Best U P, Domack H, Schmidt V, Khalifa M
Augenklinik und Augenlaserklinik Mainfranken, Am Oberen Marienbach 1, 97421, Schweinfurt, Deutschland.
Ophthalmologe. 2019 Aug;116(8):771-779. doi: 10.1007/s00347-018-0824-8.
In this prospective randomized simple blind study, we investigated the long-term results of trabecular micro-bypass stent implantation as part of routine cataract surgery in eyes with primary chronic open-angle glaucoma. The chamber angle implants drain between the anterior chamber and the canal of Schlemm and circumvent the main outflow resistance by the trabecular meshwork.
The study included 65 eyes from 56 patients with primary chronic open-angle glaucoma with at least 2 different pressure-lowering drugs. Patients with low-tension glaucoma, secondary glaucoma and ocular hypertension were excluded. Of the 65 eyes 31 underwent a combined cataract surgery with subsequent implantation of 2 iStents inject GTS-400 (Glaukos Corporation, San Clemente, CA, USA) into the canal of Schlemm. In the same time period 34 of the 65 eyes underwent standard cataract surgery without stent implantation.
The longest follow-up time was 38 months and the mean follow-up time was 14 months. In our follow-up observational study the average intraocular pressure (IOP) reduction with combined surgery was 5.9 mm Hg or 23.5% of the original value (p < 0.001). The extent of IOP reduction depended on the level of the preoperative pressure.
The combined phacoemulsification and trabecular micro-bypass implantation was shown to be an effective and safe treatment method for reduction of IOP and the burden of local administration of medication could be reduced. The implantation provides a good option for additional reduction of IOP. Our results showed a favorable risk-benefit profile. Further long-term in vivo studies are needed to determine the long-term safety and efficacy.
在这项前瞻性随机单盲研究中，我们调查了小梁微旁路支架植入术作为原发性慢性开角型青光眼患者常规白内障手术一部分的长期效果。房角植入物在前房和施莱姆管之间引流，绕过小梁网的主要流出阻力。
该研究纳入了56例原发性慢性开角型青光眼患者的65只眼，这些患者至少使用了2种不同的降压药物。低眼压性青光眼、继发性青光眼和高眼压症患者被排除。65只眼中，31只眼接受了白内障联合手术，随后将2枚iStents inject GTS - 400（美国加利福尼亚州圣克莱门特市Glaukos公司）植入施莱姆管。同期，65只眼中的34只眼接受了无支架植入的标准白内障手术。
最长随访时间为38个月，平均随访时间为14个月。在我们的随访观察研究中，联合手术使平均眼压（IOP）降低了5.9 mmHg，即原始值的23.5%（p < 0.001）。眼压降低的程度取决于术前眼压水平。
白内障超声乳化联合小梁微旁路植入术被证明是一种有效且安全的降低眼压的治疗方法，可减轻局部用药负担。该植入术为进一步降低眼压提供了一个良好的选择。我们的结果显示出有利的风险效益比。需要进一步的长期体内研究来确定长期安全性和有效性。
