Evaluate the Safety and Effectiveness of Electronic Vision-aid Device

Not Applicable

Completed

• Conditions: the Blind

• Registration Number: NCT05968365
• Lead Sponsor: Wicab Technologies (Beijing) Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-03-31
• Status Verified: 2021-12
• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-07-20
• Last Update Submitted: 2023-07-31
• Study First Posted: 2023-08-01
• Last Update Posted: 2023-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
obstacle identification	40 minutes	The success rate of obstacle identification

Secondary Outcome Measures

Name	Time	Method
obstacle avoidance test	40 minutes	the success rate of obstacle avoidance

Trial Locations

Locations (1)

Tongren Hospital; 🇨🇳 Beijing, Beijing, China