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

Reitsamer, Herbert A.; Vera, Vanessa; Ruben, Simon; Au, Leon; Vila-Arteaga, J.; Teus, Miguel A.; Lenzhofer, Markus; Shirlaw, Andrew; Bai, Zhanying; Balaram, Mini; Stalmans, Ingeborg

doi:10.1111/aos.14886

Cited by 45 publications

(78 citation statements)

References 15 publications

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“…We found that a failed trabectome surgery does not affect the outcomes, including postoperative IOP, postoperative medication score, side effects, revision rate, repeat surgery rate, and success rate, of a subsequent XEN45 gel stent implantation. Our findings, which were consistent with those of previous studies, provided further evidence for the efficacy of XEN gel stent implantation in reducing both IOP and medication scores while retaining a favorable safety profile [10][11][12][13][14][15][16].…”

Section: Discussionsupporting

confidence: 92%

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

et al. 2021

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Purpose To determine the impact of failed ab-interno trabeculectomy on the postoperative outcome of subsequent XEN45 gel stent (Allergan, CA, USA) implantation in pseudophakic eyes. Methods In this retrospective single-center study, we included 60 pseudophakic eyes from 60 participants who underwent XEN45 gel stent implantation. Thirty eyes each underwent primary stent implantation (control group) or had previously undergone a failed ab-interno trabeculectomy (trabectome group). The groups were matched at a 1:1 ratio based on the following criteria: preoperative and maximum Intraocular pressure (IOP), preoperative medication score, cup/disk-ratio, follow-up time, best-corrected visual acuity at baseline, age, and the proportion of patients classified as primary open angle glaucoma or exfoliation glaucoma. We defined a successful surgery by the following three scores: an IOP reduction > 20% and IOP at the longest follow-up < 21 mmHg (Score A) or < 18 mmHg (Score B) or IOP ≤ 15 mmHg and an IOP reduction ≥ 40% (Score C). One open conjunctival revision was allowed in all scores, and a repeat surgery was considered a failure. Results Following an average follow-up period of 22 ± 12 months, we observed a mean IOP reduction of 38%, from 23.5 ± 5.2–14.5 ± 5.0 mmHg. Comparative analyses between the groups did not reveal a significant difference in the postoperative IOP, postoperative medication score, side effects, revision rate, repeat surgery rate, or success rate. Conclusions Trabectome is a viable first-line procedure for medically uncontrolled glaucoma before filtering ab-interno microstent surgery is considered.

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Section: Discussionsupporting

confidence: 92%

“…The implant has a small lumen, which assures a moderate drainage of the aqueous humor into the subconjunctival space with minimal side effects, such as hypotony. Several researchers have reported on their favorable safety profile, along with the promising IOP-lowering potential [10][11][12][13][14][15][16].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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“…Gel stent XEN45 was introduced in its current form with 45 micrometers lumen several years prior to the PreserFlo Microshunt, hence, several studies have been published on its safety and efficacy. In these studies, the observation period ranged from 6 months [6] to 3 years [7,8], and IOP reduction success rates were comparable to the Basel groups.…”

Section: Discussionmentioning

confidence: 90%

“…Die IOD-Werte in mmHg präoperativ/am 1. postoperativen Tag/Woche 1/Monate 1/3/6/ 12 waren jeweils für PreserFlo Microshunt und XEN45 wie folgt: 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; 15,4 vs. 14,5. Die Anzahl der IOD-senkenden Medikamente war postoperativ zwischen den 2 Gruppen ausbalanciert; die Anzahl der nachträglichen Interventionen war höher in der XEN45-( 13) als in der PreserFlo-Microshunt-Gruppe (7).…”

Section: Methodsunclassified

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

Saletta

Alexoudis

Gkatzioufas

et al. 2022

Klin Monbl Augenheilkd

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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.

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“…Eight non-randomized studies compared the outcomes between XEN standalone and XEN combined with cataract surgery. Six studies directly noted that there was no significant difference between the two groups (9,19,43,53,63,81). Fea et al (12) demonstrated that compared with the combined group, more patients in the standalone group achieved complete success with IOP ≤14 mmHg and no antiglaucoma medications (41.6 vs. 22.9%, respectively; p = 0.03).…”

Section: Comparison With Other Surgeriesmentioning

confidence: 99%

The Outcomes of XEN Gel Stent Implantation: A Systematic Review and Meta-Analysis

et al. 2022

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PurposeXEN gel stents are used for the treatment of open-angle glaucoma (OAG), including primary and secondary glaucoma that are uncontrolled by previous medical therapy and cases with previous failed surgery. Our aim was to systematically review of the clinical data of currently published ab-interno XEN gel stents with an emphasis on intraocular pressure (IOP), antiglaucoma medication outcomes, and safety profiles.MethodsWe analyzed all of the publications (MEDLINE, EMBASE, Cochrane Library) on the ab-interno XEN gel stent to evaluate the reduction in IOP and antiglaucoma medications following the procedure. The primary outcomes measured for the meta-analysis were reduction in IOP and anti-glaucoma medications. The secondary outcome were adverse events. For each study, we used a random effects analysis model to calculate the mean difference and 95% confidence intervals for the continuous results (reduction in IOP and antiglaucoma medications) using the inverse variance statistical method.ResultsFive hundred twenty-seven articles were checked and 56 studies were found to be relevant with a total of 4,410 eyes. There was a significant reduction in IOP as well as in the number of medications required in patients treated with ab-interno XEN implant either alone or combined with cataract surgery. This new treatment for various types of glaucoma reduced the IOP by 35% to a final average close to 15 mmHg. This reduction was accompanied by a decrease in the number of antiglaucoma medications in all the studies, approximately 2 classes of medication at the price of more needlings. The overall complete success rate was 21.0–70.8% after 2 years using strict criteria originally designed to record success rate in filtration surgery. The incidence of complications vision-threatening was low at <1%.ConclusionsXEN gel stent was effective and safe for primary and secondary OAG. Further studies should be performed to investigate the impact of ethnicity on the success and failure rate after XEN implantation.

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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

Cited by 45 publications

References 15 publications

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

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

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

The Outcomes of XEN Gel Stent Implantation: A Systematic Review and Meta-Analysis

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