Diabetic Retinopathy
Conditions
Interventions
Gold Standard:Judgement of color fundus photograph by Zhongshan Ophthalmic Center ophthalmologists
Index test:Shenzhen 
SiBright 
AIDRScreening 
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subject must understand the study, has chosen to participate voluntarily, and has signed informed consent; 2. Aged 18 years or older male and female; 3. Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus
Exclusion criteria
Exclusion criteria: 1. As it is difficult to obtain satisfactory fundus images with small pupils, mydriasis is advisable under certain circumstances except if: 1) the subject is allergic to mydriatic drugs; 2) the subject's intraocular pressure (IOP) = 22mmHg; 3) the subject is prone to post-dilation angle closure, pupillary block, etc.; 2. The subject has refractive media opacity and/or pupil abnormalities that affect fundus examination and imaging; 3. The subject has severe vitreous hemorrhage; 4. The subject has received fundus laser treatment; 5. The subject has had eye surgery such as scleral buckling, vitrectomy, macular transposition, etc., BUT cataract surgery or external eye surgery are not included; 6. The subject is participating in other ophthalmic clinical trials; 7. In cases when the researchers believe the subject is not suitable for taking fundus photograph, including but not limited to: 1) The subject had nystagmus and could not obtain a gradable fundus photograph; 2) other disqualifying conditions deemed by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity; | — |
Countries
China
Contacts
Public ContactXiaofeng LIN
Zhongshan Ophthalmic Center, Sun Yat-sen University
Outcome results
None listed