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J. M. Martinez de la Casa, J. Garcia-Feijoo, Y. Fernandez-Barrientos, J. Garcia-Sanchez; Safety and Efficacy of the iStent Trabecular Micro-Bypass and Concurrent Cataract Surgery: 12 Month Analysis. Invest. Ophthalmol. Vis. Sci. 2007;48(13):824.
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To evaluate the safety and efficacy of the iStent in patients undergoing concurrent cataract and glaucoma surgery.
Prospective, 24-month, uncontrolled, multicenter, multi-country evaluation of 48 patients with uncontrolled primary OAG and cataract. Patients underwent clear cornea phacoemulsification followed by ab-interno implantation of the iStent. Ocular hypotensive medications were discontinued on the day of surgery and added back if deemed necessary. Forty-two patients completed 12 months of the 24-month study and are included in this interim analysis.
At baseline, mean (±SD) medicated IOP was 21.7 ± 3.98 mmHg. At 12 months, mean IOP had dropped to 17.4 ± 2.99 mmHg, a mean IOP reduction of 4.4 ± 4.54 mmHg, (18.3%) (P < 0.001). At baseline, patients were taking a mean 1.6 ± 0.8 medications. By 12 months, the mean number of medications was reduced to 0.4 ± 0.62 (P < 0.001). At month 12, half the patients achieved an IOP < 18 mmHg on no ocular hypotensive medications. The most commonly reported device-related adverse events were the appearance of stent lumen obstruction (7 eyes) and stent malposition (6 eyes), most still achieved significant IOP reduction. None of the device related adverse events were considered serious.
The iStent was safe and efficacious for the reduction of IOP in OAG patients undergoing concurrent cataract and glaucoma surgery. A prospective randomized clinical trial (iStent placement compared to cataract extraction alone) is currently in progress in the USA as part of the FDA approval process.
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