The outcome of this trial will reveal the possibilities of the retinal implant to improve the situation of patients with hereditary retinal blindness caused by degenerations of the outer retina. This pilot study will give important information on safety and efficacy of sub-retinal implants.
Although the design of the chip with a possible resolution of up to 1500 image points has the potential of providing object recognition, the quality of the image transmitted in this first human application cannot be foreseen. On the other hand clinical experience teaches us that even bare light recognition improves mobility of patients because of the ability to localize bright light sources such as windows or lamps.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Subretinal implant is either in ON or in OFF condition during test periods, such as FrACT, BaLM, grating, orientation \& mobility.
Eye Hospital Dresden-Friedrichstadt
Dresden, Germany
University Eye Hospital Tuebingen
Tübingen, Germany
Visual Acuity / Light-perception / Object-orientation are significantly improved with implant-ON versus OFF as shown via FrACT / BaLM / grating test (i.e. EFFICACY)
Time frame: within implantation period
Patient treatment shows acceptable results (i.e. SAFETY)
Time frame: within implantation period
Activities of Daily Living are significantly improved with implant-ON versus OFF, as shown via Tasks of Daily Living test / Orientation & Mobility test (i.e. EFFICACY)
Time frame: within implantation period
Non-acceptable surgical complications will terminate clinical study (i.e. SAFETY)
Time frame: within implantation period
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