The DOI matches its Crossref record; 12 of the 12 references it cites were found in a registry or an index.
Five-year safety and performance results from the argus II retinal prosthesis system clinical trial.
Open accessAbstract
PURPOSE: The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP. DESIGN: Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II. PARTICIPANTS: Thirty participants in 10 centers in the United States and Europe. METHODS: The worse-seeing eye of blind patients was implanted with the Argus II. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. MAIN OUTCOME MEASURES: The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Secondary measures included functional vision performance on objectively scored real-world tasks. RESULTS: Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks. CONCLUSIONS: The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“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 Da Cruz et al., 2016
In the citing paper
“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 Da Cruz et al., 2016
In the citing paper
“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 Da Cruz et al., 2016
In the citing paper
“A multicentre clinical trial of Argus II in patients with end-stage retinitis pigmentosa showed that the device enables basic visual tasks, such as grating visual acuity, high contrast object localisation and detection of direction of motion.”
From Correcting visual loss by genetics and prosthetics (2020) · cites this paper as da Cruz 2016
In the citing paper
“The durability of the device generally exceeded 5 years and the best reported grating visual acuity is around 1.8 logMAR equivalent (6/379 Snellen) [da Cruz 2016; Schaffrath 2019].”
From Correcting visual loss by genetics and prosthetics (2020) · cites this paper as da Cruz 2016
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
Interim results from the international trial of Second Sight's visual prosthesis
Humayun, M. S., Dorn, J. D., da Cruz, L., Dagnelie, G., Sahel, J.-A., Stanga, P. E., Cideciyan, A. V., Duncan, J. L., Eliott, D., Filley, E., et al. (2012) · Ophthalmology · doi:10.1016/j.ophtha.2011.09.028 · Cited by 700
Self-citationSubretinal visual implant alpha IMS - clinical trial interim report
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., et al. (2015) · Vision Research · doi:10.1016/j.visres.2015.03.001 · Cited by 387
First-in-human trial of a novel suprachoroidal retinal prosthesis
Ayton, L. N., Blamey, P. J., Guymer, R. H., Luu, C. D., Nayagam, D. A. X., Sinclair, N. C., Shivdasani, M. N., Yeoh, J., McCombe, M. F., Briggs, R. J., et al. (2014) · PLoS ONE · doi:10.1371/journal.pone.0115239 · Cited by 333
Ahuja, A. K., Dorn, J. D., Caspi, A., McMahon, M. J., Dagnelie, G., daCruz, L., Stanga, P., Humayun, M. S., Greenberg, R. J., & Argus II Study Group (2011) · British Journal of Ophthalmology · doi:10.1136/bjo.2010.179622 · Cited by 289
Self-citationLong-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind
Ho, A. C., Humayun, M. S., Dorn, J. D., da Cruz, L., Dagnelie, G., Handa, J. T., Barale, P. O., Sahel, J., Stanga, P. E., Hafezi, F., et al. (2015) · Ophthalmology · doi:10.1016/j.ophtha.2015.04.032 · Cited by 262
Self-citationDorn, J. D., Ahuja, A. K., Caspi, A., da Cruz, L., Dagnelie, G., Sahel, J.-A., Greenberg, R. J., McMahon, M. J., & Argus II Study Group, F. T. (2013) · JAMA Ophthalmology · doi:10.1001/2013.jamaophthalmol.221 · Cited by 177
Self-citationAdvances in gene therapy technologies to treat retinitis pigmentosa
Petrs‐Silva, H., & Linden, R. (2013) · Clinical ophthalmology · doi:10.2147/opth.s38041 · Cited by 81
Geruschat, D. R., Richards, T. P., Arditi, A., Cruz, L., Dagnelie, G., Dorn, J. D., Duncan, J. L., Ho, A. C., Olmos de koo, L. C., Sahel, J., et al. (2016) · Clinical and Experimental Optometry · doi:10.1111/cxo.12359 · Cited by 77
Self-citationFLORA™: phase I development of a functional vision assessment for prosthetic vision users
