the BlindNCT05968365
Evaluate the Safety and Effectiveness of Electronic Vision-aid Device
A study testing electronic Vision-aid Device in people with the Blind, run by Wicab Technologies (Beijing) Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and effectiveness of electronic Vision-aid Device in walking and obstacle recognition for visually blind people Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- the Blind
- What is being tested?
- electronic Vision-aid Device
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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°);
Who cannot join
- . 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of the Safety and Effectiveness of Vision Pro Electronic Blind Aid Device
To evaluate the safety and effectiveness of electronic Vision-aid Device in walking and obstacle recognition for visually blind people
- Conditions
- the Blind
- Being tested
- electronic Vision-aid Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic Vision-aid DeviceDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
obstacle identification
The success rate of obstacle identification
Measured: 40 minutes
Secondary outcomes (1)
obstacle avoidance test
the success rate of obstacle avoidance
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Feb 2021
- Primary completion1 Feb 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the BlindStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wicab Technologies (Beijing) Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968365
- Sponsor's protocol ID
- WKKJ-2020001
- Status last verified
- Dec 2021
- First submitted
- 20 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ResMan
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of the Safety and Effectiveness of Vision Pro Electronic Blind Aid Device
- ClinicalTrials.gov ID
- NCT05968365
- Acronym / sponsor ID
- WKKJ-2020001
- Conditions
- the Blind
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Wicab Technologies (Beijing) Co., Ltd.University, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and effectiveness of electronic Vision-aid Device in walking and obstacle recognition for visually blind people
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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.
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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°);
Key exclusion criteria (4 listed)
- . 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic Vision-aid 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. | Device | – |
Primary outcome
obstacle identification
Time frame: 40 minutes
The success rate of obstacle identification
1 secondary outcome
obstacle avoidance test
Time frame: 40 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No. ResMan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic Vision-aid Device in people with the Blind, run by Wicab Technologies (Beijing) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
obstacle identification (time frame: 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.