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

April 18, 2023 updated by: Shanghai Eye Disease Prevention and Treatment Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30526

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200041
        • Shanghai Eye Disease Prevention and Treatment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
myopia staging detection possibility score
Time Frame: immediately after inputting the data
output of myopia staging task
immediately after inputting the data
myopic maculopathy detection possibility score
Time Frame: immediately after inputting the data
output of myopic maculopathy detection task
immediately after inputting the data
predicted spherical equivalent
Time Frame: immediately after inputting the data
output of assessing spherical equivalent task
immediately after inputting the data
predicted future annual spherical equivalent
Time Frame: immediately after inputting the data
output of predicting future spherical equivalent task
immediately after inputting the data
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
immediately after inputting the data

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Eye Disease Prevention and Treatment Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Friendship Hospital
Peking Union Medical College Hospital
Chinese University of Hong Kong
Zhongshan Ophthalmic Center, Sun Yat-sen University
Shanghai Jiao Tong University School of Medicine
First Affiliated Hospital of Xinjiang Medical University
The Affiliated Hospital of Inner Mongolia Medical University
First Affiliated Hospital of Kunming Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022SQ023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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