CClinicalTrials.gg
CompletedNCT05835115Updated Apr 28, 2023

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

An observational study in Myopia and Myopic Macular Degeneration, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Completed at 1 site in China. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-04-28.

Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
30,526
Ages
4 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Myopia
  • Myopic Macular Degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 30,526 is above the median of 106 across 421 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center is the lead sponsor of 64 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The SCALE, a prospective, school-based study, includes all children aged 4 to 14 years in Shanghai.

The SCALE-HM, a population-based, prospective, examiner-masked study, includes children and adolescents aged between 4 and 18 years with high myopia.

The STORM trial, a school-based, prospective, examiner-masked, cluster-randomized trial, includes children aged 6 to 9 years.

The SMS study is a school-based cross-sectional survey from Shanghai, including kindergarten and primary school students in Year 1 and 2.

The Beijing Children Eye study included children who came to the outpatient clinic of Beijing Friendship Hospital.

The JFFT study contains cross-sectional data from Shanghai, Yunnan, Inner Mongolia, Xinjiang and Guangzhou.

The Hong Kong Children Eye Study is a population-based cohort study of eye conditions in children aged 6-8 years.

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

Exclusion Criteria:

  • Participants with poor-quality fundus images
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
30,526 participants (actual)
Patient registry
No

Groups and cohorts

  • The training dataset

    The training dataset was comprised of data from a school-based, prospective cohort (the Shanghai Time Outside to Reduce Myopia \[STORM\] trial) and data from another population-based, prospective study, the High Myopia Registration Study (SCALE-HM), with annual follow-up. Participants of the two studies were divided into a training set (70%), a tuning set (10%), and an internal test set (20%), which were not duplicated by each other at the participant level.

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

  • The internal validation dataset

    The internal validation dataset was comprised of data from a school-based, prospective cohort (the Shanghai Time Outside to Reduce Myopia \[STORM\] trial) and data from another population-based, prospective study, the High Myopia Registration Study (SCALE-HM), with annual follow-up. Participants of the two studies were divided into a training set (70%), a tuning set (10%), and an internal test set (20%), which were not duplicated by each other at the participant level.

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

  • The external validation dataset

    To test the extrapolation capabilities of the deep learning sysyem, two independent datasets, the Joint Five-site Fundus Test (JFFT) and the Hong Kong Children Eye Study (HKCES), were applied as external test sets. The JFFT study, a multi-site dataset, contains cross-sectional data from Shanghai, Yunnan, Inner Mongolia, Xinjiang and Guangzhou. HKCES, a population-based cohort study of eye conditions in children aged 6-8 years.

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

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.

06

What researchers measure

Primary outcomes

  1. myopia staging detection possibility score

    output of myopia staging task

    Time frame: immediately after inputting the data

  2. myopic maculopathy detection possibility score

    output of myopic maculopathy detection task

    Time frame: immediately after inputting the data

  3. predicted spherical equivalent

    output of assessing spherical equivalent task

    Time frame: immediately after inputting the data

  4. predicted future annual spherical equivalent

    output of predicting future spherical equivalent task

    Time frame: immediately after inputting the data

  5. risk score of myopia and myopic maculopathy progression

    output of the progression of myopia and myopic maculopathy predicion task

    Time frame: immediately after inputting the data

07

Study locations

1 site
  • Shanghai Eye Disease Prevention and Treatment Center
    Shanghai, Shanghai 200041, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05835115
Lead sponsor
Shanghai Eye Disease Prevention and Treatment Center
Collaborators
Shanghai Jiao Tong University School of Medicine, Beijing Friendship Hospital, Peking Union Medical College Hospital, Zhongshan Ophthalmic Center, Sun Yat-sen University, First Affiliated Hospital of Kunming Medical University, The Affiliated Hospital of Inner Mongolia Medical University, First Affiliated Hospital of Xinjiang Medical University, Chinese University of Hong Kong
Responsible party
Sponsor
First posted
Apr 28, 2023
Start date
Apr 1, 2022
Primary completion
Apr 1, 2023
Completion
Apr 1, 2023
Last update
Apr 28, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion