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Title: Safety Studies for a 44-Channel Suprachoroidal Retinal Prosthesis: A Chronic Passive Study
Authors: Abbott, Carla
Nayagam, David
Luu, Chi
Epp, Stephanie
Williams, Richard
Salinas-LaRosa, Cesar
Villalobos, Joel
McGowan, Ceara
Shivdasani, Mohit
Burns, Owen
Leavens, Jason
Yeoh, Jonathon
Brandli, Alice
Thien, Patrick
Zhou, Jenny
Feng, Helen
Williams, Chris
Shepherd, Robert
Allen, Penelope
Keywords: Retinal prosthesis
Optical coherence tomography
Retinal histology
Retinal safety
Issue Date: Mar-2018
Publisher: IOVS
Citation: Abbott, 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.
Abstract: Abstract 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.
URI: http://repository.bionicsinstitute.org:8080/handle/123456789/288
ISSN: 1552-5783
Appears in Collections:Bionic Vision Research Publications

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