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Co–Existent Open–Angle Glaucoma and Cataract: Treatment by Cataract Surgery and the iStent^tm Trabecular Bypass Micro Stent

¹ Ophthalmology, University Eye Hosp Regensburg, Regensburg, Germany
² Augenaerztliche Gemeinschaftspraxis, Weinheim, Germany
³ Ophthalmology, Augenklinik Kantonsspital, Winterthur, Switzerland
⁴ Klinikum Neubrandenburg, Neubrandenburg, Germany
⁵ Rotkreuz Krankenhaus, Munchen, Germany
⁶ Clinico San Carlos, Madrid, Spain
⁷ Ophthalmology, University California Irvine, Irvine, CA
⁸ Glaukos Corporation, Laguna Hills, CA

Commercial Relationships: D. Spiegel, None; W. Wetzel, None; J. Sturmer, None; H. Hoh, None; T. Neuhann, None; J. Garcia–Sanchez, None; R.A. Hill, Glaukos Corporation I, C, P, R; B. Niksch, Glaukos Corporation E.

Support: None.

Abstract

Title: Co–existent open–angle glaucoma and cataract: Treatment by cataract surgery and the iStent^TM Trabecular Bypass Micro Stent

Purpose:To evaluate the safety and efficacy of the Glaukos iStent^TM Trabecular Bypass Micro Stent implanted in conjunction with cataract surgery.

Methods: Prospective study of 51 patients with "uncontrolled open angle glaucoma (including pseudoexfoliation)" and cataract. Subjects underwent clear cornea phacoemulsification cataract extraction with ab–interno gonioscopically guided implantation of the iStent^TM.

Results: In this interim analysis of 44 of 51 subjects, with a mean follow–up of 4.71 months (range: 1 to 12 months). At baseline, mean (± SD) IOP was 21.18 ± 3.25 mmHg (range 18–29), and patients were taking 1.48 ± 0.63 ocular hypotensive medications. A "last visit" analysis revealed a mean decrease in IOP of 4.98 ± 4.01 mmHg (p<0.0001), and a decrease in the number of ocular hypotensive medications to 0.52 ± 0.88 (p<0.0001). For the 8 patients with 12 months or more follow–up, the mean IOP was 16.0mmHg ± 3.16mmHg. These subjects exhibited a mean decrease in IOP of 6.88 ± 5.36 mmHg. There were no complications traditionally associated with filtering surgery, and minimal adverse events reported.

Conclusions: In this interim analysis in a population of subjects with glaucoma and cataracts, ab–interno, iStent^TM implantation in conjunction with cataract surgery represents a new surgical approach to provide clinically significant decreases in IOP and drug burden.

Keywords: intraocular pressure • trabecular meshwork • cataract

© 2005, The Association for Research in Vision and Ophthalmology, Inc., all rights reserved. For permission to reproduce any part of this abstract, contact the ARVO Office at arvo{at}arvo.org.