3-Year Outcomes of XEN Implant Compared With Trabeculectomy, With or Without Phacoemulsification for Open Angle Glaucoma

Abstract

Précis: Trabeculectomy (TRAB) surgery reduces the intraocular pressure (IOP) more than the XEN45 implant over 3 years. There is no difference in the number of antiglaucoma medications between the 2 procedures. The decision to perform either TRAB or XEN45 implantation must be evaluated on a case-by-case basis, taking into account the high rate of needling of the XEN45. Purpose: The aim of this study was to compare the differences between the efficacy and safety of the XEN45 implant and TRAB, either alone or in combination with phacoemulsification (PHACO), in patients with open angle glaucoma (OAG) at 36 months. Methods: A retrospective, single-center and comparative study conducted on OAG patients who underwent XEN45 implantation or TRAB from 2016 to 2018. Patients were divided into 4 groups: group 1 (XEN45 alone), group 2 (XEN45+PHACO), group 3 (TRAB alone), and group 4 (TRAB+PHACO). For statistical purposes, groups 1 and 2 were combined (XEN45 implant), whereas groups 3 and 4 were also combined (TRAB surgery). IOP, number of glaucoma medications, and adverse events were evaluated. The main outcome measure was the reduction in IOP at 36 months postoperatively. Results: One hundred thirty-four patients (134 eyes; 63 XEN45 and 71 TRAB) were included. The mean (95% confidence interval) IOP reduction at the end of the study follow-up was −6.3 (−11.0 to −1.6 mm Hg, P=0.025, XEN45 alone), −8.9 (−11.0 to −6.8 mm Hg, P<0.001, TRAB alone), −2.5 (−4.5 to −0.4 mm Hg, P=0.019, XEN45+PHACO), and −5.6 (−7.7 to −3.4 mm Hg, P<0.001, TRAB±PHACO). The proportion of patients achieving an IOP≥6 and ≤16 mm Hg without treatment at the end of the 36-month follow-up were 50.8% (32/63) in the XEN45 implant and 49.3% (35/71) in the TRAB surgery group, P=0.863. The mean number of glaucoma medications was significantly reduced in all the study groups. The needling rate was 19% in XEN45 versus 5.6% in the TRAB group (P=0.030), and 2.81% and 36.6% of eyes in the TRAB group presented anterior chamber flattening and hyphema, respectively. Conclusions: TRAB surgery lowered IOP significantly more than XEN45 implant with or without phacoemulsification over 3 years and had a significantly lower need for additional needling surgery. Both procedures reduced glaucoma medications to a similar rate. These findings are relevant to the informed consent process and patient decisions for one procedure over the other.

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

“…From a clinical point of view, different studies have reported the mid-and long-term efficacy, in terms of IOP lowering and the amount of ocular-hypotensive medications reduction, and safety of XEN45 implant, either alone or in combination with phacoemulsification surgery, in OAG patients. 14,16,17,[25][26][27][28][29][32][33][34][35][36][37][38] In this respect, the results of the study do not differ significantly from the published evidence.…”

“…26,39 According to the results of Chen et al, 40 both XEN-alone (mean difference: −7.8 mmHg; 95% CI: −8.21 to −7.38 mmHg, p<0.001) and XEN+Phacoemulsification (mean difference: −8.35 mmHg; 95% CI: −9.82 to −6.88 mmHg, p<0.001) significantly lowered the IOP. However, another systematic review and meta-analysis published by Wang et al 38 has shown different results. They found better results for XEN alone compared XEN+Phacoemulsification procedures in IOP lowering but not in the reduction of ocular hypotensive medications.…”

Minimally Invasive Glaucoma Surgery: Latest Developments and Future Challenges

“…There are limited data comparing XEN with trabeculectomy. The 2 procedures had similar IOP-lowering efficacy when the baseline IOP was in the low twenties; 133 whereas overall, trabeculectomy lowered IOP significantly more than the XEN 45 implant 134–136 …”

“…The 2 procedures had similar IOP-lowering efficacy when the baseline IOP was in the low twenties; 133 whereas overall, trabeculectomy lowered IOP significantly more than the XEN 45 implant. [134][135][136] Comparing the XEN 45 and XEN 63, Fernandez-García et al 137 found no difference in the amount of IOP-lowering over 36 months. However, Evers et al 138 found a slightly lower IOP after XEN 63 (IOP reduction of 44.6% vs 40.1%).…”

Three-year clinical outcome of XEN45 Gel Stent implantation versus trabeculectomy in patients with open angle glaucoma

“…Different studies have been published demonstrating the shortterm benefits and safety of XEN Gel Stent application in patients with open angle glaucoma [7][8][9]. However, results from prospective randomised controlled trials comparing trabeculectomy and XEN Gel Stent implantation are missing [10], and there are only a few published retrospective studies with follow-up data longer than one year [11][12][13]. Therefore, in our study, we aimed to compare in detail the long-term clinical outcome and safety of XEN Gel Stent implantation vs. trabeculectomy for primary open angle glaucoma and pseudoexfoliation glaucoma.…”