Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind
Retinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease, affecting only approximately 100 000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. Th...
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| Published in | Ophthalmology (Rochester, Minn.) Vol. 122; no. 8; pp. 1547 - 1554 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
01.08.2015
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| Subjects | |
| Online Access | Get full text |
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| Abstract | Retinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease, affecting only approximately 100 000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) in restoring some visual function to subjects completely blind from RP. We report clinical trial results at 1 and 3 years after implantation.
The study is a multicenter, single-arm, prospective clinical trial.
There were 30 subjects in 10 centers in the United States and Europe. Subjects served as their own controls, that is, implanted eye versus fellow eye, and system on versus system off (native residual vision).
The Argus II System was implanted on and in a single eye (typically the worse-seeing eye) of blind subjects. Subjects 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.
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.
A total of 29 of 30 subjects had functioning Argus II Systems implants 3 years after implantation. Eleven subjects experienced a total of 23 serious device- or surgery-related adverse events. All were treated with standard ophthalmic care. As a group, subjects performed significantly better with the system on than off on all visual function tests and functional vision assessments.
The 3-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. Earlier results from this trial were used to gain approval of the Argus II by the Food and Drug Administration and a CE mark in Europe. The Argus II System is the first and only retinal implant to have both approvals. |
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| AbstractList | Retinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease, affecting only approximately 100 000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) in restoring some visual function to subjects completely blind from RP. We report clinical trial results at 1 and 3 years after implantation.
The study is a multicenter, single-arm, prospective clinical trial.
There were 30 subjects in 10 centers in the United States and Europe. Subjects served as their own controls, that is, implanted eye versus fellow eye, and system on versus system off (native residual vision).
The Argus II System was implanted on and in a single eye (typically the worse-seeing eye) of blind subjects. Subjects 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.
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.
A total of 29 of 30 subjects had functioning Argus II Systems implants 3 years after implantation. Eleven subjects experienced a total of 23 serious device- or surgery-related adverse events. All were treated with standard ophthalmic care. As a group, subjects performed significantly better with the system on than off on all visual function tests and functional vision assessments.
The 3-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. Earlier results from this trial were used to gain approval of the Argus II by the Food and Drug Administration and a CE mark in Europe. The Argus II System is the first and only retinal implant to have both approvals. Purpose Retinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease, affecting only approximately 100 000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) in restoring some visual function to subjects completely blind from RP. We report clinical trial results at 1 and 3 years after implantation. Design The study is a multicenter, single-arm, prospective clinical trial. Participants There were 30 subjects in 10 centers in the United States and Europe. Subjects served as their own controls, that is, implanted eye versus fellow eye, and system on versus system off (native residual vision). Methods The Argus II System was implanted on and in a single eye (typically the worse-seeing eye) of blind subjects. Subjects 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. Results A total of 29 of 30 subjects had functioning Argus II Systems implants 3 years after implantation. Eleven subjects experienced a total of 23 serious device- or surgery-related adverse events. All were treated with standard ophthalmic care. As a group, subjects performed significantly better with the system on than off on all visual function tests and functional vision assessments. Conclusions The 3-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. Earlier results from this trial were used to gain approval of the Argus II by the Food and Drug Administration and a CE mark in Europe. The Argus II System is the first and only retinal implant to have both approvals. Retinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease, affecting only approximately 100 000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) in restoring some visual function to subjects completely blind from RP. We report clinical trial results at 1 and 3 years after implantation.PURPOSERetinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease, affecting only approximately 100 000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) in restoring some visual function to subjects completely blind from RP. We report clinical trial results at 1 and 3 years after implantation.The study is a