Article
Surgical technique of the PRIMA photovoltaic retinal implant: from animal testing to implantation in humans
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Published: | December 10, 2019 |
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Outline
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Objective: To develop a surgical method for the implantation of a subretinal photovoltaic retinal implant.
Materials and methods: Cats and Macaca fascicularis primates with healthy retina underwent vitrectomy surgery and were implanted with subretinal wireless photovoltaic microchip at the macula/central retina. The 1.5mm PRIMA chip was initially studied in feline eyes. PRIMA implant (2mm,1.5mm sizes) arrays were studied in primates. Feasibility of subretinal chip implantation was evaluated with a novel surgical technique, with surgical complications and adverse events recorded.
Results: The 1.5mm implant was successfully placed in the central retina of 11 feline eyes, with implantation duration 43-106 days. The 1.5mm implant was successfully positioned into central macula of 11 primate eyes, with follow-up periods of minimum 6 weeks (n=11), 2 years (n=2), and one eye for 3 years. One primate eye underwent multi-chip 1.5mm implantation. The 2mm implant was delivered successfully to 4 primate eyes. Optical coherence tomography confirmed successful surgical placement of photovoltaic arrays in the subretinal space in all 26 eyes. Intraoperative complications in primate eyes included minor retinal and vitreous hemorrhage that resolved spontaneously. Postoperatively, there was no case of significant ocular inflammation in 1.5mm/2mm implant groups.
Discussion: We report successful subretinal implantation of 1.5mm and 2mm photovoltaic arrays in the central retina of feline and central macula of primate eyes with a low rate of device-related complications. The in vivo PRIMA implantation technique has been developed and refined for use for a 2mm PRIMA implant in ongoing human trials