Efficacy and Safety of the Ab-interno Xen Gel Stent After Failed Trabeculectomy

Karimi, Ayesha; Hopes, Marina; Martin, Keith R; Lindfield, Dan

doi:10.1097/ijg.0000000000001044

Cited by 31 publications

(43 citation statements)

References 41 publications

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“…Overall, our data are in good agreement with the results of previously published retrospective and prospective studies, showing that the XEN45 gel stent is an effective method with a safe profile for controlling IOP in glaucoma patients. Furthermore, our results are consistent with the data of a recently published retrospective case series with 17 eyes receiving a XEN45 gel implant after failed trabeculectomy [22]. At month 12, the mean IOP was effectively reduced in these pretreated eyes from 21.5 mmHg preoperatively to 13.6 mmHg ( p < 0.05) and at the same time medication was reduced from 2.8 preoperatively to 1.0 ( p < 0.05).…”

Section: Discussionsupporting

confidence: 91%

“…With regard to trabeculectomy, however, a previous study showed that eyes with initial trabeculectomy ( n = 75) had a statistically significantly higher success rate and required statistically fewer medications at 3 years postoperatively than those that underwent repeat trabeculectomy ( n = 75) [21]. Even though individual studies on the XEN45 gel stent included patients with previous glaucoma interventions [14, 15, 22], to the best of our knowledge no comparative analysis has yet been published in a peer review article.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of Minimally Invasive XEN45 Gel Stent Implantation in Glaucoma Patients Without and With Prior Interventional Therapies

Hengerer

Conrad-Hengerer

2019

Ophthalmol Ther

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Introduction The aim of our analysis was to compare the effectiveness of the XEN45 gel stent implantation in patients without and with prior glaucoma intervention. Methods Retrospective analysis including 148 medical records of consecutive glaucoma eyes without prior glaucoma intervention (group A, n = 45) or with prior glaucoma intervention (group B, n = 103). Follow-up data up to 12 months after XEN45 gel implantation were available for all eyes. Results At 12 months, qualified success (IOP reduction of ≥ 20% and IOP < 18 mmHg without and with medication) was achieved in 76% of eyes in group A and in 72% of eyes in group B; corresponding values for complete success (IOP reduction of ≥ 20% and IOP < 18 mmHg without medication) were 56% and 55%. Mean IOP was significantly reduced by 58% from 36.0 ± 10.7 mmHg preoperatively to 14.2 ± 3.4 mmHg at 12 months in group A ( p = 0.000) and by 53% from 31.6 ± 8.9 mmHg to 14.3 ± 4.2 mmHg and in group B ( p = 0.000). The mean number of hypotensive medications had significantly decreased from 3.6 ± 0.8 at baseline to 0.3 ± 0.7 medications in group A ( p = 0.000) and from 3.0 ± 1.0 to 0.3 ± 0.7 medications in group B ( p = 0.000). Needling was required in 29% of eyes in group A and in 35% of group B within 12 months. No statistically significant differences were observed between eyes without and with prior glaucoma intervention. Conclusion The 1-year results of our retrospective analysis indicate that patients without and with previous glaucoma intervention can benefit from XEN45 gel stent implantation. Both groups achieved significant and similar reductions in IOP and hypotensive medication, with a slight trend towards greater reductions in eyes without prior glaucoma intervention. Further controlled prospective studies with longer follow-ups are required. Funding Editorial support and article processing charges were funded by Allergan.

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Comparison of Minimally Invasive XEN45 Gel Stent Implantation in Glaucoma Patients Without and With Prior Interventional Therapies

Hengerer

Conrad-Hengerer

2019

Ophthalmol Ther

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“…Our study reveals that the number of glaucoma medications required by the patient decreases after XEN ® 45 or XEN ® 63 implantation surgery, and most importantly that this reduction is maintained over time for both Gel Stent models. Similar findings were reported by Karimi et al [19] although their study focused on secondary surgeries, involving the XEN ® 45 Gel Stent implantation, after failed trabeculectomy. As for the reduction in the number of IOPlowering drugs reported in our study, within the XEN ® 45 group mean changes at 1 year, 2 years, and 3 years amounted to 70%, 74.3%, and 37.5%, respectively, whereas within the XEN ® 63 group, the changes turned out to be more stable across the study duration, the mean reduction being 75%, 79.8%, and 71.9% at one, two, and three years, respectively.…”

Section: Discussionsupporting

confidence: 87%

Comparing Medium-Term Clinical Outcomes following XEN® 45 and XEN® 63 Device Implantation

Fernández-García¹,

Zhou²,

García-Alonso

et al. 2020

Journal of Ophthalmology

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Purpose. To evaluate medium-term clinical outcomes with XEN® 45 or XEN® 63 Gel Stent (Allergan, Dublin, Ireland) for treatment of primary open angle glaucoma (POAG). Materials and Methods. Retrospective, descriptive, and observational study involving 40 patients implanted with a XEN® 45 Gel Stent and 34 implanted with a XEN® 63 Gel Stent who had undergone POAG surgery and had been followed up and controlled between 12 and 36 months. Results. IOP dropped from 18.02 ± 5.23 mmHg preop to 13.81 ± 1.88, 14.80 ± 2.23, and 14.62 ± 1.90 at 1, 2, and 3 years after surgery (p<0.001) consecutively with XEN® 45 and from 19.00 ± 6.11 mmHg preop to 15.47 ± 2.45, 14.66 ± 2.45, and 15.46 ± 2.48 at 1, 2, and 3 years after surgery (p<0.001) with XEN® 63. The number of drugs used by patients to treat their glaucoma decreased after undergoing surgery in both groups. Within the XEN® 45 group, mean changes at 1 year, 2 years, and 3 years amounted to 70%, 74.3%, and 37.5%, respectively, whereas within the XEN® 63 group, the mean reduction was 75%, 79.8%, and 71.9%. When comparing the outcomes for two groups, the differences did not prove to be statistically significant. More than 90% of the procedures included in the study (using either gel-stent device) were completed without any noteworthy complications. Conclusion. POAG surgical procedures with either XEN® 45 or XEN® 63 Gel Stent implantation could be a safe and effective treatment approach.

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“…In eyes with failed filtering surgery, the bleb intervention rates have been noted to be slightly higher at 53% with a mean of 2.4 post-operative bleb interventions needed per case. [24] The higher intervention rate may be attributable to separate inclusion of both physical and pharmacological interventions (needling and/ or injections) as bleb interventions as well as a lower threshold to intervene. They note that the quadrant of XEN gel stent implantation was different (superonasal) from the quadrant of the previously operated trabeculectomy (superior).…”

Section: Bleb Revision/needlingmentioning

confidence: 99%

XEN Gel stent: A Review

Dangda¹,

Castanos²,

Do³

et al. 2019

cleverjournal

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Over the last decade, several new surgical devices and treatment options have been developed for the management of glaucoma. Together, known as micro-invasive glaucoma surgery, they aim to provide a safer approach to glaucoma surgery. Although the early devices were used to either stent or ablate a segment of the trabecular meshwork, newer devices such as the XEN gel stent (Allergan Inc., Dublin, Ireland), offer the possibility of creating a safer, more predictable filtering bleb. Since its FDA approval in 2016, several retrospective case series and prospective studies have highlighted the efficacy of the XEN gel stent with regards IOP lowering and reduction in the need for glaucoma medications. The XEN gel stent has also been shown to have a favorable safety profile in terms of intraoperative and post-operative complications. The major concern is the need for bleb intervention in the form of needling and injection of anti-fibrotic agents. This review focuses to summarize the current knowledge on the XEN gel stent for treatment of various subtypes of glaucoma.

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Efficacy and Safety of the Ab-interno Xen Gel Stent After Failed Trabeculectomy

Cited by 31 publications

References 41 publications

Comparison of Minimally Invasive XEN45 Gel Stent Implantation in Glaucoma Patients Without and With Prior Interventional Therapies

Comparison of Minimally Invasive XEN45 Gel Stent Implantation in Glaucoma Patients Without and With Prior Interventional Therapies

Comparing Medium-Term Clinical Outcomes following XEN® 45 and XEN® 63 Device Implantation

XEN Gel stent: A Review

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