Evaluate the Safety and Effectiveness of Electronic Vision-aid Device

Wicab Technologies (Beijing) Co., Ltd.

Status: Completed

Conditions: the Blind

Treatments: Device: electronic Vision-aid Device

Study type: Interventional

Funder types: Other

Identifiers

NCT05968365

WKKJ-2020001

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)