Evaluate the Safety and Effectiveness of Electronic Vision-aid Device

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and effectiveness of electronic Vision-aid Device in walking and obstacle recognition for visually blind people

Official Title
-----------------
Clinical Trial of the Safety and Effectiveness of Vision Pro Electronic Blind Aid Device

Conditions
-----------------
the Blind

Intervention / Treatment
-----------------
* Device: electronic Vision-aid Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 (including 18 and 65 years old)； Visually impaired people； Primary blind and visually impaired people visual acuity is no light   < 0.02； visual field radius less than 5°); Exclusion Criteria: . Allergic to nickel or stainless steel; epileptic seizures; 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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: electronic Vision-aid 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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| obstacle identification | The success rate of obstacle identification | 40 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| obstacle avoidance test | the success rate of obstacle avoidance | 40 minutes |