Efficacy and safety of XEN®—Implantation vs. trabeculectomy: Data of a “real-world” setting

Abstract

ObjectiveTo compare surgical success, postoperative intraocular pressure and complication rates between trabeculectomy and XEN gelstent surgery in a cohort of glaucoma patients in a typical clinical setting. MethodsA retrospective cohort study of consecutive patients with refractory open-angle glaucoma including patients who underwent either stand-alone XEN gelstent insertion with Mitomycin C or trabeculectomy with Mitomycin C between 2016 and 2018 at the University Eye Hospital Mainz, Germany. Primary outcome measure was the proportion of surgical success 1 year after surgery. Patients with an IOP �18mmHg, an intraocular pressure reduction of >20% and in no need of revision surgery or topical medication were considered a complete surgical success. If topical therapy was necessary, they were considered a qualified success. Multivariable logistic regression analysis was carried out for the primary outcome including gender, age, preoperative intraocular pressure and number of medication classes used preoperatively as adjustment variables. Results171 eyes of 144 patients were included, including 82 eyes of 58 patients in the XEN group and 89 eyes of 86 patients in the trabeculectomy group. The primary outcome defined as the proportion of surgical success after 1 year (mean 11.1 months ± 2.2) was similar for both groups. The complete success proportion was 65.5% (95%-CI: 55.6-75.9%) in the trabeculectomy group, and 58.5% (95%-CI: 47.6-69.4%) in the XEN group and not statistically different in our analysis model (crude OR = 0.61; 95%-CI: 0.31-1.22; adjusted OR = 0.66; 95%-CI: 0.32-1.37). The intraocular pressure reduction, as secondary outcome measure, was higher in the trabeculectomy group (10.5 mmHg) compared to the XEN group (7.2 mmHg; p = 0.003) at the 12-month follow-up.Citation: Wagner FM, Schuster AK-G, Emmerich J, Chronopoulos P, Hoffmann EM (2020) Efficacy and safety of XEN®-Implantation vs. trabeculectomy: Data of a "real-world" setting. PLoS ONE 15(4): e0231614. https://doi.org/10.

Effective treatment of a normal-tension glaucoma patient with bilateral ab externo XEN Gel Stent implantation

“… 18 , 21 , 22 , 23 , 24 , 37 , 38 , 39 , 40 , 41 Direct comparison of ab interno XEN Gel Stent implantation with trabeculectomy in POAG patients found no difference in the rates of surgical success or reduction in IOP lowering medications. 24 , 39 , 42 , 43 While one study found that trabeculectomy resulted in lower postoperative IOPs, 39 others found no difference. 42 , 43 Patients receiving XEN Gel Stents benefited from fewer postoperative visits and a faster postoperative course.…”

Comparing the efficacy of trabeculectomy and XEN gel microstent implantation for the treatment of primary open-angle glaucoma: a retrospective monocentric comparative cohort study

“…The indication whether to perform TET or XEN microstent implantation was defined when the XEN microstent was first introduced to our clinic, which was before the actual retrospective study was designed. The indications relied on the following assumptions: The XEN microstent was developed as a minimally invasive procedure with the goal to generate comparable postoperative results to those after TET in terms of IOP reduction 18 – 20 . The XEN microstent is implanted using an ab interno approach.…”

Minimally invasive glaucoma surgery - current and emerging techniques to reduce intraocular pressure and medications

“…In addition, an IOP reduction at 12-month follow-up of 7.2 ± 8.2 mmHg in the XEN group and 10.5 ± 9.2 mmHg in the trabeculectomy group were observed from baseline values of 19.0 mmHg (95%CI: 16.8-25.0 mmHg) and 21.0 mmHg (95%CI: 17.0-27.0 mmHg), respectively (P = 0.003). Medication reduction was also reduced to 0.3 ± 0.5 and 0.2 ± 0.4 in the XEN and trabeculectomy cohorts, respectively from baseline values of 2.0 (95%CI: 1.0-3.0) and 3.0 (95 CI: 2.0-4.0), respectively [23] .…”

“…Key statistics on mechanism of action, effectiveness, and safety profile were extracted for each type of MIGS (an overview of these findings summarised in Table 2). Analysed procedures were limited to Schlemm's canal iStent Hooshmand et al [5] Ferguson et al [6] Ferguson et al [7] Ahmed et al [8] Katz et al [9] + Hooshmand et al [5] Samuelson et al [10] + CE + CE Samuelson et al [4] Ahmed et al [8] + CE + CE Davids et al [11] Heersink et al [12] +/-CE Esfandiari et al [13] Avar et al [14] + CE +/-CE Elmallah et al [16] + CE RCS 315 eyes 12 mo: -27.47 12 mo: -1.03 Supraciliary space/ciliary process CyPass Vold et al [17] Reiss et al [18] Fard et al [19] Fard et al [19] + Myers et al [20] + 2 iStent PCS 80 subjects 48 mo: -41.36 n/a ECP Pantalon et al [21] + CE + 2 iStent PCS 63 eyes 12 mo: -34.65 12 mo: -0.98 Subconjunctival space XEN Gel Stent Olgun et al [15] Karimi et al [22] Wagner et al [23] Gillmann et al [24] +…”

“…As a form of bleb forming procedure, it is also important to compare the XEN gel stent with trabeculectomy, which is still the predominant incisional procedure for glaucoma. Wagner et al [23] compared the 2 as standalone procedures performed in a 171-eye study, which demonstrated that complete surgical success at 12 months post-operative follow-up was higher in the trabeculectomy group at 65.5% (95%CI: 55.6%-75.9%) compared with the XEN gel stent group at 58.5% (95%CI: 47.6%-69.4%). There was however no significant difference between both groups' surgical outcomes (P = 0.16).…”