TY - JOUR
T1 - Subretinal Visual Implant Alpha IMS - Clinical trial interim report
AU - Stingl, Katarina
AU - Bartz-Schmidt, Karl Ulrich
AU - Besch, Dorothea
AU - Chee, Caroline K.
AU - Cottriall, Charles L.
AU - Gekeler, Florian
AU - Groppe, Markus
AU - Jackson, Timothy L.
AU - MacLaren, Robert E.
AU - Koitschev, Assen
AU - Kusnyerik, Akos
AU - Neffendorf, James
AU - Nemeth, Janos
AU - Naeem, Mohamed Adheem Naser
AU - Peters, Tobias
AU - Ramsden, James D.
AU - Sachs, Helmut
AU - Simpson, Andrew
AU - Singh, Mandeep S.
AU - Wilhelm, Barbara
AU - Wong, David
AU - Zrenner, Eberhart
N1 - Funding Information:
This work was supported by Retina Implant AG, Reutlingen, Germany. This study is also part of the research programme of the Bernstein Center for Computational Neuroscience, Tübingen, Germany and was funded by the German Federal Ministry of Education and Research (BMBF; FKZ: 01GQ1002), by the NIHR Oxford Biomedical Research Centre , United Kingdom and the Tistou and Charlotte Kerstan Foundation, Germany. This project was also supported by joint grant of the National University of Singapore and Baden-Wuerttemberg , Germany (BW A/C – 191-000-016-646) and the Werner Reichardt Centre for Integrative Neuroscience (CIN) at the Eberhard Karls University of Tübingen, Germany. The CIN is an Excellence Cluster funded by the Deutsche Forschungsgemeinschaft (DFG) within the framework of the Excellence Initiative (EXC 307).
Publisher Copyright:
© 2015 The Authors.
PY - 2015/6/1
Y1 - 2015/6/1
N2 - 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.
AB - 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.
KW - Artificial vision
KW - Hereditary retinal diseases
KW - Neuroprosthetics
KW - Photoreceptor degeneration
KW - Retinitis pigmentosa
KW - Subretinal Implant Alpha IMS
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U2 - 10.1016/j.visres.2015.03.001
DO - 10.1016/j.visres.2015.03.001
M3 - Article
C2 - 25812924
AN - SCOPUS:84941315108
SN - 0042-6989
VL - 111
SP - 149
EP - 160
JO - Vision Research
JF - Vision Research
ER -