Short-Term Outcomes of XEN45 Standalone versus Combined with Phacoemulsification in Open-Angle Glaucoma Patients: A Retrospective Study

Abstract

The XEN45 is a minimally invasive glaucoma surgery device commonly used in clinical practice. This retrospective study included consecutive patients with open-angle glaucoma who underwent a XEN45 implant with mitomycin C, either alone or in combination with phacoemulsification, between June 2015 and March 2021. The primary end point was the mean change in intraocular pressure (IOP) from the baseline to month 6. A total of 677 eyes, 395 (58.3%) in the XEN alone group and 282 (41.7%) in the XEN+Phaco group, were included in this study. The preoperative IOP was significantly lowered from 28.7 ± 8.6 mmHg and 25.4 ± 6.9 mmHg to 13.5 ± 5.0 mmHg and 13.5 ± 4.1 mmHg at month 6 in the XEN solo and XEN+Phaco groups, respectively, with p < 0.0001 each. The mean (95% confidence interval) number of ocular hypotensive medications was significantly reduced from 3.3 (3.2-3.4) to 0.2 (0.1-0.2) and from 3.1 (2.9-3.2) to 0.2 (0.1-0.2) in the XEN solo and XEN+Phaco groups, respectively, with p < 0.0001 each. Needling was performed in 228 (33.7%) eyes. Conclusions: the XEN implant significantly reduces both IOP and the number of ocular hypotensive medications. IOP lowering was higher in the XEN solo group than in the XEN+Phaco one, although such a difference was only evident during the first month after surgery.

Keywords: MIGS; XEN implant; intraocular pressure; needling; open-angle glaucoma; success.

Figure 1

Mean intraocular pressure (IOP) over the course of follow-up in the XEN solo and XEN+Phaco groups. The vertical bars represent the 95% confidence interval. Mean IOP was significantly lower in the XEN solo group at day 1, week 1, and month 1, but no significant differences were observed at any of the other IOP time points measured (statistical significance was determined using the one-way ANOVA test with Scheffé’s method). n.s.: Not significant.

Figure 2

Overview of the impact of previous glaucoma surgical procedure (laser and/or filtering surgery) on the probability of achieving a specific target intraocular pressure. * Minimally invasive glaucoma procedures other than XEN. † p < 0.05 as compared to no previous glaucoma surgery. MIGS: Minimally invasive glaucoma surgery; IOP: Intraocular pressure.

Figure 3

Kaplan–Meier survival curves for failure in eyes treated with XEN alone (XEN solo) (solid line) and combined surgery XEN + phacoemulsification (XEN+Phaco) (dotted line). Failure occurred in 37 (9.4%) XEN solo-treated eyes and 39 (13.8%) XEN+PHACO-treated eyes. Mean hazard ratio (HR) 0.62; 95% confidence interval 0.38 to 0.99; p = 0.0459.