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D. Spiegel, W. Wetzel, J. Sturmer, H. Hoh, T. Neuhann, J. Garcia–Sanchez, R.A. Hill, B. Niksch; Co–Existent Open–Angle Glaucoma and Cataract: Treatment by Cataract Surgery and the iStenttm Trabecular Bypass Micro Stent . Invest. Ophthalmol. Vis. Sci. 2005;46(13):74.
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Title: Co–existent open–angle glaucoma and cataract: Treatment by cataract surgery and the iStentTM Trabecular Bypass Micro Stent Purpose:To evaluate the safety and efficacy of the Glaukos iStentTM Trabecular Bypass Micro Stent implanted in conjunction with cataract surgery. Methods: Prospective study of 51 patients with "uncontrolled open angle glaucoma (including pseudoexfoliation)" and cataract. Subjects underwent clear cornea phacoemulsification cataract extraction with ab–interno gonioscopically guided implantation of the iStentTM. Results: In this interim analysis of 44 of 51 subjects, with a mean follow–up of 4.71 months (range: 1 to 12 months). At baseline, mean (± SD) IOP was 21.18 ± 3.25 mmHg (range 18–29), and patients were taking 1.48 ± 0.63 ocular hypotensive medications. A "last visit" analysis revealed a mean decrease in IOP of 4.98 ± 4.01 mmHg (p<0.0001), and a decrease in the number of ocular hypotensive medications to 0.52 ± 0.88 (p<0.0001). For the 8 patients with 12 months or more follow–up, the mean IOP was 16.0mmHg ± 3.16mmHg. These subjects exhibited a mean decrease in IOP of 6.88 ± 5.36 mmHg. There were no complications traditionally associated with filtering surgery, and minimal adverse events reported. Conclusions: In this interim analysis in a population of subjects with glaucoma and cataracts, ab–interno, iStentTM implantation in conjunction with cataract surgery represents a new surgical approach to provide clinically significant decreases in IOP and drug burden.
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