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Development and Validation of a Deep Learning-based Myopia and Myopic Maculopathy Detection and Prediction System

Development and Validation of a Deep Learning-based Myopia and Myopic Maculopathy Detection and Prediction System

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05835115
Enrollment
30526
Registered
2023-04-28
Start date
2022-04-01
Completion date
2023-04-01
Last updated
2023-04-28

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

Conditions

Myopia, Myopic Macular Degeneration

Brief summary

Myopia has become a global public health issue. Myopia affects the psychological health of children and adolescents and poses a financial burden. Therefore, early detection and prediction of children at a high risk of myopia development and progression are critical for precise and effective interventions. In this study, we developed a deep learning system DeepMyopia, based on fundus images with the following objectives: 1) to predict myopia onset and progression; 2) To detect myopic macular degeneration for AI-assisted diagnosis; 3) To predict the development of myopic macular degeneration; 4) evaluate its cost-effectiveness.

Detailed description

Myopia has become a global public health issue. Myopia affects the psychological health of children and adolescents and poses a financial burden. Furthermore, as myopia progresses it increases the risk of ocular complications such as myopic macular degeneration, leading to irreversible visual impairment or even blindness. According to the World Health Organization , more than 1 billion people worldwide are living with vision impairment caused by myopia, hyperopia, and other problems due to late detection. Therefore, early detection and prediction of children at a high risk of myopia development and progression are critical for precise and effective interventions. In this study, we developed a deep learning system DeepMyopia, based on fundus images with the following objectives: 1) to predict myopia onset and progression; 2) To detect myopic macular degeneration for AI-assisted diagnosis; 3) To predict the development of myopic macular degeneration; 4) evaluate its cost-effectiveness.

Interventions

DIAGNOSTIC_TESTA deep learning-based myopia and myopic maculopathy detection and prediction system

This deep learning system is capable of analyzing fundus images for myopia staging, myopic maculopathy detection, cycloplegic refraction estimation and prediction, and risk stratification of myopia and myopic maculopathy onset.

Sponsors

Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Beijing Friendship Hospital
CollaboratorOTHER
Peking Union Medical College Hospital
CollaboratorOTHER
Zhongshan Ophthalmic Center, Sun Yat-sen University
CollaboratorOTHER
First Affiliated Hospital of Kunming Medical University
CollaboratorOTHER
The Affiliated Hospital of Inner Mongolia Medical University
CollaboratorOTHER
First Affiliated Hospital of Xinjiang Medical University
CollaboratorOTHER
Chinese University of Hong Kong
CollaboratorOTHER
Shanghai Eye Disease Prevention and Treatment Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

1. Subjects with fundus images in the Shanghai Child and Adolescent Large-scale Eye Study (SCALE) ; 2. Subjects with fundus images in the Shanghai Time Outside to Reduce Myopia \[STORM\] trial; 3. Subjects with fundus images in the High Myopia Registration Study \[SCALE-HM\] 4. Subjects with fundus images in the Shanghai Myopia Screening (SMS) Study; 5. Subjects with fundus images in the Beijing Children Eye Study 6. Subjects with fundus images in the First Affiliated Hospital of Kunming Medical University; 7. Subjects with fundus images at the Ophthalmology Department of the First Affiliated Hospital of Xinjiang Medical University; 8. Subjects with fundus images at the Ophthalmology Department of the Affiliated Hospital of Inner Mongolia Medical University; 9. Subjects with fundus images at Zhongshan Eye Centre, Sun Yat-sen University; 10. Subjects with fundus images in the Hong Kong Children Eye Study;

Exclusion criteria

* Participants with poor-quality fundus images

Design outcomes

Primary

MeasureTime frameDescription
myopia staging detection possibility scoreimmediately after inputting the dataoutput of myopia staging task
myopic maculopathy detection possibility scoreimmediately after inputting the dataoutput of myopic maculopathy detection task
predicted spherical equivalentimmediately after inputting the dataoutput of assessing spherical equivalent task
predicted future annual spherical equivalentimmediately after inputting the dataoutput of predicting future spherical equivalent task
risk score of myopia and myopic maculopathy progressionimmediately after inputting the dataoutput of the progression of myopia and myopic maculopathy predicion task

Countries

China

Outcome results

None listed

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