Standalone XEN45 Gel Stent implantation versus combined XEN45-phacoemulsification in the treatment of open angle glaucoma-a systematic review and meta-analysis

Purpose: The XEN45 Gel Stent is currently the only FDA-approved sub-conjunctival minimally invasive glaucoma surgery (MIGS) procedure. It has been used worldwide either as a standalone implantation procedure or in combination with phacoemulsification surgery. Concomitant phacoemulsification is understood to influence outcomes of traditional subconjunctival filtering surgery. However, the comparative efficacy between standalone XEN45 Gel Sent implantation ("Standalone XEN45") and combined XEN-phacoemulsification surgery ("XEN45-Phaco") remains unclear. This study aims to appraise current literature to compare the efficacy of Standalone XEN45 and XEN45-Phaco in open-angle glaucoma.

Methods: A comprehensive search of PubMed, CINAHL, CENTRAL databases was performed with the terms "Xen surgery" followed by selective vetting. Pilot, cohort, observational studies and randomised controlled trials that included at least 10 patients undergoing either Standalone XEN45 or XEN45-Phaco surgeries for the treatment of open-angle glaucoma were deemed eligible for inclusion after independent assessment by 2 authors. The search workflow was reported according to the PRISMA guidelines. Data was pooled using random-effects model. A meta-analysis of continuous outcome and proportions was performed using the meta routine in R v3.2.1.

Results: Ten studies were included. There was a statistically significant difference in IOP reduction favouring Standalone XEN45 at post-operative day 1, week 1, months 1, 3 and 6. There was a statistically significant difference in decrease in IOP-lowering medications favouring Standalone XEN45 at post-operative week 1 and month 1.

Conclusion: Standalone XEN45 has superior IOP-lowering outcomes compared to XEN45-Phaco in the early post-operative period, up to 6 months after surgery.