1-year outcomes of the Xen45 glaucoma implant

Smith, Michael; Charles, Roselin C.; Abdel-Hay, Ahmed; Shah, Brinda Haren; Byles, Daniel; Lim, Lei-Ai; Rossiter, J D; Kuo, Chih-Hung; Chapman, P. J.; Robertson, Shalini

doi:10.1038/s41433-018-0310-1

Cited by 61 publications

(83 citation statements)

References 16 publications

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“…There have been several noncomparative prospective and retrospective studies [6][7][8][9][10][11][12][13][14][15] with consistent studyto-study trends even though the ranges for those effects varied broadly. In general, subjects' IOPs started at a baseline in the low 20s and decreased to the low and mid-teens by the end of the first year from XEN45 Gel Stent placement.…”

Section: Comparison To the Literaturementioning

confidence: 99%

“…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%

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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

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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Section: Comparison To the Literaturementioning

confidence: 99%

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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“…[16,19] A post-operative needling rate of 2-50% and 22-51% has been reported in prospective studies and retrospective studies, respectively. [11][12][13][14][15][16][17][18][19][25][26][27] The time to initial needling/revision ranged from 6-582 days (median -59.5 days) and the median number of interventions was 2. [16,26] Smith et al, in their study on 68 eyes, noted a 70% qualified success rate in eyes which underwent bleb needling or revision.…”

Section: Bleb Revision/needlingmentioning

confidence: 99%

“…[16,26] Smith et al, in their study on 68 eyes, noted a 70% qualified success rate in eyes which underwent bleb needling or revision. [27] Widder et al, in their study on 233 eyes, performed an "open" revision for those who initially failed and achieved a success rate of 84-92% in all subgroups of patients. A conjunctival peritomy was made, and the area adjacent to and posterior to the distal end of the stent was dissected.…”

Section: Bleb Revision/needlingmentioning

confidence: 99%

“…[7] and IOP < 18mm Hg Grover et al [11] Prospective multi-center Although various studies report an incidence of 1-37% for early hypotony, it has been noted to be self-limiting and seen to resolve by post-operative week 1 in a majority of the eyes. [11][12][13][14]16,18,19,[25][26][27] Table 2 provides the details of the main adverse events seen post-XEN gel stent surgery. Other complications reported as unique by Rooney et al include suprachoroidal hemorrhage and retinal detachment due to hypotony, retraction of the XEN gel stent into the subconjunctival space due to Tenon's fibrosis, and occlusion of the internal ostium of the XEN gel stent by Descemet's membrane.…”

Section: Adverse Eventsmentioning

confidence: 99%

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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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Quantitative systems pharmacology of the eye: Tools and data for ocular QSP

Kuepfer

Fuellen

Stahnke

2023

CPT Pharmacom & Syst Pharma

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Good eyesight belongs to the most‐valued attributes of health, and diseases of the eye are a significant healthcare burden. Case numbers are expected to further increase in the next decades due to an aging society. The development of drugs in ophthalmology, however, is difficult due to limited accessibility of the eye, in terms of drug administration and in terms of sampling of tissues for drug pharmacokinetics (PKs) and pharmacodynamics (PDs). Ocular quantitative systems pharmacology models provide the opportunity to describe the distribution of drugs in the eye as well as the resulting drug‐response in specific segments of the eye. In particular, ocular physiologically‐based PK (PBPK) models are necessary to describe drug concentration levels in different regions of the eye. Further, ocular effect models using molecular data from specific cellular systems are needed to develop dose–response correlations. We here describe the current status of PK/PBPK as well as PD models for the eyes and discuss cellular systems, data repositories, as well as animal models in ophthalmology. The application of the various concepts is highlighted for the development of new treatments for postoperative fibrosis after glaucoma surgery.

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1-year outcomes of the Xen45 glaucoma implant

Cited by 61 publications

References 16 publications

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

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

Quantitative systems pharmacology of the eye: Tools and data for ocular QSP

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