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

Phase 4

Completed

• Conditions: Open Angle Glaucoma
• Interventions: Drug: Mitomycin-C(MMC) and glaucoma filtering surgery; Device: Collagen Matrix in Glaucoma Filtering Surgery

• Registration Number: NCT00538590
• Lead Sponsor: Pro Top & Mediking Company Limited

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-09-29
• Study First Submitted QC: 2007-10-01
• Study First Posted: 2007-10-02
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2012-01-19
• Status Verified: 2012-04
• Results First Submitted QC: 2012-04-01
• Last Update Submitted: 2012-04-01
• Results First Posted: 2012-04-25
• Last Update Posted: 2012-04-25

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MITOMYCIN-C	Mitomycin-C(MMC) and glaucoma filtering surgery	Following ethics committee approval, 20 patients with uncontrolled glaucoma will be will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with Mitomycin-C.
ologen (Oculusgen)	Collagen Matrix in Glaucoma Filtering Surgery	20 patients will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with ologen implant. The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.

Primary Outcome Measures

Name	Time	Method
Postoperative Intraocular Pressure Change	30 days	Postoperative intraocular pressure change at 30 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.

Secondary Outcome Measures

Name	Time	Method
Complications	360 days	Incidence (percentage) for complications recorded: Hyphema, early hypotony(\<7days), late hypotony(\>7days), shallow anterior chamber, choroidal detachment, early leak(\<7days), late leak(\>7days), Tenon's cysts, and revision surgery for up to 360 days.

Trial Locations

Locations (1)

Hospital of Universität Köln; 🇩🇪 Koln, Germany