Comparative Study of Trabeculectomy, PRESERFLO MicroShunt and XEN45 Gel Stent in Open-Angle Glaucoma

To compare the safety and efficacy of trabeculectomy, PRESERFLO MicroShunt (PRESERFLO) and XEN45 Gel Stent (XEN) in patients with open-angle glaucoma (OAG) during the first year.

A single-centre retrospective case-control study included 384 eyes undergoing standalone glaucoma surgery (2013-2020). Propensity score matching was used to balance baseline covariates. The primary outcome was surgical success at 1 year. Complete success was two-fold defined as an IOP of 6-15 or 6-18 mmHg, without loss of light perception, additional glaucoma surgery or IOP-lowering medication; qualified success allowed medication and/or selective laser trabeculoplasty. Secondary outcomes included IOP, best-corrected visual acuity, medication use and complications/interventions.

We included 117 in the trabeculectomy, 82 eyes in the PRESERFLO group and 185 in the XEN group. Complete success was lower after XEN for both IOP criteria (44.0%, IOP 6-18 mmHg and 41.5%, IOP 6-15 mmHg) compared to trabeculectomy (59.8% and 59.3%, respectively; p < 0.05) and PRESERFLO (73.5% and 73.3%, respectively; p < 0.001). All procedures effectively and comparably reduced IOP to 12.3 ± 4.1 mmHg (trabeculectomy), 12.7 ± 3.5 mmHg (PRESERFLO), 13.4 ± 4.3 mmHg (XEN). The proportion of drop-free patients was higher after PRESERFLO (81.0% vs. 58.6% and 56.6%, after trabeculectomy and XEN, respectively). Significant hypotony was uncommon and comparably so. Minor post-operative interventions were more common in trabeculectomy patients compared with PRESERFLO and XEN.

This study suggests equal success rates for PRESERFLO and trabeculectomy, both outperforming XEN at 1 year, with fewer post-operative interventions for PRESERFLO compared to trabeculectomy. Overall complication rates were comparable across groups.