The short- and medium-term outcomes of iStent have been extensively studied; however, only few studies have investigated its long-term outcomes. Here, we assessed the long-term efficacy and safety of two iStents with concomitant cataract surgery in glaucomatous eyes while also evaluating measures of disease stability using visual field and optical coherence tomography (OCT) of the optic nerve and the macula throughout 8 years of follow-up. This longitudinal, single-center consecutive case series included glaucomatous eyes that underwent implantation of two first-generation trabecular micro-bypass stents (iStent) with concomitant cataract surgery. Eight-year efficacy outcomes included mean intraocular pressure (IOP) and medications, as well as surgical success. Eight-year safety outcomes included best-corrected visual acuity (BCVA), visual field mean deviation (VF-MD), cup-to-disc ratio (CDR), retinal nerve fiber layer (RNFL) thickness, ganglion cell-inner plexiform layer (GC-IPL) thickness, and adverse events. A total of 62 eyes with primary open-angle glaucoma (POAG) were included. At 8 years postoperative, IOP reduced by 26% from 19.2 ± 3.9 mmHg preoperatively to 14.2 ± 2.4 mmHg (P < 0.001), 91.1% of eyes achieved IOP ≤ 18 mmHg (vs. 51.6% preoperatively), 69.6% of eyes achieved IOP ≤ 15 mmHg (vs. 14.5% preoperatively), and 25% of eyes achieved IOP ≤ 12 mmHg (vs. 1.6% preoperatively). Medication use decreased by 17.9% from 2.8 ± 1.1 preoperatively to 2.3 ± 1.2 (P = 0.018). Surgical success was 90%, as six eyes underwent subsequent glaucoma surgeries. Safety measures of BCVA, CDR, RNFL thickness and GC-IPL thickness remained stable through 8 years postoperative. VF-MD remained stable until postoperative year 5 and subsequently progressed according to the natural history of glaucomatous disease. Implantation of two iStents with concomitant cataract surgery is an effective and safe treatment option for surgery-naïve POAG eyes, evidenced by significant IOP and medication reductions, reasonable surgical success, and favorable safety outcomes, throughout the 8-year follow-up. Our data additionally supports the efficacy of this combined procedure in stabilizing or slowing disease progression.

中文翻译：

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两种第一代小梁微旁路支架 (iStent) 超声乳化术治疗原发性开角型青光眼的长期结果：八年结果

iStent 的短期和中期结果已得到广泛研究；然而，只有少数研究调查了其长期结果。在这里，我们评估了两个 iStent 对青光眼同时进行白内障手术的长期疗效和安全性，同时还在 8 年的随访中使用视野和视神经和黄斑的光学相干断层扫描 (OCT) 评估了疾病稳定性的措施-向上。这个纵向、单中心连续病例系列包括接受了两个第一代小梁微旁路支架 (iStent) 植入的青光眼，同时进行白内障手术。八年疗效结果包括平均眼压 (IOP) 和药物治疗，以及手术成功。八年的安全结果包括最佳矫正视力 (BCVA)、视野平均偏差 (VF-MD)、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) 厚度和不良事件。共纳入 62 只患有原发性开角型青光眼 (POAG) 的眼。术后 8 年，眼压从术前的 19.2±3.9 mmHg 降低 26% 至 14.2±2.4 mmHg（P < 0.001），91.1% 的眼达到 IOP ≤ 18 mmHg（术前为 51.6%），69.6% 的眼达到眼压≤ 15 mmHg（术前为 14.5%），25% 的眼睛达到 IOP ≤ 12 mmHg（术前为 1.6%）。药物使用量从术前的 2.8 ± 1.1 下降到 2.3 ± 1.2（P = 0.018），下降了 17.9%。手术成功率为 90%，因为 6 只眼睛随后接受了青光眼手术。BCVA、CDR、RNFL 厚度和 GC-IPL 厚度的安全措施在术后 8 年内保持稳定。VF-MD 在术后第 5 年保持稳定，随后根据青光眼疾病的自然病程进展。植入两个 iStent 并同时进行白内障手术是治疗初治 POAG 眼的一种有效且安全的治疗选择，在整个 8 年的随访期间，IOP 和药物显着降低、手术成功合理和安全结果良好证明了这一点。我们的数据还支持这种联合手术在稳定或减缓疾病进展方面的功效。在整个 8 年的随访期间，合理的手术成功和良好的安全性结果。我们的数据还支持这种联合手术在稳定或减缓疾病进展方面的功效。在整个 8 年的随访期间，合理的手术成功和良好的安全性结果。我们的数据还支持这种联合手术在稳定或减缓疾病进展方面的功效。