Oculusgen (Ologen) Glaucoma MMC Control in Estonia

Phase 3

Completed

• Conditions: Open Angle Glaucoma; Angle Closure Glaucoma; Uveitis Glaucoma; Young Age Glaucoma; Neovascular Glaucoma; High Risk Patient
• Interventions: Drug: MMC in Trabeculectomy; Device: ologen (oculusgen) collagen matrix

• Registration Number: NCT00524758
• Lead Sponsor: Pro Top & Mediking Company Limited

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 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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-04
• Study First Posted: 2007-09-05
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-26
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Max anti glaucoma medication failed,

Exclusion Criteria

• Age less than 18, woman in pregnant, hemodialysis patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MMC in Trabeculectomy	MMC in Trabeculectomy	MMC in Trabeculectomy
Ologen in Trabeculectomy	ologen (oculusgen) collagen matrix	Ologen in Trabeculectomy

Primary Outcome Measures

Name	Time	Method
IOP <21mmHg without anti glaucoma medication	180 days

Secondary Outcome Measures

Name	Time	Method
IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication	180-day

Trial Locations

Locations (1)

Tartu University Clinics; 🇪🇪 Tartu, Estonia