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F. De Feo, M. Papadia, G. Bricola, C.E. Traverso; Long Term Efficacy and Safety of a Stainless Steel Glaucoma Drainage Implant (Ex–PRESSTM) . Invest. Ophthalmol. Vis. Sci. 2005;46(13):72.
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Purpose: to evaluate the long–term efficacy and safety of a stainless steel miniature glaucoma drainage device (Ex–PRESSTM) for the surgical treatment of glaucoma. Methods: clinical, prospective, single treatment arm, non randomized, non masked study. The Ex–PRESSTM device was implanted at the limbus under a conjunctival flap (n: 42) or a scleral flap (n: 13). When combined with phacoemulsification, (n: 26) cataract extraction and in the bag IOL implantation where performed through clear cornea temporally, when both the operations were required. Primary outcome: IOP change. Secondary outcomes: side effects and VA changes. Results: 56 eyes of 54 patients were implanted with the device. Efficacy was evaluatyed with a min F.U. of 12 months (mean 25, max 48 months; n: 26) and safety on the entire sample. . Efficacy: preoperative IOP was 26 +/– 9 mmHg; at last follow – up the IOP was 17.2 (+/– 9)mmHg (32% reduction). Kaplan–Meyer determined overall success rate (IOP < 21mmHG at the last visit with or without medications) as 75%. 3 patients (5%) were treated at their last visit, 2 with 1 medication and 1 with 2 medications. Side effects: early postoperative complications were clinically mild and included 15 cases of hypotony (IOP < 5mmHg) at 1 week and no cases at 1 month, 1 case of hyphema (< 2mm.) with no clinical significant further effects. Long term complications were 2 cases (3,7%) of device rotation: one eroded the conjunctiva at 2 years, and it was exchanged; one was repositioned. Four eyes lost more than 2 lines of V.A.. Bleb needling with or without 5FU injection was used in 17/56 cases (30%). Conclusions:our data support the long–term efficacy and safety of this device. The large IOP reduction obtained was long standing and complications were minimal.
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