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Clinical trial of fundus image aided diagnosis software for diabetic retinopathy

Clinical trial of fundus image aided diagnosis software for diabetic retinopathy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200066703
Enrollment
Unknown
Registered
2022-12-14
Start date
2022-12-19
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

diabetes

Interventions

Gold Standard:Gold standard: Doctor's diagnosis Note: Each center shall appoint an ophthalmologist (definition of expert: associate chief physician or above), and the group leader shall appoint an oph
Index test:The software diagnoses the fundus image

Sponsors

Eye Optometry Hospital Affiliated to Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Above the age of 18, below the age of 75, male or female; 2) Diagnosed with diabetes mellitus; 3) After informed consent, the subject will voluntarily participate and sign the informed consent. 4) fundus color images (JPG format) taken by one or both eyes, with a field of vision of about 45°, including the entire optic disc and macular area; 5) fundus images with "good credibility". Note: The location, clarity and readability of fundus images were evaluated according to the Guidelines for Image Collection and Film Reading for Screening for Diabetic Retinopathy (2017). Images with "good credibility" could be used for evaluation.

Exclusion criteria

Exclusion criteria: 1) Persons who do not have full capacity for civil conduct; 2) Excluding patients with other fundus diseases, such as age-related macular degeneration, macular hole, retinal detachment, uveitis, optic nerve disease and other retinal vascular diseases (including retinal artery obstruction, retinal vein obstruction, retinal vasculitis, hypertensive retinopathy); 3) Patients with a history of retinal photocoagulation, vitreoretinal surgery or vitreous cavity injection; 4) Patients who are taking medications that cause light sensitivity; 5) Patients with small pupils who cannot obtain satisfactory photographs and need dilation rather than dilation; 6) Patients with severe vitreous hemorrhage; 7) Patients with refractive media opacity or pupil abnormalities affecting fundus examination and imaging; 8) Gestational diabetes mellitus; 9) Participants who have participated in clinical trials or are participating in other clinical trials within the past month; 10)Those deemed inappropriate by the investigator to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;

Countries

china

Contacts

Public ContactJia Qu

Eye Optometry Hospital Affiliated to Wenzhou Medical University

13806898805@163.com+86 13806898805

Outcome results

None listed

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