背景:为了研究XEN45植入物的长期有效性和安全性,单独或与超声乳化联合,在眼睛开角型青光眼(OAG)。
方法:对2017年2月至2021年12月接受XEN45植入的连续OAG患者进行回顾性单中心研究。主要终点是平均眼内压(IOP)低于术前值。手术成功定义为IOP从术前值降低≥20%,IOP绝对值在6和13mmHg之间,没有(完全成功)或(合格成功)抗青光眼药物。
结果:共纳入158只眼(XEN-solo34只(21.5%)眼和XEN+Phaco124只(78.5%)眼)。中位随访时间为28.5个月。在整个研究人群中,术前平均IOP从19.4±6.5mmHg显著降低至12.4±5.0mmHg.XEN-Solo组和XEN+Phaco组的术前平均眼压(95%置信区间)从21.3(19.3-23.2)mmHg和18.8(17.7-20.0)mmHg显著降低至12.0(10.4-13.6)mmHg和12.5(11.6-13.5)mmHg,分别(每个p<0.0001,分别)。在整个研究样本中,低眼压药物的平均数量显着减少(从3.4±0.9降至0.9±1.3,p<0.0001),XEN-Solo(从3.5±1.1到0.6±1.0,p<0.0001,和XEN+Phaco(从3.4±1.1到0.9±1.3,p<0.0001)组。八十四只(53.2%)眼睛被归类为成功,49(58.3%)被列为完全成功。81只(51.3%)眼接受了针刺,15只(9.5%)眼需要额外的外科手术。一只(0.6%)眼患有眼内炎。
结论:XEN植入物,单独或联合白内障超声乳化术可显著降低IOP,并减少对降眼药物的需求,同时保持良好的安全性。
BACKGROUND: To investigate the long-term effectiveness and safety of XEN45 implant, either alone or in combination with phacoemulsification, in eyes with open-angle glaucoma (OAG).
METHODS: Retrospective and single center study conducted on consecutive OAG patients who underwent a XEN45 implant between February-2017 and December-2021. The primary endpoint was the mean intraocular pressure (IOP) lowering from preoperative values. Surgical success was defined as an IOP-lowering from preoperative values ≥ 20% and an IOP absolute value between 6 and 13 mm Hg, without (Complete-success) or with (Qualified-success) antiglaucoma medications.
RESULTS: A total of 158 eyes (34 (21.5%) eyes XEN-solo and 124 (78.5%) XEN + Phaco) were included. The median follow-up time was 28.5 months. In the overall study population, the mean preoperative IOP was significantly lowered from 19.4 ± 6.5 mm Hg to 12.4 ± 5.0 mm Hg. The mean preoperative (95% confidence interval) IOP was significantly lowered from 21.3 (19.3-23.2) mm Hg and 18.8 (17.7-20.0) mm Hg to 12.0 (10.4-13.6) mm Hg and 12.5 (11.6-13.5) mm Hg in the XEN-Solo and XEN + Phaco groups, respectively (p < 0.0001 each, respectively). The mean number of ocular-hypotensive medications was significantly reduced in the overall study sample (from 3.4 ± 0.9 to 0.9 ± 1.3, p < 0.0001), XEN-Solo (from 3.5 ± 1.1 to 0.6 ± 1.0, p < 0.0001, and XEN + Phaco (from 3.4 ± 1.1 to 0.9 ± 1.3, p < 0.0001) groups. Eighty-four (53.2%) eyes were categorized as success, with 49 (58.3%) classified as complete success. Eighty-one (51.3%) eyes underwent needling and 15 (9.5%) eyes required an additional surgical procedure. One (0.6%) eye had endophthalmitis.
CONCLUSIONS: XEN implant, either alone or in combination with phacoemulsification significantly lowered IOP and reduced the need of ocular-hypotensive medication, while maintaining a good safety profile.