the Blind
Conditions
Brief summary
To evaluate the safety and effectiveness of electronic Vision-aid Device in walking and obstacle recognition for visually blind people
Interventions
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.
Sponsors
Study design
Intervention model description
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.
Eligibility
Inclusion criteria
1. Age 18-65 (including 18 and 65 years old); 2. Visually impaired people; 3. Primary blind and visually impaired people 4. visual acuity is no light \ \< 0.02; 5. visual field radius less than 5°);
Exclusion criteria
1. . Allergic to nickel or stainless steel; 2. epileptic seizures; 3. pregnant women; 4.、implanted with electronic medical devices ; 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| obstacle identification | 40 minutes | The success rate of obstacle identification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| obstacle avoidance test | 40 minutes | the success rate of obstacle avoidance |
Countries
China