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4. Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial

Author

da Cruz, Lyndon, Dorn, Jessy D, Humayun, Mark S, Dagnelie, Gislin, Handa, James, Barale, Pierre-Olivier, Sahel, José-Alain, Stanga, Paulo E, Hafezi, Farhad, Safran, Avinoam B, Salzmann, Joel, Santos, Arturo, Birch, David, Spencer, Rand, Cideciyan, Artur V, de Juan, Eugene, Duncan, Jacque L, Eliott, Dean, Fawzi, Amani, de Koo, Lisa C Olmos, Ho, Allen C, Brown, Gary, Haller, Julia, Regillo, Carl, Del Priore, Lucian V, Arditi, Aries, Greenberg, Robert J, and Group, Argus II Study

Subjects
Rehabilitation, Neurosciences, Patient Safety, Eye Disease and Disorders of Vision, Assistive Technology, Bioengineering, Clinical Research, Clinical Trials and Supportive Activities, Neurodegenerative, Eye, Adult, Aged, Blindness, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Prosthesis Design, Retina, Retinitis Pigmentosa, Time Factors, Treatment Outcome, Visual Acuity, Visual Prosthesis, Visually Impaired Persons, Argus II Study Group, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Ophthalmology & Optometry
Abstract

PurposeThe 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.DesignProspective, 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.ParticipantsThirty participants in 10 centers in the United States and Europe.MethodsThe 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 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. Secondary measures included functional vision performance on objectively scored real-world tasks.ResultsTwenty-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.ConclusionsThe 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.

Published
2016

7. Photoreceptor differentiation and integration of retinal progenitor cells transplanted into transgenic rats

Author

Qiu, Guanting, Seiler, Magdalene J, Mui, Cathy, Arai, Shinichi, Aramant, Robert B, de Juan, Eugene, and Sadda, SriniVas

Subjects
Neurodegenerative, Transplantation, Stem Cell Research, Eye Disease and Disorders of Vision, Stem Cell Research - Nonembryonic - Non-Human, Neurosciences, Regenerative Medicine, Development of treatments and therapeutic interventions, 5.2 Cellular and gene therapies, Eye, Neurological, Animals, Animals, Genetically Modified, Cell Differentiation, Cell Survival, Cells, Cultured, Disease Models, Animal, Glial Fibrillary Acidic Protein, Immunohistochemistry, Photoreceptor Cells, Rats, Retina, Retinal Degeneration, Rhodopsin, Stem Cell Transplantation, Stem Cells, Synapsins, Tomography, Optical Coherence, retinal progenitor cell, stem cell, transplant, integration, transgenic rat, hPAP, subretinal injection, Medical Biochemistry and Metabolomics, Opthalmology and Optometry, Ophthalmology & Optometry
Abstract

Previous studies evaluating neural stem cells transplanted into the mature retina have demonstrated limited levels of graft-host integration and photoreceptor differentiation. The purpose of this investigation is to enhance photoreceptor cell differentiation and integration of retinal progenitor cells (RPC) following subretinal transplantation into retinal degenerate rats by optimization of isolation, expansion, and transplantation procedures. RPCs were isolated from human placental alkaline phosphatase (hPAP)-positive embryonic day 17 (E17) rat retina and expanded in serum-free defined media. RPCs at passage 2 underwent in vitro induction with all trans retinoic acid or were transplanted into the subretinal space of post-natal day (P) 17 S334ter-3 and S334ter-5 transgenic rats. Animals were examined post-operatively by ophthalmoscopy and optical coherence tomography (OCT) at weeks 1 and 4. Differentiation profiles of RPCs, both in vitro and in vivo were analysed microscopically by immunohistochemistry for various retinal cell specific markers. Our results demonstrated that the majority of passage 2 RPCs differentiated into retina-specific neurons expressing rhodopsin after in vitro induction. Following subretinal transplantation, grafted cells formed a multi-layer cellular sheet in the subretinal space in both S334ter-3 and S334ter-5 rats. Prominent retina-specific neuronal differentiation was observed in both rat lines as evidenced by recoverin or rhodopsin staining in 80% of grafted cells. Less than 5% of the grafted cells expressed glial fibrillary acidic protein. Synapsin-1 (label for nerve terminals) positive neural processes were present at the graft-host interface. Expression profiles of the grafted RPCs were similar to those of RPCs induced to differentiate in vitro using all-trans retinoic acid. In contrast to our previous study, grafted RPCs can demonstrate extensive rhodopsin expression, organize into layers, and show some features of apparent integration with the host retina following subretinal transplantation in slow and fast retinal degenerate rats. The similarity of the in vitro and in vivo RPC differentiation profiles suggests that intrinsic signals may have a significant contribution to RPC cell fate determination.

Published
2005

9. ADVERSE EVENTS OF THE ARGUS II RETINAL PROSTHESIS: Incidence, Causes, and Best Practices for Managing and Preventing Conjunctival Erosion

Author

Rizzo, Stanislao, Barale, Pierre-Olivier, Ayello-Scheer, Sarah, Devenyi, Robert G., Delyfer, Marie-Noëlle, Korobelnik, Jean-François, Rachitskaya, Aleksandra, Yuan, Alex, Jayasundera, K. Thiran, Zacks, David N., Handa, James T., Montezuma, Sandra R., Koozekanani, Dara, Stanga, Paulo E., da Cruz, Lyndon, Walter, Peter, Augustin, Albert J., Chizzolini, Marzio, Olmos de Koo, Lisa C., Ho, Allen C., Kirchhof, Bernd, Hahn, Paul, Vajzovic, Lejla, Iezzi, Raymond, Jr, Gaucher, David, Arevalo, J. Fernando, Gregori, Ninel Z., Grisanti, Salvatore, Özmert, Emin, Yoon, Young Hee, Kokame, Gregg T., Lim, Jennifer I., Szurman, Peter, de Juan, Eugene, Jr, Rezende, Flavio A., Salzmann, Joël, Richard, Gisbert, Huang, Suber S., Merlini, Francesco, Patel, Uday, Cruz, Cynthia, Greenberg, Robert J., Justus, Sally, Cinelli, Laura, and Humayun, Mark S.

Published
2020
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10. ADVERSE EVENTS OF THE ARGUS II RETINAL PROSTHESIS: Incidence, Causes, and Best Practices for Managing and Preventing Conjunctival Erosion

Author

Rizzo, Stanislao, Barale, Pierre-Olivier, Ayello-Scheer, Sarah, Devenyi, Robert G., Delyfer, Marie-Noëlle, Korobelnik, Jean-François, Rachitskaya, Aleksandra, Yuan, Alex, Jayasundera, K. Thiran, Zacks, David N., Handa, James T., Montezuma, Sandra R., Koozekanani, Dara, Stanga, Paulo E., da Cruz, Lyndon, Walter, Peter, Augustin, Albert J., Chizzolini, Marzio, Olmos de Koo, Lisa C., Ho, Allen C., Kirchhof, Bernd, Hahn, Paul, Vajzovic, Lejla, Iezzi, Raymond, Jr, Gaucher, David, Arevalo, J. Fernando, Gregori, Ninel Z., Grisanti, Salvatore, Özmert, Emin, Yoon, Young Hee, Kokame, Gregg T., Lim, Jennifer I., Szurman, Peter, de Juan, Eugene, Jr, Rezende, Flavio A., Salzmann, Joël, Richard, Gisbert, Huang, Suber S., Merlini, Francesco, Patel, Uday, Cruz, Cynthia, Greenberg, Robert J., Justus, Sally, Cinelli, Laura, and Humayun, Mark S.

Published
2018
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11. Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind

Author

Ho, Allen C., Humayun, Mark S., Dorn, Jessy D., da Cruz, Lyndon, Dagnelie, Gislin, Handa, James, Barale, Pierre-Olivier, Sahel, José-Alain, Stanga, Paulo E., Hafezi, Farhad, Safran, Avinoam B., Salzmann, Joel, Santos, Arturo, Birch, David, Spencer, Rand, Cideciyan, Artur V., de Juan, Eugene, Duncan, Jacque L., Eliott, Dean, Fawzi, Amani, Olmos de Koo, Lisa C., Brown, Gary C., Haller, Julia A., Regillo, Carl D., Del Priore, Lucian V., Arditi, Aries, Geruschat, Duane R., and Greenberg, Robert J.

