Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy: A Study in Germany

Not Applicable

• Conditions: Open-angle Glaucoma
• Interventions: Device: Use of ologen Collagen Matrix in trabeculectomy; Drug: Use of Mitomycin-C in trabeculectomy

• Registration Number: NCT01174420
• Lead Sponsor: Aeon Astron Europe B.V.

Brief Summary

The aim of this prospective randomized study is to investigate the efficacy and safety of trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open angle glaucoma.

Detailed Description

ologen® Collagen Matrix (CM) is an artificial extracellular matrix (ECM) specifically configured to support repair in connective and epithelial ocular tissue. The device is constructed so as to minimize random growth of fibroblasts and instead to allow them to grow through the pores in the matrix. ologen® CM is a biodegradable scaffold matrix, inducing a regenerative non-scarring wound healing process without using anti-fibrotic agents. For application in glaucoma filtration surgery, ologen® CM is designed to prevent scar formation (subconjunctival and scleral flap scarring is the major risk factor for failure of trabeculectomy). After implanting the ologen® CM on top of the scleral flap in the subconjunctival space, a functional bleb can be created.

The aim of the present study is to determine the effectiveness of the ologen® CM and reduce wound scarring, thereby increasing success of trabeculectomy without side effects of MMC. A means of producing better success rate and reduced complications is the purpose of ologen® Collagen Matrix for the aid of glaucoma surgery.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-08-02
• Study First Submitted QC: 2010-08-02
• Study First Posted: 2010-08-03
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-05
• Last Update Posted: 2011-05-09
• Primary Completion: 2011-11
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age 18 years or over
• Uncontrolled open-angle glaucoma
• Subject is willing to sign informed consent
• Subject is able and willing to complete post-operative follow-up requirements

Exclusion Criteria

• Inflammatory eye diseases
• Angle-closure glaucoma
• Secondary glaucoma with anatomical malformations of the eye
• Subjects having single functional eye
• Previous conjunctival surgery
• Known allergic reactions to ingredients of ologen Collagen Matrix
• Excessive myopia (axial length (AL)> 27 mm or more than -10 diopters)
• Previous vitrectomy eye surgery
• Subjects do not consent to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ologen Collagen Matrix	Use of ologen Collagen Matrix in trabeculectomy	-
Mitomycin-C (MMC)	Use of Mitomycin-C in trabeculectomy	-

Primary Outcome Measures

Name	Time	Method
Intraocular pressure (IOP) reduction	6 months

Secondary Outcome Measures

Name	Time	Method
Incidence of complications	6 months

Trial Locations

Locations (1)

The University Hospital of Cologne; 🇩🇪 Cologne, Germany