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Subretinal Visual Implant Alpha IMS – Clinical trial interim report

2015/04/14 by Katarina Stingl, Katarína Štingl, Karl Ulrich Bartz-Schmidt +25 · 4 citations
Biochemistry, Genetics and Molecular Biology · Neuroscience · #Neuroscience and Neural Engineering #Photoreceptor and optogenetics research #Retinal Development and Disorders

paper · doi:10.1016/j.visres.2015.03.001

openalex publication_date 2015/04/14 · openalex created_date 2025/10/10 · openalex updated_date 2026/07/30

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.

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