Combined and stand‐alone XEN 45 gel stent implantation: 3‐year outcomes and success predictors

Abstract

PurposeTo evaluate the 3‐year treatment outcomes of XEN 45 gel stent in open‐angle glaucoma patients.MethodsIn this prospective, single‐centre interventional study, consecutive eyes with uncontrolled intraocular pressure (IOP) or signs of disease progression despite medical treatment underwent XEN implantation either alone or combined with phacoemulsification (Phaco + XEN).Main outcome measuresSurgical success was defined as 'complete' when 36‐month unmedicated IOP was ≤15 mmHg with a relative IOP reduction ≥ 20% from medicated baseline, while the definition of qualified success allowed no more medications than at baseline. Other definitions of success with different IOP thresholds were also analysed. Secondary outcomes included mean IOP reduction, changes in ocular hypotensive medications and rates of reoperations.ResultsOut of 149 eyes initially included, 92 eyes (61.7%) of 68 patients had complete 3‐year data (XEN: n = 26; Phaco + XEN: n = 66) after 38.2% were lost to follow‐up. Mean age was 76.3 ± 9.1 years, and 66.2% were female. Mean medicated IOP decreased from 20.8 ± 7.4 mmHg (21.0 ± 7.4 [XEN] vs. 20.0 ± 6.9 mmHg [Phaco + XEN]) at baseline to 13.1 ± 3.4 mmHg (12.9 ± 2.9 [XEN] vs. 12.9 ± 3.4 [Phaco + XEN]) at 3 years (−37.0%; p < 0.001). Medications decreased from 1.9 ± 1.3 (2.4 ± 1.5 [XEN] vs. 1.9 ± 1.2 [Phaco + XEN]) to 0.4 ± 0.9 (0.3 ± 0.8 [XEN] vs. 0.5 ± 0.9 [Phaco + XEN]) (−78.9%; p < 0.001). Complete success and qualified success were achieved in 29.0% and 31.0% of eyes, respectively. Needling revision was performed in 51 eyes (55.4%), and 26.1% underwent reoperations. Risk factors for surgical failure included male gender (odds ratio [OR]:3.6; p = 0.03), diagnosis of POAG (OR: 4.5; p < 0.01) and undergoing needling revision (OR: 4.6; p < 0.01). While the type of procedure had no effect on the outcomes of PEXG, POAG eyes undergoing combined surgery had significantly higher rates of failure (OR: 7.29; p = 0.023). Most patients stable at 12‐month remained so through to 3 years.ConclusionsAt 3 years, XEN gel stent implantation achieved clinically significant IOP and medication reduction despite relatively high rates of needling and reoperations. Identifying patients at risk preoperatively may help optimize surgical outcomes.

Three‐year effectiveness and safety of the XEN gel stent as a solo procedure or in combination with phacoemulsification in open‐angle glaucoma: a multicentre study

“…Three-year results from our multicentre study appear to be similar to those of published studies reporting 2year (single-and multicentre studies) (Reitsamer et al 2019;Gabbay et al 2020) and 3-year (single-centre study) (Gillmann et al 2020a) data. In a prospective, nonrandomized, singlecentre study (Gillman et al 2020a) of 92 eyes with OAG (POAG, 40.2%) that received the implant alone (28.3%) or phaco + implant (71.3%), mean (SD) medicated IOP decreased by 37.0% from 20.8 (7.4) mmHg at baseline to 13.1 (3.4) mmHg at 3 years (p < 0.01), and the mean (SD) number of medications dropped from 1.9 (1.3) to 0.4 (0.9), respectively (p < 0.001).…”

Functional Monitoring after Trabeculectomy or XEN Microstent Implantation Using Spectral Domain Optical Coherence Tomography and Visual Field Indices—A Retrospective Comparative Cohort Study

“…In our two groups treated with XEN microstent implantation, the mean IOP decreased from 24.1 ± 4.7 mmHg to 15.7 ± 3.0 mmHg (solo XEN) and 25.4 ± 5.6 mmHg to 14.7 ± 3.2 mmHg (combined XEN) 24 months after surgery. Similarly, the results of the APEX study showed a decrease in the mean IOP from 21.4 ± 3.6 mmHg to 15.2 ± 4.2 mmHg, and a decrease in glaucoma medication from 2.7 ± 0.9 to 1.1 ± 1.2 after 24 months of followup [31][32][33][34][35][36][37][38][39]. Similar to our cohort, eyes included in the APEX multicenter trial were naive to incisional glaucoma surgery and only eyes with POAG were included.…”

“…Similar to our cohort, eyes included in the APEX multicenter trial were naive to incisional glaucoma surgery and only eyes with POAG were included. The IOP-lowering and drug-sparing properties of XEN microstent implantation in POAG, as well as for glaucoma subtypes other than POAG, have also been confirmed in a number of other multiand single-center trials, mostly with follow-ups between 6 and 24 months, supporting the efficacy of XEN microstent implantation [24,[31][32][33][34][35][36][37][38][39].…”

Impact of failed ab-interno trabeculectomy (trabectome) on subsequent XEN45 gel stent implantation in pseudophakic eyes

“…While 42% of the patients underwent an open conjunctival revision surgery, 12% underwent a repeat surgery. Our results are concordant with those of previous studies on efficacy of XEN gel stent implantation [ 10 , 11 , 27 , 28 ].…”