Two‐year outcomes of minimally invasive XEN Gel Stent implantation in primary open‐angle and pseudoexfoliation glaucoma

Abstract

Purpose The aim of this study was to evaluate the efficacy of XEN® Gel Stent implantation in the treatment of primary open‐angle glaucoma (POAG) and pseudoexfoliation glaucoma (XFG) regarding the reduction of intraocular pressure (IOP) and number of IOP‐lowering medications over 2 years. Methods In this retrospective, observational, single‐centre study, patients with POAG or XFG underwent implantation of the XEN® Gel Stent with or without combined phacoemulsification. Changes in mean IOP, mean number of IOP‐lowering medications, number of postoperative interventions, complete or qualified surgical success rate (defined as IOP < 18 mmHg without or with IOP‐lowering medication, respectively) and complete surgical failure rate (defined as the necessity of a glaucoma‐related secondary surgical intervention or loss of light perception) were assessed 12 months (12M) and 24 months (24M) postoperatively. Results Seventy‐nine eyes of 63 patients with open‐angle glaucoma were included in the study (71% POAG, 29% XFG). Before surgery, mean IOP was 23.4 ± 7.9 mmHg. IOP was 14.6 ± 3.6 mmHg 12 months postoperatively (−31% from baseline, 95% CI −42% to −20%, n = 30, p < 0.001) and 14.8 ± 4.4 mmHg 24 months postoperatively (−29% from baseline, 95% CI −30% to −41%, n = 28, p < 0.001). Mean number of IOP‐lowering medications was significantly reduced from 2.7 ± 1.1 before surgery to 1.0 ± 1.2 (−69%, 95% CI −89% to 46%, p < 0.001) 12 months after surgery and 1.0 ± 1.2 (−64%, 95% CI −91% to −36%, p < 0.001) at 24 months after surgery. Complete surgical success was achieved in 39% (12M) and 34% (24M) of patients and qualified success in 29% (12M) and 27% (24M). 13 (16%) eyes were classified as complete surgical failure. In 62% of the patients needling procedures had to be performed. Conclusion The XEN® Gel Stent is an efficacious minimal invasive glaucoma surgery for primary open‐angle and pseudoexfoliation glaucoma, resulting in significant reduction of IOP and a reduction in glaucoma medications from baseline in two‐third of treated patients with 2‐year follow‐up. Frequent follow‐up examinations were mandatory to identify early and late bleb failure and additional needling procedures were necessary to reestablish aqueous flow.

Two-Year Outcome of Surgery in Glaucoma Patients

“…In general, we observed a significant mean drop of IOP from 21.94 mmHg preoperatively to 15.37 mmHg (29.94%) at month 24 postoperatively. These results are in agreement with the retrospective study by Rauchegger et al 17 and the prospective study by Reitsamer et al 5 . For instance, Rauchegger et al gained 31% reduction of mean IOP at 12 months and 29% at 24 months from baseline 17 .…”

“…These results are in agreement with the retrospective study by Rauchegger et al 17 and the prospective study by Reitsamer et al 5 . For instance, Rauchegger et al gained 31% reduction of mean IOP at 12 months and 29% at 24 months from baseline 17 . Similarly, the study of Reitsamer et al showed, at 12 months, a 31% IOP reduction and 28.97% at 24 months 5 .…”

“…In our study, we also evaluated the effect combined with the phacoemulsification procedure, where our surgery groups were subdivided, taking the phacoemulsification into account. Our outcomes were similar in the isolated and combined surgeries and is in agreement with many studies 5 , 17 , 23 – 26 .…”

The Outcomes of XEN Gel Stent Implantation: A Systematic Review and Meta-Analysis

“…The qualified success rate was 60.0-90.2% after 1 year (n = 4) and 34.0-86.0% after 2 years (n = 3). If the absolute IOP threshold was decreased to 18 mmHg (13,18,19,28,29,36,43,50,54), the qualified success rate was 25.0-90.6% and the complete success rate was 15.4-76.7% at the last follow-up. In a 4-year follow-up study (26), which was the longest follow-up period, XEN with an inner diameter of 63 µm was applied in patients with open-angle glaucoma.…”

“…The largest part of postoperative interventions and reoperations is needling of the XEN conjunctival bleb, the rate of which was 38.7% (5-62%). In a two-year follow-up study (54), 62% of patients required a needling procedure. In most cases, a needling was required within the first month postoperatively (25%).…”