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

Aeon Astron

Status: Unknown

Conditions: Open-angle Glaucoma

Treatments: Drug: Use of Mitomycin-C in trabeculectomy; Device: Use of ologen Collagen Matrix in trabeculectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01174420

AAE-CT-DEU-2009-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

ologen Collagen Matrix

Experimental group

Treatment:

Device: Use of ologen Collagen Matrix in trabeculectomy

Mitomycin-C (MMC)

Active Comparator group

Treatment:

Drug: Use of Mitomycin-C in trabeculectomy