Clement Colin, Howes Frank, Ioannidis Alexandros, Shiu Michael, Manning David, Lusthaus Jed A, Skalicky Simon E, Goodwin Todd W
Eye Associates, Sydney, NSW, Australia.
Fairfield Eye Surgery, Fairfield, NSW, Australia.
Clin Ophthalmol. 2022 Sep 1;16:2955-2968. doi: 10.2147/OPTH.S373290. eCollection 2022.
To evaluate 3-year safety and efficacy of two second-generation trabecular micro-bypass stents. (iStent ) with phacoemulsification.
This multicenter retrospective study of iStent implantation with phacoemulsification included data from eight surgeons across Australia. Eyes with cataract and mild to advanced glaucoma [predominantly primary open-angle (POAG), primary angle closure (PAC), or normal-tension (NTG) glaucoma] or ocular hypertension (OHT) were included. Study assessments included intraocular pressure (IOP); number of ocular hypotensive medications; proportions of eyes with 0, 1, 2, or ≥3 IOP-lowering medications; IOP ≤15 mmHg or ≤18 mmHg; visual fields (VF); retinal nerve fiber layer thickness (RNFL); central corneal thickness (CCT); intraoperative complications; adverse events; and secondary surgeries.
A total of 273 eyes underwent surgery and had 36-month follow-up. At 36 months versus preoperative, mean IOP decreased by 15.5% (16.4±4.6 mmHg to 13.9±3.5 mmHg; p<0.001), and 70.3% of eyes achieved IOP of ≤15 mmHg (versus 49.1% preoperatively; p<0.001). The mean medication burden decreased by 68.5% (from 1.51±1.17 to 0.48±0.89 medications; p<0.001); 71.4% of eyes were medication-free (versus 21.6% preoperatively; p<0.001), while 6.2% of eyes were on ≥3 medications (versus 22.3% preoperatively; p<0.001); 96.3% of eyes maintained or reduced medications vs preoperative. Significant IOP and medication reductions occurred across glaucoma subtypes (POAG, PAC, NTG, OHT): 13-22% for IOP (p<0.05 for all) and 42-94% for medication (p<0.05 for all). Favorable safety included few adverse events; stable VF, RNFL, and CCT; and filtering surgery in only 8 eyes (2.9%) over 3 years.
In this multicenter cohort from 8 surgeons across Australia, significant IOP and medication reductions were sustained through 3 years after iStent inject implantation with phacoemulsification. Results were favorable across different glaucoma subtypes (including POAG, PAC, NTG, OHT), severities, and surgeons, thereby underscoring the real-world relevance and efficacy of iStent implantation for glaucoma treatment.
评估两种第二代小梁微旁路支架（iStent ）联合超声乳化术的3年安全性和有效性。
这项关于iStent 植入联合超声乳化术的多中心回顾性研究纳入了来自澳大利亚8位外科医生的数据。纳入患有白内障和轻度至重度青光眼[主要为原发性开角型（POAG）、原发性闭角型（PAC）或正常眼压（NTG）青光眼]或高眼压症（OHT）的眼睛。研究评估包括眼压（IOP）；降眼压药物数量；使用0、1、2或≥3种降眼压药物的眼睛比例；IOP≤15 mmHg或≤18 mmHg；视野（VF）；视网膜神经纤维层厚度（RNFL）；中央角膜厚度（CCT）；术中并发症；不良事件；以及二次手术。
共有273只眼睛接受了手术并进行了36个月的随访。与术前相比，36个月时平均IOP下降了15.5%（从16.4±4.6 mmHg降至13.9±3.5 mmHg；p<0.001），70.3%的眼睛眼压≤15 mmHg（术前为49.1%；p<0.001）。平均药物负担下降了68.5%（从1.51±1.17种药物降至0.48±0.89种药物；p<0.001）；71.4%的眼睛无需使用药物（术前为21.6%；p<0.001），而6.2%的眼睛使用≥3种药物（术前为22.3%；p<0.001）；96.3%的眼睛与术前相比维持或减少了药物使用。在青光眼各亚型（POAG、PAC、NTG、OHT）中，IOP和药物使用均有显著降低：IOP降低13 - 22%（所有p<0.05），药物使用降低42 - 94%（所有p<0.05）。良好的安全性包括不良事件较少；VF、RNFL和CCT稳定；3年内仅有8只眼睛（2.9%）进行了滤过手术。
在这项来自澳大利亚8位外科医生的多中心队列研究中，iStent 植入联合超声乳化术后3年，眼压和药物使用持续显著降低。在不同青光眼亚型（包括POAG、PAC、NTG、OHT）、严重程度及外科医生中结果均良好，从而强调了iStent 植入治疗青光眼在现实世界中的相关性和有效性。
