Safety Studies for a 44-Channel Suprachoroidal Retinal Prosthesis: A Chronic Passive Study

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dc.contributor.authorAbbott, Carla
dc.contributor.authorNayagam, David
dc.contributor.authorLuu, Chi
dc.contributor.authorEpp, Stephanie
dc.contributor.authorWilliams, Richard
dc.contributor.authorSalinas-LaRosa, Cesar
dc.contributor.authorVillalobos, Joel
dc.contributor.authorMcGowan, Ceara
dc.contributor.authorShivdasani, Mohit
dc.contributor.authorBurns, Owen
dc.contributor.authorLeavens, Jason
dc.contributor.authorYeoh, Jonathon
dc.contributor.authorBrandli, Alice
dc.contributor.authorThien, Patrick
dc.contributor.authorZhou, Jenny
dc.contributor.authorFeng, Helen
dc.contributor.authorWilliams, Chris
dc.contributor.authorShepherd, Robert
dc.contributor.authorAllen, Penelope
dc.date.accessioned2018-03-20T03:45:24Z
dc.date.available2018-03-20T03:45:24Z
dc.date.issued2018-03
dc.description.abstractAbstract Purpose: Following successful clinical outcomes of the prototype suprachoroidal retinal prosthesis, Bionic Vision Australia has developed an upgraded 44-channel suprachoroidal retinal prosthesis to provide a wider field of view and more phosphenes. The aim was to evaluate the preclinical passive safety characteristics of the upgraded electrode array. Methods: Ten normal-sighted felines were unilaterally implanted with an array containing platinum electrodes (44 stimulating and 2 returns) on a silicone carrier near the area centralis. Clinical assessments (color fundus photos, optical coherence tomography, full-field electroretinography, intraocular pressure) were performed under anesthesia prior to surgery, and longitudinally for up to 20 weeks. Histopathology grading of fibrosis and inflammation was performed in two animals at 13 to 15 weeks. Results: Eight animals showed safe electrode array insertion (good retinal health) and good conformability of the array to the retinal curvature. Eight animals demonstrated good mechanical stability of the array with only minor (<2 disc diameters) lateral movement. Four cases of surgical or stability complications occurred due to (1) bulged choroid during surgery, (2) hemorrhage from a systemic bleeding disorder, (3) infection, and (4) partial erosion of thin posterior sclera. There was no change in retinal structure or function (other than that seen at surgery) at endpoint. Histopathology showed a mild foreign body response. Electrodes were intact on electrode array removal. Conclusions: The 44-channel suprachoroidal electrode array has an acceptable passive safety profile to proceed to clinical trial. The safety profile is expected to improve in human studies, as the complications seen are specific to imitations (anatomic differences) with the feline model.en_US
dc.description.sponsorshipSupported by the ARC Special Research Initiative in Bionic Vision Science and Technology grant to Bionic Vision Australia (RKS; Canberra, ACT, Australia); National Health and Medical Research Council (NHMRC) Grant 1082358 (PJA; Canberra, ACT, Australia); NHMRC Grant 1063093 (MNS). The Bionics Institute and the Centre for Eye Research Australia wish to acknowledge the support of the Victorian Government through its Operational Infrastructure Support Program (VIC, Australia).en_US
dc.identifier.citationAbbott, Carla J., David A. X. Nayagam, Chi D. Luu, Stephanie B. Epp, Richard A. Williams, Cesar M. Salinas-LaRosa, Joel Villalobos, Ceara McGowan, Mohit N. Shivdasani, Owen Burns, Jason Leavens, Jonathan Yeoh, Alice A. Brandli, Patrick C. Thien, Jenny Zhou, Helen Feng, Chris E. Williams, Robert K. Shepherd, and Penelope J. Allen. 2018. Safety Studies for a 44-Channel Suprachoroidal Retinal Prosthesis: A Chronic Passive Study. Investigative Ophthalmology & Visual Science. 59(3): 1410-1424.en_US
dc.identifier.issn1552-5783
dc.identifier.urihttp://repository.bionicsinstitute.org:8080/handle/123456789/288
dc.language.isoenen_US
dc.publisherIOVSen_US
dc.subjectRetinal prosthesisen_US
dc.subjectOptical coherence tomographyen_US
dc.subjectElectroretinographyen_US
dc.subjectRetinal histologyen_US
dc.subjectRetinal safetyen_US
dc.titleSafety Studies for a 44-Channel Suprachoroidal Retinal Prosthesis: A Chronic Passive Studyen_US
dc.typeArticleen_US
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