Long-term effectiveness and safety of XEN45 in open-angle glaucoma patients

Background To investigate the long-term effectiveness and safety of XEN45 implant, either alone or in combination with phacoemulsification, in eyes with open-angle glaucoma (OAG). Methods Retrospective and single center study conducted on consecutive OAG patients who underwent a XEN45 implant between February-2017 and December-2021. The primary endpoint was the mean intraocular pressure (IOP) lowering from preoperative values. Surgical success was defined as an IOP-lowering from preoperative values >= 20% and an IOP absolute value between 6 and 13 mm Hg, without (Complete-success) or with (Qualified-success) antiglaucoma medications. Results A total of 158 eyes (34 (21.5%) eyes XEN-solo and 124 (78.5%) XEN + Phaco) were included. The median follow-up time was 28.5 months. In the overall study population, the mean preoperative IOP was significantly lowered from 19.4 +/- 6.5 mm Hg to 12.4 +/- 5.0 mm Hg. The mean preoperative (95% confidence interval) IOP was significantly lowered from 21.3 (19.3-23.2) mm Hg and 18.8 (17.7-20.0) mm Hg to 12.0 (10.4-13.6) mm Hg and 12.5 (11.6-13.5) mm Hg in the XEN-Solo and XEN + Phaco groups, respectively (p < 0.0001 each, respectively). The mean number of ocular-hypotensive medications was significantly reduced in the overall study sample (from 3.4 +/- 0.9 to 0.9 +/- 1.3, p < 0.0001), XEN-Solo (from 3.5 +/- 1.1 to 0.6 +/- 1.0, p < 0.0001, and XEN + Phaco (from 3.4 +/- 1.1 to 0.9 +/- 1.3, p < 0.0001) groups. Eighty-four (53.2%) eyes were categorized as success, with 49 (58.3%) classified as complete success. Eighty-one (51.3%) eyes underwent needling and 15 (9.5%) eyes required an additional surgical procedure. One (0.6%) eye had endophthalmitis. Conclusion XEN implant, either alone or in combination with phacoemulsification significantly lowered IOP and reduced the need of ocular-hypotensive medication, while maintaining a good safety profile.