The purpose of this study was to evaluate the efficacy and safety of the XEN45 implant in patients with open angle glaucoma (OAG) at 36 months, versus that of TRAB alone or in conjunction with phacoemulsification (PHACO). An analysis of OAG patients who had XEN45 implantation or TRAB between 2016 and 2018; a retrospective, single-center study. Patients were randomly assigned to 1 of 4 treatment groups: 4 groups: group 1 (XEN45 alone), group 2 (XEN45+PHACO), group 3 (TRAB alone), and group 4 (TRAB+PHACO). Groups 1 and 2 were combined (XEN45 implant) for statistical considerations, as were Groups 3 and 4. (TRAB surgery). The incidence of side effects, number of glaucoma drugs, and intraocular pressure were all measured. At 36 months post-op, the decrease in intraocular pressure (IOP) was the primary outcome measure. Total enrollment was 134 people (63 XEN45 and 71 TRAB, for a total of 134 eyes). The average (95% confidence range) decrease in IOP from baseline to the end of the research was −6.3 (−11.0 to −1.6 mm Hg, P=0.025, XEN45 alone), −8.9 (−11.0 to −6.8 mm Hg, P<0.001, TRAB alone), −2.5 (−4.5 to −0.4 mm Hg, P=0.019, XEN45+PHACO), and −5.6 (−7.7 to −3.4 mm Hg, P<0.001, TRAB±PHACO). At the end of the 36-month follow-up period, 50.8% (32/63) of patients who received the XEN45 implant and 49.3% (35/71) of patients who underwent TRAB surgery had achieved an IOP more than or equal to 6 and less than or equal to 16 mm Hg without therapy (P=0.863). In all of the trial groups, the average number of glaucoma drugs dropped dramatically. Needling occurred in 19% of XEN45 eyes compared to 5.6% of TRAB eyes (P=0.030), whereas anterior chamber flattening and hyphema occurred in 2.81 and 36.6% of TRAB eyes, respectively. Over the course of 3 years, TRAB surgery reduced IOP more than the XEN45 implant with or without phacoemulsification and required much less follow-up needling surgery. Both treatments were equally effective in reducing glaucoma medication dosages. These results have implications for patient decision-making during the informed consent phase and when choosing between 2 procedures.
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