Subretinal Visual Implant Alpha IMS - Clinical trial interim report

Katarina Stingl, Karl Ulrich Bartz-Schmidt, Dorothea Besch, Caroline K. Chee, Charles L. Cottriall, Florian Gekeler, Markus Groppe, Timothy L. Jackson, Robert E. MacLaren, Assen Koitschev, Akos Kusnyerik, James Neffendorf, Janos Nemeth, Mohamed Adheem Naser Naeem, Tobias Peters, James D. Ramsden, Helmut Sachs, Andrew Simpson, Mandeep S. Singh, Barbara WilhelmDavid Wong, Eberhart Zrenner

Research output: Contribution to journalArticlepeer-review

Abstract

A subretinal visual implant (Alpha IMS, Retina Implant AG, Reutlingen, Germany) was implanted in 29 blind participants with outer retinal degeneration in an international multicenter clinical trial. Primary efficacy endpoints of the study protocol were a significant improvement of activities of daily living and mobility to be assessed by activities of daily living tasks, recognition tasks, mobility, or a combination thereof. Secondary efficacy endpoints were a significant improvement of visual acuity/light perception and/or object recognition (clinicaltrials.gov, NCT01024803).During up to 12. months observation time twenty-one participants (72%) reached the primary endpoints, of which thirteen participants (45%) reported restoration of visual function which they use in daily life. Additionally, detection, localization, and identification of objects were significantly better with the implant power switched on in the first 3 months. Twenty-five participants (86%) reached the secondary endpoints. Measurable grating acuity was up to 3.3 cycles per degree, visual acuities using standardized Landolt C-rings were 20/2000, 20/2000, 20/606 and 20/546. Maximal correct motion perception ranged from 3 to 35 degrees per second. These results show that subretinal implants can restore very-low-vision or low vision in blind (light perception or less) patients with end-stage hereditary retinal degenerations.

Original languageEnglish (US)
Pages (from-to)149-160
Number of pages12
JournalVision Research
Volume111
DOIs
StatePublished - Jun 1 2015
Externally publishedYes

Keywords

  • Artificial vision
  • Hereditary retinal diseases
  • Neuroprosthetics
  • Photoreceptor degeneration
  • Retinitis pigmentosa
  • Subretinal Implant Alpha IMS

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems

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