The artificial silicon retina microchip for the treatment of vision loss from retinitis pigmentosa.

OBJECTIVE: To determine the safety and efficacy of the artificial silicon retina (ASR) microchip implanted in the subretinal space to treat vision loss from retinitis pigmentosa. METHODS: The ASR microchip is a 2-mm-diameter silicon-based device that contains approximately 5000 microelectrode-tipped microphotodiodes and is powered by incident light. The right eyes of 6 patients with retinitis pigmentosa were implanted with the ASR microchip while the left eyes served as controls. Safety and visual function information was collected. RESULTS: During follow-up that ranged from 6 to 18 months, all ASRs functioned electrically. No patient showed signs of implant rejection, infection, inflammation, erosion, neovascularization, retinal detachment, or migration. Visual function improvements occurred in all patients and included unexpected improvements in retinal areas distant from the implant. MAIN OUTCOME MEASURES: Subjective improvements included improved perception of brightness, contrast, color, movement, shape, resolution, and visual field size. CONCLUSIONS: No significant safety-related adverse effects were observed. The observation of retinal visual improvement in areas far from the implant site suggests a possible generalized neurotrophic-type rescue effect on the damaged retina caused by the presence of the ASR. A larger clinical trial is indicated to further evaluate the safety and efficacy of a subretinally implanted ASR.

Subretinal implantation of semiconductor-based photodiodes: durability of novel implant designs.

Selective degeneration of the retinal photoreceptor layers underlies blindness in retinitis pigmentosa (RP) and other inherited retinal disorders. Because there are no therapies for these patients, we are evaluating the possibility that electrical stimulation delivered to the subretinal space by a microphotodiode array (MPA) could replace, in some aspect, the function of diseased photoreceptors. Early MPA prototypes utilized gold as the electrode material, which gradually dissolved during the postoperative period following subretinal implantation. Here we present the results obtained when different MPA materials were used. Semiconductor-based silicon MPAs (2 mm in diameter; 50 microm in thickness), incorporating iridium/iridium oxide (IrOx) or platinum (Pt) electrodes, were implanted into the subretinal space of the right eye of normal cats with the use of vitreoretinal surgical techniques. Indirect ophthalmoscopy, fundus photography, ganzfeld electroretinography, and histology were used for the evaluation of the implanted retinas postoperatively. Infrared (IR) stimulation was used to isolate electrical responses generated by the MPA. The unimplanted left eyes were used for control purposes. After the implantation surgery, subretinal MPAs retained a stable position in the subretinal space. Up to 12 months after surgery, there was little change in the magnitude of the electrical response of IrOx- and Pt-based MPAs to a standard IR light stimulus. Overlying the implant, there was a near-complete loss of the outer retinal layer, which is likely to reflect obstruction of choroidal nourishment to these layers by the solid disk implant. In addition, the inner retinal layers showed variable disorganization. Away from the implant, the retina displayed a normal appearance. In comparison to electroretinograms (ERGs) obtained from unimplanted eyes, responses recorded from implanted eyes had a normal waveform but were slightly smaller in amplitude. These results indicate that IrOx and Pt improve implant electrode durability and that implants incorporating these materials into the electrode layer do not induce panretinal abnormalities.