Abstract
BACKGROUND: The XEN45 Gel Stent is a subconjunctival filtering device that has demonstrated promising efficacy. This meta-analysis quantitatively evaluates reported complications and interventions after XEN45 implantation in the treatment of open angle glaucoma (OAG). METHODS: Pilot, cohort, observational studies, and randomised controlled trials that included at least ten patients undergoing ab interno or externo XEN45 surgery, with or without phacoemulsification were deemed eligible for inclusion. A meta-analysis of proportions with random-effect models was performed using the meta routine in R version 3.2.1. Outcomes included the rate of complications and post-operative interventions. RESULTS: One hundred and fifty-two studies were identified on initial literature search and 33 were included in final analysis. Numerical hypotony was the most common post-operative complication, involving 20% of patients (95% CI: 10-31%). Post-operative gross hyphema occurred in 14% (95% CI: 7-22%) and transient intra-ocular pressure (IOP) spikes (>30 mmHg) in 13% (95% CI: 4-27%). Stent exposure occurred in 1% (95% CI: 0-2%). Stent migration occurred in 1% (95% CI: 0-3%). XEN45 revision and/or a second XEN45 implantation was performed in 5% of patients (95% CI: 3-7%). Stent relocation was performed in 3% (95% CI: 1-7%). A second glaucoma procedure was performed in 11% (95% CI: 8-15%). 26% underwent one (95% CI: 17-36%), 13% underwent two (95% CI: 5-24%) while 4% underwent three (95% CI: 2-6%) bleb needling procedures. 35% of patients (95% CI: 29-40%) required at least one needling. The average rate of needling per patient was 0.38 (95% CI: 0.20-0.59). However, there is a lack of high-quality data, with 8 of the 33 studies assessed to have a moderate to high risk of bias. CONCLUSIONS: While literature suggests that XEN45 Gel Stent implantation is safe in the treatment of OAG, the overall current level of evidence is low and further studies are needed. More than a third of patients require at least one post-operative bleb needling procedure.