multicenter, single-arm, prospective clinical trial.DESIGNThe study is a multicenter, single-arm, prospective clinical trial.There were 30 subjects in 10 centers in the United States and Europe. Subjects served as their own controls, that is, implanted eye versus fellow eye, and system on versus system off (native residual vision).PARTICIPANTSThere were 30 subjects in 10 centers in the United States and Europe. Subjects served as their own controls, that is, implanted eye versus fellow eye, and system on versus system off (native residual vision).The Argus II System was implanted on and in a single eye (typically the worse-seeing eye) of blind subjects. Subjects 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.METHODSThe Argus II System was implanted on and in a single eye (typically the worse-seeing eye) of blind subjects. Subjects 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.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.MAIN OUTCOME MEASURESThe primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests.A total of 29 of 30 subjects had functioning Argus II Systems implants 3 years after implantation. Eleven subjects experienced a total of 23 serious device- or surgery-related adverse events. All were treated with standard ophthalmic care. As a group, subjects performed significantly better with the system on than off on all visual function tests and functional vision assessments.RESULTSA total of 29 of 30 subjects had functioning Argus II Systems implants 3 years after implantation. Eleven subjects experienced a total of 23 serious device- or surgery-related adverse events. All were treated with standard ophthalmic care. As a group, subjects performed significantly better with the system on than off on all visual function tests and functional vision assessments.The 3-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. Earlier results from this trial were used to gain approval of the Argus II by the Food and Drug Administration and a CE mark in Europe. The Argus II System is the first and only retinal implant to have both approvals.CONCLUSIONSThe 3-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. Earlier results from this trial were used to gain approval of the Argus II by the Food and Drug Administration and a CE mark in Europe. The Argus II System is the first and only retinal implant to have both approvals. |
| Author | Cideciyan, Artur V. Duncan, Jacque L. da Cruz, Lyndon Dagnelie, Gislin Birch, David Del Priore, Lucian V. Salzmann, Joel Olmos de Koo, Lisa C. Eliott, Dean Sahel, José-Alain Handa, James Humayun, Mark S. Fawzi, Amani Haller, Julia A. Greenberg, Robert J. Santos, Arturo Barale, Pierre-Olivier Geruschat, Duane R. Spencer, Rand Arditi, Aries Brown, Gary C. Regillo, Carl D. Safran, Avinoam B. Ho, Allen C. Dorn, Jessy D. Hafezi, Farhad Stanga, Paulo E. de Juan, Eugene |
| AuthorAffiliation | 15 Tecnologico de Monterrey, Guadalajara, Mexico 14 Centro de Retina Medica y Quirúrgica, SC, Guadalajara, Mexico 22 Columbia University, New York, NY 24 Lighthouse Guild, New York, NY 21 Feinberg School of Medicine, Northwestern University, Chicago, IL 18 Scheie Eye Institute, University of Pennsylvania, Philadelphia, PA 4 Moorfields Eye Hospital NHS Foundation Trust, London, UK 9 Manchester Vision Regeneration (MVR) Lab at NIHR/ Wellcome Trust Manchester CRF, UK 11 Hôpitaux Universitaires de Genève, Geneva, Switzerland 17 Texas Retina Associates, Dallas, TX 12 ELZA Institute, Zurich, Switzerland 16 Retina Foundation of the Southwest, Dallas, TX 19 University of California, San Francisco, San Francisco, CA 2 University of Southern California, Los Angeles, CA 6 Wilmer Eye Institute, Johns Hopkins University, Baltimore, MD 3 Second Sight Medical Products, Sylmar, CA 20 Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, MA 7 Centre Hospitalier National d’Ophtalmologie des Quinze-Vingts, |
| AuthorAffiliation_xml | – name: 25 Visibility Metrics, LLC, Chappaqua, NY – name: 14 Centro de Retina Medica y Quirúrgica, SC, Guadalajara, Mexico – name: 17 Texas Retina Associates, Dallas, TX – name: 23 Storm Eye Institute, Charleston, SC – name: 19 University of California, San Francisco, San Francisco, CA – name: 7 Centre Hospitalier National d’Ophtalmologie des Quinze-Vingts, Paris, France – name: 8 Manchester Royal Eye Hospital, Manchester, UK – name: 2 University of Southern California, Los Angeles, CA – name: 6 Wilmer Eye Institute, Johns Hopkins University, Baltimore, MD – name: 4 Moorfields Eye Hospital NHS Foundation Trust, London, UK – name: 3 Second Sight Medical Products, Sylmar, CA – name: 16 Retina Foundation of the Southwest, Dallas, TX – name: 20 Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, MA – name: 10 Manchester Academic Health Science Centre and Centre for Ophthalmology and Vision Research, Institute of Human Development, University of Manchester, UK – name: 1 Wills Eye Hospital, Philadelphia, PA – name: 18 Scheie Eye Institute, University of Pennsylvania, Philadelphia, PA – name: 15 Tecnologico de Monterrey, Guadalajara, Mexico – name: 9 Manchester Vision Regeneration (MVR) Lab at NIHR/ Wellcome Trust Manchester CRF, UK – name: 22 Columbia University, New York, NY – name: 11 Hôpitaux Universitaires de Genève, Geneva, Switzerland – name: 13 Sorbonne universities - UPMC Paris-6, and Institut de la Vision, Paris, France – name: 12 ELZA Institute, Zurich, Switzerland – name: 5 NHIR Moorfields Biomedical Research Centre, City Road, London, UK – name: 24 Lighthouse Guild, New York, NY – name: 21 Feinberg School of Medicine, Northwestern University, Chicago, IL |
