Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy: A Study in Germany
A Prospective Randomized Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy
  • Phase

  • Study Type

  • Status

    Unknown status
  • Intervention/Treatment

    mitomycin collagen ...
  • Study Participants

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.
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 Started
Nov 30
Primary Completion
Nov 30
Study Completion
Nov 30
Last Update
May 09

Device Use of ologen Collagen Matrix in trabeculectomy

After trabeculectomy, place ologen Collagen Matrix on the top of the scleral flap under the conjunctiva before suturing

Drug Use of Mitomycin-C in trabeculectomy

After creating a scleral flap, a sponge with Mitomycin-C (0.02%) is applied on the scleral surface for 3 minutes. Afterwards, Mitomycin-C was rinsed out with balanced salt solution.

ologen Collagen Matrix Experimental

Mitomycin-C (MMC) Active Comparator


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
No Results Posted