Biomedical Engineering - Research Publications

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First-in-Human Trial of a Novel Suprachoroidal Retinal Prosthesis

Ayton, LN ; Blamey, PJ ; Guymer, RH ; Luu, CD ; Nayagam, DAX ; Sinclair, NC ; Shivdasani, MN ; Yeoh, J ; McCombe, MF ; Briggs, RJ ; Opie, NL ; Villalobos, J ; Dimitrov, PN ; Varsamidis, M ; Petoe, MA ; McCarthy, CD ; Walker, JG ; Barnes, N ; Burkitt, AN ; Williams, CE ; Shepherd, RK ; Allen, PJ ; Mori, K (PUBLIC LIBRARY SCIENCE, 2014-12-18)

UNLABELLED: Retinal visual prostheses ("bionic eyes") have the potential to restore vision to blind or profoundly vision-impaired patients. The medical bionic technology used to design, manufacture and implant such prostheses is still in its relative infancy, with various technologies and surgical approaches being evaluated. We hypothesised that a suprachoroidal implant location (between the sclera and choroid of the eye) would provide significant surgical and safety benefits for patients, allowing them to maintain preoperative residual vision as well as gaining prosthetic vision input from the device. This report details the first-in-human Phase 1 trial to investigate the use of retinal implants in the suprachoroidal space in three human subjects with end-stage retinitis pigmentosa. The success of the suprachoroidal surgical approach and its associated safety benefits, coupled with twelve-month post-operative efficacy data, holds promise for the field of vision restoration. TRIAL REGISTRATION: Clinicaltrials.gov NCT01603576.