An interventional study of Use of ologen Collagen Matrix in trabeculectomy and Use of Mitomycin-C in trabeculectomy in Open-angle Glaucoma, sponsored by Aeon Astron Europe B.V.. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-09.
Sponsored by Aeon Astron Europe B.V. · Not applicable, Interventional, and Prevention
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's planned enrollment of 40 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Aeon Astron Europe B.V. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Device: Use of ologen Collagen Matrix in trabeculectomy
Drug: Use of Mitomycin-C in trabeculectomy
After trabeculectomy, place ologen Collagen Matrix on the top of the scleral flap under the conjunctiva before suturing
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.
Intraocular pressure (IOP) reduction
Time frame: 6 months
Incidence of complications
Time frame: 6 months
This study is status unknown, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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Aeon Astron Europe B.V.