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A prospective study to evaluate the safety and effectiveness of electronic Vision-aid Device in walking and obstacle recognition for visually blind people

Clinical trial of the safety and effectiveness of Vision Pro electronic blind aid Device

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071636
Enrollment
Unknown
Registered
2023-05-19
Start date
2021-02-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

blind person

Interventions

test group:use a braint-port device

Sponsors

Beijing Tongren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 (including 18 and 65 years old), regardless of gender; 2. Primary blind and visually impaired people (visual acuity is no light ~ < 0.02; Or visual field radius less than 5°); 3. The subjects voluntarily participate in the experiment and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Known symptoms of neuropathy in the tactile system of the tongue or skin; 2. Allergic to nickel or stainless steel; 3. History of epilepsy or epileptic seizures; 4. Lactating or pregnant women or those who plan to become pregnant recently; 5. Personnel implanted with electronic medical devices (such as pacemakers, deep brain stimulators, cochlear implants, etc.); 6. Cognitive decline, including various forms of intellectual disability and/or mental illness; 7. Oral diseases (oral ulcers, herpes, herpes simplex, oral thrush and map tongue); 8. People with speech dysfunction, limited mobility and hearing impairment; 9. Other conditions for which the investigator deems it inappropriate to participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
The success rate of obstacle identification;the success rate of over the obstacle;

Secondary

MeasureTime frame
Tongue pain score;Device satisfaction score;

Countries

China

Contacts

Public ContactWang Ningli

Beijing Tongren Hospital

miriam0452@126.com+86 10 5826 5922

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026