Safety and efficacy outcomes of the Xen45 Gel Stent use for refractory glaucoma: a surgery series from surgeon trainees at a tertiary teaching hospital

Hong, Karen; Lind, John T.; Sheybani, Arsham

doi:10.1186/s40662-019-0171-0

Cited by 16 publications

(23 citation statements)

References 21 publications

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“…Such reports on the IOP reducing efficacy rates for adverse effects and visual recovery have been published for XEN45 9 , 10 , 11 and also for the PreserFlo Microshunt 12 . According to the literature, XEN45 was successfully applied to various forms of glaucoma, resulting in IOP readings comparable to ours 13 , 14 , 15 , 16 . However, there are fewer published studies on the PreserFlo Microshunt (industry-initiated trials), as this product has only been on the market under the current name since 2016 compared to XEN45 (since 2014).…”

Section: Discussionsupporting

confidence: 59%

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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Section: Discussionsupporting

confidence: 59%

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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“…A number of studies have examined ab interno XEN Gel Stent implantation in mixed POAG populations and found mean IOP reductions ranging from 28 to 42.1% with postoperative IOPs ranging from 12 to 15 mmHg. 18 , 21 , 22 , 23 , 24 , 37 , 38 , 39 , 40 , 41 Direct comparison of ab interno XEN Gel Stent implantation with trabeculectomy in POAG patients found no difference in the rates of surgical success or reduction in IOP lowering medications. 24 , 39 , 42 , 43 While one study found that trabeculectomy resulted in lower postoperative IOPs, 39 others found no difference.…”

Section: Discussionmentioning

confidence: 97%

Effective treatment of a normal-tension glaucoma patient with bilateral ab externo XEN Gel Stent implantation

Harris

Valle

2020

American Journal of Ophthalmology Case Reports

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Purpose To provide the first report of effective use of bilateral XEN Gel Stent implantation using an ab externo open-conjunctival approach designed to improve bleb function and meet the uniquely low intraocular pressure requirements of a Japanese patient with normal-tension glaucoma refractory to topical medical therapy. Observations A 54-year-old phakic Japanese woman with severe normal-tension glaucoma on maximally tolerated medical therapy of four topical agents presented with above-goal intraocular pressures and new medication intolerances. She underwent bilateral ab externo open-conjunctival XEN Gel Stent implantation with tenectomy and sub-Tenon's injection of 40μg of mitomycin-C, which resulted in reduction of intraocular pressures by 41.2 and 28.6% to 10 and 10 mmHg in the right and left eyes, respectively at the most recent visit. Postoperatively, a diffuse filtering bleb with good morphology developed in both eyes. The procedure has so far allowed for complete cessation of all four topical medications for up to eight months following surgery without any serious complications. Conclusions This case illustrates the potential of Xen Gel Stent implantation through an ab externo, open-conjunctival approach to be an effective, simple alternative to trabeculectomy to meet the unique low-pressure requirements of normal-tension glaucoma patients with practical and safety benefits of a micro-invasive approach.

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“…The efficacy of the XEN implant was demonstrated in intermediate and incipient glaucoma [ 14 , 15 ]. However, only few studies have evaluated the efficacy of XEN implants in OUG [ 16 – 18 ], and the longest follow-up period in these studies was 12 months. Therefore, this study aimed to retrospectively evaluate the efficacy of XEN implantation in 72 patients with OUG during a long-term follow-up period.…”

Section: Introductionmentioning

confidence: 99%

XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma: Results and Complications during a Long-Term Follow-Up

Lewczuk

Konopińska

Jabłońska

et al. 2021

Journal of Ophthalmology

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This study aimed to analyze the surgical and refractive outcomes of XEN glaucoma implant (Allergan, an Abbvie company, Irvine, CA, USA), a minimally invasive surgical device for the treatment of operated uncontrolled glaucoma. Eyes that received XEN Gel Stent placement from December 2014 to October 2019 were retrospectively investigated. Intraocular pressure (IOP) change, best-corrected visual acuity (BCVA), change in glaucoma medications, frequency of slit lamp revision procedures, and frequency of secondary glaucoma surgeries were the primary outcomes. Seventy-two eyes of 72 subjects were included in the study: 32 (44%) men and 40 (56%) women. The follow-up period ranged from 1 to 50 months (median, 26.13 months). The mean IOP before surgery was 24.82 ± 8.03 mmHg and decreased to 17.45 ± 5.84 mmHg at the end of the study (mean difference [MD] = −7.48, 95% confidence interval [CI]: −10.04, −4.93; p < 0.001 ). The mean decrease from baseline was 23%. BCVA before surgery was 0.38 ± 0.30, and that at the end of the follow-up period improved to 0.47 ± 0.37, MD = 0.09, 95% CI: 0.04, 0.13; p < 0.001 . Additional procedures (fluorouracil injection and bleb needling) were performed in 11/72 patients (15%). Further glaucoma surgery was necessary for 23.9% of the patients. XEN Gel Stent implantation is both safe and reasonably effective for lowering IOP in operated uncontrolled glaucoma patients.

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Safety and efficacy outcomes of the Xen45 Gel Stent use for refractory glaucoma: a surgery series from surgeon trainees at a tertiary teaching hospital

Cited by 16 publications

References 21 publications

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

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

Effective treatment of a normal-tension glaucoma patient with bilateral ab externo XEN Gel Stent implantation

XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma: Results and Complications during a Long-Term Follow-Up

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