de Balthasar Chloé, Patel Sweta, Roy Arup, Freda Ricardo, Greenwald Scott, Horsager Alan, Mahadevappa Manjunatha, Yanai Douglas, McMahon Matthew J, Humayun Mark S, Greenberg Robert J, Weiland James D, Fine Ione
Department of Ophthalmology and Zilkha Neurogenetic Institute, University of Southern California, Los Angeles, California, USA.
Invest Ophthalmol Vis Sci. 2008 Jun;49(6):2303-14. doi: 10.1167/iovs.07-0696.
The goal was to evaluate how perceptual thresholds are related to electrode impedance, electrode size, the distance of electrodes from the retinal surface, and retinal thickness in six subjects blind as a result of retinitis pigmentosa, who received epiretinal prostheses implanted monocularly as part of a U.S. Food and Drug Administration (FDA)-approved clinical trial.
The implant consisted of an extraocular unit containing electronics for wireless data, power recovery, and generation of stimulus current, and an intraocular unit containing 16 platinum stimulating electrodes (260- or 520-microm diameter) arranged in a 4 x 4 pattern. The electrode array was held onto the retina by a small tack. Stimulation was controlled by a computer-based external system that allowed independent control over each electrode. Perceptual thresholds (the current necessary to see a percept on 79% of trials) and impedance were measured for each electrode on a biweekly basis. The distance of electrodes from the retinal surface and retinal thickness were measured by optical coherence tomography on a less regular basis.
Stimulation thresholds for detecting phosphenes correlated with the distance of the electrodes from the retinal surface, but not with electrode size, electrode impedance, or retinal thickness.
Maintaining close proximity between the electrode array and the retinal surface is critical in developing a successful retinal implant. With the development of chronic electrode arrays that are stable and flush on the retinal surface, it is likely that the influence of other factors such as electrode size, retinal degeneration, and subject age will become more apparent. (ClinicalTrials.gov number, NCT00279500.).
目标是评估在6名因色素性视网膜炎而失明的受试者中,感知阈值与电极阻抗、电极尺寸、电极与视网膜表面的距离以及视网膜厚度之间的关系。这些受试者作为美国食品药品监督管理局(FDA)批准的一项临床试验的一部分,单眼植入了视网膜外假体。
该植入物包括一个眼外单元,其包含用于无线数据、能量回收和刺激电流生成的电子设备,以及一个眼内单元,该眼内单元包含以4×4模式排列的16个铂刺激电极(直径为260或520微米)。电极阵列通过一个小钉固定在视网膜上。刺激由基于计算机的外部系统控制,该系统允许对每个电极进行独立控制。每两周测量一次每个电极的感知阈值(在79%的试验中看到感知所需的电流)和阻抗。电极与视网膜表面的距离和视网膜厚度通过光学相干断层扫描不定期测量。
检测光幻视的刺激阈值与电极离视网膜表面的距离相关,但与电极尺寸、电极阻抗或视网膜厚度无关。
在开发成功的视网膜植入物时,保持电极阵列与视网膜表面紧密接近至关重要。随着稳定且与视网膜表面齐平的慢性电极阵列的发展,电极尺寸、视网膜变性和受试者年龄等其他因素的影响可能会变得更加明显。(ClinicalTrials.gov编号,NCT00279500。)