State of the art, advantages and drawbacks of XEN 63 gel stent in glaucoma surgery

Matteo Mario Carlà , Gloria Gambini , Alfonso Savastano , Federico Giannuzzi , Francesco Boselli , Stanislao Rizzo
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Abstract

Purpose

The XEN gel stent (Allergan) is a minimally-invasive, subconjunctival bleb-forming device designed for glaucoma surgery. Originally available in three sizes (45, 63 and 140 μm), it consists of a flexible, permanent collagen implant that is positioned ab-interno.

Design

Narrative review.

Methods

A search was conducted in the Cochrane Central, PubMed/Medline, Google Scholar, Web of Science, and ClinicalTrials.gov databases for studies related to the XEN 63 model up to May 2024.

Results

Initial studies with the previous version of the XEN 63 device indicated a significant reduction in intraocular pressure (IOP), although the failure rate was over 30 % due to the absence of intraoperative mitomycin C. The complete success rate—defined as final IOP ≤18 mmHg with at least a 20 % reduction from baseline—was approximately 25 %. Subsequent reports following the introduction of the revised XEN 63 stent model demonstrated IOP reductions of 40–45 % from baseline. This newer model also significantly reduced the need for postoperative topical medications. After 12–18 months of follow-up, the complete success rates reported were around 60 %, and the final IOP values were lower than those observed with the XEN 45 stent in comparative studies. The most common postoperative complication is hypotony, which varies from 18 to 66 %. While usually subclinical and treatable with medical intervention, 3–5 % of cases lead to complications such as choroidal detachment or anterior chamber shallowing. Other infrequent adverse events include anterior chamber hemorrhage and hyphema. The rates of needing subsequent needling procedures are similar to those observed with the XEN 45 stent, ranging from 10 to 35 %.

Conclusion

The XEN 63 stent has shown promising results and greater efficacy in lowering IOP compared to the XEN 45 stent. Further research is essential to determine its long-term efficacy and confirm the rate of postoperative complications.

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XEN 63 凝胶支架在青光眼手术中的应用现状、优点和缺点
目的XEN凝胶支架(Allergan)是一种微创、结膜下形成眼泡的装置,设计用于青光眼手术。该装置最初有三种尺寸(45、63 和 140 μm),由一个灵活的永久性胶原植入物组成,可在内部进行定位。结果对前一版本的 XEN 63 设备进行的初步研究表明,该设备能显著降低眼压(IOP),但由于术中未使用丝裂霉素 C,失败率超过 30%。在推出改进型 XEN 63 支架后,随后的报告显示眼压比基线降低了 40-45%。这种新型号还大大减少了术后局部用药的需求。经过 12-18 个月的随访,完全成功率约为 60%,最终的眼压值低于对比研究中观察到的 XEN 45 支架。最常见的术后并发症是眼睑下垂,比例从 18% 到 66% 不等。虽然通常为亚临床症状,可通过药物干预治疗,但也有 3%-5% 的病例会导致脉络膜脱离或前房变浅等并发症。其他不常见的不良反应包括前房出血和眼底出血。结论与 XEN 45 支架相比,XEN 63 支架在降低眼压方面显示出良好的效果和更高的疗效。进一步的研究对确定其长期疗效和确认术后并发症的发生率至关重要。
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