[Microinvasive glaucoma surgery-Efficacy of trabecular stents in combined interventions : A clinical study on 65 eyes].

BACKGROUND AND OBJECTIVE: 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. PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.