June 2020
Volume 61, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2020
A 44 channel suprachoroidal retinal prosthesis : interim safety and stability results for our 2 year clinical trial.
Author Affiliations & Notes
  • Penelope J Allen
    Bionic Eye Unit, Centre for Eye Research Australia, Melbourne, Victoria, Australia
    Surgery (Ophthalmology), University of Melbourne, Melbourne, Victoria, Australia
  • David Nayagam
    Bionics Institute, Melbourne, Victoria, Australia
    Pathology, University of Melbourne, Melbourne, Victoria, Australia
  • Stephanie Epp
    Bionics Institute, Melbourne, Victoria, Australia
  • Chi D Luu
    Bionic Eye Unit, Centre for Eye Research Australia, Melbourne, Victoria, Australia
    Surgery (Ophthalmology), University of Melbourne, Melbourne, Victoria, Australia
  • Nicholas Barnes
    Research School of Electrical, Energy and Materials Engineering, Australian National University, Canberra, Australian Capital Territory, Australia
  • Maria Kolic
    Bionic Eye Unit, Centre for Eye Research Australia, Melbourne, Victoria, Australia
    Surgery (Ophthalmology), University of Melbourne, Melbourne, Victoria, Australia
  • Elizabeth Kate Baglin
    Bionic Eye Unit, Centre for Eye Research Australia, Melbourne, Victoria, Australia
    Surgery (Ophthalmology), University of Melbourne, Melbourne, Victoria, Australia
  • Carla J Abbott
    Bionic Eye Unit, Centre for Eye Research Australia, Melbourne, Victoria, Australia
    Surgery (Ophthalmology), University of Melbourne, Melbourne, Victoria, Australia
  • Robert Briggs
    Otolaryngology, University of Melbourne, Melbourne, Victoria, Australia
  • Jonathan Yeoh
    Bionic Eye Unit, Centre for Eye Research Australia, Melbourne, Victoria, Australia
  • William Kentler
    School of Engineering, University of Melbourne, Melbourne, Victoria, Australia
  • Jessica Kvansakul
    Bionics Institute, Melbourne, Victoria, Australia
  • Sam Titchener
    Bionics Institute, Melbourne, Victoria, Australia
  • Matthew A Petoe
    Bionics Institute, Melbourne, Victoria, Australia
  • Christopher E Williams
    Bionics Institute, 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); Nicholas Barnes, ANU (P), BVT (F); Maria Kolic, BVT (F); Elizabeth Baglin, BVT (F); Carla Abbott, BVT (F); Robert Briggs, BVT (F); Jonathan Yeoh, BVT (F); William Kentler, BVT (F); Jessica Kvansakul, BVT (F); Sam Titchener, BVT (F); Matthew Petoe, BI (P), BVT (F); Christopher Williams, BI (P), BVT (F)
  • Footnotes
    Support  NHMRC grant 1082358
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 2200. doi:
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      Penelope J Allen, David Nayagam, Stephanie Epp, Chi D Luu, Nicholas Barnes, Maria Kolic, Elizabeth Kate Baglin, Carla J Abbott, Robert Briggs, Jonathan Yeoh, William Kentler, Jessica Kvansakul, Sam Titchener, Matthew A Petoe, Christopher E Williams; A 44 channel suprachoroidal retinal prosthesis : interim safety and stability results for our 2 year clinical trial.. Invest. Ophthalmol. Vis. Sci. 2020;61(7):2200.

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

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Abstract

Purpose : The success of our prototype clinical trial of a suprachoroidal retinal prosthesis led us to develop a second generation fully implantable device, with the aim of providing visual information to profoundly visually impaired patients to aid their navigation and daily visual tasks in the home environment.

Methods : Four patients (P 1 - 4) with rod - cone dystrophy and perception of light visual acuity were implanted with a 44 channel electrode array in the suprachoroidal space during 2018 (NCT03406416).
Post operative follow-up included clinical examination, fundus photography and optical coherence tomography (OCT) to assess recovery.
OCT imaging was used to track the retinotopic location of the leading edge of the implant. The translation and rotation of the array relative to baseline (1 week post-implantation) was calculated at 63 weeks post-implantation for all four patients, and also at 73 weeks for P1 and 78 weeks for P2, the time points reached thus far by the participants.

Results :
The surgical procedures were uncomplicated. Post operative recovery was uneventful. Fundus imaging and OCT imaging confirmed the device position and the absence of retinal trauma.
OCT imaging showed some movement of the device in the early post operative period.
P1 – had early rotational movement of 3°, after week 30 this has remained stable. Translation temporally has been minimal. P2 - had 4.3° rotation clockwise once again early but after week 30 is stable with minimal translation nasally. P3 – had significant rotational movement (up to 17° ) until week 16 anticlockwise, which subsequently settled and remained stable. Translation temporally also occurred early and settled. P4 – developed 7.0° rotation anticlockwise between weeks 10-25 which settled to 1° and stabilised to week 63. Translation temporally has been minimal also.
All four patients have had reliable improvements in orientation and mobility and activities of daily living tasks and continue to demonstrate improved functionality with unsupervised use.

Conclusions :
A 44 channel retinal prosthesis can be safely implanted in the suprachoroidal space. Fundus photography and OCT imaging confirm safety and stability of the approach after the initial settling period. The safety and stability of the approach makes this an excellent option for retinal prosthesis surgery and the device offers positive functional benefits to our patients.

This is a 2020 ARVO Annual Meeting abstract.

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