Efficacy and safety of a steel drainage device implanted under a scleral flap

Objective: To evaluate the efficacy and safety of a stainless steel miniature glaucoma drainage device (Ex-PRESS X200) implanted under a scleral flap for the surgical treatment of primary open-angle glaucoma (POAG). Study Design: Clinical, prospective, noncomparative, nonrandomized study. The efficacy and safety were evaluated on the full sample, with a minimum follow-up of 12 months (maximum 24, mean 18). Participants: Thirty-seven eyes of 35 patients. Methods: The Ex-PRESS device was implanted under a scleral flap in patients with POAG. Results: Preoperative intraocular pressure (IOP) was 27.6 (SD 8.7) mm Hg; at last follow-up, IOP was 12.4 (SD 3.4) mm Hg (55.1% reduction). The success rates (IOP < 18 mm Hg and < 15 mm Hg at last visit without medications) were 78.4% (29/37) and 70.3% (26/37), respectively. Kaplan-Meier analyses (probability of IOP < 18 mm Hg and < 15 mm Hg without medications) at last follow-up were 72.6% and 47.9%, respectively. Early postoperative complications were clinically mild and included postoperative IOP < 5 mm Hg: 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, of which 3 spontaneously resolved, whereas 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. Conclusions: Our data support the efficacy and safety of the implantation of this device under a scleral flap. The IOP reduction obtained was significant and long standing and complications were mild.