Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery

Condition(s) targeted: Open Angle Glaucoma

Intervention: Collagen Matrix in Glaucoma Filtering Surgery (Device); Mitomycin-C(MMC) and glaucoma filtering surgery (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pro Top & Mediking Company Limited

Official(s) and/or principal investigator(s):
Thomas Dietlein, Ph. D, MD, Principal Investigator, Affiliation: Universität Köln

To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.

Official title: Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Postoperative Intraocular Pressure Change

Postoperative Intraocular Pressure Change

Postoperative Intraocular Pressure Change

Postoperative Intraocular Pressure Change

Secondary outcome: Complications

Detailed description: To compare the safety and effectiveness in between oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) for glaucoma surgery. The surgery is performed by the gold standard of trabeculectomy. Mitomycin-C(MMC) is applied for those who not collagen matrix implanted.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Open angle glaucoma

- Maxima anti-glaucoma medication failed

- Age>18

- Able to complete the follow up

Exclusion Criteria:

- Topical eye inflammation

- Angle closure glaucoma

- Deformity glaucoma

- One eye glaucoma

- Previous conjunctiva opened

- Allergy to collagen

Hospital of Universität Köln, Koln 50931, Germany

ologen collagen matrix website.

Publication on Eye

Starting date: July 2007
Last updated: April 1, 2012