ABSTRACT
INTRODUCTION: The main purpose of the current study was to evaluate the long-term effectiveness and safety of XEN45 implant, either alone or in combination with cataract surgery, in patients with glaucoma. METHODS: Retrospective and single center study conducted on consecutive patients who underwent a XEN45 implant, either alone or in combination with cataract surgery, between November 2016 and October 2021. The primary endpoint was the mean intraocular pressure (IOP) lowering from preoperative values. RESULTS: Among the 230 screened patients, 206 eyes (176 patients) were included. Fifty-three (25.7%) eyes had undergone XEN alone and 153 (74.3%) eyes had undergone a combined procedure (XEN+phacoemulsification). The mean preoperative IOP was significantly higher in the XEN-alone (22.2 ± 5.9 mm Hg) than in the XEN+Phaco (19.8 ± 4.5 mm Hg) group (p = 0.0035). In the overall study population, the mean preoperative IOP was significantly lowered from 20.5 ± 5.0 mm Hg to 15.8 ± 4.4 at year-4, p < 0.0001. The mean preoperative (95% confidence interval) IOP was significantly lowered from 22.2 (20.6-23.8) mm Hg and 19.8 (19.1-20.6) mm Hg to 15.6 (12.2-16.9) mm Hg and 15.9 (15.2-16.5) mm Hg at year-4 in the XEN-alone and XEN+Phaco groups, respectively (p < 0.0001 each, respectively). The number of ocular hypotensive medications was significant reduced from 2.6 ± 1.0 drugs to 1.3 ± 1.3 drugs, with no significant differences between XEN-alone and XEN+Phaco groups (p = 0.1671). On the first postoperative day, 62 (30.1%) eyes presented some type of complication. Fifteen (7.3%) eyes underwent a needling procedure. CONCLUSION: XEN45, either alone or in combination with phacoemulsification, significantly lowered the IOP and reduced the need of ocular hypotensive medication in the long-term.