In this early feasibility trial the safety and performance of the new retinal prothesis PRIMA is tested in five subjects suffering from atrophic dry age related macular degeneration.
PRIMA is a new photovoltaic sub-retinal wireless prosthesis for partial restoration of visual perception in patients with vision loss from atrophic dry Age-related Macular Degeneration. The implantable part of the device is placed under the retina. A mini camera mounted on a pair of glasses captures the visual scene in the environment. The visual scene is processed and simplified by the pocket computer connected to the glasses in order to extract useful information from the images. The simplified images are then sent back to the glasses where a miniaturized projector then projects the processed images wirelessly via pulses of near infrared light on the PRIMA implant at the back of the eye under the retina. The photovoltaic cells convert this optical information into electrical stimulation to excite the nerve cells of the retina and induce visual perception. In this early feasibility study five human subjects suffering from atrophic dry age related macular degeneration will receive the implant. The performance and the safety of the device will be monitored for up to 36 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Implantation of PRIMA device
Byers Eye Institute-Stanford University
Palo Alto, California, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
UPMC Eye Center
Pittsburgh, Pennsylvania, United States
Near Visual Acuity
Near Visual acuity measured by FrACT
Time frame: 12 months after implantation
Near Visual Acuity
Near Visual acuity measured by FrACT
Time frame: 3, 6, 9, 18, 24, and 36 months after implantation
Visual Acuity
Visual acuity measured by ETDRS
Time frame: 3, 6, 9, 12, 18, 24 and 36 months after implantation
Reading Acuity Test
Reading acuity measured by Radner Charts
Time frame: 6, 12, 24, 36 months after implantation
Quality of Life
The change in quality of life is measure by the Impact of Vision Impairment (IVI) Questionnaire
Time frame: 12, 24, and 36 months after implantation
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