June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Passive safety outcomes of a preclinical 44-channel suprachoroidal retinal prosthesis
Author Affiliations & Notes
  • Carla J Abbott
    Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia
    Department of Surgery (Ophthalmology), University of Melbourne, East Melbourne, Victoria, Australia
  • Chi D Luu
    Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia
    Department of Surgery (Ophthalmology), University of Melbourne, East Melbourne, Victoria, Australia
  • David A.X. Nayagam
    Bionics Institute, East Melbourne, Victoria, Australia
    Department of Pathology, University of Melbourne, St Vincent's Hospital, Fitzroy, Victoria, Australia
  • Alice Brandli
    Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia
    Department of Surgery (Ophthalmology), University of Melbourne, East Melbourne, Victoria, Australia
  • Jonathan Yeoh
    Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia
    Department of Surgery (Ophthalmology), University of Melbourne, East Melbourne, Victoria, Australia
  • Joel Villalobos
    Bionics Institute, East Melbourne, Victoria, Australia
  • Owen Burns
    Bionics Institute, East Melbourne, Victoria, Australia
  • Stephanie B Epp
    Bionics Institute, East Melbourne, Victoria, Australia
  • Mohit Naresh Shivdasani
    Bionics Institute, East Melbourne, Victoria, Australia
    Medical Bionics Department, University of Melbourne, East Melbourne, Victoria, Australia
  • Patrick C. Thien
    Bionics Institute, East Melbourne, Victoria, Australia
    Medical Bionics Department, University of Melbourne, East Melbourne, Victoria, Australia
  • Ceara McGowan
    Bionics Institute, East Melbourne, Victoria, Australia
  • Richard Williams
    Department of Pathology, University of Melbourne, St Vincent's Hospital, Fitzroy, Victoria, Australia
    St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia
  • Robyn H Guymer
    Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia
    Department of Surgery (Ophthalmology), University of Melbourne, East Melbourne, Victoria, Australia
  • Chris E Williams
    Bionics Institute, East Melbourne, Victoria, Australia
    Medical Bionics Department, University of Melbourne, East Melbourne, Victoria, Australia
  • Robert K Shepherd
    Bionics Institute, East Melbourne, Victoria, Australia
    Medical Bionics Department, University of Melbourne, East Melbourne, Victoria, Australia
  • Penelope J Allen
    Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia
    Department of Surgery (Ophthalmology), University of Melbourne, East Melbourne, Victoria, Australia
  • Footnotes
    Commercial Relationships   Carla Abbott, None; Chi Luu, None; David Nayagam, None; Alice Brandli, None; Jonathan Yeoh, None; Joel Villalobos, Bionics Institute (P); Owen Burns, Bionics Institute (P); Stephanie Epp, None; Mohit Shivdasani, Bionics Institute (P); Patrick C. Thien, None; Ceara McGowan, None; Richard Williams, None; Robyn Guymer, None; Chris Williams, Bionics Institute (P); Robert Shepherd, None; Penelope Allen, Centre for Eye Research Australia (P)
  • Footnotes
    Support  ARC Special Research Initiative in Bionic Vision Science and Technology grant to Bionic Vision Australia; NHMRC grant 1082358 to CIA Dr Penny Allen. The Centre for Eye Research Australia and the Bionics Institute wish to acknowledge the support of the Victorian Government through its Operational Infrastructure Support Program.
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 4179. doi:
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    • Get Citation

      Carla J Abbott, Chi D Luu, David A.X. Nayagam, Alice Brandli, Jonathan Yeoh, Joel Villalobos, Owen Burns, Stephanie B Epp, Mohit Naresh Shivdasani, Patrick C. Thien, Ceara McGowan, Richard Williams, Robyn H Guymer, Chris E Williams, Robert K Shepherd, Penelope J Allen; Passive safety outcomes of a preclinical 44-channel suprachoroidal retinal prosthesis. Invest. Ophthalmol. Vis. Sci. 2017;58(8):4179.

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

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Abstract

Purpose : Following successful clinical outcomes of the prototype 24-channel suprachoroidal retinal prosthesis (SRP), an upgraded fully-implantable 44-channel SRP has recently been developed by Bionic Vision Australia. Our aim was to evaluate the surgical implantation safety and long-term conformability and stability of the 44-channel suprachoroidal electrode array in a large-eye model.

Methods : Eight normal-sighted felines were unilaterally implanted with an array containing platinum electrodes (44 stimulating and 2 returns) in a medical-grade silicone base. Assessments were conducted under anesthesia at baseline, then at 2-, 4-, 8-, 12- and 16-weeks post-surgery, including retinal trauma and implant position from color fundus photography, retinal structure, electrode-retina (ER) distance and conformability from spectral-domain optical coherence tomography, and retinal function from full-field electroretinograms.

Results : The array was positioned near the area centralis in all animals. Most animals showed no surgical trauma to the retina (5/8), no increase in ER distance over time (6/8; p>0.05, ANOVA), minimal (<1 disc diameter (DD)) lateral array movement (6/8), and good array conformability to the retinal curvature (7/8). There was minor surgical trauma in two animals with localized, mild retinal folds and tapetum thinning at the implant edge. One animal showed minor axial (100±32µm increase, p=0.0002, ANOVA) and lateral (1.7DD) array movement at 12-weeks that subsequently stabilized. There was major surgical trauma in one animal (device buckling due to a bulged choroid) with many overlying retinal folds and a large increase in ER distance (451±177μm, p<0.0001, ANOVA) from 2- to 8-weeks resulting in poor conformability. One animal had an infection at the implant anchor site (due to overlying conjunctival erosion) associated with a large lateral (3.7DD) movement at 4-weeks. All animals showed no further changes (than that seen due to surgery) in retinal structure between 2- and 16-weeks. There was no change in retinal function either over time or to control eyes (a-wave amplitude, p>0.05, ANOVA).

Conclusions : The array has an acceptable surgical safety, conformability and stability profile to proceed to clinical trial. The two major complications (due to bulged choroid and infection) are more likely in feline surgery than human due to choroidal and scleral anatomical differences.

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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