Subretinal visual implant alpha IMS - clinical trial interim report
Open accessAbstract
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.
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Multiple phosphene patterns may not automatically group into perceptually intelligible objects.
“However, it should be noted that multiple phosphene patterns may not automatically group into perceptually intelligible objects (Stingl et al 2015, Shivdasani et al 2017, Christie et al 2022).”
From Axonal stimulation affects the linear summation of single-point perception in three Argus II users (2024) · cites this paper as Stingl et al 2015
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Eggenberger, S. C., James, N. L., Ho, C., Eamegdool, S. S., Tatarinoff, V., Craig, N. A., Gow, B. S., Wan, S., Dodds, C. W. D., La Hood, D., et al. (2021) · Biomaterials · doi:10.1016/j.biomaterials.2021.121191 · Cited by 21 · see citing works
New frontiers of retinal therapeutic intervention: a critical analysis of novel approaches
Nanegrungsunk, O., Au, A., Sarraf, D., & Sadda, S. R. (2022) · Annals of Medicine · doi:10.1080/07853890.2022.2066169 · Cited by 20 · see citing works
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Retinal prostheses: where to from here?
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Spectral distribution of local field potential responses to electrical stimulation of the retina
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Axonal stimulation affects the linear summation of single-point perception in three Argus II users
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Testing vision is not testing for vision
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A model of ganglion axon pathways accounts for percepts elicited by retinal implants
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Minimizing iridium oxide electrodes for high visual acuity subretinal stimulation
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A Deep Learning-based in silico Framework for Optimization on Retinal Prosthetic Stimulation
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Navigating the regulatory pathway for an innovative bionic vision system
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Deep Learning–Based Control of Electrically Evoked Activity in Human Visual Cortex
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- Authors
- Stingl, K., Bartz-Schmidt, K. U., Besch, D., Chee, C. K., Cottriall, C. L., Gekeler, F., Groppe, M., Jackson, T. L., MacLaren, R. E., Koitschev, A., Kusnyerik, A., Neffendorf, J., Nemeth, J., Naeem, M. A. N., Peters, T., Ramsden, J. D., Sachs, H., Simpson, A., Singh, M. S., Wilhelm, B., Wong, D., & Zrenner, E.
- Affiliations
- University of Tübingen (DE)
- National University Health System (SG)
- University of Oxford (GB)
- Katharinenhospital (DE)
- King's College London (GB)
- Olgahospital (DE)
- STZ eyetrial (DE)
- Oxford University Hospitals NHS Trust (GB)
- Krankenhaus Dresden-Friedrichstadt (DE)
- University of Hong Kong (HK)
- Corresponding author
- Zrenner, Eberhart
- ORCID
- Venue
- Vision Research
- Publisher
- Elsevier BV
- Published
- 2015-06
- Volume
- 111
- Issue
- Pt B
- Pages
- 149-160
- ISSN
- 0042-6989 (ISSN-L)
- OpenAlex
- W1969768092
- Cited by
- 387
- References
- 46
- Citations by year
- 2026: 31 · 2025: 18 · 2024: 26 · 2023: 21 · 2022: 28 · 2021: 37 · 2020: 34 · 2019: 49 · 2018: 47 · 2017: 44 · 2016: 46 · 2015: 6
- FWCI
- 22.24
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Vision Research (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research Portal (King's College London) (publishedVersion, other-oa)
- Funders
- German Federal Ministry of Education and Research
- NIHR Oxford Biomedical Research Centre
- National University of Singapore and Baden-Wuerttemberg
- Werner Reichardt Centre for Integrative Neuroscience
- Deutsche Forschungsgemeinschaft
- Topics
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neuroscience and Neural Engineering
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Retinal Development and Disorders
- Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
- Keywords
- retinal prosthesis, outer retinal degeneration, inherited retinal degeneration, blindness, low vision, vision restoration, activities of daily living, object recognition, visual acuity, light perception, motion perception, grating acuity
- MeSH terms
- Activities of Daily Living, Adult, Aged, Blindness, Electrodes, Implanted, Female, Form Perception, Humans, Male, Middle Aged, Motion Perception, Retinal Degeneration, Retinitis Pigmentosa, Visual Acuity, Visual Perception
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