ABSTRACT
INTRODUCTION: 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 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 intraocular pressure (IOP) was significantly higher in the XEN-alone (22.2±5.9 mmHg) than in the XEN+Phaco (19.8±4.5 mmHg) group (p=0.0035). In the overall study population, the mean preoperative IOP was significantly lowered from 20.5±5.0 mmHg to 15.8±4.4 at year-4, p<0.0001. The mean preoperative (95% CI) IOP was significantly lowered from 22.2 (20.6 to 23.8) mmHg and 19.8 (19.1 to 20.6) mmHg to 15.6 (12.2 to 16.9) mmHg and 15.9 (15.2 to 16.5) mmHg 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 reduce the need of ocular hypotensive medication in the long-term.
