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Proceedings Paper

New styrene-b-isobutylene-b-styrene (SIBS) glaucoma drainage implant
Author(s): Marcia Orozco; Ana C. Acosta; Edgar M. Espana; Leonard Pinchuk; Bruce A. Weber; Stewart Davis; Esdras Arrieta; Sander Dubovy; Francisco Fantes; Mohamed Aly; Yonghua Zhou; Jean-Marie Parel
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Paper Abstract

Purpose: To design and test the Miami-InnFocus Drainage Implant (MiDi) as a glaucoma shunt that is biocompatible, flexible, and significantly smaller than existing commercial implants in order to prevent postoperative hypotony, inflammation, scarring, erosion, and extrusion. Methods: A new biomaterial composed of styrene-b-isobutylene-b-styrene (SIBS) was used in a novel design for a glaucoma drainage implant. The implant consists of a tube 11mm long with an inner diameter of 70, 100, and 150 μm and outer diameter of 250 μm with a 1mm2 tab located 4.5mm from the proximal tip to prevent migration. The device was implanted in 15 New Zealand White rabbits for biocompatibility and efficacy testing. A similarly designed implant made of polydimethylsiloxane was implanted in 6 other animals as a pseudo-control. Typical GDI implantation technique was modified for this device. The proximal end of the new SIBS implant was inserted 2mm into the anterior chamber and the distal end placed in a subconjunctival space created by the surgeon. Biocompatibility of the device was studied by slit-lamp follow-up and intraocular pressure (IOP) measurements recorded periodically. Results: Biocompatibility of the MiDi was excellent. A low and diffuse bleb was observed with these devices. All SIBS tubes were patent 9 months after insertion. Immunostaining demonstrated non-continuous deposition of collagen with virtually no encapsulation. No macrophages or myofibroblast were visible around the SIBS polymer which was found more bioinert than the control PDMS. Conclusion: This newly designed glaucoma implant is clinically biocompatible in the rabbit model and maintained 100% patency at 9 months.

Paper Details

Date Published: 7 March 2006
PDF: 8 pages
Proc. SPIE 6138, Ophthalmic Technologies XVI, 61380U (7 March 2006); doi: 10.1117/12.652297
Show Author Affiliations
Marcia Orozco, Bascom Palmer Eye Institute, Miller School of Medicine, Univ. of Miami (United States)
Univ. of Miami (United States)
Ana C. Acosta, Bascom Palmer Eye Institute, Miller School of Medicine, Univ. of Miami (United States)
Edgar M. Espana, Bascom Palmer Eye Institute, Miller School of Medicine, Univ. of Miami (United States)
Leonard Pinchuk, Bascom Palmer Eye Institute, Miller School of Medicine, Univ. of Miami (United States)
Univ. of Miami (United States)
InnFocus, LLC (United States)
Bruce A. Weber, InnFocus, LLC (United States)
Stewart Davis, InnFocus, LLC (United States)
Esdras Arrieta, Bascom Palmer Eye Institute, Miller School of Medicine, Univ. of Miami (United States)
Sander Dubovy, Bascom Palmer Eye Institute, Miller School of Medicine, Univ. of Miami (United States)
Francisco Fantes, Bascom Palmer Eye Institute, Miller School of Medicine, Univ. of Miami (United States)
Mohamed Aly, Bascom Palmer Eye Institute, Miller School of Medicine, Univ. of Miami (United States)
Yonghua Zhou, InnFocus, LLC (United States)
Jean-Marie Parel, Bascom Palmer Eye Institute, Miller School of Medicine, Univ. of Miami (United States)
Univ. of Miami (United States)
Univ. of Liege (Belgium)


Published in SPIE Proceedings Vol. 6138:
Ophthalmic Technologies XVI
Fabrice Manns; Per G. Söderberg; Arthur Ho, Editor(s)

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