目的:HORIZON试验报道了Hydrus微支架联合白内障手术的中期和长期结果。然而,在随机临床试验之外,超过24个月的结局以前没有报道.这里,我们在随机临床试验设置之外,研究了Hydrus微支架与白内障手术的3年结局.
方法:单外科医生连续病例系列。
方法:合并白内障手术后植入Hydrus微支架的青光眼,在蒙特利尔的一个眼科中心,加拿大。
方法:根据缺乏特定的失败标准来定义成功:A)青光眼再次手术;B)选择性激光小梁成形术;C)眼内压(IOP)<5mmHg,>18mmHg,或使用抗青光眼药物(AGM)的数量增加(在术后第一个月后连续两次就诊时注意到),或由于青光眼引起的光感知丧失;D)标准A-C的聚集。评估了治疗失败的预测因素以及术后IOP和AGM使用的变化。安全性包括最佳矫正视力(BCVA),杯盘比(CDR),视网膜神经纤维层(RNFL)厚度,神经节细胞内丛状层(GC-IPL)厚度,视野平均偏差(VF-MD)和模式标准偏差(VF-PSD),和不良事件。
方法:手术成功,治疗失败的预测因素,术后IOP和AGM使用的变化,以及疾病稳定性的结构和功能标记。
结果:共106只眼,平均年龄70.2±9.7岁。术后3年,根据标准A至D的手术成功率为86%,83%,91%,67%,分别。IOP从18.9±4.8下降到13.9±2.3mmHg(p<0.001),降低了26.5%,AGM的使用从3.0±1.2下降到2.0±1.2(p<0.001),降低了33%。术后BCVA的改善得以保留(p<0.001)。疾病稳定性的结构和功能标志物,包括CDR,RNFL和GC-IPL厚度,VF-MD和VF-PSD保持稳定(p>0.05)。术后不良事件很少且短暂。
结论:这项研究的36个月结果表明,在轻度至重度开角型青光眼患者中,Hydrus微支架联合超声乳化术在降低IOP和AGM使用方面是安全有效的,并且可以通过保留结构和功能参数来减缓疾病进展。
HORIZON trials have reported the medium- and long-term outcomes of the Hydrus microstent. However, outside of randomized clinical trials, outcomes beyond 24 months have not been previously reported. Here, we examine the 3-year outcomes of the Hydrus microstent with cataract surgery outside of a randomized clinical trial setting.
Single-surgeon consecutive case series.
Glaucomatous eyes that underwent implantation of a Hydrus microstent with concomitant cataract surgery at a single ophthalmology center in Montreal, Canada.
Success was defined according to the absence of specific failure criteria: (A) glaucoma reoperation; (B) selective laser trabeculoplasty; (C) intraocular pressure (IOP) < 5 mmHg, > 18 mmHg, or increase in the number of antiglaucoma medications (AGMs) used (after the first postoperative month), or loss of light perception due to glaucoma; (D) aggregation of criteria A-C. Predictors of treatment failure and postoperative changes in IOP and AGM use were assessed. Safety included best-corrected visual acuity (BCVA), cup-to-disc ratio (CDR), retinal nerve fiber layer (RNFL) thickness, ganglion cell inner plexiform layer (GC-IPL) thickness, visual field mean deviation (VF-MD) and pattern standard deviation (VF-PSD), and adverse events.
Surgical success, predictors of treatment failure, postoperative changes in IOP and AGM use, and structural and functional markers of disease stability.
One hundred six eyes were included. The 3-year surgical success according to Criteria A to D was 86%, 83%, 91%, and 67%, respectively. Intraocular pressure decreased by 26.5% from 18.9 ± 4.8 to 13.9 ± 2.3 mmHg (P < 0.001) and AGM use reduced by 33% from 3.0 ± 1.2 to 2.0 ± 1.2 medications (P < 0.001). The postoperative improvement in BCVA was preserved (P < 0.001). The structural and functional markers of disease stability, including CDR, RNFL, and GC-IPL thickness, as well as VF-MD and VF-PSD, remained stable (P > 0.05). Postoperative adverse events were few and transient.
The 36-month results from this study show that the Hydrus microstent with phacoemulsification is safe and effective in reducing the IOP and AGM among patients with mild to severe open-angle glaucoma and can slow down the disease progression by preserving both structural and functional parameters.
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