Status:
COMPLETED
Evaluate the Safety and Effectiveness of Electronic Vision-aid Device
Lead Sponsor:
Wicab Technologies (Beijing) Co., Ltd.
Conditions:
the Blind
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
To evaluate the safety and effectiveness of electronic Vision-aid Device in walking and obstacle recognition for visually blind people
Eligibility Criteria
Inclusion
- 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
- . 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;
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05968365
Start Date
February 1 2021
End Date
March 31 2021
Last Update
August 3 2023
Active Locations (1)
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1
Tongren Hospital
Beijing, Beijing Municipality, China, 066004