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.

Date Published: 7 March 2006
PDF: 8 pages
Proc. SPIE 6138, Ophthalmic Technologies XVI, 61380U (7 March 2006); doi: 10.1117/12.652297

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