Validation of the Utility of Ophthalmology Intelligent Diagnostic System

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT03499145

Collaborator

Ministry of Health, China (Other), Xidian University (Other)

615

Enrollment

Location

Actual Duration (Months)

36.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The prevention and treatment of diseases via artificial intelligence represents an ultimate goal in computational medicine. Application scenarios of the current medical algorithms are too simple to be generally applied to real-world complex clinical settings. Here, the investigators use "deep learning" and "visionome technique", an novel annotation method for artificial intelligence in medical, to create an automatic detection and classification system for four key clinical scenarios: 1) mass screening, 2) comprehensive clinical triage, 3) hyperfine diagnostic assessment, and 4) multi-path treatment planning. The investigator also establish a telemedicine system and conduct clinical trial and website-based study to validate its versatility.

Condition or Disease	Intervention/Treatment	Phase
Ophthalmopathy Artificial Intelligence	Device: Ophthalmology diagnostic system.

Study Design

Study Type:

Observational

Actual Enrollment :

615 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Validation of the Utility of Ophthalmology Intelligent Diagnostic System: A Clinical Trial

Actual Study Start Date :

Apr 1, 2018

Actual Primary Completion Date :

Aug 31, 2019

Actual Study Completion Date :

Aug 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Eligible patients for AI test. Device: ophthalmology diagnostic system. An artificial intelligence to make comprehensive evaluation and treatment decision of ocular diseases.	Device: Ophthalmology diagnostic system. An artificial intelligence to make comprehensive evaluation and treatment decision of ocular diseases.

Arm

Intervention/Treatment

Eligible patients for AI test.

Device: ophthalmology diagnostic system. An artificial intelligence to make comprehensive evaluation and treatment decision of ocular diseases.

Device: Ophthalmology diagnostic system.

An artificial intelligence to make comprehensive evaluation and treatment decision of ocular diseases.

Outcome Measures

Primary Outcome Measures

The proportion of accurate, mistaken and miss detection of the ophthalmology diagnostic system. [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients and residents who underwent ophthalmic examination of the eye and recorded their ocular information in the outpatient clinic and community.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

Sun Yat-sen University
Ministry of Health, China
Xidian University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haotian Lin, Clinical Professor, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT03499145

Other Study ID Numbers:

CCPMOH2018-China-2

First Posted:

Apr 17, 2018

Last Update Posted:

Oct 21, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Haotian Lin, Clinical Professor, Sun Yat-sen University

Additional relevant MeSH terms:

Eye Diseases

Study Results

No Results Posted as of Oct 21, 2019