Stingl Katarina, Bartz-Schmidt Karl Ulrich, Besch Dorothea, Chee Caroline K, Cottriall Charles L, Gekeler Florian, Groppe Markus, Jackson Timothy L, MacLaren Robert E, Koitschev Assen, Kusnyerik Akos, Neffendorf James, Nemeth Janos, Naeem Mohamed Adheem Naser, Peters Tobias, Ramsden James D, Sachs Helmut, Simpson Andrew, Singh Mandeep S, Wilhelm Barbara, Wong David, Zrenner Eberhart
Centre for Ophthalmology, University of Tübingen, Schleichstr. 12-16, 72076 Tübingen, Germany.
Department of Ophthalmology, National University Health System, 1E Kent Ridge Road, Singapore 119228, Singapore.
Vision Res. 2015 Jun;111(Pt B):149-60. doi: 10.1016/j.visres.2015.03.001. Epub 2015 Mar 23.
A subretinal visual implant (Alpha IMS, Retina Implant AG, Reutlingen, Germany) was implanted in 29 blind participants with outer retinal degeneration in an international multicenter clinical trial. Primary efficacy endpoints of the study protocol were a significant improvement of activities of daily living and mobility to be assessed by activities of daily living tasks, recognition tasks, mobility, or a combination thereof. Secondary efficacy endpoints were a significant improvement of visual acuity/light perception and/or object recognition (clinicaltrials.gov, NCT01024803). During up to 12 months observation time twenty-one participants (72%) reached the primary endpoints, of which thirteen participants (45%) reported restoration of visual function which they use in daily life. Additionally, detection, localization, and identification of objects were significantly better with the implant power switched on in the first 3 months. Twenty-five participants (86%) reached the secondary endpoints. Measurable grating acuity was up to 3.3 cycles per degree, visual acuities using standardized Landolt C-rings were 20/2000, 20/2000, 20/606 and 20/546. Maximal correct motion perception ranged from 3 to 35 degrees per second. These results show that subretinal implants can restore very-low-vision or low vision in blind (light perception or less) patients with end-stage hereditary retinal degenerations.
在一项国际多中心临床试验中，29名患有外层视网膜变性的盲人参与者植入了一种视网膜下视觉植入物（Alpha IMS，德国罗伊特林根的视网膜植入公司）。该研究方案的主要疗效终点是通过日常生活任务、识别任务、活动能力或其组合来评估日常生活活动和活动能力的显著改善。次要疗效终点是视力/光感和/或物体识别的显著改善（clinicaltrials.gov，NCT01024803）。在长达12个月的观察期内，21名参与者（72%）达到了主要终点，其中13名参与者（45%）报告恢复了他们在日常生活中使用的视觉功能。此外，在最初3个月内，打开植入物电源时，物体的检测、定位和识别明显更好。25名参与者（86%）达到了次要终点。可测量的光栅视力高达每度3.3周，使用标准化兰多尔特C环的视力分别为20/2000、20/2000、20/606和20/546。最大正确运动感知范围为每秒3至35度。这些结果表明，视网膜下植入物可以恢复患有晚期遗传性视网膜变性的盲人（光感或更低）患者的极低视力或低视力。
