gms | German Medical Science

Artificial Vision 2017

The International Symposium on Visual Prosthetics

01.12. - 02.12.2017, Aachen

Functional results of the subretinal implant retina implant Alpha AMS

Meeting Abstract

  • Katarina Stingl - Centre for Ophthalmology, University of Tübingen, Tübingen, Germany
  • R. Schippert - Retina Implant AG, Reutlingen, Germany
  • K. U. Bartz-Schmidt - Centre for Ophthalmology, University of Tübingen, Tübingen, Germany
  • D. Besch - Centre for Ophthalmology, University of Tübingen, Tübingen, Germany
  • T. L. Edwards - Nuffield Laboratory of Ophthalmology, Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust, University of Oxford, Oxford, UK
  • F. Gekeler - Centre for Ophthalmology, University of Tübingen, Tübingen, Germany; Klinikum Stuttgart - Katharinenhospital, Eye Hospital, Stuttgart, Germany
  • R. E. MacLaren - Nuffield Laboratory of Ophthalmology, Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust, University of Oxford, Oxford, UK
  • J. Roider - Department of Ophthalmology, University of Kiel, Kiel, Germany
  • H. Sachs - Klinikum Dresden Friedrichstadt, University Teaching Hospital, Eye Hospital, Dresden, Germany
  • E. Zrenner - Centre for Ophthalmology, University of Tübingen, Tübingen, Germany; Werner Reichardt Centre for Integrative Neuroscience, University of Tübingen, Tübingen, Germany

Artificial Vision 2017. Aachen, 01.-02.12.2017. Düsseldorf: German Medical Science GMS Publishing House; 2017. Doc17artvis23

doi: 10.3205/17artvis23, urn:nbn:de:0183-17artvis231

Published: November 30, 2017

© 2017 Stingl et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.


Outline

Text

Objective: Efficacy of the subretinal electronic implant RETINA IMPLANT Alpha AMS in patients with end stage hereditary retinal degeneration was assessed in two clinical trials (https://www.clinicaltrials.gov/ NCT01024803 and NCT02720640).

Materials & Methods: The subretinal visual implant RETINA IMPLANT Alpha AMS (Retina Implant AG, Reutlingen, Germany) was implanted in 15 blind patients with hereditary retinal degenerations. Functional outcome measures were performed over a 12 months follow-up period and included light perception, light localization, grating acuity, visual acuity with Landolt C-rings, grey level discrimination and performance during lab tasks of daily living activities (ADL-table tasks).

Results: Implant-mediated light perception as well light source localization as was possible in 13/15 patients. Grating acuity was measurable for a maximal spatial frequency of 0.1 cpd (cycles per degree) in 4/15; 0.33 cpd in 3/15; 0.66 cpd in 2/15; 1.0 cpd in 2/15 and 3.3 cpd in 1/15 patients. Two patients had a visual acuity (VA) measurable with Landolt C- rings; 20/546 and 20/1111. On average 4.6 ± 0.8 grey levels were identifiable by the implant mediated vision. Improvements (power ON vs. OFF) of ADL table tasks were measured in 13/15 patients. The achieved results were on average stable during the 12 months follow-up period [1].

Conclusions: RETINA IMPLANT Alpha AMS can restore limited visual functions in blind patients with degenerations of the outer retina with an improved longevity, if compared with the previous implant Alpha IMS. Alpha AMS is certified as medical device in Europe (CE approval).

Acknowledgment: This work was supported by Retina Implant AG, Reutlingen, Germany, the research program of the Bernstein Center for Computational Neuroscience, Tübingen and was funded by the German Federal Ministry of Education and Research (BMBF; FKZ: 01GQ1002) and by the German Research Council (to EZ) in the Excellence Center Program (Exc 307), as well as NIHR Invention for Innovation (i4i) Challenge Award for industry collaboration, made jointly to RM and Retina Implant AG, Oxford UniversityHospitals NHS Foundation Trust NIHR Biomedical Research Centre.


References

1.
Stingl K, Schippert R, Bartz-Schmidt KU, Besch D, Cottriall CL, Edwards TL, Gekeler F, Greppmaier U, Kiel K, Koitschev A, Kühlewein L, MacLaren RE, Ramsden JD, Roider J, Rothermel A, Sachs H, Schröder GS, Tode J, Troelenberg N, Zrenner E. Interim Results of a Multicenter Trial with the New Electronic Subretinal Implant Alpha AMS in 15 Patients Blind from Inherited Retinal Degenerations. Front Neurosci. 2017 Aug 23;11:445. DOI: 10.3389/fnins.2017.00445 External link