Gel Stent Versus Trabeculectomy: The Randomized, Multicenter, Gold-Standard Pathway Study (GPS) of Effectiveness and Safety at 12 Months

SHEYBANI, ARSHAM; Vera, Vanessa; GROVER, DAVINDER S.; VOLD, STEVEN D.; COTTER, FRANK; BEDROOD, SAHAR; SAWHNEY, GAGAN; PIETTE, SCOTT D.; Simonyi, Susan; GU, XUEMIN; BALARAM, MINI; Gallardo, Mark J.

doi:10.1016/j.ajo.2023.03.026

Cited by 17 publications

(9 citation statements)

References 62 publications

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“…The Gold-Standard Pathway Study (GPS) [ 108 ] was the first multicenter, prospective, and randomized study comparing the effectiveness and safety of XEN45 versus trabeculectomy in glaucoma that was poorly controlled with topical IOP-lowering therapy. The results of this study showed that the mean IOP change from baseline was significantly greater at month 12 in the trabeculectomy group (0.024), although both treatments significantly lowered IOP from preoperative values ( p < 0.001).…”

Section: Resultsmentioning

confidence: 99%

“…In addition, XEN was noninferior to trabeculectomy, regarding the prespecified primary endpoint (62.1% and 68.2% achieved the primary endpoint, respectively; p = 0.487), namely the percentage of patients achieving ≥20% IOP reduction from baseline at Month 12 without medication increase, clinical hypotony, vision loss to counting fingers, or secondary surgical intervention. Finally, XEN resulted in less need for in-office postoperative interventions ( p = 0.024 after excluding laser suture lysis), faster visual recovery ( p < 0.05), and greater 6-month improvements in visual function problems ( p ≤ 0.022) [ 108 ].…”

Section: Resultsmentioning

confidence: 99%

“…Compared to trabeculectomy [ 12 , 48 , 58 , 65 , 72 , 84 , 108 , 109 , 110 , 111 ], XEN seems not to be comparable in terms of IOP lowering, although XEN has similar efficacy in reducing the number of ocular hypotensive medications and provided a better safety profile.…”

Section: Discussionmentioning

confidence: 99%

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Effectiveness and Safety of Xen Gel Stent in Glaucoma Surgery: A Systematic Review of the Literature

Traverso

Carassa²,

Fea

et al. 2023

JCM

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Although topical medical therapy and selective-laser-trabeculoplasty represent the treatments of choice to reduce intraocular pressure, many patients do not achieve adequate glaucoma control; therefore, they require further options and eventually surgery. Trabeculectomy is still considered the gold standard, but the surgical management of glaucoma has undergone continuous advances in recent years, XEN-gel-stent has been introduced as a safer and less traumatic means of lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG). This study aimed to review the effectiveness and safety of clinical data on XEN-stent in OAG patients with a Synthesis-Without-Meta-analysis (SWiM) methodology. A total of 339 studies were identified following a literature search adhering to PRISMA guidelines and, after evaluation, 96 studies are discussed. XEN63 and XEN45 device data were collected both short and long term. In addition, this document has evaluated different aspects related to the XEN implant, including: its role compared to trabeculectomy; the impact of mitomycin-C dose on clinical outcomes; postoperative management of the device; and the identification of potential factors that might predict its clinical outcomes. Finally, current challenges and future perspectives of XEN stent, such as its use in fragile or high myopia patients, were discussed.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Effectiveness and Safety of Xen Gel Stent in Glaucoma Surgery: A Systematic Review of the Literature

Traverso

Carassa²,

Fea

et al. 2023

JCM

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“…Mitomycin C is used intraoperatively. In the prospective, randomized XEN-45 versus trabeculectomy study, both XEN and trabeculectomy decreased IOP and decreased medications [18 ]. Trabeculectomy decreased IOP more than XEN, but XEN resulted in fewer adverse events.…”

Section: Advancements In Bleb Surgerymentioning

confidence: 99%

Glaucoma surgical procedures under development

Levin,

Sheybani

2023

Current Opinion in Ophthalmology

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Purpose of review Rapid innovation in glaucoma surgery is expanding surgical options in the angle, subconjunctival space, and supraciliary space. Recent findings Advancements in glaucoma surgery make it possible for surgeons to provide treatments with less risk. In particular, new devices and lasers are available for minimally invasive glaucoma surgeries. There are also new implants and techniques for bleb-forming glaucoma surgery. Summary As glaucoma surgeons have access to an increasing number of procedures, devices, and treatments, it is important for evidence to drive decision-making.

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“…Advantages of MIGS and MIBS procedures compared to conventional glaucoma surgeries are less tissue trauma and faster postoperative recovery and patient satisfaction [ 15 , 16 ]. According to Sheybani et al the XEN45 Gel Stent appears to be noninferior to trabeculectomy, per the percentage of patients achieving ≥ 20% IOP, while requiring fewer postoperative interventions, having better visual recovery, and fewer adverse events [ 17 ]. Thus, there has been a significant shift from conventional glaucoma surgeries to MIGS recently [ 18 ], which are commonly performed as standalone procedures or in combination with cataract surgery.…”

Section: Introductionmentioning

confidence: 99%

Swiss Multicenter Ab Interno XEN45 Gel Stent Study: 2-Year Real-World Data

Papazoglou,

Höhn,

Schawkat

et al. 2024

Ophthalmol Ther

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Introduction The aim of this study was to investigate the 2-year postoperative efficacy of the XEN45 Gel Stent by evaluating the reduction of intraocular pressure (IOP) and the need for eye pressure-lowering medications in a multicenter setting in Switzerland. Methods Patients with various types of glaucoma who received a XEN45 Gel Stent with or without combined phacoemulsification cataract surgery at five hospitals in Switzerland were retrospectively enrolled. Pre- and postoperative IOP, the number of antiglaucoma medications, and the need of subsequent interventions to control IOP were assessed. The success rate was defined as a ≥ 20% reduction of IOP 2 years postoperatively without the need for subsequent glaucoma surgery. Results A total of 345 eyes were included: 44.3% with primary open-angle, 42.0% pseudoexfoliation, and 13.7% with other types of glaucoma. Of these, 206 patients were followed for 2 years. Preoperatively, the mean IOP was 26.3 ± 8.9 mmHg and the mean number of antiglaucoma medications administered was 3.0 ± 1.3. Two years postoperatively, the success rate was 66.0% (95% confidence interval 59.3–72.1%), the IOP had dropped by 43.8% to 14.8 ± 5.7 mmHg, and the number of medications was reduced by a mean of 2.0 ± 1.7 per day. Postoperative complications and the need for interventions remained low. Conclusion The XEN45 Gel Stent successfully reduced IOP and the number of antiglaucoma drugs in most patients at 2 years postoperatively.

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Gel Stent Versus Trabeculectomy: The Randomized, Multicenter, Gold-Standard Pathway Study (GPS) of Effectiveness and Safety at 12 Months

Cited by 17 publications

References 62 publications

Effectiveness and Safety of Xen Gel Stent in Glaucoma Surgery: A Systematic Review of the Literature

Effectiveness and Safety of Xen Gel Stent in Glaucoma Surgery: A Systematic Review of the Literature

Glaucoma surgical procedures under development

Swiss Multicenter Ab Interno XEN45 Gel Stent Study: 2-Year Real-World Data

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