研究目的
To test the durability of the PRIMA implant in vitro, evaluating resistance to corrosion and/or water ingress and repeated stimulation at the highest parameters under accelerated conditions, and to estimate implant lifespan in vivo.
研究成果
The PRIMA implant can withstand corrosive and electrical stimulation pressures in conditions similar to those of human eye for at least a decade. The pixel failure rate was negligible, and no implants malfunctioned. Statistical reliability analysis estimates a PRIMA median lifespan of over 27 years. Future studies should attempt to confirm these results in vivo.
研究不足
The generation of in vivo lifetime estimations from in vitro data remains speculative. Many physiological, electrical, and mechanical aspects of the human eye are unreproducible in a laboratory.
1:Experimental Design and Method Selection:
The study investigated two potential failure modes: corrosion and overstimulation. Real-time aging was tested at 37°C, and accelerated aging at 77°C using the Arrhenius theory. Confirmatory testing involved different temperatures and weakened implant coatings.
2:Sample Selection and Data Sources:
175 implants of five different designs were tested.
3:List of Experimental Equipment and Materials:
Balanced saline solution (BSS), pulsed infrared laser, temperature-regulated oven, optical microscope, calibrated power meter, and photodiode.
4:Experimental Procedures and Operational Workflow:
Implants were immersed in BSS at various temperatures for corrosion testing. For stimulation testing, implants were activated with a pulsed infrared laser at maximum parameters.
5:Data Analysis Methods:
Weibull analysis for pixel reliability at a 95% confidence interval was performed using Weibull++ software.
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