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NCT00524758 Clinical Trial

Oculusgen (Ologen) Glaucoma MMC Control in Estonia

Open Angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00524758
Other study ID # oculusgen 2006-02-20
Secondary ID
Status Completed
Phase Phase 3
First received September 4, 2007
Last updated June 26, 2017
Start date July 2007
Est. completion date October 2011

Study information
Verified date June 2017
Source Pro Top & Mediking Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Max anti glaucoma medication failed,

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Estonia Tartu University Clinics Tartu

Sponsors (1)
Lead Sponsor Collaborator
Pro Top & Mediking Company Limited

Country where clinical trial is conducted

Estonia, 

Outcome
Type Measure Description Time frame Safety issue
Primary IOP <21mmHg without anti glaucoma medication 180 days
Secondary IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication 180-day
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