7 March 2006 New styrene-b-isobutylene-b-styrene (SIBS) glaucoma drainage implant
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Proceedings Volume 6138, Ophthalmic Technologies XVI; 61380U (2006) https://doi.org/10.1117/12.652297
Event: SPIE BiOS, 2006, San Jose, California, United States
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.
© (2006) COPYRIGHT Society of Photo-Optical Instrumentation Engineers (SPIE). Downloading of the abstract is permitted for personal use only.
Marcia Orozco, Marcia Orozco, Ana C. Acosta, Ana C. Acosta, Edgar M. Espana, Edgar M. Espana, Leonard Pinchuk, Leonard Pinchuk, Bruce A. Weber, Bruce A. Weber, Stewart Davis, Stewart Davis, Esdras Arrieta, Esdras Arrieta, Sander Dubovy, Sander Dubovy, Francisco Fantes, Francisco Fantes, Mohamed Aly, Mohamed Aly, Yonghua Zhou, Yonghua Zhou, Jean-Marie Parel, Jean-Marie Parel, } "New styrene-b-isobutylene-b-styrene (SIBS) glaucoma drainage implant", Proc. SPIE 6138, Ophthalmic Technologies XVI, 61380U (7 March 2006); doi: 10.1117/12.652297; https://doi.org/10.1117/12.652297

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