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F. De Feo, A. Bagnis, G. Bricola, C.E. Traverso; Efficacy and Safety of a Stainless Steel Glaucoma Drainage Device Implanted Under a Scleral Flap . Invest. Ophthalmol. Vis. Sci. 2006;47(13):25.
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to evaluate efficacy and safety of the implantation of a stainless steel miniature glaucoma drainage device under a scleral flap (Flap–Ex–PRESSTM) for the surgical treatment of glaucoma.
clinical, prospective, single treatment arm, non randomized, non masked study. The Ex–PRESSTM device was implanted at the limbus under a scleral flap (n=25). When combined with phacoemulsification, cataract extraction and in the bag IOL implantation were performed through clear cornea temporally (n=6). Primary outcome: IOP change. Secondary outcomes: side effects and VA changes.
the efficacy was evaluated with a min. follow–up (F.U.) of 12 months (mean 12, max 18 months, n=17) and safety on the sample with min. F.U. of 6 months (n=25). Efficacy: preoperative IOP was 30.37 +/– 12.02 mmHg; at last follow–up > 12 months (n=17) the IOP was 12.65 +/– 3.55 mmHg (58.3% reduction). The overall success rate (IOP < 18 mmHg at last visit with or without medications) was 94.1% (16/17). The complete success rate (IOP < 18 mmHg at last visit without medications) was 82.3% (14/17). Kaplan–Mayer determined overall success rate (IOP <18 mmHg at last visit with or without medications) as 84%. Three patients (17.7%, n=17)) were treated at their last visit, 2 (11.8%) with 1 medication and 1 (5.9%) with 2 medications. Side effects: early postoperative complications were clinically mild and included 9 cases (36%, n=25) with IOP < 5 mmHg at 1 day, 11 cases (44%) at 1 week and 2 cases (8%) at 1 month; 3 cases (12%) with IOP > 30 mmHg at 1 day; 2 cases (8%) of choroidal detachment, spontaneously resolved. In 3 cases (12%) a viscoelastic injection in the anterior chamber was required at 1 day and 1 week. In one case (4%) a bleb revision was performed at 2 months due to an increase in IOP. No sight threatening consequence of the surgical procedure was observed. Bleb needling, with or without 5FU injection, was used in 8 cases (32%).
our data support the long–term efficacy and safety of the under scleral flap technique. The large IOP reduction obtained was long standing and complications were minimal.
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