| Author_xml | – sequence: 1 givenname: Allen C. surname: Ho fullname: Ho, Allen C. email: acho@midatlanticretina.com organization: Wills Eye Hospital, Philadelphia, Pennsylvania – sequence: 2 givenname: Mark S. surname: Humayun fullname: Humayun, Mark S. organization: University of Southern California, Los Angeles, California – sequence: 3 givenname: Jessy D. surname: Dorn fullname: Dorn, Jessy D. organization: Second Sight Medical Products, Sylmar, California – sequence: 4 givenname: Lyndon surname: da Cruz fullname: da Cruz, Lyndon organization: Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom – sequence: 5 givenname: Gislin surname: Dagnelie fullname: Dagnelie, Gislin organization: Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland – sequence: 6 givenname: James surname: Handa fullname: Handa, James organization: Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland – sequence: 7 givenname: Pierre-Olivier surname: Barale fullname: Barale, Pierre-Olivier organization: Centre Hospitalier National d’Ophtalmologie des Quinze-Vingts, Paris, France – sequence: 8 givenname: José-Alain surname: Sahel fullname: Sahel, José-Alain organization: Centre Hospitalier National d’Ophtalmologie des Quinze-Vingts, Paris, France – sequence: 9 givenname: Paulo E. surname: Stanga fullname: Stanga, Paulo E. organization: Manchester Royal Eye Hospital, Manchester, United Kingdom – sequence: 10 givenname: Farhad surname: Hafezi fullname: Hafezi, Farhad organization: University of Southern California, Los Angeles, California – sequence: 11 givenname: Avinoam B. surname: Safran fullname: Safran, Avinoam B. organization: Hôpitaux Universitaires de Genève, Geneva, Switzerland – sequence: 12 givenname: Joel surname: Salzmann fullname: Salzmann, Joel organization: Hôpitaux Universitaires de Genève, Geneva, Switzerland – sequence: 13 givenname: Arturo orcidid: 0000-0003-4640-7263 surname: Santos fullname: Santos, Arturo organization: Centro de Retina Medica y Quirúrgica, SC, Guadalajara, Mexico – sequence: 14 givenname: David orcidid: 0000-0002-6594-2897 surname: Birch fullname: Birch, David organization: Retina Foundation of the Southwest, Dallas, Texas – sequence: 15 givenname: Rand surname: Spencer fullname: Spencer, Rand organization: Texas Retina Associates, Dallas, Texas – sequence: 16 givenname: Artur V. surname: Cideciyan fullname: Cideciyan, Artur V. organization: Scheie Eye Institute, University of Pennsylvania, Philadelphia, Pennsylvania – sequence: 17 givenname: Eugene surname: de Juan fullname: de Juan, Eugene organization: University of California, San Francisco, San Francisco, California – sequence: 18 givenname: Jacque L. surname: Duncan fullname: Duncan, Jacque L. organization: University of California, San Francisco, San Francisco, California – sequence: 19 givenname: Dean surname: Eliott fullname: Eliott, Dean organization: University of Southern California, Los Angeles, California – sequence: 20 givenname: Amani surname: Fawzi fullname: Fawzi, Amani organization: University of Southern California, Los Angeles, California – sequence: 21 givenname: Lisa C. surname: Olmos de Koo fullname: Olmos de Koo, Lisa C. organization: University of Southern California, Los Angeles, California – sequence: 22 givenname: Gary C. surname: Brown fullname: Brown, Gary C. organization: Wills Eye Hospital, Philadelphia, Pennsylvania – sequence: 23 givenname: Julia A. surname: Haller fullname: Haller, Julia A. organization: Wills Eye Hospital, Philadelphia, Pennsylvania – sequence: 24 givenname: Carl D. surname: Regillo fullname: Regillo, Carl D. organization: Wills Eye Hospital, Philadelphia, Pennsylvania – sequence: 25 givenname: Lucian V. surname: Del Priore fullname: Del Priore, Lucian V. organization: Columbia University, New York, New York – sequence: 26 givenname: Aries surname: Arditi fullname: Arditi, Aries organization: Lighthouse Guild, New York, New York – sequence: 27 givenname: Duane R. surname: Geruschat fullname: Geruschat, Duane R. organization: Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland – sequence: 28 givenname: Robert J. surname: Greenberg fullname: Greenberg, Robert J. organization: Second Sight Medical Products, Sylmar, California |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/26162233$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | 2015 American Academy of Ophthalmology American Academy of Ophthalmology Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. 2015 by the American Academy of Ophthalmology. 2015 |
| Copyright_xml | – notice: 2015 American Academy of Ophthalmology – notice: American Academy of Ophthalmology – notice: Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. – notice: 2015 by the American Academy of Ophthalmology. 2015 |
| CorporateAuthor | Argus II Study Group |
| CorporateAuthor_xml | – name: Argus II Study Group |
| DBID | 6I. AAFTH AAYXX CITATION CGR CUY CVF ECM EIF NPM 7X8 5PM |
| DOI | 10.1016/j.ophtha.2015.04.032 |
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| Snippet | Retinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease,... Purpose Retinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare... |
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| SubjectTerms | Adult Aged Blindness - rehabilitation Electrodes, Implanted Female Follow-Up Studies Humans Male Microelectrodes Middle Aged Ophthalmology Prospective Studies Prosthesis Implantation Reproducibility of Results Retinitis Pigmentosa - physiopathology Retinitis Pigmentosa - surgery Single-Blind Method Vision, Low - rehabilitation Visual Acuity - physiology Visual Prosthesis |
| Title | Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind |
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