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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04892316
Other study ID # SFLV-2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 27, 2020
Est. completion date December 27, 2021

Study information

Verified date May 2021
Source Sun Yat-sen University
Contact Jianmin Hu, M.D., Ph.D.
Phone +8615359595888
Email doctorhjm@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

According to the WHO's definition of visual impairment, as of 2018, there were approximately 1.3 billion people with visual impairment in the world, and only 10% of countries can provide assisting services for the rehabilitation of visual impairment. Although China is one of the countries that can provide rehabilitation services for patients with visual impairment, due to restrictions on the number of professionals in various regions, uneven diagnosis and treatment, and regional differences in economic conditions, not all visually impaired patients can get the rehabilitation of assisting device fitting. Traditional statistical methods were not enough to solve the problem of intelligent fitting of assisting devices. At present, there are almost no intelligent fitting models of assisting devices in the world. Therefore, in order to allow more low-vision patients to receive accurate and rapid rehabilitation services, we conducted a cross-sectional study on the assisting devices fitting for low-vision patients in Fujian Province, China in the past five years, and at the same time constructed a machine learning model to intelligently predict the adaptation result of the basic assisting devices for low vision patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 27, 2021
Est. primary completion date July 27, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Years to 105 Years
Eligibility Inclusion Criteria: - Low vision - Aged 3 to 105 Exclusion Criteria: - Severe systemic disease - Failure to sign informed consent or unwilling to participate

Study Design


Intervention

Diagnostic Test:
Diagnostic test
The training dataset was used to train the model, which was validated and tested by the other two datasets.

Locations

Country Name City State
China 2nd Affilliated Hospital of Fujian Medical University Quanzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of fitting results for assisting devices The investigator will calculate the accuracy of fitting results for assisting devices in different group according to the ground truth. baseline
Secondary Time cost for fitting assisting devices The investigator will calculate time cost for fitting assisting devices in different group. baseline
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