Electronic Retinal Prosthesis for Severe Loss of Vision in Geographic Atrophy in Age-Related Macular Degeneration: First-in-Human Use

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Author(s)

  • Paulo Stanga
  • Emmanouil Tsamis
  • Irene Siso-Fuertes
  • Jessy Dorn
  • Francesco Merlini
  • Andy Fisher
  • Fiona Crawford
  • Shakti Kasbia
  • Alessandro Papayannis
  • Heidi Baseler
  • Antony Morland
  • Rachel L W Hanson
  • Mark Humayun
  • Robert Greenberg

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Publication details

JournalEuropean Journal of Ophthalmology
DateAccepted/In press - 18 Jan 2021
DateE-pub ahead of print (current) - 18 Mar 2021
Early online date18/03/21
Original languageEnglish

Abstract

BACKGROUND: To date there are yet no available approved therapies for Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD).
METHODS: Single site, non-randomized safety and efficacy study presenting the preliminary results in a cohort of five late stage AMD (GA) patients successfully implanted with the Argus II Retinal Prosthesis System (Second Sight Medical Products Inc., Sylmar, California, USA). Extensive fundus imaging including retinal photographs from which the GA area was measured. A combination of custom and traditional tests designed for very low vision subjects assessed visual function in study subjects. A Functional Low-Vision Observer Rated Assessment was carried out to evaluate the impact of the system on the subject’s daily life. In addition, a study to evaluate structural characteristics of the visual cortex of the brain was performed in one subject using magnetic resonance imaging.
RESULTS: 7 device-related adverse events were reported, 4 of which were classed as serious adverse events. Retinal detachment was reported in 3 patients and was successfully treated within 12 months of onset. Testing showed an improvement in visual function in 3 of 5 patients with the system turned on. Magnetic resonance imaging assessed in one patient after implantation indicates a selective increase in cortical myelin and thickness in visual brain regions one year post implantation.
CONCLUSIONS: Epiretinal prostheses can successfully be implanted in those affected by GA secondary to late-stage AMD and can elicit visual percepts by electrical stimulation of residual neuroretinal elements and improve basic visual function in those affected.

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