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A study for real-world efficiency of artificial intelligence technology in diabetic retinopathy screening

A study for real-world efficiency of artificial intelligence technology in diabetic retinopathy screening

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800019875
Enrollment
Unknown
Registered
2018-12-05
Start date
2019-03-01
Completion date
Unknown
Last updated
2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Interventions

Gold Standard:The diagnostic result of three ophthalmologists with 15-20 years of experience based on 7SF photography, and the diagnostic results confirmed by at least 2 ophthalmologists.
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Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diabetes patients: 1. Glycosylated hemoglobin (HbA1c) = 6.5%; 2. Fasting plasma glucose (FPG)=126 mg/dL (7.0mm/L); 3. 2h plasma glucose concentration of oral glucose tolerance test (OGTT) (2h-pg)=200 mg/dL (11.1mm/L); 4. Presenting symptoms of hyperglycemia, random blood glucose (RPG)=200 mg/dL (11.1mm/L); 5. Diopter diopter fluoroscopy meets the requirements of fundus photography; 6. Patients who have signed inform consent form and Willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Diagnosed as fundus disease patients other than DR; 2. Diagnosed as macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radioactive retinopathy or retinal vein obstruction; 3. Pregnant women, hypersensitivity to dilating agents, unclear refractive media, family history of glaucoma, and narrow atrial Angle; 4. History of laser therapy, retinal surgery or injection of anti-vascular endothelial growth factor; 5. Photosensitivity or taking medication that causes photosensitivity.

Design outcomes

Primary

MeasureTime frame
Sensitivity, Specificity, AUC;Diabetic retinopathy staging;

Countries

China

Contacts

Public ContactLisha Mou

Shenzhen Second People's Hospital

lishamou@gmail.com+86 15899876015

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026