June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Optical coherence tomography in patients with Alpha IMS subretinal implant
Author Affiliations & Notes
  • Laura Kuehlewein
    Department of Ophthalmology, Center for Ophthalmology, Tuebingen, Germany
  • Veronique Kitiratschky
    Augenklinik des Ortenau Klinikums, Offenburg-Gengenbach, Germany
  • Mariya Gosheva
    Department of Ophthalmology, Center for Ophthalmology, Tuebingen, Germany
  • Thomas Edwards
    John Radcliffe Hospital and Nuffield Laboratory of Ophthalmology, Oxford, United Kingdom
  • Robert E MacLaren
    John Radcliffe Hospital and Nuffield Laboratory of Ophthalmology, Oxford, United Kingdom
  • Akos Kusnyerik
    Department of Ophthalmology at the Semmelweis University, Budapest, Hungary
  • Cristina Angelescu
    King’s College Hospital NHS Foundation Trust, London, United Kingdom
  • Timothy L Jackson
    King’s College Hospital NHS Foundation Trust, London, United Kingdom
  • Chen-Hsin Sun
    Department of Ophthalmology of the National University Hospital, Singapore, Singapore
  • Caroline Chee
    Department of Ophthalmology of the National University Hospital, Singapore, Singapore
  • Helmut G Sachs
    Staedtisches Klinikum Dresden-Friedrichstadt, Dresden, Germany
  • Barbara Wilhelm
    STZ Eyetrial, Tuebingen, Germany
  • Florian Gekeler
    Katharinenhospital Stuttgart, Stuttgart, Germany
  • Karl Ulrich Bartz-Schmidt
    Department of Ophthalmology, Center for Ophthalmology, Tuebingen, Germany
  • Eberhart Zrenner
    Department of Ophthalmology, Center for Ophthalmology, Tuebingen, Germany
    Werner Reichardt Centre for Integrative Neuroscience, Tuebingen, Germany
  • Katarina Stingl
    Department of Ophthalmology, Center for Ophthalmology, Tuebingen, Germany
  • Footnotes
    Commercial Relationships   Laura Kuehlewein, Retina Implant AG (F); Veronique Kitiratschky, None; Mariya Gosheva, None; Thomas Edwards, None; Robert MacLaren, None; Akos Kusnyerik, None; Cristina Angelescu, None; Timothy Jackson, None; Chen-Hsin Sun, None; Caroline Chee, Bayer (F), Bayer (R), Novartis (F), Novartis (R); Helmut Sachs, Retina Implant AG (F); Barbara Wilhelm, Retina Implant AG (F); Florian Gekeler, Retina Implant AG (F); Karl Bartz-Schmidt, Retina Implant AG (F); Eberhart Zrenner, Retina Implant AG (F), Retina Implant AG (I), Retina Implant AG (C), Retina Implant AG (P), Retina Implant AG (R), Retina Implant AG (S); Katarina Stingl, Retina Implant AG (F)
  • Footnotes
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Investigative Ophthalmology & Visual Science June 2017, Vol.58, 4189. doi:
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      Laura Kuehlewein, Veronique Kitiratschky, Mariya Gosheva, Thomas Edwards, Robert E MacLaren, Akos Kusnyerik, Cristina Angelescu, Timothy L Jackson, Chen-Hsin Sun, Caroline Chee, Helmut G Sachs, Barbara Wilhelm, Florian Gekeler, Karl Ulrich Bartz-Schmidt, Eberhart Zrenner, Katarina Stingl; Optical coherence tomography in patients with Alpha IMS subretinal implant. Invest. Ophthalmol. Vis. Sci. 2017;58(8):4189.

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

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Abstract

Purpose : We analyzed optical coherence tomography (OCT) data from a prospective, interventional clinical study to determine changes in retinal thickness after implantation of the RETINA IMPLANT Alpha IMS.

Methods : The RETINA IMPLANT Alpha IMS subretinal device (Retina Implant AG, Reutlingen, Germany) carries 1500 photodiodes, amplifiers and electrodes on a 9 mm2 chip. It has been developed to partially restore vision by stimulating the bipolar cells of the retina in patients suffering from profound photoreceptor loss due to degenerative diseases such as retinitis pigmentosa. Spectral domain OCT scans of 27 patients who received the Alpha IMS in a multi centre trial (ClinicalTrials.gov, NCT01024803) acquired with Spectralis OCT (Heidelberg Engineering, Heidelberg, Germany) or Cirrus OCT (Carl Zeiss Meditec AG, Jena, Germany) were analyzed using the built-in software to assess changes in retinal thickness anterior to the implant between two time points: within 6 weeks and 6 ± 1 months after implantation. Three thickness measurements were performed in each of the 4 quadrants of the retina anterior to the implant for each of the two visits. Statistical analyses were performed with IBM SPSS Statistics for Windows, Version 23.0 using paired samples t-test. The significance level was set at 5%.

Results : Due to lack of fixation and common presence of nystagmus, images of a good enough quality to perform quantitative analyses in all 4 quadrants at each of the two time points were available from 15 patients. We observed no statistically significant change in the mean retinal thickness within 6 weeks (288 µm) and 6 ± 1 months (309 µm) after implantation of the Alpha IMS. The results of the detailed analysis for each of the 4 quadrants are shown in Table 1. Epiretinal membranes – if present - remained essentially stable and no proliferative vitreoretinopathy was observed in the areas evaluated.

Conclusions : In patients with RETINA IMPLANT Alpha IMS, it is possible to acquire OCT scans and assess the thickness of the retina anterior to the implant. No major changes (e.g. thinning of the retina induced by the implant, induction of epiretinal membranes/proliferative vitreoretinopathy in the analyzed areas) were found during the observation period. With more patients receiving subretinal implants and with advanced OCT technology, the data set will be extended to study possible changes in retinal structure in finer detail.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

 

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