Xen45 gel stent versus trabeculectomy for glaucoma: A systematic review and meta-analysis of efficacy and safety

Although trabeculectomy is invasive, it remains the gold standard for refractory glaucoma. The XEN45 Gel Stent provides a minimally-invasive alternative; however, comprehensive data comparing its efficacy and safety to trabeculectomy remain limited. This meta-analysis evaluates outcomes between XEN45 and trabeculectomy. We conducted a systematic review and meta-analysis, following PRISMA guidelines. We searched PubMed, Web of Science, and CENTRAL from inception to July 2025. We pooled weighted mean differences (WMDs), proportions, and odds ratios (ORs), using random-effects maximum likelihood models. Primary outcomes included intraocular pressure (IOP) reduction; complete success, qualified success, and failure rates; and risk of hyphema and hypotony. Twelve studies (2,381 eyes [XEN45: 1,106; trabeculectomy: 1,275]) were included. Open-angle glaucoma was the predominant diagnosis (XEN45: 78.7%; trabeculectomy: 74.7%). Trabeculectomy showed greater IOP reduction rates (WMD: 11.9mmHg [95%CI: 10.2–13.7]) compared to the XEN45 Gel Stent (WMD: 9.1mmHg [95%CI: 7.4–10.8], p=0.02). Trabeculectomy achieved higher complete success rates (63.0%[95%CI: 56.0–70.0]) than XEN45 (47.0%[95%CI: 40.0–55.0], p=0.004), with no significant difference in qualified success (67.0% vs. 58.0%, p=0.44). Failure rates were significantly lower in the trabeculectomy group (10.0% vs. 25.0%, p=0.002). XEN45 demonstrated a superior safety profile, with significantly reduced risks of hyphema (OR: 0.34, p=0.04), hypotony (OR: 0.31, p=0.01), bleb fibrosis (OR: 0.68, p=0.01), and bleb leak (OR: 0.16, p<0.01). Trabeculectomy demonstrates superior IOP control and higher complete success rates, but at the expense of a higher complication profile. XEN45 offers a relatively safer but less effective alternative. A patient-tailored approach is essential when selecting the optimal surgical intervention.