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Andre Rosentreter, Andrea M. Schild, Stergiani Gaki, Anne C. Mellein, Thomas S. Dietlein; A Prospective Randomised Trial Of Trabeculectomy Using Mitomycin C Vs. An OlogenTM Implant (Version 2) In Open Angle Glaucoma. Invest. Ophthalmol. Vis. Sci. 2011;52(14):624.
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To present the results of the interim analysis of the prospective randomised clinical trial which assesses the efficacy and complications of trabeculectomy with a biodegradable implant (ologenTM implant, version 2) versus trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open angle glaucoma.
In the MMC group (10 patients) trabeculectomy was performed according to standard protocols. In the ologenTM group (10 patients) after standard trabeculectomy the implant was positioned on top of the scleral flap and no mitomycin C was applied. Intraocular pressure (IOP), visual acuity, visual field, ultrasound biomicroscopy, and filtering bleb score were recorded.
The mean preoperative IOP was 26.9 ± 10.5 mmHg for the ologen group and 22.8 ± 4.7 mmHg for the MMC group (p = 0.34). Three months after surgery the mean IOP was 12.3 ± 1.9 mmHg in the ologenTM group (p<0.01, 54 % reduction) and 9.9 ± 3.5 mmHg in the MMC group (p<0.01, 57 % reduction). No antiglaucomatous medication was necessary in both groups; in all cases absolute success was achieved.
MMC and ologenTM seem to be adequate adjuncts in antiglaucomatous filtering surgery. Observations over a longer period and with larger numbers of patients are required to confirm these findings and to examine the role of ologen in antiglaucomatous surgery.
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