title: First-in-human trial of a novel suprachoroidal retinal prosthesis.
abstract: 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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01603576.
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.
authors.forename: Lauren N
authors.initials: LN
authors.lastname: Ayton
authors.affiliation: Bionics Institute, East Melbourne, Australia; Department of Medical Bionics, University of Melbourne, East Melbourne, Australia.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Blamey
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.
authors.forename: Robyn H
authors.initials: RH
authors.lastname: Guymer
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.
authors.forename: Chi D
authors.initials: CD
authors.lastname: Luu
authors.affiliation: Bionics Institute, East Melbourne, Australia; Department of Pathology, University of Melbourne, St Vincent's Hospital Melbourne, Fitzroy, Australia.
authors.forename: David A X
authors.initials: DA
authors.lastname: Nayagam
authors.affiliation: Bionics Institute, East Melbourne, Australia.
authors.forename: Nicholas C
authors.initials: NC
authors.lastname: Sinclair
authors.affiliation: Bionics Institute, East Melbourne, Australia; Department of Medical Bionics, University of Melbourne, East Melbourne, Australia.
authors.forename: Mohit N
authors.initials: MN
authors.lastname: Shivdasani
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Yeoh
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.
authors.forename: Mark F
authors.initials: MF
authors.lastname: McCombe
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Briggs
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.
authors.forename: Nicholas L
authors.initials: NL
authors.lastname: Opie
authors.affiliation: Bionics Institute, East Melbourne, Australia.
authors.forename: Joel
authors.initials: J
authors.lastname: Villalobos
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.
authors.forename: Peter N
authors.initials: PN
authors.lastname: Dimitrov
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.
authors.forename: Mary
authors.initials: M
authors.lastname: Varsamidis
authors.affiliation: Bionics Institute, East Melbourne, Australia.
authors.forename: Matthew A
authors.initials: MA
authors.lastname: Petoe
authors.affiliation: NICTA, Computer Vision Research Group, Canberra, Australia; National Institute for Mental Health Research, Australian National University, Canberra, Australia.
authors.forename: Chris D
authors.initials: CD
authors.lastname: McCarthy
authors.affiliation: NICTA, Computer Vision Research Group, Canberra, Australia; National Institute for Mental Health Research, Australian National University, Canberra, Australia.
authors.forename: Janine G
authors.initials: JG
authors.lastname: Walker
authors.affiliation: NICTA, Computer Vision Research Group, Canberra, Australia; National Institute for Mental Health Research, Australian National University, Canberra, Australia.
authors.forename: Nick
authors.initials: N
authors.lastname: Barnes
authors.affiliation: Bionics Institute, East Melbourne, Australia; Centre for Neural Engineering, University of Melbourne, National Information and Communications Technology Australia (NICTA), Ltd., Melbourne, Australia.
authors.forename: Anthony N
authors.initials: AN
authors.lastname: Burkitt
authors.affiliation: Bionics Institute, East Melbourne, Australia.
authors.forename: Chris E
authors.initials: CE
authors.lastname: Williams
authors.affiliation: Bionics Institute, East Melbourne, Australia; Department of Medical Bionics, University of Melbourne, East Melbourne, Australia.
authors.forename: Robert K
authors.initials: RK
authors.lastname: Shepherd
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.
authors.forename: Penelope J
authors.initials: PJ
authors.lastname: Allen
mesh_terms: D002829:Choroid / Q000601:surgery; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013508:Ophthalmologic Surgical Procedures / Q000295:instrumentation* / Q000379:methods; D011183:Postoperative Complications; D012174:Retinitis Pigmentosa / Q000601:surgery*; D012590:Sclera / Q000601:surgery; D057488:Visual Prosthesis / Q000009:adverse effects*