Efficacy and Safety of Open-Conjunctiva Ab Externo 63 µm vs. 45 µm XEN® Gel Stent in Glaucoma Surgery: One-Year Follow-Up

Abstract

Intraocular surgery; Minimally invasive glaucoma surgery; Open-conjunctiva approach

Cirugía intraocular; Cirugía de glaucoma mínimamente invasiva; Abordaje conjuntival abierto

Cirurgia intraocular; Cirurgia de glaucoma mínimament invasiva; Abordatge conjuntival obert

Background: To compare the efficacy and safety of the XEN® 63 µm and 45 µm devices with the ab externo open conjunctiva with a 30G needle approach. Methods: A retrospective, non-randomized and single-center study was conducted. Consecutive eyes undergoing a XEN® 63 µm implant were compared with a matched cohort of cases with a XEN® 45 µm implant. Standalone and combined procedures with phacoemulsification were included. Results: A total of 28 XEN® 45 µm and 28 XEN® 63 µm were included. Complete surgical success was achieved in 17 cases (60.7%) in the 45 µm group and in 20 cases (71.4%) in the 63 µm group, with no statistical differences. One year after the surgery, the mean IOP was 13.8 ± 3.3 mmHg for the 45 µm group and 12.4 ± 4.2 mmHg for the 63 µm group (p-value > 0.05). Likewise, the use of glaucoma medication was lowered in the 63 µm device (0.32 ± 0.87) compared to the 45 µm device (0.39 ± 0.86), with no statistical significance. Postoperative hypotony was more frequent in the 63 µm device (39.3%) than in the 45 µm group (28.6%), with no statistical differences. However, hypotony-associated complications (including choroidal detachment, hypotony keratopathy, and hypotony maculopathy) were significantly higher in the 63 µm group (p = 0.011). Conclusions: Although the XEN® 63 µm may offer a greater IOP-lowering effect with better complete surgical success, no significant differences were detected compared to the 45 µm device. Hypotony-related complications were higher in the XEN 63 µm, although most of them resolved with conservative management.