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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05680090
Other study ID # 2021KYPJ046
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 10, 2022
Est. completion date January 20, 2023

Study information

Verified date December 2022
Source Sun Yat-sen University
Contact Haotian Lin, M.D., Ph.D
Phone 8613802793086
Email haot.lin@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 20, 2023
Est. primary completion date January 13, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Suffering acute ophthalmic symptoms within one month 2. Visiting the ocular emergency department for the first time 3. Must be able to complete the triage form for ophthalmic emergency 4. 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Artificial intelligent system for eye 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.

Locations

Country Name City State
China Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Acceptance of the patients Questionnaire scores 2023.1
Primary The accuracy of the triage model Use the triage model to classify patients with acute ocular symptoms, and count the proportion of correct classification. 2023.1
Secondary The accuracy of the primary diagnostic model Use the primary diagnostic model to diagnose patients with ophthalmic emergencies, and count the proportion of correct diagnosis in all patients. 2023.1
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