A Prospective Randomized Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy
Overview
- Phase
- Not Applicable
- Intervention
- Use of ologen Collagen Matrix in trabeculectomy
- Conditions
- Open-angle Glaucoma
- Sponsor
- Aeon Astron Europe B.V.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Intraocular pressure (IOP) reduction
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
ologen Collagen Matrix
Intervention: Use of ologen Collagen Matrix in trabeculectomy
Mitomycin-C (MMC)
Intervention: Use of Mitomycin-C in trabeculectomy
Outcomes
Primary Outcomes
Intraocular pressure (IOP) reduction
Time Frame: 6 months
Secondary Outcomes
- Incidence of complications(6 months)