NCT04892316

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2021

Completed
Last Updated

May 20, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

May 17, 2021

Last Update Submit

May 19, 2021

Conditions

Keywords

Artificial IntelligenceLow Vision

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Time cost for fitting assisting devices

    baseline

Study Arms (3)

Junior doctor group

Patients receive assisting devices fitting services from junior doctors

Diagnostic Test: Diagnostic test

Senior doctor group

Patients receive assisting devices fitting services from senior doctors

Diagnostic Test: Diagnostic test

Algorithm assisted group

Patients receive assisting devices fitting services from junior doctors assisted by the machine learning model

Diagnostic Test: Diagnostic test

Interventions

Diagnostic testDIAGNOSTIC_TEST

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

Algorithm assisted groupJunior doctor groupSenior doctor group

Eligibility Criteria

Age3 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Visually disabled patients were referred by the Town Disability Federation in Fujian Province and Guangdong Province

You may qualify if:

  • Low vision
  • Aged 3 to 105

You may not qualify if:

  • Severe systemic disease
  • Failure to sign informed consent or unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affilliated Hospital of Fujian Medical University

Quanzhou, Fujian, 362000, China

RECRUITING

MeSH Terms

Conditions

Vision, Low

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Jianmin Hu, M.D., Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 19, 2021

Study Start

July 27, 2020

Primary Completion

July 27, 2021

Study Completion

December 27, 2021

Last Updated

May 20, 2021

Record last verified: 2021-05

Locations