Cited by 387Neuroscience and Neural EngineeringRetinal Development and DisordersRetinal Diseases and Treatments

Subretinal visual implant alpha IMS - clinical trial interim report

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Stingl, Katarina, Bartz-Schmidt, Karl Ulrich, Besch, Dorothea, Chee, Caroline K., Cottriall, Charles L., Gekeler, Florian, Groppe, Markus, Jackson, Timothy L. +14 more·2015·Vision Research

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.

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Crossref · 10.1016/j.visres.2015.03.001

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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
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
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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