Buffault J, Baudouin C, Labbé A
Service d'ophtalmologie, centre hospitalier national d'ophtalmologie des Quinze-Vingts, 28, rue de Charenton, 75012 Paris, France.
Service d'ophtalmologie, centre hospitalier national d'ophtalmologie des Quinze-Vingts, 28, rue de Charenton, 75012 Paris, France; Service d'ophtalmologie, université de Versailles Saint-Quentin-en-Yvelines, hôpital Ambroise-Paré, AP-HP, 9, avenue Charles-De-Gaulle, 92100 Boulogne Billancourt, France; Inserm, U968, université UPMC Paris VI, UMR S 968, institut de la vision , CNRS, UMR 7210, 75012 Paris, France.
J Fr Ophtalmol. 2019 Apr;42(4):391-403. doi: 10.1016/j.jfo.2018.10.005. Epub 2019 Mar 14.
The purpose of this study was to analyze the change in intraocular pressure (IOP) and glaucoma medications using the XEN Gel Stent as a solo procedure or in association with phacoemulsification in patients with chronic open angle glaucoma (OAG).
We included cohort studies with at least one year of follow-up in patients with primary open angle glaucoma (POAG), pseudo-exfoliative glaucoma (PXG) or pigmentary glaucoma (PG) who received a XEN® gel stent. The main outcome measure was IOP reduction at 12 months follow-up. Secondary outcomes were the decrease in glaucoma medications 12 months after surgery, frequency and type of postoperative interventions and complication rate.
A total of 8 case series published between 2016 and 2018 were included; six were prospective studies, and two were retrospective. There was no randomized controlled trial. The data concerned a total of 958 eyes of 777 patients. The various studies showed a mean IOP at 12 months between 13 and 16mmHg, which represented an IOP reduction between 25 and 56% (mean: 42%). This decrease was associated with a reduction in glaucoma medications in all studies. The decrease in IOP was significantly greater in XEN implantation as a stand-alone procedure (44%) than in combined surgery (32%) (P<0.05). Transient hypotony (<1 month) (3%), choroidal detachment or choroidal folds (1.5%), hyphema (1.9%), bleb leak (1.1%) and shallow anterior chamber (1.1%) were the most frequent complications. As for severe complications, four cases of malignant glaucoma (0.4%) and one case of retinal detachment have been reported. In the follow-up period, needling has been required in 32% of cases, and a total of 55 eyes (5.7%) required repeat filtering surgery or cyclodestructive procedure.
XEN Gel Stent appears effective for reducing IOP and the number of medications in OAG patients within 1 year postoperatively with an acceptable safety profile. However, vigilant postoperative follow-up and frequent postoperative maneuvers are required.
本研究旨在分析在慢性开角型青光眼（OAG）患者中，单独使用XEN凝胶支架或与超声乳化术联合使用时，眼内压（IOP）和青光眼药物的变化。
我们纳入了对接受XEN®凝胶支架治疗的原发性开角型青光眼（POAG）、假性剥脱性青光眼（PXG）或色素性青光眼（PG）患者进行至少一年随访的队列研究。主要结局指标是随访12个月时的眼压降低情况。次要结局指标包括术后12个月青光眼药物的减少情况、术后干预的频率和类型以及并发症发生率。
共纳入2016年至2018年间发表的8个病例系列；6个为前瞻性研究，2个为回顾性研究。没有随机对照试验。数据涉及777例患者的958只眼。各项研究显示，12个月时的平均眼压在13至16mmHg之间，眼压降低了25%至56%（平均：42%）。在所有研究中，这种降低与青光眼药物的减少相关。单独植入XEN时眼压的降低（44%）显著大于联合手术（32%）（P<0.05）。短暂性低眼压（<1个月）（3%）、脉络膜脱离或脉络膜皱褶（1.5%）、前房积血（1.9%）、滤过泡渗漏（1.1%）和浅前房（1.1%）是最常见的并发症。至于严重并发症，报告了4例恶性青光眼（0.4%）和1例视网膜脱离。在随访期间，32%的病例需要进行针刺治疗，共有55只眼（5.7%）需要重复滤过手术或睫状体破坏手术。
XEN凝胶支架在术后1年内似乎能有效降低OAG患者的眼压和药物使用量，且安全性可接受。然而，需要进行密切的术后随访和频繁的术后操作。
