Effectiveness and Safety of XEN45 in Eyes With High Myopia and Open Angle Glaucoma

Precis:XEN45 implant was an effective and safe procedure in primary open angle glaucoma (OAG) eyes with high myopia. Although the hypotony incidence rate was relatively high, it resolved with medical therapy and was of short duration. Purpose:The purpose of this study is to evaluate the effectiveness and safety of the XEN45 stent in eyes with OAG and high myopia. Design:Retrospective and multicenter study. Methods:Consecutive OAG patients who underwent a XEN45, either alone or in combination with cataract surgery, and had a refractive error higher than -6 D and an axial length >= 26 mm. The primary endpoint was the mean intraocular pressure (IOP) lowering at the last follow-up visit. Results:Thirty-one eyes were included (96.8% with a primary OAG diagnosis). The mean refraction was -13.2 +/- 5.6 (range: -6.75 to-23.0) D. In the overall study sample, preoperative mean IOP (95% CI) was significantly lowered from 23.5 (20.5-26.4) mm Hg to 13.0 (12.2-13.8) mm Hg at the last follow-up visit, P<0.0001. At the last follow-up visit, 16 (57.1%) eyes achieved an IOP <= 14 mm Hg, 11 (68.9%) of them without treatment. The number of ocular hypotensive medications was significantly reduced from 3.0 +/- 1.1 drugs at preoperatively to 0.6 +/- 1.0 drugs at the last follow-up visit, P<0.0001. Median (95% CI) follow-up was 24.0 (12.0-24.0) months. Linear regression analysis showed a significant correlation between the preoperative refraction and the IOP lowering (r=0.43, P=0.0155). Needling procedure was performed in 11 eyes (39.3%) and hypotony (defined as an IOP <6 mm Hg) was observed in 8 eyes (28.6%) during the first postoperative day and remained for a week. Conclusion:Although the Xen implant effectively lowered IOP in highly myopic eyes with glaucoma, the incidence of hypotony was high, and in most cases, resolved within the first month with medical management and monitoring.