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 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.