Geruschat, D. R., Flax, M., Tanna, N., Bianchi, M., Fisher, A., Goldschmidt, M., Fisher, L., Dagnelie, G., Deremeik, J., Smith, A., et al. (2015) · Clinical and Experimental Optometry · doi:10.1111/cxo.12242 · Cited by 75
Self-citationSafety evaluation of “retina implant alpha IMS”—a prospective clinical trial
Kitiratschky, V. B. D., Štingl, K., Wilhelm, B., Peters, T. M., Besch, D., Sachs, H. G., Gekeler, F., Bartz‐Schmidt, K. U., & Zrenner, E. (2014) · Graefe s Archive for Clinical and Experimental Ophthalmology · doi:10.1007/s00417-014-2797-x · Cited by 55
Flagged first, then by citations
Cited by
Sorted by citations
Items 301–358 of 358
Innovative Technologies To Improve Low Vision
Pitakova, I. (2021) · Bulgarian Review of Ophthalmology · doi:10.14748/bro.v65i2.7826
AC power supply circuit architecture for a miniaturised retinal prosthesis device
Mori, Y., Chia‐Chi, C., Endo, H., Hata, M., Shodo, K., Terasawa, Y., Noda, T., Tokuda, T., Haruta, M., Tashiro, H., et al. (2021) · The Journal of Engineering · doi:10.1049/tje2.12058
Wireless Bioelectronic Interfaces Electromagnetic Performance and Safety
Kim, H., Dong, Z., & Ho, J. S. (2022) · Handbook of Neuroengineering · doi:10.1007/978-981-15-2848-4_24-2
Begaj, T., Parikh, R., & Eliott, D. (2021) · Springer eBooks · doi:10.1007/978-3-030-63978-5_5
Self-citationOrtega, A. M. L. (2022) · Digital Repository (Polytechnic University of Cartagena) · doi:10.31428/10317/11200
Hardware Strategies in Medical Systems for Visually Impaired Treatment
Ran, Z., & Sun, H. (2022) · International Conference on Systems and Informatics (ICSAI) · doi:10.1109/icsai57119.2022.10005387
Nishida, K., Morimoto, T., Terasawa, Y., Sakaguchi, H., Kamei, M., Miyoshi, T., Fujikado, T., & Nishida, K. (2023) · Japanese Journal of Ophthalmology · doi:10.1007/s10384-022-00972-7
Visual Prostheses: Neuroengineering Handbook
Guo, T., Shivdasani, M. N., Tsai, D., Ayton, L. N., Rathbun, D. L., & Lovell, N. H. (2023) · Handbook of Neuroengineering · doi:10.1007/978-981-16-5540-1_31
Modern methods of treating neurological diseases
Bednarz, K., Basiaga, B., Trojan, S., Leśniak, M., Kwieciński, J., Miszuda, S., Błaszczyk, A., Fussek-Styga, U., Szwedkowicz, A., & Heluszka, J. (2023) · Quality in Sport · doi:10.12775/qs.2023.12.01.006
Hereditary Retinal Dystrophies: Current Scientific Knowledge
Мермеклиева, Е. (2023) · Proceedings of the Bulgarian Academy of Sciences · doi:10.7546/crabs.2023.08.01
Development of a low luminance vision-related performance-based measure
Venugopal, D. (2023) · Queensland University of Technology · doi:10.5204/thesis.eprints.244765
Advancements in Retinal Prosthesis Systems: A Review of the Literature
Kim, M. H., Lee, J., Kim, Y., Choi, J. H., Yu, J., & Chung, Y.-R. (2023) · Journal of Retina · doi:10.21561/jor.2023.8.2.73
Spicer, J. B., Song, H., Patterson, A. L., Kang, J., & Boctor, E. M. (2023) · IEEE Nanotechnology Materials and Devices Conference (NMDC) · doi:10.1109/nmdc57951.2023.10344180
Firsov, M. L. (2024) · Neuroscience and Behavioral Physiology · doi:10.1007/s11055-024-01597-8
An Eye for an Eye?: Problematic Risk–Benefit Trade-Offs in Whole Eye Transplantation
Weinlander, E. J., Erb, B. M., & Thiessen, C. (2024) · The American Journal of Bioethics · doi:10.1080/15265161.2024.2328285
Firsov, M. L. (2023) · Сенсорные системы · doi:10.31857/s0235009223030046
Expanding Human Capabilities with Neurotechnology
Chaudhary, U. (2025) · Springer eBooks · doi:10.1007/978-3-031-78991-5_10
Hinrichs, S., Tisserand, Y., Scialom, E., & Ghezzi, D. (2025) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/2025.03.27.645647
Cognitive hybrids and hybrid qualia
Poczobut, R. (2025) · Analiza i Egzystencja · doi:10.18276/aie.2025.69-01
Skaza, J., Murlidaran, S., Varshney, A., Wen, Z., Eckstein, M. P., & Beyeler, M. (2025) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/2025.06.23.660990
Retinal Prostheses for Profound Vision Loss—Have We Lost Our Way?
