To assess the effectiveness of the XEN 45 gel stent, either alone or combined with cataract surgery, in advanced stage open angle glaucoma (OAG) patients. Retrospective and single-center study conducted on consecutive OAG patients who underwent a XEN 45 gel stent implantation surgery, between July 2017 and September 2018. The primary efficacy end-point was the mean intraocular pressure (IOP) reduction at the end of the follow-up period. Success was defined as an IOP reduction of at least 20% and an IOP value ≤18 mm Hg without (complete) or with (qualified) hypotensive medication. Seventy-four patients (80 eyes) were included in the study. In the overall study sample, XEN implant significantly reduced IOP from 21.0 (19.8 to 22.1) mm Hg at baseline to 9.3 (8.2 to 10.4), 10.7 (9.6 to 11.9), 13.4 (12.2 to 14.7), 14.5 (13.6 to 15.4), 14.7 (13.8 to 15.6), and 14.7 (13.9 to 15.4) mm Hg at 1d, 1wk, 1, 3, 6, and 12mo of follow-up, respectively (P<0.0001 each). In the overall study population, at the end of the study the mean IOP reduction was 27.4% (23.3% to 31.5%). Adjusted IOP reduction was similar in XEN and XEN+phacoemulsification groups [30.0 (23.4 to 36.4) mm Hg vs 24.8 (18.4 to 31.2) mm Hg, respectively, P=0.2939]. At the last follow-up visit, 52 (65.0%) eyes were considered success, 29 (36.3%) eyes as complete success and 23 (28.7%) as qualified success. Mean number of hypotensive medications was significantly reduced from 2.8 (2.7 to 3.0) at baseline to 1.1 (0.8 to 1.3), P<0.0001. Kaplan-Meier survival analysis did not find any difference in the success rate between XEN and XEN+PHACO, mean hazard ratio 0.56, 95%CI 0.26 to 1.23; P=0.1469. Needling was performed in 7 (8.8%) eyes at months 1 (n=3); 3 (n=2); 4 (n=1) and 11 (n=1). Eleven (13.8%) eyes presented adverse events. XEN implant, either alone or in combination with phacoemulsification, significantly reduced the IOP and the number of hypotensive medications in patients with OAG in advanced stage.

Purpose: To evaluate the 3-year effectiveness and safety of the XEN63 Gel Stent, both as a standalone procedure and combined with phacoemulsification, in patients with primary open-angle glaucoma (POAG). Methods: This prospective, multicenter, non-randomized study included 85 eyes (85 patients) with medically-uncontrolled POAG. Subjects underwent either XEN63-standalone implantation (n = 46) or combined XEN63 + Phacoemulsification (n = 39). The primary endpoint was the cumulative probability of complete success (IOP ≥ 6 and ≥18 mmHg and reduction in IOP ≥ 20% from baseline without ocular-hypotensive medications) at 36 months. Results: At 36-months, the overall surgical success rate was 67.1% (95% CI: 50.8–86.9%), with significant differences between the standalone (78.3%) and combined groups (53.9%; p = 0.0173). Complete success was achieved in 45.9% of the total cohort. Preoperative mean IOP decreased significantly from 21.3 ± 4.7 mmHg to 14.3 ± 4.3 mmHg at the last-follow-up visit (LFUV) (p < 0.0001). Correspondingly, the mean number of medications was significantly reduced from 2.3 ± 0.8 to 0.7 ± 1.0 (p < 0.0001). Multivariable analysis showed that surgical strategy did not significantly influence IOP reduction. Numerical hypotony (IOP < 6 mmHg) occurred in 23.5% of eyes at Day 1 but resolved in 95% of cases by Month 1. One case of hypotonic maculopathy required device explantation. Serious late-onset events included one endophthalmitis (Month 30) and one retinal detachment (Month 26). Secondary needling was required in 8.2% of eyes. Conclusions: The XEN63 Gel Stent provided sustained IOP reduction and a significantly decreased medication burden over 36 months. Outcomes remained consistent regardless of whether the stent was implanted as a standalone procedure or combined with cataract surgery.

Risk prediction in primary angle closure suspects: current perspectives