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C. E. Traverso, F. De Feo, GC001 Study Group; Trabecular Micro-Bypass Stent for refractory open-angle glaucoma patients: 24-month results. Invest. Ophthalmol. Vis. Sci. 2009;50(13):456.
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To evaluate the efficacy of the Trabecular Micro-Bypass Stent (iStent Glaukos Corp.) in patients with open angle glaucoma, refractory to previous medical and surgical therapies.
Prospective, open-labeled, 24 month, multi-center evaluation of 43 patients with uncontrolled advanced primary open-angle glaucoma who underwent ab-interno trabecular stent implantation 28 patients reached 24-month follow-up (F.U.). Subjects had undergone previous conventional medical and surgical therapies that failed or were considered to have a poor prognosis for filtration surgery. Primary end point was achievement of an IOP ≤21 mm Hg. IOP lowering medications were discontinued on the day of surgery and added during F.U. as needed. Secondary end point was reduction in mean medication use.
mean age was 64.9 ±11.0 years. Mean preoperative IOP was 28.4 (±6.39) mm Hg at baseline and 18.3 (±5.04) mm Hg at month 24, an average decrease of 25.9% from the medicated baseline. At baseline, the mean number of medications was 2.1 (±0.94); by month 24 the mean number of medications was 1.1 (±1.26, P<0.001). Overall, 23 eyes (82.1%) had an IOP of ≤ 21 mm Hg. More than half the patients (12/23 eyes, 52.2%) with an IOP of ≤ 21 mm Hg were on no medications at final follow-up (24 months). The most commonly reported adverse event was the need for trabeculectomy for insufficient IOP control (n=15).
The stent was safe and effective for reducing IOP in patients with refractory glaucoma who have failed at least one glaucoma surgery. There were no serious adverse events, and the majority of patients were able to remain medication-free at 24 months.
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