Patients suffering from hereditary retinal degeneration receive a retinal implant to restore sight. Subretinal implant "ON" results in significant visual acuity improvement, when compared to "OFF" condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
39
Surgical implantation of medical device named "Retina Implant" into eye to restore vision partially. Randomized intra-individual implant activation in patient under test conditions such as: FrACT, BaLM, BaGA, maze, ADL.
Helmut Sachs, MD, PD
Dresden, Germany
Johann Roider, MD, Prof.
Kiel, Germany
Karl-Ulrich Bartz-Schmidt, MD, Prof.
Tübingen, Germany
Miklos Resch, MD, PhD
Budapest, Hungary
Activities of daily living and mobility significantly improve with implant-ON shown via activities of daily living tasks, recognition tasks, mobility, or a combination thereof.
Time frame: every 3 months for a period of one year
Visual acuity/light-perception and/or object-recognition are significantly improved with implant-ON versus OFF as shown via: FrACT/BaLM/BaGA/VFQ-25 or a combination thereof.
Time frame: every 3 months for a period of one year
Patient long term safety and stability of implant function
Time frame: every 3 months for a period of one year
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Timothy L Jackson, MB.ChB, PhD, FRCOphth
London, United Kingdom
Robert MacLaren, MD, Prof., DPhil DipEd FRCOphth FRCS
Oxford, United Kingdom