Précis: Trabeculectomy (TRAB) surgery reduces the intraocular pressure (IOP) more than the XEN45 implant over 3 years. There is no difference in the number of antiglaucoma medications between the 2 procedures. The decision to perform either TRAB or XEN45 implantation must be evaluated on a case-by-case basis, taking into account the high rate of needling of the XEN45. Purpose: The aim of this study was to compare the differences between the efficacy and safety of the XEN45 implant and TRAB, either alone or in combination with phacoemulsification (PHACO), in patients with open angle glaucoma (OAG) at 36 months. Methods: A retrospective, single-center and comparative study conducted on OAG patients who underwent XEN45 implantation or TRAB from 2016 to 2018. Patients were divided into 4 groups: group 1 (XEN45 alone), group 2 (XEN45+PHACO), group 3 (TRAB alone), and group 4 (TRAB+PHACO). For statistical purposes, groups 1 and 2 were combined (XEN45 implant), whereas groups 3 and 4 were also combined (TRAB surgery). IOP, number of glaucoma medications, and adverse events were evaluated. The main outcome measure was the reduction in IOP at 36 months postoperatively. Results: One hundred thirty-four patients (134 eyes; 63 XEN45 and 71 TRAB) were included. The mean (95% confidence interval) IOP reduction at the end of the study follow-up was −6.3 (−11.0 to −1.6 mm Hg, P=0.025, XEN45 alone), −8.9 (−11.0 to −6.8 mm Hg, P<0.001, TRAB alone), −2.5 (−4.5 to −0.4 mm Hg, P=0.019, XEN45+PHACO), and −5.6 (−7.7 to −3.4 mm Hg, P<0.001, TRAB±PHACO). The proportion of patients achieving an IOP≥6 and ≤16 mm Hg without treatment at the end of the 36-month follow-up were 50.8% (32/63) in the XEN45 implant and 49.3% (35/71) in the TRAB surgery group, P=0.863. The mean number of glaucoma medications was significantly reduced in all the study groups. The needling rate was 19% in XEN45 versus 5.6% in the TRAB group (P=0.030), and 2.81% and 36.6% of eyes in the TRAB group presented anterior chamber flattening and hyphema, respectively. Conclusions: TRAB surgery lowered IOP significantly more than XEN45 implant with or without phacoemulsification over 3 years and had a significantly lower need for additional needling surgery. Both procedures reduced glaucoma medications to a similar rate. These findings are relevant to the informed consent process and patient decisions for one procedure over the other.

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.

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). Thirtysix (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.