Clinical trial NCT03899623: Multi-modal Imaging and Artificial Intelligence Diagnostic System for Multi-level Clinical Application
Official title: Multi-modal Imaging and Artificial Intelligence Diagnostic System for Multi-level Clinical Application
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabete Mellitus
Diabetic Retinopathy
Keywords: Diabete Mellitus
Diabetic Retinopathy
Artificial Intelligence
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stratified sampling

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.


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.

Primary outcomes:
measure: The diagnostic sensitivity, specificity and ROC curve of the artificial intelligence（AI） system compared with reference standard (ophthalmologist).
timeFrame: It will take 15~20min for each subject to take the exams.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Opthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Opthalmic Center
name: Yuan Jin, Professor
role: PRINCIPAL_INVESTIGATOR
References: