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D. Spiegel, J. G. Feijoo, J. M. Martinez de la Casa, J. G. Sanchez, GC-002 Study Group; Trabecular Micro-Bypass and Concurrent Cataract Surgery: 18 Month Analysis of the iStent. Invest. Ophthalmol. Vis. Sci. 2008;49(13):4192.
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To evaluate the safety and efficacy of a trabecular micro-bypass stent (iStent, Glaukos Corp.) in patients undergoing concurrent cataract and glaucoma surgery.
Prospective, open-labeled, 24-month, multi-country evaluation of 48 patients with uncontrolled primary OAG and cataract. Patients underwent clear cornea phacoemulsification followed by gonioscopicallyab-interno implantation of the iStent. Ocular hypotensive (OH) medications were discontinued on the day of surgery. Forty-one patients completed 18 months and are included in this interim analysis. Primary outcome measures were reduction in IOP and subsequent reduction in OH medications.
At baseline, mean (±SD) IOP was 21.9 ± 3.98 mmHg on maximum tolerated therapy. At 18 months, mean IOP was 16.9 ± 3.24 mmHg, a 21.4% decrease (P < 0.001). At baseline, patients were taking a mean 1.7 ± 0.9 medications, by month 18 that had been reduced to 0.5 ± 0.74 (P < 0.001). At month 18, more than half the patients achieved an IOP ≤ 18 mmHg without requiring OH medications. The most commonly reported device-related adverse events were the appearance of stent lumen obstruction (7 eyes) and stent malposition (9 eyes), and most still achieved significant IOP reduction and reduction in drug burden. None of the adverse events were considered serious.
The implantation of the iStent is safe and efficacious for reducing IOP in OAG patients and can help reduce or eliminate the number of glaucoma medications. 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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