1. Subretinal Visual Implant Alpha IMS – Clinical trial interim report
- Author
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Dorothea Besch, Markus Groppe, Andrew Simpson, Charles L Cottriall, James D. Ramsden, James E. Neffendorf, David Wong, Helmut G. Sachs, Assen Koitschev, Katarina Stingl, Caroline Chee, Mohamed Adheem Naser Naeem, Robert E MacLaren, János Németh, Akos Kusnyerik, Tobias Peters, Karl Ulrich Bartz-Schmidt, Mandeep S. Singh, Barbara Wilhelm, Timothy L Jackson, Eberhart Zrenner, and Florian Gekeler
- Subjects
Adult ,Male ,Retinal degeneration ,medicine.medical_specialty ,Activities of daily living ,Visual acuity ,genetic structures ,Neuroprosthetics ,Motion Perception ,Visual Acuity ,Hereditary retinal diseases ,Blindness ,chemistry.chemical_compound ,Optics ,Photoreceptor degeneration ,Ophthalmology ,Activities of Daily Living ,Retinitis pigmentosa ,medicine ,Humans ,Artificial vision ,Aged ,Subretinal Implant Alpha IMS ,business.industry ,Retinal Degeneration ,Retinal ,Middle Aged ,medicine.disease ,Sensory Systems ,Electrodes, Implanted ,Form Perception ,Clinical trial ,chemistry ,Visual Perception ,Female ,Implant ,medicine.symptom ,business - 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 12months 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 3months.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.
- Published
- 2015
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