Multi-modal Imaging and Artificial Intelligence Diagnostic System for Multi-level Clinical Application

NCT ID: NCT03899623

Last Updated: 2019-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-23
• Study Completion Date: 2019-12-31

Brief Summary

This study is to build an multi-modal artificial intelligence ophthalmological imaging diagnostic system covering multi-level medical institutions. We are going to evaluate this system in an evidence-based medicine view, taking diabetic retinopathy as an example. And clinical diagnostic criteria will be made based on this multi-modal artificial intelligence imaging diagnostic system. The study is designed as a cross-sectional study involving 1,000 normal individuals, 1,000 diabetes patients without ocular complications, and 1,000 with diabetic ocular complications. Statistical analysis of the diagnostic sensitivity and specificity of the artificial intelligence system will be made, and ROC curve wil be draw.

Conditions

Diabete Mellitus; Diabetic Retinopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

Group A(normal individuals): Meet all the items 1 ~ 5 below

1. No familial or hereditary retinopathy;

2. No history of ocular trauma and / or history of ocular disease (except for mild to moderate refractive errors and / or age-related cataracts);

3. No drug use history that may cause side effects of retina (such as chloroquine, hydroxychloroquine, chlorpromazine, rifampin, etc.); 4 binocular diopter ≤ ± 6.00D; No systemic diseases that may affect the retina.

Group B(diabetes patients without ocular complications): meet any of 1 to 3, and both 4 to 5 items

1. Diagnosed with type 1 diabetes for more than 5 years;

2. Diagnosed with type 2 diabetes patients;

3. Diagnosis of gestational diabetes patients;

4. Without systemic disease that may affect the retina except for diabetes;

5. Meet the standards of 1 to 4 items.

Group C(patients with diabetic ocular complications): meet with any of 1 to 3, and all 4 to 6 items

1. Diagnosed with type 1 diabetes for more than 5 years;

2. Diagnosed with type 2 diabetes patients;

3. Diagnosis of gestational diabetes patients;

4. Meet the guidelines for diagnosis and treatment of diabetic retinopathy in any stage of diabetic retinopathy and / or diabetic macular edema.

5. Without systemic disease that may affect the retina except for diabetes;

6. A group to meet the criteria for 1 to 4 items.

Exclusion Criteria

1. Refractive pathway is turbid, so that fundus image can not be clearly photographed;

2. With other fundus diseases and / or other diseases that seriously affect the visual function;

3. Any eye infection, such as conjunctivitis, keratitis, scleritis, endophthalmitis, acute and chronic dacryocystitis, or eye injury;

4. Serious systemic diseases such as diabetes, hypertension, heart failur,renal failure;

5. Can not cooperate with the examiner due to mental or other reasons.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jin Yuan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuan Jin, Professor

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Opthalmic Center

Locations

Zhongshan Opthalmic Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuan Jin, Professor

Role: CONTACT

yuanjincornea@126.com

8602087333391

Facility Contacts

Yuan Jin, Professor

Role: primary

yuanjincornea@126.com

8602087333391

Other Identifiers

2017KYPJ104

Identifier Type: -

Identifier Source: org_study_id