Shultz Mitchell, Chorbajian Abraham, Zohouralen Ala
Shultz Chang Vision, 18350 Roscoe Blvd #101, Northridge, CA, 91325, USA.
Western School of Medicine, Pomona, CA, USA.
Ophthalmol Ther. 2023 Dec;12(6):3307-3322. doi: 10.1007/s40123-023-00819-5. Epub 2023 Oct 6.
This study compared outcomes of the iStent inject trabecular micro-bypass system versus the Hydrus Microstent in patients with primary open-angle glaucoma (POAG).
Forty subjects (80 eyes) with POAG were included in this single-center, retrospective, contralateral-eye analysis. All patients underwent phacoemulsification with either iStent inject or Hydrus implantation in one eye and the other device in the contralateral eye, with ≥ 3-month follow-up. In 58 eyes (27 iStent inject, 31 Hydrus) the surgery also included ab interno canaloplasty (ABiC). Twelve-month outcomes included intraocular pressure (IOP), medications, and adverse events. Subgroup analyses were completed for iStent inject versus Hydrus, and with versus without ABiC.
At 12 months versus baseline, mean IOP reduced from 16.8 ± 3.7 to 13.6 ± 2.9 (p = 0.003) in iStent inject eyes, and from 18.1 ± 4.5 to 14.9 ± 3.2 mmHg (p = 0.003) in Hydrus eyes (between-group IOP reduction p = 0.582). Mean number of glaucoma medications reduced from 1.23 ± 0.97 to 0.30 ± 0.76 (p < 0.001) in iStent inject eyes and from 1.20 ± 1.02 to 0.39 ± 0.72 (p = 0.001) in Hydrus eyes (between-group medication reduction p = 0.943). At 12 months, 82.6% of iStent inject eyes and 73.9% of Hydrus eyes were medication-free versus 20.0% preoperatively in both groups (p < 0.0001 both groups). There were no statistically significant IOP or medication differences between iStent inject and Hydrus pre- or postoperatively, both in the overall cohort and in the with/without ABiC subgroups. Outcomes also were similar between eyes with/without ABiC in the overall cohort and in the iStent inject/Hydrus subgroups. There were no adverse events in the iStent inject group; two eyes in the Hydrus group had device-related complications requiring five additional surgeries (one Hydrus repositioning, one Hydrus exchange, one Hydrus removal, two goniotomies).
In this contralateral-eye comparison of iStent inject versus Hydrus, the groups had similar IOP and medication outcomes, regardless of stratification by ABiC completion. Eyes receiving Hydrus had more complications and subsequent surgeries.
本研究比较了iStent inject小梁微旁路系统与Hydrus微支架在原发性开角型青光眼（POAG）患者中的治疗效果。
本单中心回顾性对侧眼分析纳入了40例（80只眼）POAG患者。所有患者一只眼接受iStent inject或Hydrus植入联合白内障超声乳化手术，对侧眼植入另一种装置，随访时间≥3个月。58只眼（27只iStent inject，31只Hydrus）的手术还包括内路小梁成形术（ABiC）。12个月的观察指标包括眼压（IOP）、用药情况及不良事件。完成了iStent inject与Hydrus以及有/无ABiC的亚组分析。
与基线相比，12个月时，iStent inject组眼的平均IOP从16.8±3.7降至13.6±2.9（p = 0.003），Hydrus组眼从18.1±4.5降至14.9±3.2 mmHg（p = 0.003）（组间眼压降低p = 0.582）。iStent inject组眼青光眼药物的平均使用数量从1.23±0.97降至0.30±0.76（p < 0.001），Hydrus组眼从1.20±1.02降至0.39±0.72（p = 0.001）（组间药物使用减少p = 0.943）。12个月时，iStent inject组82.6%的眼和Hydrus组73.9%的眼无需用药，而两组术前无需用药的比例均为20.0%（两组p均< 0.0001）。在整个队列以及有/无ABiC亚组中，iStent inject与Hydrus术前及术后的眼压或用药情况均无统计学显著差异。在整个队列以及iStent inject/Hydrus亚组中，有/无ABiC的眼的治疗效果也相似。iStent inject组未发生不良事件；Hydrus组有两只眼出现与装置相关的并发症，需要额外进行五次手术（一次Hydrus重新定位、一次Hydrus置换、一次Hydrus移除、两次房角切开术）。
在本次iStent inject与Hydrus的对侧眼比较中，无论是否根据ABiC完成情况进行分层，两组的眼压和用药效果相似。接受Hydrus治疗的眼出现的并发症及后续手术更多。