da Cruz, L. (2025) · Clinical and Experimental Ophthalmology · doi:10.1111/ceo.14564
Global Treatment Approaches Part 2: Optogenetics and Retinal Implants
Mercer, G., Ballios, B. G., & Kertes, P. J. (2025) · Advances in experimental medicine and biology · doi:10.1007/978-3-031-72230-1_62
Toward a Deep Understanding of Retinal Spike Trains via MLLMs and Diffusion Models
Zhao, S., Qin, C., Wu, J., Li, P., Chen, L., Shao, W., & Zheng, F. (2025) · International Journal of Pattern Recognition and Artificial Intelligence · doi:10.1142/s021800142552024x
Energy-conversion nano/micromaterial based retinal prostheses for vision restoration
Li, R., Shang, Y., Gao, T., Lan, X., & Feng, P. (2025) · Nanoscale · doi:10.1039/d5nr02287h · Cited by 1
Zhao, Z., & Asakawa, T. (2025) · BioScience Trends · doi:10.5582/bst.2025.01341 · Cited by 1
Prototype Hardware for Closed-loop Stimulation of the Retina
Zhang, M., Kékesi, O., & Suaning, G. J. (2025) · Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC) · doi:10.1109/embc58623.2025.11251820
Bilateral retinal implants for improving visual restoration: a simulated bionic vision study
Rodriguez-Miguez, P., Soria, P. R., & Barriga‐Rivera, A. (2026) · Medical & Biological Engineering & Computing · doi:10.1007/s11517-026-03513-3
Keeping a PROMise: embedding patient voices in ophthalmic outcomes
Crabb, D. P. (2026) · British Journal of Ophthalmology · doi:10.1136/bjo-2025-328622
Motion perception with visual prostheses
Renshaw, K. T., & Pezaris, J. S. (2026) · Progress in Biomedical Engineering · doi:10.1088/2516-1091/ae46fd · Cited by 1
Patterson, A. L., Song, H., Zhang, D., Billings, S., Boctor, E. M., & Spicer, J. B. (2026) · IEEE Nanotechnology Magazine · doi:10.1109/mnano.2026.3660024
Neuromorphic Image Processing for Enhancing Simulated Prosthetic Vision
Mathew, B. S., Subhash, K. M., & Pournami, P. N. (2025) · International Conference on Intelligent Systems and Embedded Design (ISED) · doi:10.1109/ised67359.2025.11404894
Non-invasive photoacoustic contact lens for sight restoration
Ruikes, T. R., Li, Y., Voillot, J., Leong, A., Cornebois, M., Cheng, J., Louise, J.-D., Yang, C., Picaud, S. A., & Moulet, H. (2026) · Ophthalmic Technologies · doi:10.1117/12.3084066
Brain-Computer Interfaces for Vision Recovery in Precortical Vision Loss
Yang, C., Guo, A., & Lin, K. (2026) · Eye and Brain · doi:10.2147/eb.s561691
Zhou, J., Hu, D., Wu, M., Hong, Z., li, R., Chen, Q., Mi, X.-S., & Zhang, J. (2026) · Advances in Ophthalmology Practice and Research · doi:10.1016/j.aopr.2026.03.005
Apport des dispositifs de restauration de la vision et de la résolution temporelle
Poujade, M. (2019) · theses.fr (ABES) · doi:10.70675/36673ad1zae20z4163zabbfz33afe4422dd6
Sonogenetic stimulation for vision restoration.
