Purpose: To assess the effectiveness of XEN45, either alone or in combination with phacoemulsification, in open-angle glaucoma (OAG) patients in clinical practice. Methods: Retrospective and single-center study conducted on OAG patients who underwent XEN45 implant, either alone or in combination with cataract surgery. We compared the clinical outcomes of the eyes of thosewho underwent XEN-solo versus those who underwent XEN+Phacoemulsification. The primary endpoint was the mean change in intraocular pressure (IOP) from baseline to the last follow-up visit. Results: A total of 154 eyes, 37 (24.0%) eyes that underwent XEN-solo and 117 (76.0%) eyes that underwent XEN+Phacoemulsification, were included. The mean preoperative IOP was significantly lowered from 19.1± 5.0 mmHg to 14.9± 3.8 mmHg at month-36, p< 0.0001. Preoperative IOP was significantly lowered from 21.2± 6.2 mmHg and 18.4± 4.3 mmHg to 14.3± 4.0 mm Hg and 15.2± 3.7 mmHg at month-36 in the XEN-solo and XEN+Phacoemulsification groups, p< 0.0004 and p=0.0009; with no significant differences between them. In the overall study population, the mean number of antiglaucoma medications was significantly reduced from 2.1± 0.8 to 0.2± 0.6, p< 0.0001. There were no significant differences in the proportion of eyes with a final IOP ≤ 14 mmHg and ≤ 16 mmHg between XEN-solo and XEN+Phaco groups (p=0.8406 and 0.04970, respectively). Thirty-six (23.4%) eyes required a needling procedure. Conclusion: XEN implant significantly lowered IOP and reduced the need of ocular hypotensive medication, while maintaining a good safety profile. Beyond week-1, there were no significant differences in IOP lowering between XEN-solo and XEN+Phacoemulsification groups.

Purpose: To evaluate the 3-year effectiveness and safety of the XEN63 Gel Stent, both as a standalone procedure and combined with phacoemulsification, in patients with primary open-angle glaucoma (POAG). Methods: This prospective, multicenter, non-randomized study included 85 eyes (85 patients) with medically-uncontrolled POAG. Subjects underwent either XEN63-standalone implantation (n = 46) or combined XEN63 + Phacoemulsification (n = 39). The primary endpoint was the cumulative probability of complete success (IOP ≥ 6 and ≥18 mmHg and reduction in IOP ≥ 20% from baseline without ocular-hypotensive medications) at 36 months. Results: At 36-months, the overall surgical success rate was 67.1% (95% CI: 50.8–86.9%), with significant differences between the standalone (78.3%) and combined groups (53.9%; p = 0.0173). Complete success was achieved in 45.9% of the total cohort. Preoperative mean IOP decreased significantly from 21.3 ± 4.7 mmHg to 14.3 ± 4.3 mmHg at the last-follow-up visit (LFUV) (p < 0.0001). Correspondingly, the mean number of medications was significantly reduced from 2.3 ± 0.8 to 0.7 ± 1.0 (p < 0.0001). Multivariable analysis showed that surgical strategy did not significantly influence IOP reduction. Numerical hypotony (IOP < 6 mmHg) occurred in 23.5% of eyes at Day 1 but resolved in 95% of cases by Month 1. One case of hypotonic maculopathy required device explantation. Serious late-onset events included one endophthalmitis (Month 30) and one retinal detachment (Month 26). Secondary needling was required in 8.2% of eyes. Conclusions: The XEN63 Gel Stent provided sustained IOP reduction and a significantly decreased medication burden over 36 months. Outcomes remained consistent regardless of whether the stent was implanted as a standalone procedure or combined with cataract surgery.

Purpose: To assess the effectiveness of XEN45, either alone or in combination with phacoemulsification, in open-angle glaucoma (OAG) patients in a real-world scenario. Additionally, we evaluated the effect of the surgeon's experience on clinical outcomes. Methods: Retrospective and single center study conducted on OAG patients who underwent XEN45-implant, either alone or in combination with cataract surgery. We compared the clinical outcomes of the first-30 XEN devices implanted from June-2016 (First-cohort) versus the first-30 XEN devices implanted from January-2018 (second-cohort). The primary endpoint was the mean change in intraocular pressure (IOP) from baseline to the last follow-up visit. Results: One Hundred-and-fifty-four eyes, 37 (24.0%) eyes who underwent XEN-alone and 117 (76.0%) eyes who underwent XEN+Phacoemulsification were included. The mean preoperative IOP was significantly lowered from 19.1±5.0 mmHg to 14.9±3.8 mmHg at month-36, p<0.0001. Preoperative IOP was significantly lowered from 19.2±5.3 mmHg and 18.9±4.7 mmHg to 15.2±4.0 mm Hg and 14.1±3.1 mmHg at month-24 in the first- and second-cohorts, respectively; p<0.0001 each, with no significant differences between them. In the overall study population, the mean number of antiglaucoma medications was significantly reduced from 2.1±0.8 to 0.2±0.6, p<0.0001. The proportion of eyes with a final IOP ≤14 mmHg and ≤16 mmHg, without treatment, was significantly greater in the second cohort (p=0.0471 and 0.0047, respectively). Thirty-six (23.4%) eyes required a needling procedure. Conclusions: XEN implant, significantly lowered IOP and reduced the need of ocular hypotensive medication, while maintaining a good safety profile. Additionally, XEN45 was associated with a short learning curve.