Department of Neurophysics, Philipps-University Marburg, Marburg, Germany.
Invest Ophthalmol Vis Sci. 2011 Jan 21;52(1):449-55. doi: 10.1167/iovs.09-4410.
Electrical stimulation of retinal neurons has been shown to be a feasible way to elicit visual percepts in patients blind from retinal degenerations. The EPIRET3 retinal implant is the first completely wireless intraocular implant for epiretinal stimulation. Stimulation tests have been performed during a clinical trial that was carried out at the eye clinics of Aachen and Essen to evaluate the safety and the efficacy of the implant.
Six legally blind retinitis pigmentosa patients were included in the study. In accordance with the regulations laid down in the study protocol, three 1-hour perceptual tests for each subject were performed within 4 weeks of surgery. Stimuli were charge-balanced square current pulses of various durations and current amplitudes.
All subjects reported visual percepts as a result of electrical stimulation by the implant. Thresholds for eliciting visual percepts varied between them but were below the safety limits of electrical stimulation. Stimulation success depended stronger on pulse duration than on current amplitude or total charge delivered. Subjects were able to discriminate between stimulation patterns of different orientations or at different locations of the electrode array.
The EPIRET3 system is suitable to elicit visual percepts in blind retinitis pigmentosa patients.
已经证明,视网膜神经元的电刺激是使因视网膜变性而失明的患者产生视觉感知的一种可行方法。EPIRET3 视网膜植入物是第一个完全无线的眼内视网膜刺激植入物。在亚琛和埃森的眼科诊所进行的临床试验中进行了刺激测试,以评估植入物的安全性和有效性。
该研究纳入了 6 名法律上失明的色素性视网膜炎患者。根据研究方案规定的规定,在手术后 4 周内,每个受试者进行了 3 次每次 1 小时的感知测试。刺激是各种持续时间和电流幅度的平衡电荷的方形电流脉冲。
所有受试者均报告说,植入物的电刺激产生了视觉感知。引发视觉感知的阈值因人而异,但低于电刺激的安全限制。刺激成功更取决于脉冲持续时间,而不是电流幅度或传递的总电荷量。受试者能够区分电极阵列不同方向或不同位置的刺激模式。
EPIRET3 系统适合在失明的色素性视网膜炎患者中引发视觉感知。