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Evaluate the Safety and Effectiveness of Electronic Vision-aid Device

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05968365
Enrollment
36
Registered
2023-08-01
Start date
2021-02-01
Completion date
2021-03-31
Last updated
2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the Blind

Brief summary

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

Interventions

DEVICEelectronic 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.

Sponsors

Wicab Technologies (Beijing) Co., Ltd.
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frameDescription
obstacle identification40 minutesThe success rate of obstacle identification

Secondary

MeasureTime frameDescription
obstacle avoidance test40 minutesthe success rate of obstacle avoidance

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026