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

Abstract

Purpose: XEN gel stents are used for the treatment of open-angle glaucoma (OAG), including primary and secondary glaucoma that are uncontrolled by previous medical therapy and cases with previous failed surgery. Our aim was to systematically review of the clinical data of currently published ab-interno XEN gel stents with an emphasis on intraocular pressure (IOP), antiglaucoma medication outcomes, and safety profiles.

Methods: We analyzed all of the publications (MEDLINE, EMBASE, Cochrane Library) on the ab-interno XEN gel stent to evaluate the reduction in IOP and antiglaucoma medications following the procedure. The primary outcomes measured for the meta-analysis were reduction in IOP and anti-glaucoma medications. The secondary outcome were adverse events. For each study, we used a random effects analysis model to calculate the mean difference and 95% confidence intervals for the continuous results (reduction in IOP and antiglaucoma medications) using the inverse variance statistical method.

Results: Five hundred twenty-seven articles were checked and 56 studies were found to be relevant with a total of 4,410 eyes. There was a significant reduction in IOP as well as in the number of medications required in patients treated with ab-interno XEN implant either alone or combined with cataract surgery. This new treatment for various types of glaucoma reduced the IOP by 35% to a final average close to 15 mmHg. This reduction was accompanied by a decrease in the number of antiglaucoma medications in all the studies, approximately 2 classes of medication at the price of more needlings. The overall complete success rate was 21.0-70.8% after 2 years using strict criteria originally designed to record success rate in filtration surgery. The incidence of complications vision-threatening was low at <1%.

Conclusions: XEN gel stent was effective and safe for primary and secondary OAG. Further studies should be performed to investigate the impact of ethnicity on the success and failure rate after XEN implantation.

Keywords: XEN gel stent; complications; meta-analysis; minimally invasive glaucoma surgeries; trabeculectomy.

Figure 1

Flow chart of included studies for the meta-analysis.

Figure 2

Mean difference (MD) of the reduction in intraocular pressure between the baseline and the final follow-up by XEN alone, phacoemulsification combined with XEN (phaco + XEN).

Figure 3

Mean difference (MD) of the reduction in anti-glaucoma medications between the baseline and the final follow-up by XEN alone, phacoemulsification combined with XEN (phaco + XEN).

Figure 4

Mean difference (MD) of the reduction in intraocular pressure between the patients after XEN implantation and trabeculectomy.