Comparative efficacy and safety of ab-interno XEN 45 gel implantation versus trabeculectomy for glaucoma: a systematic review and meta-analysis.

BACKGROUND

Trabeculectomy remains the standard surgical treatment for glaucoma, but is associated with postoperative complications. XEN gel stent implantation has emerged as a minimally invasive alternative, though comparative evidence regarding its efficacy and safety remains inconsistent.

OBJECTIVES

To compare the efficacy and safety of ab-interno XEN 45 gel stent implantation versus trabeculectomy in patients with glaucoma.

DESIGN

Systematic review and meta-analysis.

DATA SOURCES AND

METHODS

A comprehensive literature search was conducted across PubMed, Embase, Scopus, the Cochrane Library, and Web of Science to identify studies comparing the XEN Gel Stent with trabeculectomy. Random-effects meta-analyses were performed using odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals (CIs).

RESULTS

Eleven studies comprising 1260 eyes (645 XEN, 615 trabeculectomy) were included. Trabeculectomy achieved significantly greater intraocular pressure (IOP) reduction (MD: -2.16 mmHg (95% CI: -2.88 to -1.44); I 2 = 43%) and higher qualified (OR: 1.59 (95% CI: 1.18 to 2.14); I 2 = 0%) and complete surgical success rates (OR: 1.72 (95% CI: 1.16 to 2.56); I 2 = 43%). No significant difference was observed in the number of antiglaucoma medications (MD: -0.03 (95% CI: -0.23 to 0.18); I 2 = 53%). Rates of hyphema, choroidal detachment, hypotony, flat anterior chamber, bleb revision, and reoperation showed no statistically significant differences between procedures, although substantial heterogeneity was observed for hyphema (I 2 = 60%), hypotony (I 2 = 76%), and reoperation (I 2 = 53%). XEN demonstrated significantly lower risks of bleb leakage and endophthalmitis but higher rates of bleb needling.

CONCLUSION

Trabeculectomy achieves greater intraocular pressure reduction and higher surgical success rates than ab-interno XEN45 gel stent implantation, whereas XEN is associated with lower rates of selected bleb-related complications. Procedure selection should be individualized according to target intraocular pressure, glaucoma severity, and postoperative management requirements.

TRIAL REGISTRATION: PROSPERO (CRD420251075034).