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ADVERSE EVENTS OF THE ARGUS II RETINAL PROSTHESIS

Incidence, Causes, and Best Practices for Managing and Preventing Conjunctival Erosion

Rizzo, Stanislao, MD1; Barale, Pierre-Olivier, MD2,3; Ayello-Scheer, Sarah, MD3; Devenyi, Robert G., MD4,5; Delyfer, Marie-Noëlle, MD, PhD6,7; Korobelnik, Jean-François, MD6,7; Rachitskaya, Aleksandra, MD8; Yuan, Alex, MD, PhD8; Jayasundera, K. Thiran, MD9; Zacks, David N., MD PhD9; Handa, James T., MD10; Montezuma, Sandra R., MD11; Koozekanani, Dara, MD, PhD11; Stanga, Paulo E., MD12; da Cruz, Lyndon, MD, PhD13; Walter, Peter, MD14; Augustin, Albert J., MD15; Chizzolini, Marzio, MD16; Olmos de Koo, Lisa C., MD MBA17; Ho, Allen C., MD18; Kirchhof, Bernd, MD19; Hahn, Paul, MD, PhD20; Vajzovic, Lejla, MD21; Iezzi, Raymond Jr, MD22; Gaucher, David, MD, PhD23,24; Arevalo, J. Fernando, MD10; Gregori, Ninel Z., MD25; Grisanti, Salvatore, MD26; Özmert, Emin, MD27; Yoon, Young Hee, MD, PhD28; Kokame, Gregg T., MD29; Lim, Jennifer I., MD30; Szurman, Peter, MD31; de Juan, Eugene Jr, MD32; Rezende, Flavio A., MD, PhD33; Salzmann, Joël, MD34; Richard, Gisbert, MD35; Huang, Suber S., MD, MBA36; Merlini, Francesco, MSc37; Patel, Uday, PhD37; Cruz, Cynthia, MSc37; Greenberg, Robert J., MD, PhD37; Justus, Sally, MD38; Cinelli, Laura, MD1; Humayun, Mark S., MD, PhD39,40

doi: 10.1097/IAE.0000000000002394
Original Study: PDF Only

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.

Conjunctival erosion is a serious adverse event associated with the Argus II Retinal Prosthesis. This retrospective study offers recommendations for the prevention and management of this complication, including: placement of inverted sutures at the implant tabs; use of 5-0 Mersilene rather than nylon sutures; graft tissue; and accurate Tenon's and conjunctiva closure.

1Azienda Ospedaliera Universitaria Careggi, Department of Medicine and Translational Surgery, University of Florence, Florence, Italy;

2Sorbonne University, UPMC Univ Paris 06, INSERM U968, CNRS UMR 7210, Institute of Vision, Paris, France;

3CHNO des Quinze-Vingts, DHU Sight Restore, INSERM-DGOS CIC 1423, Paris, France;

4Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada;

5Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada;

6Inserm, Bordeaux Population Health Research Center, Team LEHA, University of Bordeaux, Bordeaux, France;

7Department of Ophthalmology, Bordeaux University Hospital, Bordeaux, France;

8Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio;

9Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan;

10The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland;

11Department of Ophthalmology and Visual Neurosciences, University of Minnesota, Minneapolis, Minnesota;

12Manchester Vision Regeneration (MVR) Lab, Manchester Royal Eye Hospital, NIHR Manchester Clinical Research Facility and Manchester University NHS Foundation Trust, Manchester, United Kingdom;

13NIHR Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital, London, United Kingdom;

14Department of Ophthalmology, RWTH Aachen University, Aachen, Germany;

15Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany;

16Unità Operativa Complessa di Oculistica, Camposampiero-Cittadella (Padova), Padua, Italy;

17Department of Ophthalmology, UW Medicine Eye Institute, University of Washington, Seattle, Washington;

18The Retina Service of Wills Eye Hospital, Mid Atlantic Retina, Philadelphia, Pennsylvania, Pennsylvania;

19Department of Retina and Vitreous Surgery, Center of Ophthalmology, University of Cologne, Cologne, Germany;

20New Jersey Retina, Teaneck, New Jersey;

21Department of Ophthalmology, Duke University School of Medicine, Durham, North Carolina;

22Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota, Minnesota;

23Nouvel Hôpital Civil, University Hospitals of Strasbourg, Strasbourg, France;

24Laboratory of Bacteriology (EA- 7290), The Federation of Translational Medicine of Strasbourg, University of Strasbourg, Strasbourg, France;

25Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami;

26Department of Ophthalmology, University of Luebeck, UKSH Luebeck, Germany;

27Department of Ophthalmology, Ankara University Faculty of Medicine, Ankara, Turkey;

28Department of Ophthalmology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea;

29Retina Consultants of Hawaii, Aiea, Hawaii;

30Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, Illinois;

31Knappschaft Eye Clinic Sulzbach, Knappschaft Hospital Saar, Sulzbach/Saar, Germany;

32ForSight Labs, Menlo Park, California;

33Department of Ophthalmology, Hôpital Maisonneuve-Rosemont, University of Montreal, Montreal, Québec, Canada;

34Department of Ophthalmology, Clinique Générale-Beaulieu, Geneva, Switzerland;

35Department of Ophthalmology, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany;

36Retina Center of Ohio, South Euclid, Ohio;

37Second Sight Medical Products, Inc, Sylmar, California;

38Harvard Medical School, Boston, Massachusetts;

39USC Institute for Biomedical Therapeutics, USC Roski Eye Institute, University of Southern California, Los Angeles, California; and

40Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, California

Reprint requests: Stanislao Rizzo, MD, Azienda Ospedaliera Universitaria Careggi, Dipartimento di Medicina e Chirurgia Traslazionale, University of Florence, Largo Palagi Piero, 1, 50139, Florence, Italy; e-mail: stanislao.rizzo@gmail.com

R. G. Devenyi, S. R. Montezuma, P. E. Stanga, A. J. Augustin, A. C. Ho, P. Hahn, L. Vajzovic, E. Özmert, and S. S. Huang are consultants for Second Sight.

None of the authors has any conflicting interests to disclose.

© 2018 by Ophthalmic Communications Society, Inc.