Short-Term Efficacy and Safety of Open Conjunctiva Ab Externo XEN45 Gel Stent Implantation in Glaucoma Patients

Abstract

Prcis: We examined the safety and efficacy of the open conjunctiva ab externo approach for XEN45 gel stent implantation. There was a significant reduction in intraocular pressure (IOP) and number of glaucoma medications at 12 months follow-up.

Purpose: This study aims to determine the safety and efficacy of the open conjunctiva ab externo approach to XEN45 stent implantation.

Materials and methods: Retrospective chart review of all patients between July 2018 and March 2020 who underwent XEN45 implantation. IOP and the number of glaucoma medications were measured at the preoperative, 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months postoperative appointments. The primary outcome of this study is the number of cases achieving complete success at 12 months postoperatively.

Results: Forty-four eyes of 44 patients were included. Mean preoperative IOP was 26.2±8.7 mm Hg on 3.2±0.7 IOP-lowering medications. At 12 months postoperative, mean IOP was 18.9±9.1 mm Hg (n=35, P <0.0001; mean reduction of 27.9%) on 0.9±1.4 (n=35, P <0.0001) IOP-lowering medications. Postoperative needling was performed in 5 cases (11.4%). Of the 35 cases with a postoperative visit at 12 months, complete success was achieved in 14 cases (40.0%) and qualified success in 3 cases (8.6%). Eighteen cases (51.4%) were recorded as failures at 12 months, comprised of 4 cases requiring reoperation for glaucoma (2 XEN45 implants, 1 trabeculectomy, and 1 Baerveldt implant), and 14 cases that did not meet the IOP-lowering criteria for success. During the postoperative course, there was 1 case of self-limited hypotony, 2 self-resolving choroidal effusions, and 3 cases of bleb leakage.

Conclusions: The open conjunctiva ab externo approach to XEN45 implantation achieved successful levels of IOP reduction in 48.6% of glaucoma cases within the first year. The most common adverse events included the need for additional glaucoma surgery (excluding needling procedures), transient hypotony, and bleb leak.