Multi-modal Imaging and Artificial Intelligence Diagnostic System for Multi-level Clinical Application
Trial ID: NCT03899623
Status: UNKNOWN
Study type: OBSERVATIONAL
Start date: 2018-04-23
Completion date: 2019-12-31
Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Conditions: Diabete Mellitus; Diabetic Retinopathy
Locations: Zhongshan Opthalmic Center
Countries: China
Enrollment: 3000
Age range: None - None
Sex: ALL

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.

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.

Outcomes:
The diagnostic sensitivity, specificity and ROC curve of the artificial intelligence（AI） system compared with reference standard (ophthalmologist).