Pilot Study for the Development of a Cortical Visual Neuroprosthesis for the Blind Based on Intracortical Microelectrodes

What this Trial Is About

Researchers are evaluating a cortical visual prosthesis that uses intracortical microelectrodes to provide a limited but useful sense of vision to people who are profoundly blind. This pilot study aims to gather important information about the safety and effectiveness of this neuroprosthetic device, which may help restore some vision when the communication between the eye and brain is lost due to conditions like glaucoma or optic nerve damage. Visual prostheses offer hope to those with blindness caused by retinal or nerve damage where other treatments have limited success. The study involves implanting the CORTIVIS vision neuroprosthetic system, which uses an FDA-cleared microelectrode array, into blind volunteers through a minimally invasive surgical procedure called a minicraniotomy. The array is placed near the occipital pole or other visual areas of the brain. Researchers will collect feedback on the electrical stimulation that produces visual perceptions and investigate if participants can learn to interpret these signals into meaningful patterns that aid in recognizing and locating objects or navigating environments. Participants will be monitored during the post-surgical period in hospital rooms and psychophysical laboratories. The study will measure thresholds for visual perceptions, map visual phosphenes, assess visual acuity, motion perception, and overall visual function over up to six months. Safety is closely monitored by tracking adverse events. The trial aims to improve quality of life by enabling blind individuals to gain some functional vision through this neuroprosthetic system.

Development of a Cortical Visual Neuroprosthesis for the Blind