July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Changes in Microchip Position after Implantation of a Subretinal Vision Prosthesis in Humans
Author Affiliations & Notes
  • Laura Kuehlewein
    Department of Ophthalmology, University of Tuebingen, Tuebingen, Germany
  • Nicole Troelenberg
    Retina Implant AG, Reutlingen, Germany
  • Krunoslav Stingl
    Department of Ophthalmology, University of Tuebingen, Tuebingen, Germany
  • Sebastian Schleehauf
    Retina Implant AG, Reutlingen, Germany
  • Akos Kusnyerik
    Ophthalmology, Semmelweis University, Budapest, Hungary
  • Helmut Sachs
    Staedtisches Klinikum Dresden-Friedrichstadt, Dresden, Germany
  • Johann Roider
    Ophthalmology, University of Kiel, Kiel, Germany
  • Timothy L Jackson
    King’s College Hospital, NHS Foundation Trust, London, United Kingdom
  • Robert E MacLaren
    Oxford Eye Hospital at the Oxford University Hospitals NHS Foundation Trust and Nuffield Laboratory of Ophthalmology, University of Oxford, Oxford, United Kingdom
  • Caroline Chee
    Department of Ophthalmology, National University Hospital Singapore, Singapore, Singapore
  • Barbara Wilhelm
    STZ eyetrial, Tuebingen, Germany
  • Florian Gekeler
    Department of Ophthalmology, University of Tuebingen, Tuebingen, Germany
  • Karl Ulrich Bartz-Schmidt
    Department of Ophthalmology, University of Tuebingen, Tuebingen, Germany
  • Eberhart Zrenner
    Department of Ophthalmology, University of Tuebingen, Tuebingen, Germany
    Werner Reichardt Centre for Integrative Neuroscience, University of Tuebingen, Tuebingen, Germany
  • Katarina Stingl
    Department of Ophthalmology, University of Tuebingen, Tuebingen, Germany
  • Footnotes
    Commercial Relationships   Laura Kuehlewein, Retina Implant (F); Nicole Troelenberg, Retina Implant (E); Krunoslav Stingl, Schumacher Foundation (F); Sebastian Schleehauf, Retina Implant (E); Akos Kusnyerik, None; Helmut Sachs, Retina Implant (F); Johann Roider, Retina Implant (F); Timothy Jackson, None; Robert MacLaren, None; Caroline Chee, Bayer (F), Bayer (R), Novartis (R), Novartis (F); Barbara Wilhelm, Retina Implant (F); Florian Gekeler, Retina Implant (F); Karl Ulrich Bartz-Schmidt, Retina Implant (F); Eberhart Zrenner, Retina Implant (F), Retina Implant (P), Retina Implant (R), Retina Implant (I), Retina Implant (C), Retina Implant (S); Katarina Stingl, Retina Implant (F)
  • Footnotes
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Investigative Ophthalmology & Visual Science July 2018, Vol.59, 4561. doi:
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      Laura Kuehlewein, Nicole Troelenberg, Krunoslav Stingl, Sebastian Schleehauf, Akos Kusnyerik, Helmut Sachs, Johann Roider, Timothy L Jackson, Robert E MacLaren, Caroline Chee, Barbara Wilhelm, Florian Gekeler, Karl Ulrich Bartz-Schmidt, Eberhart Zrenner, Katarina Stingl; Changes in Microchip Position after Implantation of a Subretinal Vision Prosthesis in Humans. Invest. Ophthalmol. Vis. Sci. 2018;59(9):4561.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Retinal prosthetic devices have been developed to partially restore very-low-vision in legally blind patients with end-stage hereditary retinal dystrophies. Subretinal implants, unlike epiretinal implants, are not attached to the retina by a tack. The aim of this study was to assess and analyze possible changes over time in the subretinal position of the RETINA IMPLANT Alpha IMS and AMS (ClinicalTrials.gov NCT01024803).

Methods : Imaging studies were performed on fundus photographs using GIMP (Version 2.8.14). All photographs of the implanted eye were scaled and aligned. If no obvious microchip displacement occurred between any of the visits, the implant was considered stable. In those eyes, in which displacement occurred, landmarks were chosen and distances between landmarks were measured to then calculate the displacement of the microchip using a transformation matrix for rotational and translational movements. Analyses were performed using MATLAB 8.6 (The MathWorks Inc., Natick, MA).

Results : Of the 27 datasets with the Alpha IMS device, 12 (44%) remained stable without displacement of the microchip relative to the optic disc and the major blood vessels, whereas in 15 (56%), displacement occurred. The mean ± SD displacement in those 15 eyes was 0.66 ± 0.35 mm (range, 0.24 - 1.67 mm, Fig. 1). Of the 8 datasets with the Alpha AMS device, 1 (13%) remained stable without displacement of the microchip relative to the optic disc and the major blood vessels, whereas in 7 (87%), displacement occurred. The mean ± SD displacement in those 7 eyes was 0.66 ± 0.26 mm (range, 0.32 - 0.97 mm, Fig. 1).

Conclusions : In this study, we assessed postoperative changes in the position of the RETINA IMPLANT Alpha IMS and AMS in 36 eyes, which constitutes for a rather large cohort given the number of patients in which RETINA IMPLANT Alpha IMS or AMS surgery has been performed until now. We show that the subretinal position of the visual implant can change after implantation in some patients, but the overall mean displacement of the chip remains minor.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

 

Fig. 1 Mean movement (mm) of the RETINA IMPLANT Alpha IMS and AMS after implantation in those eyes, in which displacement occured (N = 15 for Alpha IMS and N = 7 for Alpha AMS). Note that there is no difference in the mean between the two cohorts (0.66 mm).

Fig. 1 Mean movement (mm) of the RETINA IMPLANT Alpha IMS and AMS after implantation in those eyes, in which displacement occured (N = 15 for Alpha IMS and N = 7 for Alpha AMS). Note that there is no difference in the mean between the two cohorts (0.66 mm).

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