NCT05622565

Brief Summary

To establish a deep learning system of various ocular fundus disease analytics based on the results of multimodal examination images. The system can analyze multimodal ocular fundus images, make diagnoses and generate corresponding reports.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
11.9 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

12.9 years

First QC Date

November 15, 2022

Last Update Submit

July 10, 2023

Conditions

Keywords

Retinal diseaseChoroidal diseaseDeep learning

Outcome Measures

Primary Outcomes (1)

  • Area under the receiver operating characteristic curve of the deep learning system

    The investigators will calculate the area under the receiver operating characteristic curve of the deep learning system and compare this index with human ophthalmologists.

    Baseline

Secondary Outcomes (2)

  • Intersection-Over-Union of the models' explanation accuracy

    Baseline

  • Sensitivity and Specificity of the deep learning system

    Baseline

Study Arms (3)

Training set

Multimodal ocular fundus images and corresponding reports collected from multiple screening sites in China.

Internal Validation set

Records separated from the training set.

External Test set

Multimodal ocular fundus images and corresponding reports collected from multi-centers in China and around the world.

Diagnostic Test: Various modalities of ocular fundus imaging

Interventions

Through various modalities of ocular fundus imaging, combining with clinical data and the experience of clinicians to diagnose different fundus diseases.

External Test set

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Ocular fundus images were collected from different health care institutes all over China and from other countries.

You may qualify if:

  • The quality of multimodal ocular fundus disease examination images and corresponding reports should be clinically acceptable.

You may not qualify if:

  • Reports with key information missing.
  • Images with severe image resolution reductions, blur or artifacts were excluded from further analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Eye DiseasesRetinal DiseasesChoroid Diseases

Condition Hierarchy (Ancestors)

Uveal Diseases

Study Officials

  • Yingfeng Zheng, M.D. Ph.D

    Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity,Guangzhou, Guangdong, China, 510060

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingfeng Zheng, M.D. Ph.D

CONTACT

Wenjia Cai, M.D. Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, Ph.D

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 18, 2022

Study Start

January 1, 2011

Primary Completion

December 1, 2023

Study Completion

July 1, 2024

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations