Interim results of a multicenter trial with the new electronic subretinal implant Alpha AMS in 15 Patients blind from inherited retinal degenerations.
Open accessAbstract
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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Several retinal devices have already been approved for patients with retinal dystrophies.
“At present, retinal prostheses are the most successful approach in this field, and several retinal devices have already been approved for patients with retinal dystrophies (Da Cruz et al., 2016; Stingl et al., 2017).”
From Toward Long-Term Communication With the Brain in the Blind by Intracortical Stimulation: Challenges and Future Prospects (2020) · cites this paper as Stingl et al., 2017
Several research groups are focusing on developing artificial vision approaches based on electric stimulation of the retina.
“several research groups are focusing their efforts on the development of new approaches for artificial vision based on electric stimulation of the retina”
From Toward Long-Term Communication With the Brain in the Blind by Intracortical Stimulation: Challenges and Future Prospects (2020) · cites this paper as Stingl et al., 2017
At present, retinal prostheses are the most successful approach in the field of visual prostheses.
“At present, retinal prostheses are the most successful approach in this field, and several retinal devices have already been approved for patients with retinal dystrophies (Da Cruz et al., 2016; Stingl et al., 2017).”
From Toward Long-Term Communication With the Brain in the Blind by Intracortical Stimulation: Challenges and Future Prospects (2020) · cites this paper as Stingl et al., 2017
The best documented grating acuity with Alpha AMS was about 0.95 logMAR (6/60 Snellen), though it varied significantly over time and between patients.
“The best documented grating visual acuity with Alpha AMS has been equivalent to around 0.95 logMAR (6/60 Snellen), although significant variations exist over time and between patients [Stingl 2017; Edwards 2018].”
From Correcting visual loss by genetics and prosthetics (2020) · cites this paper as Stingl 2017
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Oculomotor Responses to Dynamic Stimuli in a 44-Channel Suprachoroidal Retinal Prosthesis
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Nanotechnology for vision restoration
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Laser Driven Miniature Diamond Implant for Wireless Retinal Prostheses
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Neurosensory Prosthetics: An Integral Neuromodulation Part of Bioelectronic Device
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Adaptive Interfacial Materials and Implants for Visual Restoration
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Feasibility of Intraocular Projection for Treatment of Intractable Corneal Opacity
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Aligning Visual Prosthetic Development With Implantee Needs
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Human-in-the-loop optimization of visual prosthetic stimulation
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Estimating Phosphene Locations Using Eye Movements of Suprachoroidal Retinal Prosthesis Users
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Fabrication of Subretinal 3D Microelectrodes with Hexagonal Arrangement
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Asymmetric Activation of ON and OFF Pathways in the Degenerated Retina
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Glow in the dark: Using a heat-sensitive camera for blind individuals with prosthetic vision
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High‐Frequency Stimulation of Normal and Blind Mouse Retinas Using TiO2 Nanotubes
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The mechanism of human color vision and potential implanted devices for artificial color vision
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In vivo feasibility of epiretinal stimulation using ultrananocrystalline diamond electrodes
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Restriction of eye motility in patients with RETINA IMPLANT Alpha AMS
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Advancing treatment of retinal disease through in silico trials
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Neuromodulation using electroosmosis
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Responsive Neural Activities in the Primary Visual Cortex of Retina-Degenerated Rats
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Hybrid Neural Autoencoders for Stimulus Encoding in Visual and Other Sensory Neuroprostheses.
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Restoration of Sight with Electronic Retinal Prostheses
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Sputtered Iridium Oxide as Electrode Material for Subretinal Stimulation
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Cross-task perceptual learning of object recognition in simulated retinal implant perception
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Activation of retinal ganglion cells using a biomimetic artificial retina
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Building resilience when neural implants are abandoned
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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)
- Venue
- Frontiers in Neuroscience
- Publisher
- Frontiers Media SA
- Published
- 2017-08-23
- Volume
- 11
- Pages
- 445-445
- ISSN
- 1662-453X (ISSN-L)
- 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 · 2015: 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
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › 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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