- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05680090
Artificial Intelligent System for Eye Emergency Triage and Primary Diagnosis
Prospective Validation of an Artificial Intelligent System for Eye Emergency Triage and Primary Diagnosis
Ophthalmic emergencies are acute vision-threatening disorders, for which a delay in prompt emergency response could result in catastrophic vision loss. Triage is an effective process for ensuring that timely emergency care is provided despite limited resource by prioritizing patients to appropriate orders for visits. Historically, registered nurses classify emergency patients based on personal experiences with high variation. Additionally, primary healthcare providers have been conventionally at the forefront of providing first aid care. However, most of ocular emergencies are wrongly diagnosed or referred due to non-eye specialists' limited knowledge and training in the ophthalmology.
Here, the investigators established and validated an artificial intelligence system, EE-Explorer, to triage eye emergencies and assist in primary diagnosis using metadata and ocular images. This system has been integrated into a website to be prospectively validated in the real world.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Haotian Lin, M.D., Ph.D
- Phone Number: 8613802793086
- Email: haot.lin@hotmail.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
-
Contact:
- Haotian Lin, M.D., Ph.D
- Phone Number: 8613802793086
- Email: linht5@mail.sysu.edu.cn
-
Contact:
- Xiaohang Wu, M.D., Ph.D
- Phone Number: 8615913177657
- Email: wxhang@mail2.sysu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Suffering acute ophthalmic symptoms within one month
- Visiting the ocular emergency department for the first time
- Must be able to complete the triage form for ophthalmic emergency
- Must be able to cooperate either by submitting smartphone photographs or receiving slit-lamp examination
Exclusion Criteria:
The image quality does not meet the clinical requirements.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Eligible participants for AI-based ophthalmic emergency triage and primary diagnosis
|
An intelligent triage and diagnostic system for ophthalmic emergencies has been developed.
In the prospective test, patients with acute ocular symptoms can achieve remote self-triage and primary diagnosis after uploading metadata and ocular images.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The accuracy of the triage model
Time Frame: 2023.1
|
Use the triage model to classify patients with acute ocular symptoms, and count the proportion of correct classification.
|
2023.1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The accuracy of the primary diagnostic model
Time Frame: 2023.1
|
Use the primary diagnostic model to diagnose patients with ophthalmic emergencies, and count the proportion of correct diagnosis in all patients.
|
2023.1
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptance of the patients
Time Frame: 2023.1
|
Questionnaire scores
|
2023.1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021KYPJ046
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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