Diagnostic Performance of Deep Learning for Angle Closure

April 3, 2021 updated by: Xiulan Zhang, Sun Yat-sen University

Diagnostic Performance of Deep Convolutional Neural Networks for Angle Closure Glaucoma: an International Multicenter Study

Primary angle closure diseases (PACD) are commonly seen in Asia. In clinical practice, gonioscopy is the gold standard for angle width classification in PACD patietns. However, gonioscopy is a contact examination and needs a long learning curve. Anterior segment optical coherence tomography (AS-OCT) is a non-contact test which can obtain three dimensional images of the anterior segment within seconds. Therefore, the investigators designed the study to verify if AS-OCT based deep learning algorithm is able to detect the PACD subjects diagnosed by gonioscopy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

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 (Anticipated)

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.
3000

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
    • Guangdong
      • Guangzhou, Guangdong, China, 51000
        • Zhongshan Ophthalmic 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The training and primary validation datasets were collected from the databases of electronic medical and research records at Zhongshan Ophthalmic Center from September 1, 2016, to September 1, 2019. The external test dataset was obtained from the Singapore Eye Research Institute (SERI), Singapore during June 2008 to November 2019, and the Chulalongkorn University and King Chulalongkorn Memorial Hospital (KCMH, Bangkok, Thailand) from October, 2019 to April, 2020.

Description

The inclusion criteria in the study were as follows: (1) All participants must be ≥ 18 years old; (2) Study subjects had a previous diagnosis of the ACA status (narrow or open, PAS or non-PAS) based on gonioscopy, SS-OCT scans and medical history records. Exclusion criteria of the data include: (1) poor compliance in receiving gonioscopy examination; (2) unclear AS-OCT scans due to blinking or out of focus; (3) recent use of miotics within a month; 4) secondary angle closure sue to subluxation or dislocation, uveitis, neovascular glaucoma, et al.; 5) history of ocular surgery or laser iridotomy; 6) patients who previously had an episode of primary angle closure (which was obtained on history by asking the patients).

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

  • Observational Models: Other
  • Time Perspectives: Retrospective

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.
Angle closure group
Diagnostic test: Deep learning algorithm based on AS-OCT scans
The OCT scans of study subjects would be imported into the algorithm. Automated classfication of angle width and detection of synechia would be performed by the algorithm. The diagnostic performance of the algorithm would be compared with gonioscopy records.
Open angle group
Diagnostic test: Deep learning algorithm based on AS-OCT scans
The OCT scans of study subjects would be imported into the algorithm. Automated classfication of angle width and detection of synechia would be performed by the algorithm. The diagnostic performance of the algorithm would be compared with gonioscopy records.
Peripheral synechia (PAS) group
Diagnostic test: Deep learning algorithm based on AS-OCT scans
The OCT scans of study subjects would be imported into the algorithm. Automated classfication of angle width and detection of synechia would be performed by the algorithm. The diagnostic performance of the algorithm would be compared with gonioscopy records.
Non-peripheral synechia (PAS) group
Diagnostic test: Deep learning algorithm based on AS-OCT scans
The OCT scans of study subjects would be imported into the algorithm. Automated classfication of angle width and detection of synechia would be performed by the algorithm. The diagnostic performance of the algorithm would be compared with gonioscopy records.

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
Area under receiver operating curve (AUC)
Time Frame: Immediately after obtaining the AS-OCT images
AUC value of the deep learning algorithm in angle width classfication and synechia detection
Immediately after obtaining the AS-OCT images

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity
Time Frame: Immediately after obtaining the AS-OCT images
Sensitivity and specificity of the automated algorithm in angle width classfication and synechia detection
Immediately after obtaining the AS-OCT images

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.
Sun Yat-sen 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.
January 15, 2019

Primary Completion (Anticipated)

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.
December 1, 2021

Study Completion (Anticipated)

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.
March 1, 2022

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).
January 23, 2020

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.
January 23, 2020

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.
January 27, 2020

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 8, 2021

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 3, 2021

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, 2021

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.
  • 2018KYPJ074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The imaging data of study subjects would be available to other researchers upon reasonable request. Part of the data would be open as public datasets after the related article is published.

IPD Sharing Time Frame

Part of the data would be open as public datasets after the related article is published.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Analytic Code

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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