Strabismus Clinical Trial
Official title:
Validation of a Smartphone-based Intelligent Diagnosis and Measurement for Strabismus
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.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | April 1, 2023 |
| Est. primary completion date | March 1, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 3 Years and older |
| Eligibility | Inclusion Criteria: The quality of facial videos should be clinically acceptable. |
| Country | Name | City | State |
|---|---|---|---|
| China | Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Sun Yat-sen University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The effectiveness of smartphone-based diagnosis | The accurate and the area under curve of the smartphone-based diagnosis. | Baseline | |
| Primary | The consistency between manual and smartphone measurement | Agreement between the manual and automated tests was represented in Bland-Altman plots and concordance correlation coefficients. | Baseline |
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