XEN^® Gel Stent compared to PRESERFLO™ MicroShunt implantation for primary open‐angle glaucoma: two‐year results

Abstract

To evaluate the long-term efficacy and safety of two minimally invasive glaucoma surgery implants with a subconjunctival drainage approach: the XEN45 Gel Stent â (Xen) implant and the PRESERFLO TM MicroShunt (MicroShunt). Methods: Retrospective comparative case series of primary open-angle glaucoma (POAG) patients with at least 6 months of follow-up after a MicroShunt or Xen implantation augmented with mitomycin C. Results: Forty-one eyes of 31 patients underwent Xen implantation, and 41 eyes of 33 patients, MicroShunt implantation. Baseline characteristics were similar, except for more combined surgeries with phacoemulsification in the Xen group (37% vs. 2%). Mean baseline IOP AE standard deviation dropped from 19.2 AE 4.4 to 13.8 AE 3.8 mmHg (n = 26) in the Xen group and from 20.1 AE 5.0 to 12.1 AE 3.5 (n = 14) in the MicroShunt group at 24 months of follow-up (p = 0.19, t-test). The number of IOP-lowering medications dropped from 2.5 AE 1.4 to 0.9 AE 1.2 in the Xen group and from 2.3 AE 1.5 to 0.7 AE 1.1 in the MicroShunt group. The probability of qualified success was 73% and 79% at 24 months of follow-up for the Xen and MicroShunt groups, respectively. Postoperative complications were usually mild and self-limiting. The number of bleb needling and secondary glaucoma surgery procedures was similar in both groups; however, in the Xen group more additional MicroPulse â transscleral cyclophotocoagulation procedures were performed. Conclusion: Xen Gel Stent and PreserFlo MicroShunt implantations achieved comparable results in POAG eyes in terms of IOP-lowering and surgical success, with a similar high safety profile.

Clinical outcomes of combined Preserflo Microshunt implantation and cataract surgery in open-angle glaucoma patients

“…We found a slightly greater proportion of complete success (62.1% vs 58.0%, respectively) and qualified success (82.8% vs 79.0%, respectively) than that reported by Scheres et al at month 12, although our sample had a higher baseline IOP 12 .…”

“…Similarly, Scheres et al 12 , in a retrospective study, which included 14 eyes who underwent PMS implantation, reported that mean IOP was significantly decreased from 20.1 ± 5.0 mmHg at baseline to 13.3 ± 2.9 at month-12 (mean difference − 6.8 ± 4.1 mmHg, 95% CI − 10.0 to − 3.6 mmHg, p < 0.0001).…”

Efficacy of the XEN-Implant in Glaucoma and a Meta-Analysis of the Literature

“…The literature search yielded a total of 311 articles of which 19 including 2215 XEN-implant surgeries were included and considered eligible for the meta-analyses ( Figure S1 ) [ 8 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 ]. Most studies analyzed a mixture of different types of glaucoma and were limited to a follow-up of one year ( Table S1 ).…”

“…The WMD (95% CI; I 2 ) for IOP (in mmHg) was 7.33 (6.90–7.76; 94%), and for IOP-lowering medication, 1.63 (1.51–1.74; 70%) after two-year follow-up. Unfortunately, only four studies evaluated differences in IOP and IOP-lowering medication between XEN-implant as a standalone procedure and as a combined procedure [ 23 , 25 , 28 , 29 ]. Nonetheless, differences were not statistically significant at follow-up ( Figure S4 ).…”

Efficacy and Safety of PreserFlo® MicroShunt After a Failed Trabeculectomy in Eyes with Primary Open-Angle Glaucoma: A Retrospective Study

“…Mitomycin C (MMC) is also used during the implantation. The device redirects the aqueous humor posteriorly, and has been found to be effective at reducing IOP in initial non-comparative studies on glaucoma and ocular hypertensive eyes, with a low rate of complications, both in the short and in the long term [11][12][13][14]. As a result of the moderately invasive nature of the procedure compared to a trabeculectomy or a GDI, as well as the benefit of posterior aqueous humor redirection, the PreserFlo Ò MicroShunt may be a viable surgical option in eyes with a failed trabeculectomy.…”