Oculusgen (Ologen) Glaucoma MMC Control in Estonia

Sponsor

Pro Top & Mediking Company Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT00524758

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma Angle Closure Glaucoma Uveitis Glaucoma Young Age Glaucoma Neovascular Glaucoma High Risk Patient	Device: ologen (oculusgen) collagen matrix Drug: MMC in Trabeculectomy	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ologen in Trabeculectomy Ologen in Trabeculectomy	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. Other Names: ologen collagen matrix oculusgen collagen matrix
Active Comparator: MMC in Trabeculectomy MMC in Trabeculectomy	Drug: MMC in Trabeculectomy MMC in Trabeculectomy

Arm

Intervention/Treatment

Experimental: Ologen in Trabeculectomy

Ologen in Trabeculectomy

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.

Other Names:

ologen collagen matrix

oculusgen collagen matrix

Active Comparator: MMC in Trabeculectomy

MMC in Trabeculectomy

Drug: MMC in Trabeculectomy