Tongren Hospital
Beijing, Beijing Municipality, 066004, China
Completed
NCT Number: NCT05968365
Evaluate the Safety and Effectiveness of Electronic Vision-aid Device
To evaluate the safety and effectiveness of electronic Vision-aid Device in walking and obstacle recognition for visually blind people
Completed
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Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- . 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;
Treatment and study plan
electronic Vision-aid Device
DeviceElectronic 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.
Primary outcomes
-
obstacle identification
Time frame: 40 minutes
The success rate of obstacle identification
Secondary outcomes
-
obstacle avoidance test
Time frame: 40 minutes
the success rate of obstacle avoidance
Sponsors and collaborators
Lead sponsor
Wicab Technologies (Beijing) Co., Ltd.
Other
Registry information
Official study title
Clinical Trial of the Safety and Effectiveness of Vision Pro Electronic Blind Aid Device
Important dates
- Study start
- 2021
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Aug 1, 2023
- Registry last updated
- Aug 3, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.