Published
2015
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20. List of contributors

Author

Ahmed, Iqbal Ike K., primary, Altan-Yaycioglu, Rana, additional, Aylward, George William, additional, Azuara-Blanco, Augusto, additional, Bagnis, Alessandro, additional, Baldeschi, Lelio, additional, Banitt, Michael R., additional, Barton, Keith, additional, Baskin, Darrell E., additional, Baumeister, Martin, additional, Bellucci, Roberto, additional, Benjamin, Larry, additional, Berdahl, John P., additional, Brazier, John, additional, Brod, Roy D., additional, Bühren, Jens, additional, Freidl, Kathryn Burleigh, additional, Busin, Massimo, additional, Cantor, Louis B., additional, Carassa, Roberto G., additional, Colin, Joseph, additional, Coupland, Sarah E., additional, Damato, Bertil, additional, Dresner, Steven C., additional, Dupps, William J., additional, Eke, Tom, additional, Elder, Mark J., additional, Elies, Daniel, additional, Elizalde, Javier, additional, Epstein, Daniel, additional, Fine, I. Howard, additional, Fineman, Mitchell S., additional, Flynn, Harry W., additional, Freedman, Jeffrey, additional, Gandorfer, Arnd, additional, Gardner, Thomas W., additional, Goldberg, Robert A., additional, Goyal, Saurabh, additional, Gris, Oscar, additional, Groenewald, Carl, additional, Güell, Jose L., additional, Gupta, Shelly R., additional, Hallahan, Katie, additional, Han, Dennis P., additional, Haritoglou, Christos, additional, Heimann, Heinrich, additional, Hetzler, Kathy J., additional, Hintschich, Christoph, additional, Hoffman, Richard S., additional, Holz, Frank G., additional, Hutchinson, Amy K., additional, Hwang, Catherine J., additional, Iyengar, Srinivas S., additional, Johnston, Robert L., additional, de Juan, Eugene, additional, Uzbek, Aylin Kılıç, additional, Dipl-Ing, Oliver K. Klaproth, additional, Kohnen, Thomas, additional, Kontadakis, Georgios A., additional, Kook, Daniel, additional, Kymionis, George D., additional, Lambert, Scott R., additional, Lawrence, Scott D., additional, Lee, Richard K., additional, Li, Tina G., additional, Lin, Phoebe, additional, Lindsay, Rebecca Anderson, additional, Little, Brian C., additional, Macrì, Angelo, additional, Malen, Marissa R., additional, Manero, Felicidad, additional, Marinho, Antonio, additional, McCannel, Tara A., additional, Miller, Darlene, additional, Moorman, Consuela, additional, Morral, Merce, additional, Moster, Marlene R., additional, Netland, Peter A., additional, Ng, John D., additional, Nischal, Ken K., additional, Nunery, William R., additional, O’Brien, Joan, additional, Olver, Jane, additional, Packer, Mark, additional, Papadia, Marina, additional, Pasquale, Louis R., additional, Patel, Amit, additional, Patel, Shuchi B., additional, Pe’er, Jacob, additional, Poetter, Richard, additional, Prasad, Som, additional, Quillen, David A., additional, Ritch, Robert, additional, Rose, Geoffrey E., additional, Bsc, Paul Rosen, additional, Samuelson, Thomas W., additional, Schachat, Andrew P., additional, Schalenbourg, Ann, additional, Schaudig, Ulrich H., additional, Schorr, Norman, additional, Scotto, Riccardo, additional, Sculfor, David, additional, Shields, Carol L., additional, Shields, Jerry A., additional, Shun-Shin, Georges Adrien, additional, Siganos, Dimitrios S., additional, Singh, Arun D., additional, Skalet, Alison H., additional, Smith, Jennifer Hasenyager, additional, Sokol, Jason A., additional, Spaeth, George L., additional, Stanzel, Boris V., additional, Sullivan, Timothy J., additional, Tadayoni, Ramin, additional, Tam, Diamond Y., additional, Tham, Clement C.Y., additional, Timoney, Peter J., additional, Traverso, Carlo Enrico, additional, Tyers, Anthony G., additional, Uzcategui, Nicolas, additional, Venzano, Davide, additional, Verity, David H., additional, Watts, Mark T., additional, Wickham, Louisa, additional, Yee, Allison B., additional, Zehetmayer, Martin, additional, and Zografos, Leonidas, additional

Published
2012
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26. Contributors

Author

Aaberg, Thomas M., primary, Abdel-Rahman, Mohamed H., additional, Abrams, Gary W., additional, Agarwal, Anita, additional, Ai, Everett, additional, Albert, Daniel M., additional, Alexander, Judith, additional, Anand, Rajiv, additional, Anastassiou, Gerasimos, additional, Aylward, G. William, additional, Barazi, Mohammed K., additional, Bingaman, David, additional, Bird, Alan C., additional, Blodi, Barbara A., additional, Blumenkranz, Mark S., additional, Bolling, James P., additional, Bornfeld, Norbert, additional, Bressler, Susan B., additional, Bressler, Neil M., additional, Brinton, Daniel A., additional, Brown, Jeremiah, additional, Brown, Gary C., additional, Brown, Justin C., additional, Buettner, Helmut, additional, de Bustros, Serge, additional, Byrne, Sandra Fraser, additional, Cahill, Mark T., additional, Campochiaro, Peter A., additional, Carr, Ronald E., additional, Chang, Stanley, additional, Charles, Steve, additional, Chen, Jeannie, additional, Chen, Clara A., additional, Chew, Emily Y., additional, Chorich, Louis J., additional, Chow, David R., additional, Ciardella, Antonio P., additional, Ciulla, Thomas A., additional, Coscas, Gabriel J., additional, Cruess, Alan F., additional, da Cruz, Lyndon, additional, Damato, Bertil E., additional, Davidorf, Frederick H., additional, Davis, Matthew D., additional, Davis, Janet L., additional, Deutman, August F., additional, Dhaliwal, Ranjit S., additional, Do, Diana V., additional, Dugel, Pravin U., additional, Earle, John D., additional, Edwards, Albert O., additional, Eliott, Dean, additional, Emerson, Geoffrey G., additional, Fekrat, Sharon, additional, Feldon, Steven E., additional, Ferris, Frederick L., additional, Fine, Stuart L., additional, Finkelstein, Daniel, additional, Fisher, Steven K., additional, Flannery, John, additional, Folk, James C., additional, Foulds, Wallace S., additional, Frank, Robert N., additional, Freeman, William R., additional, Friedlander, Martin, additional, Frishman, Laura J., additional, Fu, Arthur D., additional, Fujii, Gildo Y., additional, Gallemore, Ron P., additional, Garibaldi, Daniel C., additional, Garcia-Valenzuela, Enrique, additional, Gass, J. Donald M., additional, Gautier, Sandrine, additional, Geller, Scott, additional, Goldberg, Morton F., additional, Gonzales, Christine R., additional, Gottlieb, Justin L., additional, Gragoudas, Evangelos S., additional, Green, Ronald L., additional, Green, W. Richard, additional, Gregor, Zdenek J., additional, Gregory-Evans, Kevin, additional, Gross, Nicole E., additional, Gullapalli, Vamsi K., additional, Guyer, David R., additional, Guymer, Robyn, additional, Haller, Julia A., additional, Harbour, J. William, additional, Harlan, Joseph B., additional, Harris, Alon, additional, Hartnett, Mary Elizabeth, additional, Hartzer, Michael K., additional, Hawkins, Barbara S., additional, Heimann, Heinrich, additional, Hinton, David R., additional, Hinz, Brad J., additional, Hoffmann, Stephan, additional, Holekamp, Nancy M., additional, Holland, Gary N., additional, Hoyng, Carel B., additional, Humayun, Mark S., additional, Ikuno, Yasushi, additional, Jabs, Douglas A., additional, Jaffe, Glenn J., additional, Jallet, Valérie, additional, Jampol, Lee M., additional, Joffe, Leonard, additional, Johnson, Robert N., additional, Joseph, Daniel P., additional, de Juan, Eugene, additional, Michael Jumper, J., additional, Kaplan, Henry J., additional, Kelley, James S., additional, Khodair, Mohamad A., additional, Kirchhof, Bernd, additional, Klais, Christina M., additional, Klein, Barbara E.K., additional, Klein, Ronald, additional, Kline, Robert W., additional, Knox, David L., additional, Kosobucki, Brian R., additional, Kreiger, Allan E., additional, Kunimoto, Derek Y., additional, Kwun, Robert Choi, additional, Lakhanpal, Rohit R., additional, Lam, Linda A., additional, Landers, Maurice B., additional, Lane, Anne Marie, additional, Lee, Michael S., additional, Lee, Henry C., additional, Lewis, Hilel, additional, Lewis, Geoffrey P., additional, Lim, Wee-Kiak, additional, Lit, Eugene S., additional, Loewenstein, Anat, additional, Lopez, José Manuel, additional, Lutty, Gerard A., additional, Madreperla, Steven, additional, Maguire, Albert M., additional, Mainster, Martin A., additional, Mansfield, Nancy C., additional, Marmor, Michael F., additional, Martin, Bruce J., additional, Massey, Stephen C., additional, Mavrofrides, Elias