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Status unknownNCT05615519Updated Dec 5, 2022

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

An observational study in Strabismus, Exotropia and Esotropia, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-05.

Sponsored by Sun Yat-sen University · Observational

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
3 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Strabismus
  • Exotropia
  • Esotropia
  • Vertical Strabismus

Keywords

  • Mobile health
  • Artificaial intelligence medicine
  • Pediatric ophthalmology
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Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Outpatients from strabismus \& optometry departments or participants from the internet.

Eligibility criteria

Inclusion Criteria:

The quality of facial videos should be clinically acceptable.

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Eligible participants for smartphone-based strabismus measurement and diagnosis

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

    Diagnostic Test: 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.

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

05

What researchers measure

Primary outcomes

  1. The effectiveness of smartphone-based diagnosis

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

    Time frame: Baseline

  2. The consistency between manual and smartphone measurement

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

    Time frame: Baseline

06

Study locations

1 of 1 sites recruiting
  • Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
    Guangzhou, Guangdong 510060, China
    • Haotian Lin, Ph.D · Contact · gddlht@aliyun.com · +86-020-87330274
    • Haotian Lin, Ph.D · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT05615519
Lead sponsor
Sun Yat-sen University
Responsible party
Haotian Lin (Clinical Professor, Sun Yat-sen University) — Principal investigator
First posted
Nov 14, 2022
Start date
Dec 2, 2022 (estimated)
Primary completion
Mar 1, 2023 (estimated)
Completion
Apr 1, 2023 (estimated)
Last update
Dec 5, 2022

Study contacts

Haotian Lin, M.D., Ph.D
Contact
haot.lin@hotmail.com
8613802793086
Ruixin Wang, M.D., Ph.D
Contact
ruiruiw413@aliyun.com
8615360458084

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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