Evaluation of the Efficacy of an Assistive Device for Blind People: A Prospective, Non-Randomized, Single Arm, and Open Label Clinical Trial.

Purpose: To evaluate the efficacy of an assistive device (BrainPort^® Vision Pro) for blind people in object recognition and orientation-and-mobility.

Methods: This prospective, single arm, and open label clinical trial enrolled 24 participants who had profound visual impairment (visual acuity < 1/60 and/or visual field constriction <5°). After a three-hour training of BrainPort Vision Pro device instruction, participants were instructed to perform functional tasks including an assistive walking program and object recognition project. Five chances were given for each task, and success was defined as correctly completing at least three times. Success rates were used to evaluate the effectiveness of the device.

Results: The success rates of participants wearing the device were significantly higher for both orientation-and-mobility task and objects/place-setting recognition tasks, compared to those without the aid. Device-related adverse events did not occur throughout the study.

Conclusion: This is the first attempt to evaluate the efficacy of the BrainPort Vision Pro for blind people in China. It is shown as a viable assistive device for blind individuals to directly interact with their environments through a real perception from tongue stimulation, without remarkable side effects in the current study. With the advancement and popularization, more blind people will have access to and benefit from the BrainPort Vision Pro in the future.