Real-world of AI in Diagnosing Retinal Diseases

Sponsor
Beijing Tongren Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05981950
Collaborator
(none)
100,000
1
72
1388.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: artificial intelligence algorithm

Detailed Description

The objective of this study is to apply an artificial intelligence algorithm 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. tic 45-degree fundus cameras, trained operators took binocular fundus photography on participants. Operators were then asked to identify gradable images and unload for algorithm diagnosis. The effectiveness and accuracy of this algorithm are evaluated by sensitivity, specificity, positive predictive value, negative predictive value, area under curve, and F1 score.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Real-world Application of Using Artificial Intelligence in Diagnosing Retinal Diseases
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2028
Anticipated Study Completion Date :
Aug 1, 2029

Arms and Interventions

Arm Intervention/Treatment
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
Retinal diseases diagnosed by artificial intelligence algorithm

Outcome Measures

Primary Outcome Measures

  1. Area under curve [1 month]

    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.

  2. Sensitivity and specificity [1 month]

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

  3. Positive predictive value, negative predictive value [1 month]

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

  4. F1 score [1 month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 100 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • fundus photography around 45° field which covers optic disc and macula

  • complete identification information

Exclusion Criteria:
  • insufficient information for diagnosis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wen-Bin Wei Beijing Beijing China 100730

Sponsors and Collaborators

  • Beijing Tongren Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wenbin Wei, Prof, Beijing Tongren Hospital
ClinicalTrials.gov Identifier:
NCT05981950
Other Study ID Numbers:
  • Real-world RAIDS
First Posted:
Aug 8, 2023
Last Update Posted:
Aug 8, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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 Aug 8, 2023