Retrospective Analysis of 12 Months Glaucoma Implant Efficacy: XEN45 and PreserFlo Microshunt

Abstract

Purpose Several new implant devices have recently been introduced to glaucoma surgery using various techniques for reducing intraocular pressure (IOP). Two implants introduced during the past couple of years, XEN45 and PreserFlo Microshunt, are both designed to control subconjunctival filtration. There are two Swiss multicenter studies that collected the data retrospectively to analyze the efficacy and safety of these two devices separately. In this study, we report the analysis of the combined data subset from the University Hospital of Basel. Subjects and Methods The XEN45 implantation technique was introduced to Basel University Hospital in 2016 and PreserFlo Microshunt in 2018. Sixty operated patients, thirty in each group, were operated on by one surgeon, clinically followed up, and their data retrospectively analyzed from medical records. Only standalone procedures, without combined phacoemulsification, were considered in this analysis; the lens status, however, was neither an inclusion nor an exclusion criterion. Further inclusion criteria were the diagnosis of open-angle glaucoma, no previous glaucoma surgery, other than laser trabeculoplasty, and complete medical records during the 12 months of follow-up. IOP reduction during a 12-month postoperative period was the primary outcome measure as well as the number of IOP reducing drugs. The number of subsequent surgical interventions and complications/adverse events are descriptively reported. Results Patient age, gender, ophthalmological diagnosis, and initial preoperative IOP were well balanced between the two groups. Postoperative IOP course was comparable between the two methods for the first 12 months. IOP measurements were taken preoperatively and then on the first postop day, week 1, month 1, and months 3, 6, and 12 for the PreserFlo Microshunt vs. XEN45 (mmHg): 23.6 vs. 24.9, 9.0 vs. 8.9, 11.4 vs. 10.6, 13.0 vs.18.3, 16.8 vs.15.1, 15.9 vs.15.0, and 15.4 vs.14.5, respectively. IOP reducing medications were also comparable between the two groups. The study showed that subsequent interventions were more frequent in the XEN45 (13) than in the PreserFlo Microshunt group (7). Conclusion Both methods demonstrate satisfactory IOP control within a 12-month postoperative period with practically no serious adverse events/complications, but with relatively high numbers of subsequent interventions (needlings), particularly in the XEN45 group.

Long-term Outcomes of PreserFlo MicroShunt versus XEN45 Gel Stent in Open-Angle Glaucoma

“…Regarding the number of needling procedures, there was no difference between the two groups. This contrasts with previously published studies in which the needling rate tended to be higher in the XEN group 19 , 21 .…”

“…There was no statistically significant difference between the two groups. A third study with direct comparison of XEN and MicroShunt as a stand-alone procedure with a follow-up of 12 months was performed at the University Eye Hospital in Basel by Saletta et al [21]. Thirty eyes per group were included.…”

Efficacy of the PRESERFLO MicroShunt and a Meta-Analysis of the Literature

“…The literature search yielded a total of 311 articles of which 14 studies (including 1213 PRESERFLO MicroShunt surgeries) were included in the current study and considered eligible for the meta-analysis ( Table S1, Figure S2 ) [ 9 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 ]. Follow-up ranged from 12 months to 72 months.…”

Swiss Multicenter Ab Interno XEN45 Gel Stent Study: 2-Year Real-World Data

“…All patients were treated with a XEN Gel Stent 45 μm through a classic ab interno approach as described previously in multiple publications, e.g., Fae et al [ 19 ], Vera et al [ 12 ] and Saletta et al [ 20 ]. The XEN45 implantation was performed as a standalone surgery or in combination with phacoemulsification cataract surgery.…”