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Validation of the automated DRSS classification system for diabetic retinopathy

Validation of the automated DRSS classification system for diabetic retinopathy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000036308
Enrollment
Unknown
Registered
2020-08-22
Start date
2020-08-24
Completion date
Unknown
Last updated
2020-09-07

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:Third-party independent retinal disease imaging reading center
Index test:Diabetic&#32

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent form and are willing to abide by the follow-up arrangements specified by the institute; 2. Aged 18 to 80 years old; 3. History of type 1 or type 2 diabetes; 4. The research eye clearly diagnoses diabetic retinopathy.

Exclusion criteria

Exclusion criteria: 1. Study the eye with other retinal vascular diseases, including central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), ocular ischemia syndrome, hypertensive retinopathy, radiation retinopathy, etc.; 2. Study the eye with other eye diseases that affect vision, such as glaucoma, uveitis, optic neuropathy, retinal detachment, age-related macular degeneration (AMD), choroidal neovascularization (CNV), cataracts and other causes The refractive medium is turbid, etc.; 3. Study the neovascularization of the iris and angle of the eye; 4. Patients with diagnosed type 2 diabetes but recurrent hypoglycemia (occurred at least twice within a month, random blood glucose =150mmHg or diastolic blood pressure >=100mmHg after treatment with antihypertensive drugs); 7. Any uncontrollable clinical problems (such as serious mental, neurological, cardiovascular, respiratory and other system diseases and malignant tumors); 8. Pregnant and lactating women (where pregnancy is defined as a positive urine pregnancy or blood pregnancy test).

Design outcomes

Primary

MeasureTime frame
Accuracy;Sensitivity;Specificity;the area under the receiver operating characteristic;

Countries

China

Contacts

Public ContactYu Qi

Shanghai General Hospital

yu.qi@sjtu.edu.cn+86 13482066686

Outcome results

None listed

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