Paletta Guedes Eye Institute, Juiz de Fora, Minas Gerais, Brazil.
Federal University of Juiz de Fora, Juiz de Fora, Minas Gerais, Brazil.
Adv Ther. 2019 Oct;36(10):2797-2810. doi: 10.1007/s12325-019-01067-5. Epub 2019 Aug 22.
This retrospective consecutive case series assessed 12-month effectiveness and safety of iStent or iStent inject trabecular micro-bypass implants with cataract surgery in patients with open-angle glaucoma (OAG) in a real-world clinical setting.
Effectiveness outcomes consisted of intraocular pressure (IOP) reduction; glaucoma medication reduction; proportions of eyes achieving IOP < 18, < 15, or < 12 mmHg; and proportional analysis of medication usage. Safety outcomes included adverse events, secondary surgeries, and best-corrected visual acuity (BCVA).
This evaluation included 58 eyes with OAG (35 iStent, 23 iStent inject), with 96.6% of eyes having mild or moderate glaucoma. Diagnoses included primary open-angle glaucoma (the majority; 72.4%), pseudoexfoliative glaucoma, and pigmentary glaucoma. Baseline mean IOP and medications were statistically comparable between groups: 16.1 ± 3.6 mmHg on a mean of 1.8 ± 0.8 medications in the iStent group, and 16.2 ± 3.1 mmHg on a mean of 1.7 ± 0.8 medications in the iStent inject group. Twelve months after stent-cataract surgery, mean IOP was significantly lower in the iStent inject group than in the iStent group (13.1 mmHg vs. 15.4 mmHg, respectively; p < 0.001), and the percent reduction in IOP from baseline was significantly greater in iStent inject eyes than in iStent eyes (19.1% vs. 4.3% reduction, respectively; p < 0.001). At 12 months postoperative, significantly greater proportions of iStent inject eyes than iStent eyes achieved IOP < 18 mmHg (100% vs. 80.0% of eyes, respectively; p = 0.035), IOP < 15 mmHg (73.9% vs. 34.3% of eyes, respectively; p = 0.003), and IOP < 12 mmHg (26.1% vs. 0% of eyes, respectively; p = 0.002). Meanwhile, both groups achieved significant medication reductions at 12 months vs. baseline (94.1% reduction in iStent inject eyes, p < 0.0001; and 72.2% reduction in iStent eyes, p < 0.0001), with the percent reduction being significantly greater in iStent inject eyes than in iStent eyes (p = 0.023). At 12 months, mean number of medications was significantly lower in iStent inject eyes than iStent eyes (0.1 vs. 0.5 medications, respectively; p = 0.021), and significantly more iStent inject eyes (95.7%) than iStent eyes (71.4%) were off medications entirely (p = 0.021). A similarly high safety profile was observed in both groups.
iStent or iStent inject implantation with cataract surgery resulted in substantial and safe reductions in IOP and medications through 12 months postoperative. Consistent with prior observations, greater efficacy was observed with iStent inject than with iStent.
The Rapid Service Fees were funded by Glaukos Corporation.
本回顾性连续病例系列研究评估了在真实临床环境中，在伴有开角型青光眼（OAG）的患者中行白内障手术后，应用 iStent 或 iStent inject 小梁微旁路植入物的 12 个月有效性和安全性。
有效性结果包括眼压（IOP）降低；青光眼药物减少；IOP<18mmHg、<15mmHg 和<12mmHg 的眼比例；以及药物使用的比例分析。安全性结果包括不良事件、二次手术和最佳矫正视力（BCVA）。
本评估纳入了 58 只伴有 OAG 的眼（35 只为 iStent，23 只为 iStent inject），其中 96.6%的眼为轻度或中度青光眼。诊断包括原发性开角型青光眼（大多数；72.4%）、假性剥脱性青光眼和色素性青光眼。两组的基线平均 IOP 和药物使用情况在统计学上无显著差异：iStent 组的平均 IOP 为 16.1±3.6mmHg，平均使用 1.8±0.8 种药物；iStent inject 组的平均 IOP 为 16.2±3.1mmHg，平均使用 1.7±0.8 种药物。支架-白内障手术后 12 个月，iStent inject 组的平均 IOP 明显低于 iStent 组（分别为 13.1mmHg 和 15.4mmHg；p<0.001），iStent inject 组的 IOP 降低百分比显著大于 iStent 组（分别为 19.1%和 4.3%的降低；p<0.001）。术后 12 个月，与 iStent 组相比，iStent inject 组达到 IOP<18mmHg 的眼比例显著更高（分别为 100.0%和 80.0%的眼；p=0.035），IOP<15mmHg 的眼比例显著更高（分别为 73.9%和 34.3%的眼；p=0.003），IOP<12mmHg 的眼比例显著更高（分别为 26.1%和 0%的眼；p=0.002）。同时，两组在术后 12 个月与基线相比均显著减少了药物使用（iStent inject 组的药物减少 94.1%，p<0.0001；iStent 组的药物减少 72.2%，p<0.0001），iStent inject 组的药物减少百分比显著大于 iStent 组（p=0.023）。术后 12 个月，iStent inject 组的平均用药数量显著少于 iStent 组（分别为 0.1 种和 0.5 种药物；p=0.021），且显著更多的 iStent inject 组（95.7%）的患者完全停掉了药物（而 iStent 组为 71.4%；p=0.021）。两组均观察到相似的高安全性。
在伴有开角型青光眼的患者中行白内障手术后，应用 iStent 或 iStent inject 小梁微旁路植入物可在术后 12 个月内显著、安全地降低眼压和药物使用。与既往观察结果一致，iStent inject 的疗效优于 iStent。
快速服务费由 Glaukos 公司资助。
