Evaluate the Safety and Effectiveness of Electronic Vision-aid Device

July 31, 2023 updated by: Wicab Technologies (Beijing) Co., Ltd.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 066004
        • Tongren Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
obstacle identification
Time Frame: 40 minutes
The success rate of obstacle identification
40 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
obstacle avoidance test
Time Frame: 40 minutes
the success rate of obstacle avoidance
40 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wicab Technologies (Beijing) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • WKKJ-2020001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

ResMan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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