Diagnostic Performance of Deep Learning for Angle Closure

Sponsor
Sun Yat-sen University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04242108
Collaborator
(none)
3,000
1
37.5
80

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Deep learning algorithm based on AS-OCT scans

Study Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Diagnostic Performance of Deep Convolutional Neural Networks for Angle Closure Glaucoma: an International Multicenter Study
Actual Study Start Date :
Jan 15, 2019
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Area under receiver operating curve (AUC) [Immediately after obtaining the AS-OCT images]

    AUC value of the deep learning algorithm in angle width classfication and synechia detection

Secondary Outcome Measures

  1. Sensitivity and specificity [Immediately after obtaining the AS-OCT images]

    Sensitivity and specificity of the automated algorithm in angle width classfication and synechia detection

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan Ophthalmic Center Guangzhou Guangdong China 51000

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiulan Zhang, Director of Clinical Research Center, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT04242108
Other Study ID Numbers:
  • 2018KYPJ074
First Posted:
Jan 27, 2020
Last Update Posted:
Apr 8, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2021