Evaluate the Safety and Effectiveness of Electronic Vision-aid Device

NCT ID: NCT05968365

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-03-31

Brief Summary

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

Conditions

the Blind

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wicab Technologies (Beijing) Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tongren Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

WKKJ-2020001

Identifier Type: -

Identifier Source: org_study_id