XEN® Gel Implant for Glaucoma;Prospective Cohort Study in a High-Volume Department

Purpose: To evaluate the 3-year efficiency and safety of XEN® 45 gel stent implantation in a heterogenous group of open angle glaucoma patients. Methods: In this prospective, non-randomized observational study we identified patients who had undergone either stand-alone XEN® implantation (XEN solo) or XEN® implantation in combination with phacoemulsification (XEN combi). All patients who had undergone an implantation during the period 01.04.17-31.10.19 at the Department of Ophthalmology, Drammen Hospital, Norway, were asked to participate. Success was defined as IOP between 5 - 18 mmHg and 20% pressure reduction without medications. Qualified success required the same pressure interval and reduction but allowed medications. The procedure was deemed as failure if pressure requirements were not met, vision was reduced to light perception or worse, or if there was a converion to secondary glaucoma surgery. Results: Out of 115 patients and 133 eyes identified, 87 patients and 99 eyes consented to participate. All patients were Caucasians with a mean age of 73.6 years. The study had a mean (range) follow-up of 38.9 (28 - 54) months. The mean medicated baseline (SD) was reduced from 22.6 (7.9) mmHg on 3.2 (1.1) medications to 14.2 (5.6) mmHg on 1.4 (1.6) medications. Success and qualified success were achieved in 22.2% and 21.2%, respectively. Needling was performed in 34 eyes. Conclusion: XEN® 45 gel stent implantation is a safe procedure, offering a significantly lower IOP and number of medications in a subset of patients with open angle glaucoma.

XEN凝胶引流管植入治疗原发性开角型青光眼的初步疗效观察

目的初步评估XEN凝胶引流管植入术在原发性开角型青光眼(POAG)治疗中的有效性及安全性。方法回顾性分析2020年1月至2022年3月就诊于华中科技大学同济医学院附属同济医院的8例(10眼)进行了XEN凝胶引流管植入术的患者,其中男性6例(8眼),女性2例(2眼)。年龄分布24~41岁,平均(33.9±5.9)岁。比较手术前后各项指标的变化,包括视力、眼压、青光眼用药数量及术后并发症。结果8例患者均诊断为原发性开角型青光眼,平均随访时间为(13.0±3.9)个月。术前平均眼压为(24.7±6.2)mmHg,末次随访时平均眼压为(13.9±1.7)mmHg,较术前下降了43.7%。术前平均用药数量为3.1种,末次随访时为0.2种。4眼(40%)进行了滤过泡分离手术,其中1眼发生色素颗粒阻塞引流管出口,行滤过泡分离时清除阻塞物,房水顺利流出。截至末次随访,3眼获得手术完全成功,5眼获得部分成功,总成功率为80%。2眼术后发生前房积血,均在术后1个月内自行消退。其余患者未发生其他严重并发症。结论XEN凝胶引流管植入术是POAG的一种有效的外科治疗方法,在1年的随访中,患者眼压和青光眼用药数量显著降低。

XEN凝胶支架引流装置植入术治疗青光眼

青光眼是主要的致盲眼病之一,眼压越高,视神经损伤越大,降低眼压对于减轻及延缓青光眼病情具有重要的意义,而手术是降低眼压的重要手段。目前青光眼引流装置植入术因其具有安全、有效、并发症较少等优点,已成为治疗青光眼的主要手术方法,在临床得到广泛应用。同时青光眼微创手术的创新和发展使青光眼手术展现出良好的治疗前景。本文分析总结XEN凝胶支架引流装置的结构特点,就XEN凝胶支架引流装置植入术治疗青光眼的作用进行综述。

XEN引流管植入术治疗青光眼

本文总结了XEN引流管植入术的适应证、手术操作过程、术后疗效与安全性,并与传统小梁切除术和其他类型青光眼微创手术(minimally invasive glaucoma surgery,MIGS)进行了对比。

In vivo confocal microscopy:qualitative investigation of the conjunctival and corneal surface in open-angle glaucomatous patients undergoing the XEN-Gel implant,trabeculectomy or medical therapy

Purpose:Assessing the quality of the ocular surface by in vivo scanning laser confocal microscopy(IVCM)in primary open-angle glaucoma(POAG)patients treated by XEN 45 Gel Stent,medical therapy and trabeculectomy.Methods:Retrospective,single-center,single-masked,comparative study including 60 eyes of 30 patients(mean age 61.16±10 years)affected by POAG.Eyes were divided into 3 groups:Group 1 eyes underwent the XEN 45 Gel Stent procedure,Group 2 eyes^were under medical therapy,Group 3 eyes were surgically treated by trabeculectomy.All patients underwent HRTII IVCM analysis of cornea,limbus,conjunctiva,sub-tenionian space and sclera.Results:The XEN 45 Gel Stent,if properly positioned in the sub-conjunctival space preserves goblet cells and limits ocular surface inflammation.Regular corneal epithelial cells with microcysts,and normo-reflective sub-epithelial nerve plexus are documented by IVCM.In sub Tenon's implants an alternative lamellar intra-scleral filtration is detectable.Combined surgical procedures show a noticeable number of inflammatory cells with rare microcysts.Post-trabeculectomy inflammatory reaction is more evident than XEN 45 Gel Stent associated surgical procedures,but less than medical therapy where a conspicuous presence of Langerhans cells,peri-neural infiltrates,marked loss of goblet cells and fibrosis is visible.Conclusion:Ocular surface inflammation was more notable in topical therapy than after trabeculectomy,which itself causes more inflammation than XEN Gel Stents.

In vivo confocal microscopy: qualitative investigation of the conjunctival and corneal surface in open angle glaucomatous patients undergoing the XEN-Gel implant, trabeculectomy or medical therapy

Purpose:Assessing the quality of the ocular surface by in vivo scanning laser confocal microscopy(IVCM)in primary open angle glaucoma(POAG)patients treated by Xen 45 Gel Stent,medical therapy and trabeculectomy.Methods:Retrospective,single-center,single-masked,comparative study including 60 eyes of 30 patients(mean age 61.16±10 years)affected by POAG.Eyes were divided into 3 groups:Group 1 eyes underwent the Xen 45 Gel Stent procedure,Group 2 eyes were under medical therapy,Group 3 eyes were surgically treated by trabeculectomy.All patients underwent HRT II IVCM analysis of cornea,limbus,conjunctiva,sub-tenionian space and sclera.Results:The Xen 45 Gel stent,if properly positioned in the sub-conjunctival space preserves goblet cells and limits ocular surface inflammation.Regular corneal epithelial cells with micro-cysts,and normo-reflective sub-epithelial nerve plexus are documented by IVCM.In sub Tenon’s implants an alternative lamellar intra-scleral filtration is detectable.Combined surgical procedures show a noticeable number of inflammatory cells with rare micro-cysts.Post-trabeculectomy inflammatory reaction is more evident than Xen 45 Gel Stent associated surgical procedures,but less than medical therapy where a conspicuous presence of Langerhans cells,peri-neural infiltrates,marked loss of goblet cells and fibrosis is visible.Conclusion:Ocular surface inflammation was more notable in topical therapy than after trabeculectomy,which itself causes more inflammation than XEN Gel stents.

XEN凝胶支架植入术治疗青光眼的临床应用

XEN凝胶支架植入术是新型微创青光眼手术,属于外引流手术。该手术具有组织损伤小、手术时间短、能有效降低眼压、并发症少且易于学习掌握等优点,术后严格管理滤过泡对提高手术成功率至关重要。