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Clinical Trials/NCT05615519
NCT05615519
Recruiting
Not Applicable

Validation of a Smartphone-based Intelligent Diagnosis and Measurement for Strabismus

Sun Yat-sen University1 site in 1 country300 target enrollmentDecember 2, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Strabismus
Sponsor
Sun Yat-sen University
Enrollment
300
Locations
1
Primary Endpoint
The effectiveness of smartphone-based diagnosis
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The current measurement methods of strabismus include the corneal light reflection method, prism alternate covering, etc., which especially rely on the subjective experience of doctors, and there is a large error between different measurers, leading to serious underestimation of strabismus prevalence and insufficient care for strabismus patients. Here, the investigators established and validated an artificial intelligence system to achieve an automatic diagnosis of strabismus based on patient-sourced videos of programmatic cover tests. Three-dimensional reconstruction methods are used to digitize the parameters of head and eye positions. This system has been integrated into a smartphone platform to be further validated through hospital-based and population-based clinical trials.

Registry
clinicaltrials.gov
Start Date
December 2, 2022
End Date
April 1, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Haotian Lin

Clinical Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • The quality of facial videos should be clinically acceptable.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The effectiveness of smartphone-based diagnosis

Time Frame: Baseline

The accurate and the area under curve of the smartphone-based diagnosis.

The consistency between manual and smartphone measurement

Time Frame: Baseline

Agreement between the manual and automated tests was represented in Bland-Altman plots and concordance correlation coefficients.

Study Sites (1)

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