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Alan Y. Chow, MD; Vincent Y. Chow, BS; Kirk H. Packo, MD; John S. Pollack, MD; Gholam A. Peyman, MD; Ronald Schuchard, PhD

Arch Ophthalmol. 2004;122:460-469.

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.

From Optobionics Corporation, Naperville, Ill (Dr A. Chow and Mr V. Chow); Department of Ophthalmology, Rush-Presbyterian-St Luke's Medical Center, Chicago, Ill (Drs Packo and Pollack); Department of Ophthalmology, Tulane University School of Medicine, New Orleans, La (Dr Peyman); and the Atlanta Veterans Administration Rehabilitation Research and Development Center and Emory University School of Medicine, Atlanta, Ga (Dr Schuchard). Dr A. Chow and Mr V. Chow are employees of Optobionics Corporation with stock ownership. Dr Peyman is a consultant to Optobionics Corporation with stock ownership.

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