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E R Craven, Julian García, Magda Rau, Marco Nardi, Pravoslava Guguchkova, Tsontcho Ianchulev; Standalone CyPass Micro-Stent implantation in patients refractory to topical glaucoma therapy: 1 year results. Invest. Ophthalmol. Vis. Sci. 2014;55(13):822.
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Evaluate the safety and outcomes of supraciliary micro-stent implantation as a treatment for primary open-angle glaucoma (POAG).
In a prospective, multicenter interventional single-arm study (DUETTE),the CyPass Micro-Stent (Transcend Medical, Inc, Menlo Park, CA) was implanted into the supraciliary space through a 1.5 mm corneal incision in subjects with POAG for whom medical therapy was insufficient to control intraocular pressure. Safety data, including adverse events, complications, intraocular pressure, and medications, are reported up to 12 months (12M) postoperative.
Sixty-five subjects were enrolled in the study, and there were 47 patients evaluable at 12M. At baseline, the majority of subjects (69%) were on 2 or more medications and all had a baseline medicated IOP ≥ 21 mmHg. Mean ± standard deviation (SD) medicated IOP at baseline was 24.5 ± 2.8 mmHg. There were no cases of suprachoroidal hemorrhage, bleb-related complications, retinal complications or hypotony maculopathy. At 12 months after surgery, mean ± SD IOP was 16.7 ± 5.5 mmHg with a 32% reduction in IOP from baseline (p<0.0001). Mean ± SD medication usage (meds) also decreased from 2.2 ± 1.1 meds to 1.5 ± 1.3 meds at 12M (p=0.008).
The results of this study demonstrate the performance of a supraciliary micro-stent as a standalone treatment for patients with POAG, without the potentially confounding effects of phaco-cataract surgery. The supraciliary CyPass Micro-Stent provided safe and sustained IOP reduction in patients with POAG refractory to medications.
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