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D. Spiegel, J. Garcia-Feijoo, J. M. Martinez de la Casa, J. Garcia-Sanchez, GC-002 Study Group; iStent Trabecular Micro-Bypass and Concurrent Cataract Surgery: 24 Month Results. Invest. Ophthalmol. Vis. Sci. 2009;50(13):455.
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To evaluate the safety and efficacy of the iStent in 59 patients undergoing concurrent cataract and glaucoma surgery.
Prospective, open-labeled, 24-month, multi-country evaluation. 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 necessary. Primary outcome was IOP at all time points; secondary outcome was medication use and visual acuity.
At baseline, mean (±SD) IOP was 21.5 ± 4.1 mmHg. At 24 months, 45 patients (84.9%; n=53) had an IOP of ≤ 18 mm Hg, with a mean IOP of 15.8 ±2.1 mm Hg. Of those 45 patients, 26 (57.8%) had a mean IOP of 15.6 ±1.75 mm Hg and were on no ocular hypotensive medications. At 24 months, the average IOP decrease from a medicated baseline was 5.1 mm Hg. At baseline, the mean number of medications was 1.7 ±0.9. After 24 months, the mean number of medications was reduced to 0.5 ±0.7, a mean reduction of 1.1 ± 0.8 medications. The most commonly reported device-related adverse events were the appearance of stent lumen obstruction (7 eyes) and stent malposition (9 eyes); most of the patients still achieved significant IOP reduction. None of the adverse events were considered serious.
The iStent was safe and efficacious for reducing IOP in OAG patients undergoing concurrent cataract and glaucoma surgery. There were no serious adverse events, and the majority of patients were able to remain medication-free at 24 months. A prospective randomized clinical trial (iStent placement vs. phacoemulsification alone) is under way in the USA as part of the FDA approval process.
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