C., additional, McCuen, Brooks W., additional, Richard McDonald, H., additional, Meier, Petra, additional, Merbs, Shannath L., additional, Meredith, Travis A., additional, Mieler, William F., additional, Miller, Robert F., additional, Miller, Joan W., additional, Milne, Peter, additional, Mittra, Robert A., additional, Moshfeghi, Darius M., additional, Moshfeghi, Andrew A., additional, Moshiri, Ala, additional, Mruthyunjaya, Prithvi, additional, Murata, Toshinori, additional, Murphree, A. Linn, additional, Murphy, Robert P., additional, Nanda, Sumit K., additional, Nguyen, Quan Dong, additional, Nussenblatt, Robert B., additional, Ober, Michael D., additional, Ober, Richard R., additional, Ogden, Thomas E., additional, Oh, Kean T., additional, Ohji, Masahito, additional, Olsen, Karl R., additional, Palanker, Daniel, additional, Palmer, Earl A., additional, Parel, Jean-Marie, additional, Park, Carl H., additional, Pederson, Jonathan E., additional, Pelzek, Christopher D., additional, Pepose, Jay S., additional, Phelps, Dale L., additional, Phillips, Stephen, additional, Pokorny, Joel, additional, Puliafito, Carmen A., additional, Rao, Narsing A., additional, Kumar Rao, P., additional, Recchia, Franco M., additional, Reh, Thomas A., additional, Robertson, Dennis M., additional, Robertson, Joseph E., additional, Rubin, Gary S., additional, Ryan, Stephen J., additional, Sadda, Srinivas R., additional, Sadun, Alfredo A., additional, Sahel, José Alain, additional, de la Maza, Maite Sainz, additional, Samuel, Michael A., additional, Sanborn, George E., additional, Sarks, John P., additional, Sarks, Shirley H., additional, Schachat, Andrew P., additional, Sebag, J., additional, Seddon, Johanna M., additional, Sharma, Sanjay, additional, Sheffield, Val C., additional, Shields, Carol L., additional, Shields, Jerry A., additional, Singh, Arun, additional, Sjaarda, Raymond N., additional, Slakter, Jason S., additional, Smith, Vivianne C., additional, Smith, Ronald E., additional, Solomon, Sharon D., additional, Soubrane, Gisele, additional, Spencer, Rand, additional, Sternberg, Paul, additional, Stewart, Jay M., additional, Stone, Edwin M., additional, Sugino, Ilene K., additional, Sunness, Janet S., additional, Tano, Yasuo, additional, Tasman, William S., additional, Thomas, Matthew A., additional, Thompson, John T., additional, Thorne, Jennifer E., additional, Thumann, Gabriele, additional, Toth, Cynthia A., additional, Trese, Michael T., additional, Tsai, Linda M., additional, Turner, Patricia L., additional, Tweito, Timothy H., additional, Updike, Paul G., additional, Van Gelder, Russell N., additional, van Lith-Verhoeven, Janneke J.C., additional, Vaudaux, Jean D., additional, Villain, Franck, additional, Vitale, Albert T., additional, Walker, Jonathan D., additional, Walsh, Alexander C., additional, Wang, Hao, additional, Webster, Andrew R., additional, Weiland, James D., additional, Weiter, John J., additional, Weleber, Richard G., additional, Wharam, Moody D., additional, Jeffrey Whitehead, A., additional, Wiedemann, Peter, additional, Wilkinson, C.P., additional, Williams, George A., additional, Willson, James K.V., additional, Wilson, David J., additional, Win, Peter H., additional, Yannuzzi, Lawrence A., additional, Yoon, Young Hee, additional, Young, Tara A., additional, Zarbin, Marco A., additional, and Zhang, Kang, additional

Published
2006
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32. Retinal Prosthesis

Author

Humayun, Mark, primary, Juan, Eugene de, additional, Margalit, Eyal, additional, Eong, Kah-Guan, additional, and Weiland, James, additional

Published
2002
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36. Sensorial prostheses

Author

Liu, Wentai, primary, McGucken, Elliot, additional, Cavin, Ralph, additional, Clements, Mark, additional, Vichienchom, Kasin, additional, emarco, Chris, additional, Humayun, Mark, additional, de Juan, Eugene, additional, Weiland, James, additional, and Greenberg, Robert, additional

Published
2000
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43. Heat Effects on the Retina

Author

Piyathaisere, Duke V., Margalit, Eyal, Chen, Shih-Jen, Shyu, Jeng-Shyong, DʼAnna, Salvatore A., Weiland, James D., Grebe, Rhonda R., Grebe, Lynnea, Fujii, Gildo, Kim, Sahng Yeon, Greenberg, Robert J., De Juan, Eugene, Jr., and Humayun, Mark S.

Published
2003

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