Artificial Intelligence System for Assessing Image Quality of Fundus Images and Its Effects on Diagnosis

NCT ID: NCT04289064

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Fundus images are widely used in ophthalmology for the detection of diabetic retinopathy, glaucoma and other diseases. In real-world practice, the quality of fundus images can be unacceptable, which can undermine diagnostic accuracy and efficiency. Here, the researchers established and validated an artificial intelligence system to achieve automatic quality assessment of fundus images upon capture. This system can also provide guidance to photographers according to the reasons for low quality.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinal Diseases Artificial Intelligence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fundus image quality assessment

Device: an artificial intelligence system for quality assessment of fundus images. These patients are enrolled in primary healthcare units or the AI clinic at Zhongshan Ophthalmic Center.

Taking a fundus image

Intervention Type DEVICE

The participant only needs to take a fundus image as usual.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Taking a fundus image

The participant only needs to take a fundus image as usual.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients should be aware of the contents and signed for the informed consent.

Exclusion Criteria

* 1\. Patients who cannot cooperate with a photographer such as some paralytics, the patients with dementia and severe psychopaths.
* 2\. Patients who do not agree to sign informed consent.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Haotian Lin

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IMAQUA2020-China-01

Identifier Type: -

Identifier Source: org_study_id