Oculusgen (Ologen) Glaucoma MMC Control in Estonia

NCT ID: NCT00524758

Last Updated: 2017-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-10-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ologen in Trabeculectomy

Ologen in Trabeculectomy

Group Type: EXPERIMENTAL

ologen (oculusgen) collagen matrix

Intervention Type: DEVICE

Implant ologen collagen matrix on the top of sclera flap after loose stiched the sclera flap. The traditional trabeculectomy is performed.

MMC in Trabeculectomy

MMC in Trabeculectomy

Group Type: ACTIVE_COMPARATOR

MMC in Trabeculectomy

Intervention Type: DRUG

MMC in Trabeculectomy

Interventions

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.

Intervention Type: DEVICE

MMC in Trabeculectomy

MMC in Trabeculectomy

Intervention Type: DRUG

Other Intervention Names

ologen collagen matrix; oculusgen collagen matrix

Eligibility Criteria

Inclusion Criteria

• Max anti glaucoma medication failed,

Exclusion Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pro Top & Mediking Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kuldar Kaljurand, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tartu

Locations

Tartu University Clinics

Tartu, , Estonia

Countries

Estonia

References

Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.

Reference Type: DERIVED

PMID: 36912740 (View on PubMed)

Other Identifiers

oculusgen 2006-02-20

Identifier Type: -

Identifier Source: org_study_id