Cadoni, S. (2020) · theses.fr (ABES) · doi:10.70675/6faaecedzde98z48a5zacaazdb2942b5966e
Mechanistic modeling of pitting corrosion in thin film microelectrodes
Diyaroglu, C., Niemiec, M., Candland, P., Oterkus, E., Rieth, L. W., Raza, U., Negi, S., Solzbacher, F., & Kim, K. (2026) · Corrosion Science · doi:10.1016/j.corsci.2026.113879
Approved retinal prostheses: comparison, current knowledge, and developments—a systematic review
Moser, E., Wedrich, A., Posch-Pertl, L., Ivastinović, D., Casazza, M., & Strauss, R. W. (2026) · Spektrum der Augenheilkunde · doi:10.1007/s00717-026-00614-0
Wireless image transfer across opaque cornea: A novel approach to visual rehabilitation
Natarajan, R. (2026) · Indian Journal of Ophthalmology · doi:10.4103/ijo.ijo_368_26
Phillips, A., Lotlikar, A., Kling, A., Hays, M. R., Vasireddy, P., Hofflich, B., Sharon, A., Sommeling, M., Brown, J. B., Baum, C., et al. (2026) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.64898/2026.05.04.721188 · Cited by 1
Gamification Enhances User Engagement and Task Performance in Prosthetic Vision Testing
Turkstra, L. M., Johnson, B. A., Kartha, A., Dagnelie, G., & Beyeler, M. (2026) · Translational Vision Science & Technology · doi:10.1167/tvst.15.5.16
Self-citationParameter-Dependent Effects of Focused Ultrasound on Retinal Ganglion Cell Excitability
Badawe, H. M., Semaan, J. F. A., Saleh, S. A., Mourad, P. D., & Khraiche, M. L. (2025) · International IEEE/EMBS Conference on Neural Engineering · doi:10.1109/ner61569.2025.11589099
Hwang, S., Jeong, H. S., & Jun, S. B. (2026) · Biomedical Engineering Letters · doi:10.1007/s13534-026-00604-w
Trends in neuroprosthetic technologies to restore sensations
Park, B., Butterworth, W., Lee, N., & Kim, S. (2026) · Biomedical Engineering Letters · doi:10.1007/s13534-026-00603-x
Sinha, A., & Parmar, B. (2026) · Paediatrics and Child Health · doi:10.1016/j.paed.2026.07.008
Biomaterials in Retinal Surgery: Engineering the Future
Dindar, I. A., Shoichet, M. S., Labriola, J. M., Forman, A., & Devenyi, R. G. (2026) · American Journal of Ophthalmology · doi:10.1016/j.ajo.2026.08.039
Yu, C., Jia, F., Chen, D., Yan, L., Zhao, M., Luo, X., Wang, Z., Wu, Z., Lawson, T., & Liu, Y. (2026) · Biomaterials · doi:10.1016/j.biomaterials.2026.124617
Raz-Prag, D., Rigler, D., Mendelewicz, R., Bez, M., Stalmans, P., Weinberger, D., Barak, A., & Schwartz, S. (2026) · Ophthalmology Science · doi:10.1016/j.xops.2026.101420
Baldi, M., Pischedda, S., Musolino, M., Calabrìa, F., Iester, M., & Vagge, A. (2026) · European Journal of Ophthalmology · doi:10.1177/11206721261491572
Ma, Y., Li, Y., Zhang, S., Liang, L., & Li, G. (2026) · Neural Networks · doi:10.1016/j.neunet.2026.109693
A 1600-Channel Retinal Prosthesis SoC with On-Chip Edge Detection and Ambient Light Adaptation
Oh, Y., & Kim, J. (2026) · Electronics · doi:10.3390/electronics15194551
Transparent Self-Calibrating Neurointerfaces for Visual Information Substitution
