Cited by 199Neuroscience and Neural EngineeringRetinal Development and DisordersRetinal Diseases and Treatments

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Interim results of a multicenter trial with the new electronic subretinal implant Alpha AMS in 15 Patients blind from inherited retinal degenerations.

Open access

Stingl, Katarina, Schippert, Ruth, Bartz-Schmidt, Karl U., Besch, Dorothea, Cottriall, Charles L., Edwards, Thomas L., Gekeler, Florian, Greppmaier, Udo, Kiel, Katja, Koitschev, Assen, Kühlewein, Laura, MacLaren, Robert E., Ramsden, James D., Roider, Johann, Rothermel, Albrecht, Sachs, Helmut, Schröder, Greta S., Tode, Jan, Troelenberg, Nicole, Zrenner, Eberhart·2017·Frontiers in Neuroscience

DOI 10.3389/fnins.2017.00445PMC PMC5572402

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Abstract

Purpose: We assessed the safety and efficacy of a technically advanced subretinal electronic implant, RETINA IMPLANT Alpha AMS, in end stage retinal degeneration in an interim analysis of two ongoing prospective clinical trials. Methods: The subretinal visual prosthesis RETINA IMPLANT Alpha AMS (Retina Implant AG, Reutlingen, Germany) was implanted in 15 blind patients with hereditary retinal degenerations at four study sites with a follow-up period of 12 months (www.clinicaltrials.gov NCT01024803 and NCT02720640). Functional outcome measures included 1) screen-based standardized 2- or 4-alternative forced-choice tests of light perception, light localization, grating detection (basic grating acuity (BaGA) test) and Landolt C-rings; 2) grey level discrimination; 3) performance during activities of daily living (ADL-table tasks). Results: Implant-mediated light perception was observed in 13/15 patients. During the observation period implant mediated localization of visual targets was possible in 13/15 patients. Correct grating detection was achieved for spatial frequencies 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. In two patients visual acuity assessed with Landolt C- rings was 20/546 and 20/1111. Of 6 possible grey levels on average 4.6 +/-0.8 (mean +/- SD, n=10) were discerned. Improvements (power ON vs. OFF) of ADL table tasks were measured in 13/15 patients. Overall, results were stable during the observation period. Serious adverse events were reported in 4 patients: 2 movements of the implant, readjusted in a second surgery; 4 conjunctival erosion/dehiscence, successfully treated; 1 pain event around the coil, successfully treated; 1 partial reduction of silicone oil tamponade leading to distorted vision (silicon oil successfully refilled). The majority of adverse events were transient and mostly of mild to moderate intensity. Conclusions: Psychophysical and subjective data show that RETINA IMPLANT Alpha AMS is reliable, well tolerated and can restore limited visual functions in blind patients with degenerations of the outer retina. Compared with the previous implant Alpha IMS, longevity of the new implant Alpha AMS has been considerably improved. Alpha AMS has meanwhile been certified as a commercially available medical device, reimbursed in Germany by the public health system.

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Switching Between Different Neuroprosthetic Renderings to Better Perceive the Environment
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New Avenues of Delivery (Subretinal Gene Therapy, Port Delivery, Suprachoroidal)
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Retina Stimulator with Channel Dependent Arbitrary Waveforms in 28nm CMOS Process
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Advancements in Retinal Prosthesis Systems: A Review of the Literature
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Highly Photoresponsive Vertically Stacked Silicon Nanowire Photodetector with Biphasic Current Stimulator IC for Retinal Prostheses
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Visual Prostheses
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Authors: Stingl, K., Schippert, R., Bartz-Schmidt, K. U., Besch, D., Cottriall, C. L., Edwards, T. L., Gekeler, F., Greppmaier, U., Kiel, K., Koitschev, A., Kühlewein, L., MacLaren, R. E., Ramsden, J. D., Roider, J., Rothermel, A., Sachs, H., Schröder, G. S., Tode, J., Troelenberg, N., & Zrenner, E.
Affiliations: University of Tübingen (DE)
University of Oxford (GB)
Katharinenhospital (DE)
Städtisches Klinikum Dresden (DE)
Olgahospital (DE)
Christian-Albrechts-Universität zu Kiel (DE)
Universität Ulm (DE)
ORCID: Edwards, Thomas L.
Greppmaier, Udo
Koitschev, Assen
MacLaren, Robert E.
Tode, Jan
Zrenner, Eberhart
Venue: Frontiers in Neuroscience
Publisher: Frontiers Media SA
Published: 2017-08-23
Volume: 11
Pages: 445-445
ISSN: 1662-453X (ISSN-L)
DOI: 10.3389/fnins.2017.00445
PMC: PMC5572402
OpenAlex: W2748114767
Cited by: 198
References: 27
Citations by year: 2026: 21 · 2025: 15 · 2024: 17 · 2023: 21 · 2022: 22 · 2021: 28 · 2020: 29 · 2019: 23 · 2018: 20 · 2017: 1
FWCI: 9.76
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
Locations: Frontiers in Neuroscience (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Minerva Access (University of Melbourne) (submittedVersion, cc-by)
Multimedialen Archiv und Publikationsserver der Christian-Albrechts-Universität zu Kiel (Christian-Albrechts-Universität zu Kiel) (submittedVersion, cc-by)
OPen Access Repositorium der Universität Ulm (OPARU) (Ulm University) (submittedVersion, cc-by)
Universität Ulm, Kommunikations- und Informationszentrum (kiz) (cc-by)
Funders: National Institute for Health and Care Research (II-C2-0713-20005)
University of Oxford
Bundesministerium für Bildung und Forschung (FKZ 01GQ1002, 01GQ1002)
Oxford University Hospitals NHS Foundation Trust
Invention for Innovation
Topics: Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neuroscience and Neural Engineering
Health Sciences › Medicine › Ophthalmology › Retinal Development and Disorders
Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
Keywords: inherited retinal degeneration, light perception, light localization, grating detection, Landolt C, activities of daily living, implant safety, conjunctival erosion, silicone oil tamponade

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Interim results of a multicenter trial with the new electronic subretinal implant Alpha AMS in 15 Patients blind from inherited retinal degenerations.

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