The value of preoperative tests in the selection of blind patients for a permanent microelectronic implant.
The value of preoperative tests in the selection of blind patients for a permanent microelectronic implant.
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发表时间：
2003
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通讯作者：
D. Yanai;R. Lakhanpal;J. Weiland;M. Mahadevappa;G. V. Van Boemel;G. Fujii;R. Greenberg;Sean Caffey-Sean-Caf
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作者：
D. Yanai;R. Lakhanpal;J. Weiland;M. Mahadevappa;G. V. Van Boemel;G. Fujii;R. Greenberg;Sean Caffey-Sean-Caf
目的通过一系列术前视觉、心理物理和电生理测试，确定长期植入微电子视网膜植入物的最佳候选者（即，需要向视网膜输送最低电流水平以引起视觉感知的患者）。方法本研究方案获得了美国食品药品监督管理局的研究器械豁免，并获得了南加州大学机构审查委员会的批准。在获得知情同意后，所有受试者均接受以下术前测试：暗适应明亮闪光和30 Hz闪烁视网膜电图，使用Burian-Allen角膜电极刺激地球仪的电诱发反应（EER），以及评估光和电诱发视觉感知的心理物理测试。视网膜的眼内刺激（IOS）是通过定位在内界板上的电极阵列进行的。结果：低视力与较不敏感的心理物理反应相关（P<.0001）。较低的视力和较不敏感的心理物理测试与刺激脉冲宽度为2 ms（P<.0008）和4 ms（P<.0002）的EER值较高相关。较低的IOS电流与更敏感的心理物理反应（P<.02）和4 ms时较低的EER值（P<.04）相关。结论：术前测试，特别是心理物理和电生理测试，以评估光和电驱动的视觉反应，可以帮助评估患者是否适合接受永久性微电子视网膜植入。需要进一步研究。
PURPOSE To determine the best candidates (ie, those requiring lowest current levels delivered to the retina to elicit visual perceptions) for long-term implantation of a microelectronic retinal implant through a series of preoperative visual, psychophysical, and electrophysiological tests. METHODS This study protocol was granted an investigational device exemption by the Food and Drug Administration and was approved by the institutional review board at the University of Southern California. After informed consent was obtained, all subjects underwent the following preoperative tests: dark-adapted bright flash and 30-Hz flicker electroretinograms, electrical evoked responses (EERs) using a Burian-Allen corneal electrode to stimulate the globe, and psychophysical tests to evaluate the light and electrically elicited visual perceptions. Intraocular stimulation (IOS) of the retina was performed by an array of electrodes positioned on the internal limiting lamina. RESULTS Lower vision correlated with less sensitive psychophysical responses (P<.0001). Lower vision and less sensitive psychophysical tests correlated with higher EER values for stimulus pulse widths of 2 ms (P<.0008) and 4 ms (P<.0002). Lower IOS currents correlated with more sensitive psychophysical responses (P<.02) and lower EER values at 4 ms (P<.04). CONCLUSIONS Preoperative testing, especially psychophysical and electrophysiological tests to assess light and electrically driven visual responses, can help in evaluating patients for suitability for receiving a permanent microelectronic retinal implant. Further study is warranted.