Kimura, A. (2026) · Lecture notes in computer science · doi:10.1007/978-981-92-6913-6_3
Liu, Z., Liu, J., Pang, J., Guo, X., Wang, L., Song, X., Li, H., Chai, X., Gan, H., Gong, S., et al. (2026) · Cognitive Neurodynamics · doi:10.1007/s11571-026-10573-6
Metadata
- Authors
- da Cruz, L., Dorn, J. D., Humayun, M. S., Dagnelie, G., Handa, J., Barale, P.-O., Sahel, J.-A., Stanga, P. E., Hafezi, F., Safran, A. B., Salzmann, J., Santos, A., Birch, D., Spencer, R., Cideciyan, A. V., de Juan, E., Duncan, J. L., Eliott, D., Fawzi, A., Olmos de Koo, L. C., Ho, A. C., Brown, G., Haller, J., Regillo, C., Del Priore, L. V., Arditi, A., & Greenberg, R. J.
- Affiliations
- Second Sight Medical Products (US)
- University of Southern California (US)
- Johns Hopkins University (US)
- Centre hospitalier national d'ophtalmologie des Quinze-Vingts (FR)
- Institut de la Vision (FR)
- Manchester Academic Health Science Centre (GB)
- Centro de Retina Médica y Quirúrgica (MX)
- Retina Foundation of the Southwest (US)
- Texas Retina Associates (United States) (US)
- University of Pennsylvania (US)
- University of California, San Francisco (US)
- Northwestern University (US)
- Wills Eye Hospital (US)
- Lighthouse Guild (US)
- Corresponding author
- Dorn, Jessy D.
- ORCID
- Venue
- Ophthalmology
- Publisher
- Elsevier BV
- Published
- 2016-10
- Volume
- 123
- Issue
- 10
- Pages
- 2248-2254
- ISSN
- 0161-6420 (ISSN-L)
- PMC
- PMC5035591
- OpenAlex
- W2476154117
- Cited by
- 359
- References
- 12
- Citations by year
- 2026: 30 · 2025: 23 · 2024: 20 · 2023: 33 · 2022: 33 · 2021: 45 · 2020: 47 · 2019: 48 · 2018: 41 · 2017: 35 · 2016: 3
- FWCI
- 23.74
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Ophthalmology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Archive ouverte UNIGE (University of Geneva) (publishedVersion, other-oa)
- PubMed Central (acceptedVersion)
- Institutional Repository of Tecnológico de Monterrey (Tecnológico de Monterrey) (submittedVersion, other-oa)
- UCL Discovery (University College London) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by-nc-nd)
- Archive ouverte UNIGE (University of Geneva) (submittedVersion, other-oa)
- Funders
- National Eye Institute (R01EY012893, RC3EY020778)
- Topics
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neuroscience and Neural Engineering
- Health Sciences › Medicine › Ophthalmology › Retinal Development and Disorders
- Health Sciences › Health Professions › Occupational Therapy › Assistive Technology in Communication and Mobility
- Keywords
- Argus II, retinal prosthesis, retinitis pigmentosa, outer retinal degeneration, long-term safety, visual function, functional vision, electrode arrays, blind patients, adverse events
- MeSH terms
- Adult, Aged, Blindness, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Prosthesis Design, Retina, Retinitis Pigmentosa, Time Factors, Visual Acuity, Treatment Outcome, Persons with Visual Disabilities, Visual Prosthesis
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
