Long-Term Effectiveness of XEN 45 Gel-Stent in Open-Angle Glaucoma Patients.

Abstract

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.