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F. De Feo, F. Badalà, S. Gandolfi, E. Sellem, C.E. Traverso; Long– termI effects on IOP of a stainless steel glaucoma drainage implant (Ex–PRESS) in combined surgery with phacoemulsification. . Invest. Ophthalmol. Vis. Sci. 2004;45(13):929.
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Purpose: To evaluate efficacy and safety in long term of a stainless steel miniature glaucoma drainage device (Ex–PRESS R50) for the surgical treatment of POAG and cataract, when combined with phacoemulsification . Methods: clinical, prospective, multicenter, single treatment arm, non randomized, non masked study. Phacoemulsification and in–the–bag IOL implantation were performed through clear cornea temporally. Primary outcome: IOP change. Secondary outcomes: side effects and VA changes. Results: 26 eyes of 25 patients were implanted with the device. The mean (±SD) follow–up was 23.9±10.4 months and the mean age was 74.8±6.7years. 17/26 eyes are beyond 3 years of F.U. One case was discontinued due to device removal, 1 due to death (not related to the device) and 3 were lost to follow up. Efficacy: preoperative IOP was 21±4 mmHg; at 1, 2 and 3 years IOP was 15.3±3.1mmHg (35% reduction), 16.6±2.7mmHg (29% reduction) and 16±2.6mmHg (22% reduction), respectively. Kaplan–Meyer determined overall success rate (IOP≤21mmHg at last visit with or without antiglaucoma medications) was 89%. The number of antiglaucoma medications was reduced by 95%, 86% and 100% at year 1, 2 and 3 respectively. Side effects: early postoperative complications were clinically mild and included 6 (23.1%) cases of hypotony (IOP≤5mmHg), 3 (11%) cases of hyphema <2mm with no clinical significant further effects. Long term complications were 2 (7.7%) cases of device rotation ( 1 treated by reposition) , 2 (7.7%) conjunctival erosions at 2 years. Conclusions:This technique is clinically safe and effective, maintaining in long term a large reduction of IOP and of the number of antiglaucoma medications.
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