Evaluate the Safety and Effectiveness of Electronic Vision-aid Device

Sponsor

Wicab Technologies (Beijing) Co., Ltd. (Other)

Overall Status

Completed

CT.gov ID

NCT05968365

Collaborator

(none)

Enrollment

Location

1.9

Actual Duration (Months)

18.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
the Blind	Device: electronic Vision-aid Device	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Actual Primary Completion Date :

Feb 1, 2021

Actual Study Completion Date :

Mar 31, 2021

Outcome Measures

Primary Outcome Measures

obstacle identification [40 minutes]
The success rate of obstacle identification

Secondary Outcome Measures

obstacle avoidance test [40 minutes]
the success rate of obstacle avoidance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongren Hospital	Beijing	Beijing	China	066004

Sponsors and Collaborators

Wicab Technologies (Beijing) Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wicab Technologies (Beijing) Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05968365

Other Study ID Numbers:

WKKJ-2020001

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 3, 2023

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 3, 2023