A 4-Year Retrospective Study: Clinical Outcomes of XEN45 in Patients with Glaucoma.

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.