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Vision Res. 2015 Jun;111(Pt B):149-60. doi: 10.1016/j.visres.2015.03.001. Epub 2015 Mar 23.

Subretinal Visual Implant Alpha IMS--Clinical trial interim report.

Author information

1
Centre for Ophthalmology, University of Tübingen, Schleichstr. 12-16, 72076 Tübingen, Germany.
2
Department of Ophthalmology, National University Health System, 1E Kent Ridge Road, Singapore 119228, Singapore.
3
Oxford Eye Hospital and Nuffield Laboratory of Ophthalmology, University of Oxford, Oxford OX3 9DU, United Kingdom.
4
Centre for Ophthalmology, University of Tübingen, Schleichstr. 12-16, 72076 Tübingen, Germany; Klinikum Stuttgart - Katharinenhospital, Eye Clinic, Kriegsbergstraße 60, 70174 Stuttgart, Germany(1).
5
King's College Hospital and King's College London, Denmark Hill, London SE5 9RS, United Kingdom.
6
Klinikum Stuttgart - Olgahospital, ORL-Department, Pediatric Otorhinolaryngology and Otology, Kriegsbergstr. 62, 70176 Stuttgart, Germany.
7
Department of Ophthalmology, Semmelweis University, Maria utca 39, H-1085 Budapest, Hungary.
8
STZ Eyetrial, Center for Ophthalmology, University of Tübingen, Schleichstr. 12-16, 72076 Tübingen, Germany.
9
Department of Otolaryngology, Oxford University Hospitals NHS Trust, Oxford OX3 9DU, United Kingdom.
10
Klinikum Dresden Friedrichstadt, Univ. Teaching Hospital, Eye Clinic, Friedrichstr. 41, 01067 Dresden, Germany.
11
Li Ka Shing Faculty of Medicine, University of Hong Kong, 301 Block B, Cyberport 4, Hong Kong.
12
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.

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.

KEYWORDS:

Artificial vision; Hereditary retinal diseases; Neuroprosthetics; Photoreceptor degeneration; Retinitis pigmentosa; Subretinal Implant Alpha IMS

PMID:
25812924
DOI:
10.1016/j.visres.2015.03.001
[Indexed for MEDLINE]
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