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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomized Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy

Conditions
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Open-angle Glaucoma

Intervention / Treatment
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* Device: Use of ologen Collagen Matrix in trabeculectomy
* Drug: Use of Mitomycin-C in trabeculectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ologen Collagen Matrix<br> | Device: Use of ologen Collagen Matrix in trabeculectomy<br>* After trabeculectomy, place ologen Collagen Matrix on the top of the scleral flap under the conjunctiva before suturing<br>|
| Active Comparator: Mitomycin-C (MMC)<br> | Drug: Use of Mitomycin-C in trabeculectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure (IOP) reduction |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complications |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ologen, Mitomycin-C, Collagen Matrix, trabeculectomy, glaucoma, filtering surgery