April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
Standalone CyPass Micro-Stent implantation in patients refractory to topical glaucoma therapy: 1 year results
Author Affiliations & Notes
  • E R Craven
    Glaucoma, Wilmer Eye Institute, Baltimore, MD
    Glaucoma, King Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia
  • Julian García
    Hospital Clinico San Carlos, Universidad Complutense, Madrid, Spain
  • Magda Rau
    Eye Clinic, Cham, Germany
  • Marco Nardi
    University of Pisa, Pisa, Italy
  • Pravoslava Guguchkova
    Eye Institute of Sofia, Sofia, Bulgaria
  • Tsontcho Ianchulev
    University of California, San Francisco, San Francisco, CA
    Transcend Medical, Inc., Menlo Park, CA
  • Footnotes
    Commercial Relationships E Craven, Glaukos (C), Transcend Medical, Inc. (C); Julian García, Glaukos (C), Ivantis (C), Transcend Medical, Inc. (C); Magda Rau, Transcend Medical, Inc. (C); Marco Nardi, Transcend Medical, Inc. (F); Pravoslava Guguchkova, Transcend Medical, Inc. (F); Tsontcho Ianchulev, Transcend Medical, Inc. (E)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 822. doi:
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    • Get Citation

      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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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract
 
Purpose
 

Evaluate the safety and outcomes of supraciliary micro-stent implantation as a treatment for primary open-angle glaucoma (POAG).

 
Methods
 

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.

 
Results
 

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).

 
Conclusions
 

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.

     
Keywords: 462 clinical (human) or epidemiologic studies: outcomes/complications • 568 intraocular pressure • 427 aqueous  
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