July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
A 44 channel suprachoroidal retinal prosthesis : surgical approach, safety and stability.
Author Affiliations & Notes
  • Penelope J Allen
    Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia
    Department of Surgery (Ophthalmology), University of Melbourne, Melbourne, Victoria, Australia
  • David AX Nayagam
    Bionics Institute, Melbourne, Victoria, Australia
    Medical Bionics Department, University of Melbourne, Melbourne, Victoria, Australia
  • Stephanie B Epp
    Bionics Institute, Melbourne, Victoria, Australia
  • Chi D Luu
    Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia
    Department of Surgery (Ophthalmology), University of Melbourne, Melbourne, Victoria, Australia
  • Nick Barnes
    Data 61, Commonwealth Scientific and Industrial Research Organisation, Canberra, Australian Capital Territory, Australia
    The Australian National University, Canberra, Australian Capital Territory, Australia
  • Maria Kolic
    Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia
  • Kiera A Young
    Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia
  • Elizabeth Kate Baglin
    Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia
  • Carla J Abbott
    Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia
    Department of Surgery (Ophthalmology), University of Melbourne, Melbourne, Victoria, Australia
  • Robert Briggs
    Otolaryngology, University of Melbourne, Melbourne, Victoria, Australia
  • Jonathan Yeoh
    Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia
  • William G Kentler
    School of Engineering, University of Melbourne, Melbourne, Victoria, Australia
  • Samuel A Titchener
    Bionics Institute, Melbourne, Victoria, Australia
  • Matthew A Petoe
    Bionics Institute, Melbourne, Victoria, Australia
    Medical Bionics Department, University of Melbourne, Melbourne, Victoria, Australia
  • Chris E Williams
    Bionics Institute, Melbourne, Victoria, Australia
    Medical Bionics Department, University of Melbourne, Melbourne, Victoria, Australia
  • Footnotes
    Commercial Relationships   Penelope Allen, BVT (F), CERA (P); David Nayagam, BI (P), BVT (F); Stephanie Epp, BVT (F); Chi Luu, BVT (F); Nick Barnes, BVT (F), Data 61Commonwealth Scientific and Industrial Research organisation (P); Maria Kolic, BVT (F); Kiera Young, BVT (F); Elizabeth Baglin, BVT (F); Carla Abbott, BVT (F); Robert Briggs, BVT (F); Jonathan Yeoh, BVT (F); William Kentler, BVT (F); Samuel Titchener, BVT (F); Matthew Petoe, BI (P), BVT (F); Chris Williams, Bionics Institute (P), BVT (F)
  • Footnotes
    Support  NHMRC 2015 Safety and efficacy of a surgically implanted suprachoroidal retinal prosthesis. Bionic Vision Technology 2018 44 Channel fully implnatable study. Victorian government infrastructure support.
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 4983. doi:https://doi.org/
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    • Get Citation

      Penelope J Allen, David AX Nayagam, Stephanie B Epp, Chi D Luu, Nick Barnes, Maria Kolic, Kiera A Young, Elizabeth Kate Baglin, Carla J Abbott, Robert Briggs, Jonathan Yeoh, William G Kentler, Samuel A Titchener, Matthew A Petoe, Chris E Williams; A 44 channel suprachoroidal retinal prosthesis : surgical approach, safety and stability.. Invest. Ophthalmol. Vis. Sci. 2019;60(9):4983. doi: https://doi.org/.

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

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Abstract

Purpose : The success of our prototype clinical trial (NCT01603576) of a suprachoroidal retinal prosthesis lead us to develop a 44 channel fully implantable device, with the aim of providing visual information to profoundly visually impaired patients, allowing them to utilise this device at home.

Methods : Four patients (P1, P2, P3 and P4) with end-stage rod - cone dystrophy and perception of light visual acuity were implanted with a 44 channel electrode array in the suprachoroidal space during 2018 (NCT03406416). After recovery they commenced stimulation of the device in the psychophysics laboratory.
Post operative follow-up included clinical examination, fundus photography and optical coherence tomography (OCT) to assess surgical recovery and impact on the eye.
OCT imaging was used to track the retinotopic location of the leading edge of the implant at weekly intervals. The translation and rotation of the array relative to baseline (1 week post-implantation) was calculated at 10 weeks post-implantation for all four patients, and also at 25 weeks post-implantation for P1 and P2.

Results : The surgical procedures took between 204 and 260 minutes and were uncomplicated. At the completion of surgery, impedance testing showed in all patients, all electrodes were functional. Post operative recovery was uneventful. Fundus imaging and OCT imaging confirmed the device position and the absence of retinal trauma. Fundus imaging showed movement only in P3.
OCT imaging showed some movement of the device and for P1, P2, and P3, movement was primarily rotational, while for P4 movement was primarily translational.
P1 - 10 weeks: 1.5°rotation clockwise, 19μm translation nasally; 25 weeks: 3.3° rotation clockwise, 52μm translation temporally. P2 - 10 weeks: 3.1° rotation clockwise, 38μm translation temporally; 25 weeks: 4.3° rotation clockwise, 4μm translation nasally. P3 – 10 weeks: 13° rotation anticlockwise, 112μm translation temporally. P4 – 10 weeks: 0.8° rotation anticlockwise 252μm translation temporally.

Conclusions : A 44 channel retinal prosthesis can be safely implanted in the suprachoroidal space. Over three – six months of follow-up clinical findings, fundus photography and OCT imaging confirm safety and stability of the approach with no serious adverse events and only slight movement on OCT imaging, which can be either rotational or translational or both. Only P3 had movement had significant movement in both dimensions.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

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