First-in-human trial of a novel suprachoroidal retinal prosthesis

PLoS One. 2014 Dec 18;9(12):e115239. doi: 10.1371/journal.pone.0115239. eCollection 2014.

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.

Trial registration: Clinicaltrials.gov NCT01603576.

Publication types

  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Choroid / surgery
  • Female
  • Humans
  • Male
  • Middle Aged
  • Ophthalmologic Surgical Procedures / instrumentation*
  • Ophthalmologic Surgical Procedures / methods
  • Postoperative Complications
  • Retinitis Pigmentosa / surgery*
  • Sclera / surgery
  • Visual Prosthesis / adverse effects*

Associated data

  • ClinicalTrials.gov/NCT01603576

Grant support

This research was supported by the Australian Research Council (http://www.arc.gov.au) through its Special Research Initiative (SRI) in Bionic Vision Science and Technology grant to Bionic Vision Australia (BVA). The Centre for Eye Research Australia (CERA) and the Bionics Institute receive Operational Infrastructure Support from the Victorian Government. CERA is also supported by a NH&MRC Centre for Clinical Research Excellence (#529923) grant – Translational Clinical Research in Major Eye Diseases (https://www.nhmrc.gov.au). RG is supported by an NHMRC practitioner fellowship (#529905). NICTA is funded by the Australian Government through the Department of Communications and the Australian Research Council through the ICT Centre of Excellence Program (http://www.arc.gov.au/ncgp/centres/centres_nicta.htm). Additional support for this project came from the Ian Potter Foundation (http://www.ianpotter.org.au), John T. Reid Charitable Trusts (http://www.johntreidtrusts.com.au), Retina Australia (http://www.retinaaustralia.com.au) and the Bertalli Family Foundation (http://fbe.unimelb.edu.au/scholarships/opportunities/undergraduate/the_bertalli_family_foundation_scholarships). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.