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Research on the development and effectiveness of artificial intelligence software to assist in the diagnosis of diabetic retinopathy complicated with cataract

Research on the development and effectiveness of artificial intelligence software to assist in the diagnosis of diabetic retinopathy complicated with cataract

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000036702
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-21

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:Ophthalmologists read films independently.
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Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The inclusion criteria in the first part of the study: 1. 18 years of age or older, no gender limitation; 2. Diabetes diagnosed by the standard diagnosis of the endocrinology department; 3. Can cooperate with fundus photography. The inclusion criteria in the second part of the study: 1. The patient can fully understand the research purpose, research content, accidents, benefits and risks of this clinical study, and can make their own decision to participate or not to participate. Those who can understand the purpose of this clinical research, volunteer to participate in this research, and sign an informed consent form. 2. Diagnosed as cataract, mild or moderate, the fundus image can be obtained through infrared imaging before cataract surgery. 3. Diagnosed as diabetes.

Exclusion criteria

Exclusion criteria: The exclusion criteria in the first part of the study: 1. Excluding the existence or treatment history of other ocular diseases except for the ocular diseases studied. 2. Other unqualified conditions identified by the investigator, including but not limited to nystagmus, inability to stare, and other reasons that cannot complete the normal examination. 3. Those with poor compliance. The exclusion criteria in the second part of the study: 1. Any eye can not accept fundus photography examination. 2. Those who have participated in or are participating in other clinical trials within 1 month before signing the informed consent. 3. Other circumstances that the researcher thinks cannot be selected. 4. Insufficient image quality, such as inconsistent field of view, poor image exposure, inaccurate image focus, stains, dark shadows or crescent shadows, etc. 5. The cataract is too severe, or there are images such as vitreous hemorrhage that cause the fundus to be inaccessible or the fundus image is blurred.

Design outcomes

Primary

MeasureTime frame
Consensus rate of diagnosis results;

Secondary

MeasureTime frame
Sensitivity;Specificity;Positive predictive value;Negative predictive value;

Countries

China

Contacts

Public ContactHaidong Zou

Shanghai General Hospital, Shanghai Jiao Tong University

zouhaidong@hotmail.com+86 13311986528

Outcome results

None listed

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