- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05981950
Real-world of AI in Diagnosing Retinal Diseases
August 1, 2023 updated by: Wenbin Wei, Beijing Tongren Hospital
Real-world Application of Using Artificial Intelligence in Diagnosing Retinal Diseases
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
100000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wenbin Wei, MD
- Phone Number: 58269516
- Email: weiwenbintr@163.cim
Study Contact Backup
- Name: Ruiheng Zhang, MD
- Phone Number: 18801121782
- Email: zhangruihengsy@outlook.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Wen-Bin Wei
-
Contact:
- Wen-Bin Wei, MD
- Phone Number: 58269516
- Email: weiwenbintr@163.com
-
Principal Investigator:
- Wen-Bin Wei, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
The study population is derived from an anonymous database that contains health examination results of the general population.
Description
Inclusion Criteria:
- fundus photography around 45° field which covers optic disc and macula
- complete identification information
Exclusion Criteria:
- insufficient information for diagnosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
|
Retinal diseases diagnosed by artificial intelligence algorithm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Area under curve
Time Frame: 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.
|
1 month
|
|
Sensitivity and specificity
Time Frame: 1 month
|
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
Time Frame: 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.
|
1 month
|
|
F1 score
Time Frame: 1 month
|
We used F1 score to examine the ability of this artificial intelligence algorism recognition and classification of retinal diseases.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2023
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2029
Study Registration Dates
First Submitted
August 1, 2023
First Submitted That Met QC Criteria
August 1, 2023
First Posted (Actual)
August 8, 2023
Study Record Updates
Last Update Posted (Actual)
August 8, 2023
Last Update Submitted That Met QC Criteria
August 1, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Real-world RAIDS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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