The efficacy and safety of the XEN63 glaucoma gel stent without Mitomycin C over the first 10 years

Abstract

Abstract Purpose Long-term data regarding filtering minimally invasive glaucoma surgery remain scarce. Therefore, this study aimed to evaluate the 10-years long-term efficacy and safety of the XEN63 implant (63µm inner diameter, Aquesys Inc./AbbVie Plc). Methods This prospective, monocentric longitudinal study included 28 eyes of 26 patients with open angle glaucoma. Implantation of the XEN63 implant was performed at a tertiary study center either as solo procedure or combined with cataract surgery. Notably, neither Mitomycin C nor primary needling was used. Annual examinations of intraocular pressure (IOP), number of IOP-lowering-medications, best-corrected visual acuity (BCVA), visual field mean deviation (VF-MD), complications, surgical success and secondary procedures were analyzed over the first 10 years. Results The preoperative mean IOP of 23.3±4.3mmHg and mean number of IOP-lowering-medications of 3.1±1.1 significantly reduced to 12.8±2.7mmHg and 1.1±1.2, respectively, at 10 years (n=8, p<0.001). 50% (14/28) of all eyes dropped out due to secondary IOP-lowering surgery or explantation until 10 years follow-up. Overall surgical success was achieved in 42% after 8 years and 36% after 10 years, apparently at the expense of 88% (7/8) eyes that required an average of 3.7±2.4 needlings. VF-MD remained stable. Conclusions XEN63 implantation significantly reduced IOP (-45%) and the number of IOP-lowering-medications (-65%) at the 10 years follow-up. However, limitations must be taken into account here with regard to a potentially attrition effect. A comparison of the results of our early learning curve study population with those reported in the literature on conventional trabeculectomy suggests lower surgical success rates; however, this was accompanied by a comparable need for medications but higher needling rates, while at the same time fewer complications occurred.