NCT05680090

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

January 11, 2023

Status Verified

December 1, 2022

Enrollment Period

1 month

First QC Date

December 13, 2022

Last Update Submit

December 25, 2022

Conditions

Keywords

Artificial intelligenceOphthalmic emergency triagePrimary diagnosisMultimodal data

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The accuracy of the primary diagnostic model

    2023.1

Other Outcomes (1)

  • Acceptance of the patients

    2023.1

Study Arms (1)

Eligible participants for AI-based ophthalmic emergency triage and primary diagnosis

Diagnostic Test: Artificial intelligent system for eye emergency triage and primary diagnosis

Interventions

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.

Eligible participants for AI-based ophthalmic emergency triage and primary diagnosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Through the online popular science, news reports, and other channels, we will promote and inform patients about the relevant knowledge of ophthalmic emergencies, so that they can judge by themselves and freely decide whether to participate in this study or not.

You may qualify if:

  • 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

You may not qualify if:

  • The image quality does not meet the clinical requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

EmergenciesEye Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Haotian Lin, M.D., Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 13, 2022

First Posted

January 11, 2023

Study Start

December 10, 2022

Primary Completion

January 13, 2023

Study Completion

January 20, 2023

Last Updated

January 11, 2023

Record last verified: 2022-12

Locations