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OpenTrials
Completed

NCT Number: NCT05835115

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

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.

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Key information

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, 200041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Participants with poor-quality fundus images

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

  1. myopia staging detection possibility score

    Time frame: immediately after inputting the data

    output of myopia staging task

  2. myopic maculopathy detection possibility score

    Time frame: immediately after inputting the data

    output of myopic maculopathy detection task

  3. predicted spherical equivalent

    Time frame: immediately after inputting the data

    output of assessing spherical equivalent task

  4. predicted future annual spherical equivalent

    Time frame: immediately after inputting the data

    output of predicting future spherical equivalent task

  5. risk score of myopia and myopic maculopathy progression

    Time frame: immediately after inputting the data

    output of the progression of myopia and myopic maculopathy predicion task

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Collaborators

  • Beijing Friendship Hospital
  • Chinese University of Hong Kong
  • First Affiliated Hospital of Kunming Medical University
  • First Affiliated Hospital of Xinjiang Medical University
  • Peking Union Medical College Hospital
  • Shanghai Jiao Tong University School of Medicine
  • The Affiliated Hospital of Inner Mongolia Medical University
  • Zhongshan Ophthalmic Center, Sun Yat-sen University

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 28, 2023
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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