Comparison of XEN gel stent for management of open-angle glaucoma: a systematic review and meta-analysis

Background The comparative efficacy of XEN gel stent implantation, either as a standalone procedure (XEN-only) or combined with phacoemulsification (Phaco-XEN), for the treatment of open-angle glaucoma (OAG) warrants further investigation. This systematic review and meta-analysis evaluated the efficacy of XEN-only and Phaco-XEN procedures compared to trabeculectomy (TB). Methods Five major electronic databases, including PubMed, ScienceDirect, and the Cochrane Library, were systematically searched from inception to September 1, 2025. We compared clinical outcomes among XEN-only, Phaco-XEN, and TB groups. Stratification analyses examined outcomes based on follow-up duration and geographic location. Efficacy endpoints included intraocular pressure (IOP), number of anti-glaucoma medications (NOAM), and bleb needling rates. Sensitivity analyses were performed to assess potential biases. Results A total of 56 eligible studies were included. (1) Both XEN-only and Phaco-XEN procedures achieved significant IOP reductions from baseline ( P < 0.001). When comparing XEN-only versus Phaco-XEN, no statistically significant differences were observed in postoperative IOP (MD: −0.22; P = 0.06), NOAM (MD: 0.10; P = 0.06), or bleb needling rates (RR: 1.79; P = 0.06). (2) Compared with trabeculectomy (TB), there was no significant difference in postoperative NOAM for XEN-only (MD: −0.16; P = 0.16), but XEN-only had lower postoperative IOP (MD: −0.93; P = 0.0003). However, extremely high heterogeneity ( I 2 = 86%) suggests this finding should be interpreted with caution. Conversely, XEN-only surgery was associated with a significantly higher rate of bleb needling compared to TB surgery (RR: 3.09; P = 0.001). Hyphema and bleb needling were identified as the most frequent postoperative complications. Conclusion Both XEN-only and Phaco-XEN surgeries provide effective IOP reduction. There was no statistically significant difference in postoperative NOAM reduction between XEN-only and Phaco-XEN surgeries ( P = 0.06). TB surgery remains superior regarding lower postoperative bleb needling rates compared to XEN-only surgery.