Clinical Trial: Oculusgen (Ologen) Glaucoma MMC Control in Estonia
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Comprative Study of the Safety and Effectiveness Between Oculusgen (Ologen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery
Brief 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 Summary:
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.
Sponsor: Pro Top & Mediking Company Limited
Current Primary Outcome: IOP <21mmHg without anti glaucoma medication [ Time Frame: 180 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication [ Time Frame: 180-day ]
Original Secondary Outcome: Same as current
Information By: Pro Top & Mediking Company Limited
Dates:
Date Received: September 4, 2007
Date Started: July 2007
Date Completion: October 2011
Last Updated: October 24, 2011
Last Verified: October 2011
