Artificial Intelligence for Detecting Retinal Diseases

Sponsor
Beijing Tongren Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04678375
Collaborator
Beijing Tulip Partner Technology Co., Ltd, China (Other)
1,000,000
1
28
35682.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Retinal diseases diagnosed by 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. The effectiveness and accuracy of this algorithm was evaluated by sensitivity, specificity, positive predictive value, negative predictive value, area under curve, and F1 score.

Study Design

Study Type:
Observational
Actual Enrollment :
1000000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Classification of Retinal Diseases by Artificial Intelligence
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Retinal diseases diagnosed by artificial intelligence algorithm

Retinal diseases diagnosed by artificial intelligence algorithm

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

  1. Area under curve [1 week]

    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 week]

    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 week]

    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 week]

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

Secondary Outcome Measures

  1. Systemic biomarkers and diseases [1 week]

    Using medical records as the gold standard, we test the accuracy of this artificial intelligence algorism recognition and classification of systemic biomarkers and diseases: age, sex, blood pressure, blood hemoglobin, cardiovascular diseases, thyroid function and kidney function.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
  • Beijing Tulip Partner Technology Co., Ltd, China

Investigators

  • Study Chair: Wenbin Wei, Beijing Tongren Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing Tongren Hospital
ClinicalTrials.gov Identifier:
NCT04678375
Other Study ID Numbers:
  • AI in retinal diseases
First Posted:
Dec 21, 2020
Last Update Posted:
Apr 15, 2021
Last Verified:
Jun 1, 2018
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 Apr 15, 2021