Rizzo, Stanislao, Barale, Pierre-Olivier, Ayello-Scheer, Sarah, Devenyi, Robert G., Delyfer, Marie-Noelle, Korobelnik, Jean-Francois, Rachitskaya, Aleksandra, Yuan, Alex ORCID: 0000-0003-0191-8035, 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, de Koo, Lisa C. Olmos, Ho, Allen C., Kirchhof, Bernd, Hahn, Paul, Vajzovic, Lejla, Iezzi, Raymond, Jr., Gaucher, David, Arevalo, J. Fernando, Gregori, Ninel Z., Grisanti, Salvatore, Ozmert, Emin, Yoon, Young Hee, Kokame, Gregg T., Lim, Jennifer, I, Szurman, Peter, de Juan, Eugene, Jr., Rezende, Flavio A., Salzmann, Joel, Richard, Gisbert, Huang, Suber S., Merlini, Francesco, Patel, Uday, Cruz, Cynthia, Greenberg, Robert J., Justus, Sally, Cinelli, Laura and Humayun, Mark S. (2020). ADVERSE EVENTS OF THE ARGUS II RETINAL PROSTHESIS Incidence, Causes, and Best Practices for Managing and Preventing Conjunctival Erosion. Retin.-J. Retin. Vitr. Dis., 40 (2). S. 303 - 312. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 1539-2864

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Abstract

Purpose: To analyze and provide an overview of the incidence, management, and prevention of conjunctival erosion in Argus II clinical trial subjects and postapproval patients. Methods: This retrospective analysis followed the results of 274 patients treated with the Argus II Retinal Prosthesis System between June 2007 and November 2017, including 30 subjects from the US and European clinical trials, and 244 patients in the postapproval phase. Results were gathered for incidence of a serious adverse event, incidence of conjunctival erosion, occurrence sites, rates of erosion, and erosion timing. Results: Overall, 60% of subjects in the clinical trial subjects versus 83% of patients in the postapproval phase did not experience device- or surgery-related serious adverse events. In the postapproval phase, conjunctival erosion had an incidence rate of 6.2% over 5 years and 11 months. In 55% of conjunctival erosion cases, erosion occurred in the inferotemporal quadrant, 25% in the superotemporal quadrant, and 20% in both. Sixty percent of the erosion events occurred in the first 15 months after implantation, and 85% within the first 2.5 years. Conclusion: Reducing occurrence of conjunctival erosion in patients with the Argus II Retinal Prosthesis requires identification and minimization of risk factors before and during implantation. Implementing inverted sutures at the implant tabs, use of graft material at these locations as well as Mersilene rather than nylon sutures, and accurate Tenon's and conjunctiva closure are recommended for consideration in all patients.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Rizzo, StanislaoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Barale, Pierre-OlivierUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ayello-Scheer, SarahUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Devenyi, Robert G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Delyfer, Marie-NoelleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Korobelnik, Jean-FrancoisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rachitskaya, AleksandraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Yuan, AlexUNSPECIFIEDorcid.org/0000-0003-0191-8035UNSPECIFIED
Jayasundera, K. ThiranUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zacks, David N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Handa, James T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Montezuma, Sandra R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koozekanani, DaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stanga, Paulo E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Da Cruz, LyndonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Walter, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Augustin, Albert J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chizzolini, MarzioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Koo, Lisa C. OlmosUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ho, Allen C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kirchhof, BerndUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hahn, PaulUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vajzovic, LejlaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Iezzi, Raymond, Jr.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gaucher, DavidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Arevalo, J. FernandoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gregori, Ninel Z.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grisanti, SalvatoreUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ozmert, EminUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Yoon, Young HeeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kokame, Gregg T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lim, Jennifer, IUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Szurman, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Juan, Eugene, Jr.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rezende, Flavio A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Salzmann, JoelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Richard, GisbertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huang, Suber S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Merlini, FrancescoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Patel, UdayUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cruz, CynthiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Greenberg, Robert J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Justus, SallyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cinelli, LauraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Humayun, Mark S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-346005
DOI: 10.1097/IAE.0000000000002394
Journal or Publication Title: Retin.-J. Retin. Vitr. Dis.
Volume: 40
Number: 2
Page Range: S. 303 - 312
Date: 2020
Publisher: LIPPINCOTT WILLIAMS & WILKINS
Place of Publication: PHILADELPHIA
ISSN: 1539-2864
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
AHMED GLAUCOMA; BOVINE PERICARDIUM; EPIRETINAL PROSTHESIS; HOMOLOGOUS SCLERA; VISION; IMPLANTS; BLIND; COMPLICATIONS; STIMULATION; PERFORMANCEMultiple languages
OphthalmologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/34600

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