Complications and post-operative interventions in XEN45 gel stent implantation in the treatment of open angle glaucoma-a systematic review and meta-analysis

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.