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To evaluate the safety and effectiveness of electronic Vision-aid Device in walking and obstacle recognition for visually blind people
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electronic Vision-aid Device | Device | Electronic blind aid is a non-invasive electronic aid product for the visually impaired. The product converts visual signals into tactile signals. The Vision Pro is designed for people with poor or no visual perception. The product does not change the previous travel mode of the visually impaired, and provides additional external information for the visually impaired on the basis of their existing cognition. The product can provide the visually impaired person with additional external information based on the cognition in front of them. The product can feedback the environmental information within 2.52.5 meters in front of the visually impaired person in the form of electrical stimulation to the visually impaired person. The visually impaired person can be stimulated by the tongue current to help them identify obstacles and give early warning. Avoid obstacles and give early warning. |
| Measure | Description | Time Frame |
|---|---|---|
| obstacle identification | The success rate of obstacle identification | 40 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| obstacle avoidance test | the success rate of obstacle avoidance | 40 minutes |
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Inclusion Criteria:
Exclusion Criteria:
5、 intellectual disability ； 6、 mental illness; 7、 Oral diseases； 8、oral ulcers, herpes, herpes simplex, oral thrush and map tongue； 9、 speech dysfunction, 10、limited mobility and hearing impairment;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongren Hospital | Beijing | Beijing Municipality | 066004 | China |
ResMan
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The clinical trial was a prospective, single-group, uncontrolled design using the target value method
Three centers participated
A total of 36 patients were enrolled. It was developed and produced by Weikan Technology in subjects who agreed to be enrolled
The "Vision Pro" is trained, and after no less than 3 hours of training, the subject is good at it
Evaluate the safety and effectiveness of obstacle perception and recognition in the process of walking, and evaluate the test product in auxiliary sight
Safety and effectiveness of obstacle perception and recognition for disabled walkers.
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