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Biocompatibility and Function in Normal Rabbit Eyes

Ana C. Acosta, MD; Edgar M. Espana, MD; Hideo Yamamoto, MD; Stewart Davis, MD; Leonard Pinchuk, PhD; Bruce A. Weber, MA; Marcia Orozco, MS; Sander Dubovy, MD; Francisco Fantes, MD; Jean-Marie Parel, PhD

Arch Ophthalmol. 2006;124:1742-1749.

Objective  To report clinical evaluation, flow patency, and histopathological findings of a novel glaucoma drainage implant (GDI) made of poly(styrene-b-isobutylene-b-styrene) (SIBS) in rabbits.

Methods  In 16 normal eyes, the proximal end of the SIBS GDI was inserted into the anterior chamber while the distal end was placed in the subconjunctival space. A control group underwent implantation of a similarly designed silicone GDI. Slitlamp follow-up and intraocular pressure measurements were recorded. Flow patency was evaluated by injecting 0.01% fluorescein into the anterior chamber. Immunostaining against collagen IV, macrophages, and smooth muscle actin was performed.

Results  Slitlamp examination suggested adequate biocompatibility. A low and diffuse bleb was observed in the SIBS group. All SIBS tubes were patent 6 months after insertion. Immunostaining demonstrated noncontinuous collagen deposition. No macrophages or myofibroblasts were visible around the SIBS tubes. In contrast, silicone induced collagen deposition and myofibroblast differentiation.

Conclusion  This new GDI is clinically biocompatible in the rabbit and maintained 100% patency at 6 months. A remarkable difference was the absence of myofibroblasts in the surrounding tissue in the SIBS group.

Clinical Relevance  This novel GDI made of SIBS would prevent the feared complication of hypotony and will decrease the amount of subconjunctival fibrosis.

Author Affiliations: Ophthalmic Biophysics Center, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine (Drs Acosta, Espana, Yamamoto, Orozco, Dubovy, Fantes, and Parel), and Department of Biomedical Engineering, University of Miami College of Engineering (Drs Orozco and Parel), Miami, Fla; InnFocus LLC, Miami, Fla (Drs Davis, Pinchuk, and Weber); and the University of Liege, CHU Sart-Tilman, Liege, Belgium (Dr Parel).