NCT04678375

Brief Summary

The objective of this study is to apply an artificial intelligence algorithm to diagnose multi retinal diseases from fundus photography. The effectiveness and accuracy of this algorithm was evaluated by sensitivity, specificity, positive predictive value, negative predictive value, and area under curve.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
Last Updated

April 15, 2021

Status Verified

June 1, 2018

Enrollment Period

2.1 years

First QC Date

December 16, 2020

Last Update Submit

April 12, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Area under curve

    We used the receiver operating characteristic (ROC) curve and area under curve to examine the ability of this artificial intelligence algorism recognition and classification of retinal diseases.

    1 week

  • Sensitivity and specificity

    We used sensitivity and specificity to examine the ability of this artificial intelligence algorism recognition and classification of retinal diseases.

    1 week

  • Positive predictive value, negative predictive value

    We used positive predictive value and negative predictive value to examine the ability of this artificial intelligence algorism recognition and classification of retinal diseases.

    1 week

  • F1 score

    We used F1 score to examine the ability of this artificial intelligence algorism recognition and classification of retinal diseases.

    1 week

Secondary Outcomes (1)

  • Systemic biomarkers and diseases

    1 week

Study Arms (1)

Retinal diseases diagnosed by artificial intelligence algorithm

Retinal diseases diagnosed by artificial intelligence algorithm

Diagnostic Test: Retinal diseases diagnosed by artificial intelligence algorithm

Interventions

An artificial intelligence algorithm was applied to diagnose referral diabetes retinopathy, referral age-related macular degeneration, referral possible glaucoma, pathological myopia, retinal vein occlusion, macular hole, macular epiretinal membrane, hypertensive retinopathy, myelinated fibers, retinitis pigmentosa and other retinal lesions from fundus photography.

Retinal diseases diagnosed by artificial intelligence algorithm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is derived from an anonymous database that contains health examination results of the general population.

You may qualify if:

  • fundus photography around 45° field which covers optic disc and macula
  • complete identification information

You may not qualify if:

  • insufficient information for diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wen-Bin Wei

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Wenbin Wei

    Beijing Tongren Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 21, 2020

Study Start

June 1, 2018

Primary Completion

June 30, 2020

Study Completion

October 1, 2020

Last Updated

April 15, 2021

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations