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R. Scotto, F. De Feo, A. Bagnis, C. E. Traverso; Long Term Efficacy and Safety of a Stainless Steel Glaucoma Drainage Device Implanted Under a Scleral Flap. Invest. Ophthalmol. Vis. Sci. 2008;49(13):4188.
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To evaluate the efficacy and safety of a stainless steel miniature glaucoma drainage device (Ex-PRESSTM X200) implanted under a scleral flap for the surgical treatment of primary open-angle glaucoma (POAG).
In this single-centre study the Ex-PRESSTM device was implanted at the limbus under a scleral flap in 37 eyes of 35 patients with POAG. Primary outcome: IOP change. Secondary outcomes: side effects and VA changes.
The efficacy and safety were evaluated on the full sample, with a minimum FU of 12 months (max 24, mean 18). Pre-operative IOP was 27.6±8.7 mmHg; at last follow-up IOP was 12.4±3.4 mmHg (55.1% reduction). The success rate (IOP < 18 mmHg at last visit without medications) was 94.6% (35/37). Early post-operative complications were clinically mild and included: post-operative IOP < 5 mmHg: 12 cases at 1 day, 8 cases at 1 week, 3 cases at 1 month, 1 case at 3 months; serous choroidal detachment: 9 cases, 3 spontaneusly resolved, while in 6 cases hypotony and flat chamber were treated with viscoelastic injection in the anterior chamber. At last follow-up 6 patients were treated with 2 IOP lowering medications. No sight-threatening consequences of surgery were observed. There were 8 cases (21.6%, n=37) of bleb needling, with or without 5FU.
Our data support the efficacy and safety of the implantation of this device under a scleral flap (Flap-Ex-PRESS). The IOP reduction obtained was significant, long-standing and complications were minimal.
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