NCT05981950

Brief Summary

The objective of this study is to apply an artificial intelligence algorithm to diagnose multi-retinal diseases in real-world settings. The effectiveness and accuracy of this algorithm are evaluated by sensitivity, specificity, positive predictive value, negative predictive value, and area under curve.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Aug 2023Aug 2029

First Submitted

Initial submission to the registry

August 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

5 years

First QC Date

August 1, 2023

Last Update Submit

August 1, 2023

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 month

  • Sensitivity and specificity

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

    1 month

  • 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 month

  • F1 score

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

    1 month

Study Arms (1)

Retinal diseases diagnosed by artificial intelligence algorithm

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.

Diagnostic Test: artificial intelligence algorithm

Interventions

Retinal diseases diagnosed by artificial intelligence algorithm

Retinal diseases diagnosed by artificial intelligence algorithm

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Age GroupsChild (0-17), Adult (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

RECRUITING

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Wenbin Wei, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 8, 2023

Study Start

August 1, 2023

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2029

Last Updated

August 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations