Early Clinical Results of a Novel Ab Interno Gel Stent for the Surgical Treatment of Open-angle Glaucoma

Sheybani, Arsham; Dick, H. Burkhard; Ahmed, Iqbal Ike K.

doi:10.1097/ijg.0000000000000352

Cited by 110 publications

(87 citation statements)

References 19 publications

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“…In 2016, Sheybani et al published a prospective study of 49 patients with open‐angle glaucoma who underwent insertion of the XEN Gel Implant with mitomycin C . Patients had a baseline IOP of 23.1 ± 4.1 mmHg on an average of 3.0 ± 1.1 medications.…”

Section: Subconjunctival Spacementioning

confidence: 99%

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Minimally invasive glaucoma surgery as primary stand‐alone surgery for glaucoma

Kerr

Wang

Barton

2017

Clinical Exper Ophthalmology

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Recently, many new devices and procedures have been developed to lower intraocular pressure in a less invasive and purportedly safer manner than traditional glaucoma surgery. These new devices might encourage an earlier transition to surgery and reduce the long-term commitment to topical glaucoma medications with their associated compliance and intolerance issues. Although often seen as an adjunct to cataract surgery, a growing body of evidence suggests that primary minimally invasive glaucoma surgery may be a viable initial treatment option. New studies have shown that primary ab interno trabeculectomy (Trabectome, NeoMedix Inc., Tustin, CA, USA), trabecular micro-bypass stent insertion (iStent and iStent Inject, Glaukos Corporation, Laguna Hills, CA, USA), canalicular scaffolding (Hydrus, Invantis Inc., Irvine CA, USA), the ab interno gel Implant (XEN, Allergan, Dublin, Ireland) or supraciliary stenting (CyPass Micro-Stent, Alcon, Fort Worth, TX, USA) may lower the lowering intraocular pressure and/or topical medication burden in phakic or pseudophakic patients with glaucoma. This effect seems to last at least 12 months but reliable cost-effectiveness and quality of life indicators have not yet been established by investigator-initiated randomized trials of sufficient size and duration.

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Section: Subconjunctival Spacementioning

confidence: 99%

“…Patients had a baseline IOP of 23.1 ± 4.1 mmHg on an average of 3.0 ± 1.1 medications. At 12 months, 89% of patients achieved an IOP ≤ 18 mmHg and ≥ 20% reduction . Forty percent of patients were medication‐free at 12 months …”

Section: Subconjunctival Spacementioning

confidence: 99%

Minimally invasive glaucoma surgery as primary stand‐alone surgery for glaucoma

Kerr

Wang

Barton

2017

Clinical Exper Ophthalmology

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“…Given its relatively recent appearance on the market (FDA approval on November 21, 2016), the XEN45 MIGS procedure is not as commonly performed as incisional or other available MIGS procedures. The first prospective studies started with examination of the larger XEN63 and XEN140 devices [4,5] and since then there have been prospective [6][7][8][9][10][11] and retrospective [12][13][14][15] studies examining the safety and efficacy of XEN45 Gel Stent placement. Overall, the consensus is that the XEN45 is effective in lowering IOP in patients with open angle glaucoma over the course of 12 months [16].…”

Section: Introductionmentioning

confidence: 99%

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

2020

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Background: To study the effect of an ab interno gelatin stent (XEN45 Gel Stent, Allergan Inc., Irvine, California, USA) on intraocular pressure (IOP) as placed by glaucoma fellowship trainees in eyes with refractory glaucoma. Methods: A prospective noncomparative study at a tertiary training center on 28 unique eyes undergoing ab interno gelatin stent implantation by glaucoma fellowship trainees. Data was collected at baseline and postoperatively at day 1, week 1, and months 1, 3, 5, and 12. Primary outcome was mean IOP change. Secondary outcomes included change in number of glaucoma medication classes and visual acuity. Safety outcomes included needling rates. Surgical success was defined by achieving ≥20% reduction in IOP with the same or fewer classes of antiglaucoma medications from baseline without the need for secondary surgical intervention and/or stent removal. Results: At baseline, 28.6% (8/28) of the subjects had prior failed incisional glaucoma surgery in a study population that was 54% African-American, with 78% with severe glaucoma (average mean deviation of − 14.58 dB). Thirteen subjects terminated their clinic visits before their 12-month postoperative visit, leaving 15 subjects for end point analysis. Average IOP went from 21.6 mmHg (range 12.0-31.0, SD 6.6) at baseline to 12.5 mmHg (range 7.0-19.0, SD 3.6), a 42.1% reduction (p < 0.007). All subjects decreased the number of medication classes they were taking with an average reduction of 3.8 (range 2-5, SD 0.9) to 1.3 (range 0-3, SD 1.0) classes, or a 65.8% decrease (p < 0.006). Crude surgical success was 80.0% for the 15 subjects that followed up at 12 months. The Kaplan-Meier cumulative probability of success for all 28 subjects at 12 months was 70.4% (95% CI: 44.7-85.8%). Regardless of the length of follow-up, 21.4% (6/28) met failure criteria: 3 subjects failed because they required secondary surgical intervention, and the other 3 did not have adequate IOP reduction. Initial bleb needling rate was 28.6% (8/28) and repeat was 17.9% (5/28). Conclusions: Compared to the reported literature with experienced ocular surgeons, ab interno gel stent placements by glaucoma fellowship trainees have similar mean IOP, topical medication reduction, surgical success, and needling rates at 12-month follow-up.

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“…Sheybani et al noted an initial complete success rate of 40-47% (85-89% qualified success), with a 32-47% bleb needling rate and a 9-35% incidence of hypotony on day 1. [9,10] As the XEN 45 is the primary version currently utilized worldwide, this review article will further focus only on the results of the XEN 45 implant. The current clinical practice also advocates the use of MMC, which was not utilized in the initial studies.…”

Section: Clinical Resultsmentioning

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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Early Clinical Results of a Novel Ab Interno Gel Stent for the Surgical Treatment of Open-angle Glaucoma

Abstract: The XEN140 gel stent lowers IOP with few complications when implanted for the surgical treatment of open-angle glaucoma.

Cited by 110 publications

References 19 publications

Minimally invasive glaucoma surgery as primary stand‐alone surgery for glaucoma

Minimally invasive glaucoma surgery as primary stand‐alone surgery for glaucoma

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

XEN Gel stent: A Review

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