be much less.

Conditions

• Open Angle Glaucoma
• Angle Closure Glaucoma
• Uveitis Glaucoma
• Young Age Glaucoma
• Neovascular Glaucoma
• High Risk Patient

Interventions

Type	Name	Description
DEVICE	ologen (oculusgen) collagen matrix	Implant ologen collagen matrix on the top of sclera flap after loose stiched the sclera flap. The traditional trabeculectomy is performed.
DRUG	MMC in Trabeculectomy	MMC in Trabeculectomy

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2007-09-05
• Last updated: 2017-06-27

Locations

1 site across 1 country: Estonia