Does mitomycin-C concentration have any influence on XEN45 gel stent outcomes in a real-world setting?

Abstract

To compare the effectiveness and safety of XEN45 implanted with mitomycin-C (MMC) 0.01% versus (vs) XEN45 implanted with MMC 0.02%. Retrospective and single-center study conducted on consecutive patients with open-angle glaucoma or ocular hypertension who underwent XEN45-implant, either alone or in combination with cataract surgery. The primary end-point was the mean change in intraocular pressure (IOP) from baseline to the last follow-up visit. Fifty-five patients (63 eyes) were included. Thirty-seven (58.7%) eyes underwent surgery with MMC 0.01% and 26 (41.3%) ones with MMC 0.02%. In the overall study sample, the mean (standard error) IOP was significantly lowered from 17.6 (0.7) mm Hg at baseline to 12.6 (0.3) mm Hg at month 12. The IOP was significantly lowered from 17.3 (15.4 to 19.2) mm Hg and 17.9 (16.1 to 17.8) mm Hg at baseline to 12.3 (11.3 to 13.3) mm Hg and 13.1 (12.3 to 13.9) mm Hg at month 12 in the MMC 0.01% and MMC 0.02% groups, respectively; p < 0.0001 each. The mean number of ocular-hypotensive medications significantly decreased from 2.1 (1.9 to 2.3) at baseline to 0.2 (0.04 to 0.3) at month 12, p < 0.0001, with no significant differences between MMC 0.01% and MMC 0.02% groups, p = 0.5181. At month 12, 50 (80.6%) eyes had functioning blebs. Regarding safety, 18 (28.6%) eyes have experience adverse events. XEN45, either alone or in combination with cataract surgery, showed a good effectiveness and safety profile. MMC dose had no influence on the IOP lowering, which may support the use of the lowest dose.