目的:为了评估XEN45凝胶支架的有效性,单独或联合白内障手术,晚期开角型青光眼(OAG)患者。
方法:对连续接受XEN45凝胶支架植入手术的OAG患者进行回顾性和单中心研究,2017年7月至2018年9月。主要疗效终点是随访期结束时的平均眼内压(IOP)降低。成功定义为IOP降低至少20%,并且IOP值≤18mmHg,没有(完全)或使用(合格)降压药物。
结果:74例患者(80只眼)被纳入研究。在整个研究样本中,XEN植入物将眼压从基线时的21.0(19.8至22.1)mmHg显著降低至9.3(8.2至10.4),10.7(9.6至11.9),13.4(12.2至14.7),14.5(13.6至15.4),14.7(13.8至15.6),1d时14.7(13.9至15.4)mmHg,1wk,随访1、3、6和12个月,分别(P<0.0001)。在整个研究人群中,在研究结束时,平均IOP降低为27.4%(23.3%~31.5%).XEN和XEN+超声乳化组调整眼压降低相似[30.0(23.4至36.4)mmHgvs24.8(18.4至31.2)mmHg,分别,P=0.2939]。在最后一次后续访问中,52只(65.0%)眼睛被认为是成功的,29只(36.3%)眼为完全成功,23只(28.7%)为合格成功。低血压药物的平均数量从基线时的2.8(2.7至3.0)显着减少到1.1(0.8至1.3),P<0.0001。Kaplan-Meier生存分析未发现XEN和XEN+PHACO之间的成功率有任何差异,平均风险比0.56,95CI0.26至1.23;P=0.1469。在1个月(n=3);3(n=2);4(n=1)和11(n=1)的7只(8.8%)眼进行了针刺。11只(13.8%)眼出现不良事件。
结论:XEN植入物,单独或与超声乳化联合,显着降低晚期OAG患者的IOP和降压药物的数量。
OBJECTIVE: To assess the effectiveness of the XEN 45 gel stent, either alone or combined with cataract surgery, in advanced stage open angle glaucoma (OAG) patients.
METHODS: Retrospective and single-center
study conducted on consecutive OAG patients who underwent a XEN 45 gel stent implantation surgery, between July 2017 and September 2018. The primary efficacy end-point was the mean intraocular pressure (IOP) reduction at the end of the follow-up period. Success was defined as an IOP reduction of at least 20% and an IOP value ≤18 mm Hg without (complete) or with (qualified) hypotensive medication.
RESULTS: Seventy-four patients (80 eyes) were included in the
study. In the overall
study sample, XEN implant significantly reduced IOP from 21.0 (19.8 to 22.1) mm Hg at baseline to 9.3 (8.2 to 10.4), 10.7 (9.6 to 11.9), 13.4 (12.2 to 14.7), 14.5 (13.6 to 15.4), 14.7 (13.8 to 15.6), and 14.7 (13.9 to 15.4) mm Hg at 1d, 1wk, 1, 3, 6, and 12mo of follow-up, respectively (P<0.0001 each). In the overall
study population, at the end of the
study the mean IOP reduction was 27.4% (23.3% to 31.5%). Adjusted IOP reduction was similar in XEN and XEN+phacoemulsification groups [30.0 (23.4 to 36.4) mm Hg vs 24.8 (18.4 to 31.2) mm Hg, respectively, P=0.2939]. At the last follow-up visit, 52 (65.0%) eyes were considered success, 29 (36.3%) eyes as complete success and 23 (28.7%) as qualified success. Mean number of hypotensive medications was significantly reduced from 2.8 (2.7 to 3.0) at baseline to 1.1 (0.8 to 1.3), P<0.0001. Kaplan-Meier survival analysis did not find any difference in the success rate between XEN and XEN+PHACO, mean hazard ratio 0.56, 95%CI 0.26 to 1.23; P=0.1469. Needling was performed in 7 (8.8%) eyes at months 1 (n=3); 3 (n=2); 4 (n=1) and 11 (n=1). Eleven (13.8%) eyes presented adverse events.
CONCLUSIONS: XEN implant, either alone or in combination with phacoemulsification, significantly reduced the IOP and the number of hypotensive medications in patients with OAG in advanced stage.