title: Subretinal Visual Implant Alpha IMS--Clinical trial interim report.
abstract: 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.
authors: Centre for Ophthalmology, University of Tübingen, Schleichstr. 12-16, 72076 Tübingen, Germany.
authors: Katarina
authors: K
authors: Stingl
authors: Centre for Ophthalmology, University of Tübingen, Schleichstr. 12-16, 72076 Tübingen, Germany.
authors: Karl Ulrich
authors: KU
authors: Bartz-Schmidt
authors: Centre for Ophthalmology, University of Tübingen, Schleichstr. 12-16, 72076 Tübingen, Germany.
authors: Dorothea
authors: D
authors: Besch
authors: Department of Ophthalmology, National University Health System, 1E Kent Ridge Road, Singapore 119228, Singapore.
authors: Caroline K
authors: CK
authors: Chee
authors: Oxford Eye Hospital and Nuffield Laboratory of Ophthalmology, University of Oxford, Oxford OX3 9DU, United Kingdom.
authors: Charles L
authors: CL
authors: Cottriall
authors: Centre for Ophthalmology, University of Tübingen, Schleichstr. 12-16, 72076 Tübingen, Germany; Klinikum Stuttgart - Katharinenhospital, Eye Clinic, Kriegsbergstraße 60, 70174 Stuttgart, Germany(1).
authors: Florian
authors: F
authors: Gekeler
authors: Oxford Eye Hospital and Nuffield Laboratory of Ophthalmology, University of Oxford, Oxford OX3 9DU, United Kingdom.
authors: Markus
authors: M
authors: Groppe
authors: King's College Hospital and King's College London, Denmark Hill, London SE5 9RS, United Kingdom.
authors: Timothy L
authors: TL
authors: Jackson
authors: Oxford Eye Hospital and Nuffield Laboratory of Ophthalmology, University of Oxford, Oxford OX3 9DU, United Kingdom.
authors: Robert E
authors: RE
authors: MacLaren
authors: Klinikum Stuttgart - Olgahospital, ORL-Department, Pediatric Otorhinolaryngology and Otology, Kriegsbergstr. 62, 70176 Stuttgart, Germany.
authors: Assen
authors: A
authors: Koitschev
authors: Department of Ophthalmology, Semmelweis University, Maria utca 39, H-1085 Budapest, Hungary.
authors: Akos
authors: A
authors: Kusnyerik
authors: King's College Hospital and King's College London, Denmark Hill, London SE5 9RS, United Kingdom.
authors: James
authors: J
authors: Neffendorf
authors: Department of Ophthalmology, Semmelweis University, Maria utca 39, H-1085 Budapest, Hungary.
authors: Janos
authors: J
authors: Nemeth
authors: Department of Ophthalmology, National University Health System, 1E Kent Ridge Road, Singapore 119228, Singapore.
authors: Mohamed Adheem Naser
authors: MA
authors: Naeem
authors: STZ Eyetrial, Center for Ophthalmology, University of Tübingen, Schleichstr. 12-16, 72076 Tübingen, Germany.
authors: Tobias
authors: T
authors: Peters
authors: Department of Otolaryngology, Oxford University Hospitals NHS Trust, Oxford OX3 9DU, United Kingdom.
authors: James D
authors: JD
authors: Ramsden
authors: Klinikum Dresden Friedrichstadt, Univ. Teaching Hospital, Eye Clinic, Friedrichstr. 41, 01067 Dresden, Germany.
authors: Helmut
authors: H
authors: Sachs
authors: King's College Hospital and King's College London, Denmark Hill, London SE5 9RS, United Kingdom.
authors: Andrew
authors: A
authors: Simpson
authors: Department of Ophthalmology, National University Health System, 1E Kent Ridge Road, Singapore 119228, Singapore.
authors: Mandeep S
authors: MS
authors: Singh
authors: STZ Eyetrial, Center for Ophthalmology, University of Tübingen, Schleichstr. 12-16, 72076 Tübingen, Germany.
authors: Barbara
authors: B
authors: Wilhelm
authors: Li Ka Shing Faculty of Medicine, University of Hong Kong, 301 Block B, Cyberport 4, Hong Kong.
authors: David
authors: D
authors: Wong
authors: Werner Reichardt Centre for Integrative Neuroscience (CIN), University of Tübingen, Schleichstr. 12-16, 72076 Tübingen, Germany; Centre for Ophthalmology, University of Tübingen, Schleichstr. 12-16, 72076 Tübingen, Germany. Electronic address: ezrenner@uni-tuebingen.de.
authors: Eberhart
authors: E
authors: Zrenner
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D001766:Blindness / Q000209:etiology / Q000503:physiopathology / Q000534:rehabilitation*; D004567:Electrodes, Implanted; D005260:Female; D005556:Form Perception / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009039:Motion Perception / Q000502:physiology; D012162:Retinal Degeneration / Q000150:complications / Q000503:physiopathology; D012174:Retinitis Pigmentosa / Q000503:physiopathology; D014792:Visual Acuity / Q000502:physiology; D014796:Visual Perception / Q000502:physiology*
keywords: Artificial vision; Hereditary retinal diseases; Neuroprosthetics; Photoreceptor degeneration; Retinitis pigmentosa; Subretinal Implant Alpha IMS