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

Authors :
Pierre Olivier Barale
Jean-François Korobelnik
Paul Hahn
Paulo E. Stanga
Peter Szurman
Suber S. Huang
Joel Salzmann
Lejla Vajzovic
Raymond Iezzi
Aleksandra Rachitskaya
David N. Zacks
Alex Yuan
Laura Cinelli
Cynthia Cruz
Lisa C. Olmos de Koo
David Gaucher
Francesco Merlini
Mark S. Humayun
Emin Özmert
Robert J. Greenberg
Sarah Ayello-Scheer
Allen C. Ho
Gregg T. Kokame
Marzio Chizzolini
Sandra R. Montezuma
Peter Walter
Dara D. Koozekanani
K. Thiran Jayasundera
Lyndon da Cruz
J. Fernando Arevalo
Stanislao Rizzo
Uday Patel
Flavio A. Rezende
Salvatore Grisanti
Young Hee Yoon
Marie Noelle Delyfer
Ninel Z. Gregori
Eugene de Juan
Sally Justus
Bernd Kirchhof
James T. Handa
Albert J. Augustin
Gisbert Richard
Jennifer I. Lim
Robert G. Devenyi
Bordeaux population health (BPH)
Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Source :
RETINA, RETINA, Lippincott, Williams & Wilkins, 2020, 40 (2), pp.303-311. ⟨10.1097/iae.0000000000002394⟩
Publication Year :
2020
Publisher :
HAL CCSD, 2020.

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.

Details

Language :
English
ISSN :
0275004X
Database :
OpenAIRE
Journal :
RETINA, RETINA, Lippincott, Williams & Wilkins, 2020, 40 (2), pp.303-311. ⟨10.1097/iae.0000000000002394⟩
Accession number :
edsair.doi.dedup.....af9f31a31914ab7c22a7c1611319e84e
Full Text :
https://doi.org/10.1097/iae.0000000000002394⟩