Abstract
Objectives: We evaluated the 3-year effectiveness and safety of XEN45, combined or not with phacoemulsification, in patients from the Italian XEN-Glaucoma Treatment Registry. Methods: Data from glaucoma patients who underwent XEN45 alone or combined with phacoemulsification were analyzed. Changes in intraocular pressure (IOP) and the number of ocular hypotensive medications (OHMs) were tested with repeated measures ANOVA in last observation carried forward (LOCF) and per-protocol (PP) analyses. Complete and qualified success (IOP < 18 mmHg and ≥20% IOP reduction from baseline, without or with OHMs) at 36 months and pre- and intraoperative factors predicting surgery failure were explored using survival analysis and Cox proportional-hazard models. Complications rates were evaluated to assess safety. Results: The analysis included 239 eyes (239 patients): 144 (60.2%) in the XEN alone and 95 (39.8%) in the XEN+Phaco groups. Overall success was achieved in 164 (68.1%) eyes [113 (68.9%) complete and 51 (31.1%) qualified], without significant differences in success (p = 0.07) and survival rates (p = 0.46) between groups. At the 36th month, the baseline IOP decreased from a median (IQR) of 23.0 (20.0-26.0) to 15.0 (12.0-17.5) mmHg (p < 0.01), with an overall 34.1 ± 20.1% IOP reduction. The mean ± SD number of OHMs decreased from the baseline of 2.7 ± 0.9 to 0.9 ± 1.1 at month 36 (p < 0.01). PP and LOCF analyses were comparable. Neither pre- nor intraoperative factors were significantly predictive of surgery failure. In 91 (38.1%) and 57 (23.8%) of the eyes, at least one postoperative complication occurred early (