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3-year Outcomes of XEN Implant Compared to Trabeculectomy, With or Without Phacoemulsification for Open-angle Glaucoma

J Glaucoma. 2022 Aug 1. doi: 10.1097/IJG.0000000000002090. Online ahead of print.

ABSTRACT

PRCIS: Trabeculectomy surgery reduces the intraocular pressure (IOP) more than the XEN45 implant over 3 years. There is no difference in the number of antiglaucoma medications between the two procedures. The decision to perform either trabeculectomy or XEN45 implantation must be evaluated on a case-by-case basis, taking into account the high rate of needling of the XEN45.

PURPOSE: The aim of this study was to compare the differences between the efficacy and safety of the XEN45 implant and trabeculectomy (TRAB), either alone or in combination with phacoemulsification (PHACO), in patients with open-angle glaucoma (OAG) at 36 months.

METHODS: A retrospective, single-center and comparative study conducted on OAG patients that underwent XEN45 implantation or trabeculectomy from 2016 to 2018. Patients were divided into four groups: group 1 (XEN45 alone); group 2 (XEN45+PHACO); group 3 (TRAB alone); group 4 (TRAB+PHACO). For statistical purposes, groups 1 and 2 were combined (XEN45 implant), while groups 3 and 4 were also combined (TRAB surgery). Intraocular pressure (IOP), number of antiglaucoma medications (NOAM) and adverse events were evaluated. The main outcome measure was the reduction in IOP at 36 months postoperatively.

RESULTS: One hundred and thirty-four patients (134 eyes; 63 XEN45 and 71 TRAB) were included. The mean (95% CI) IOP reduction at the end of the study follow-up was-6.3 (-11.0 to -1.6 mmHg, P=0.025, XEN45 alone),-8.9 (-11.0 to-6.8 mmHg, P<0.001, TRAB alone),-2.5 (-4.5 to -0.4 mmHg, P=0.019, XEN45+PHACO), and-5.6 (-7.7 to-3.4 mmHg, P<0.001, TRAB±PHACO). The proportion of patients achieving an IOP≥6 and≤16 mmHg without treatment at the end of the 36-month follow-up were 50.8% (32/63) in the XEN45 implant and 49.3% (35/71) in the TRAB surgery group, P=0.863. The mean number of antiglaucoma medications was significantly reduced in all the study groups. The needling rate was 19% in XEN45 versus 5.6% in the TRAB group (P=0.030), and 2.81% and 36.6% of eyes in the TRAB group presented anterior chamber (AC) flattening and hyphema, respectively.

CONCLUSIONS: Trabeculectomy surgery lowered IOP significantly more than XEN45 implant with or without phacoemulsification over 3 years and had a significantly lower need for additional needling surgery. Both procedures reduce the number of antiglaucoma medications to a similar rate. These findings are relevant to the informed consent process and patient decisions for one procedure over the other.

PMID:35939830 | DOI:10.1097/IJG.0000000000002090

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