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.

Mid‐term surgical success after transscleral ab interno glaucoma gel stent implantation

“…The XEN45 Glaucoma Gel Microstent proved to be effective in reducing IOP over the first 5 years in solo and combined surgery groups. The results are comparable to the 3-year results of a prospective multicentric trial investigating the efficacy and safety of the XEN45 implant, as well as a retrospective 4-year trial (Gillmann et al, 2020;Marcos-Parra et al, 2023;Reitsamer et al, 2022). In line with a meta-analysis investigating differences in lowering IOP and the number of IOPlowering medications, we also could not detect differences between the solo and combined surgery groups in IOP course or the course of number of IOP-lowering medications (Poelman et al, 2021).…”

“…Due to its potency and the evidence thereof in scientific literature, trabeculectomy is still the gold standard for filtering glaucoma surgeries (Lusthaus & Goldberg, 2019). MIGS/MIGS+ procedures are relatively new compared to trabeculectomy, which expresses low mid‐term and long‐term evidence levels (Gillmann et al., 2020; Marcos‐Parra et al., 2023). The XEN45 Glaucoma Gel Microstent (XEN 45 μm, Allergan Plc., USA), a member of the MIGS/MIGS+ group, channels aqueous humour from the anterior chamber to the subconjunctival space to reduce IOP, as does classic trabeculectomy (Sheybani, Lenzhofer et al., 2015; Sheybani, Reitsamer et al., 2015).…”

“…Short‐term efficacy outcomes and data about success rate outcomes showed no statistical difference after XEN45 Glaucoma Gel Microstent compared to classic trabeculectomy (Schlenker et al., 2017). To the best of our knowledge, there are no prospective data beyond a 3‐year follow‐up published on this glaucoma device (Gillmann et al., 2020; Marcos‐Parra et al., 2023).…”

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

“…A preprint has previously been published. 30 Patients ≥18 years old with insufficiently medically controlled early to advanced OAG, according to Hodapp et al, 31 intolerance to topical hypotensive treatments; or poor treatment adherence, who underwent XEN45 implantation, either alone or in combination with cataract surgery, were included in the study.…”

Minimally Invasive Glaucoma Surgery

“…Hyphema (27.9% to 45.5), hypotony (20.2% to 24.6%), wound leak (9.2%), and problems related to implant positioning (1.8% to 4.7%) are complications described in association with XGS implantation 118,123 . Bleb needling is often required in up to 23% to 36% of cases 124,125 . Less frequently observed complications include corneal edema, subconjunctival hemorrhage, endophthalmitis, and iridodialysis, each occurring in ≤1.5% of cases 118,120,121,123 .…”