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

NCT ID: NCT05615519

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-02

Study Completion Date

2023-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Strabismus Exotropia Esotropia Vertical Strabismus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Eligible participants for smartphone-based strabismus measurement and diagnosis

Facial videos dataset Facial videos were collected using smartphone and following the programmatic cover tests.

A new technology based on 3D reconstruction and deep learning algorithm to achieve an automatic diagnosis of strabismus based on patient-sourced videos of programmatic cover tests.

Intervention Type DIAGNOSTIC_TEST

Digital ruler of strabismus

Interventions

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A new technology based on 3D reconstruction and deep learning algorithm to achieve an automatic diagnosis of strabismus based on patient-sourced videos of programmatic cover tests.

Digital ruler of strabismus

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

The quality of facial videos should be clinically acceptable.
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haotian Lin

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haotian Lin, M.D., Ph.D

Role: CONTACT

8613802793086

Ruixin Wang, M.D., Ph.D

Role: CONTACT

8615360458084

Facility Contacts

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Haotian Lin, Ph.D

Role: primary

+86-020-87330274

Other Identifiers

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DRStrabismus2022

Identifier Type: -

Identifier Source: org_study_id

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