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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05615519
Enrollment
300
Registered
2022-11-14
Start date
2022-12-02
Completion date
2023-04-01
Last updated
2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esotropia, Exotropia, Strabismus, Vertical Strabismus

Keywords

Mobile health, Artificaial intelligence medicine, Pediatric ophthalmology

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.

Interventions

DIAGNOSTIC_TESTA 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

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

The quality of facial videos should be clinically acceptable.

Design outcomes

Primary

MeasureTime frameDescription
The consistency between manual and smartphone measurementBaselineAgreement between the manual and automated tests was represented in Bland-Altman plots and concordance correlation coefficients.
The effectiveness of smartphone-based diagnosisBaselineThe accurate and the area under curve of the smartphone-based diagnosis.

Countries

China

Contacts

Primary ContactHaotian Lin, M.D., Ph.D
haot.lin@hotmail.com8613802793086
Backup ContactRuixin Wang, M.D., Ph.D
ruiruiw413@aliyun.com8615360458084

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026