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Deep Learning-based Retinal Disease Screening: A Prospective Study

Uncertainty-based Multi-disease Fundus Screening for Retinal Diseases: A Prospective Clinical Validation Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400094521
Enrollment
Unknown
Registered
2024-12-24
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Retinal Diseases

Interventions

Gold Standard:Diagnostic Team: Three senior ophthalmologists conduct independent assessments. One chief retinal specialist serves as the adjudicator. Diagnostic Process: Three ophthalmologists indepen
Index test:UIOS-Pro assisted diagnosis of fundus disease

Sponsors

Meizhou People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 100 Years

Inclusion criteria

Inclusion criteria: 1. Demographics: No age restriction. All genders eligible. 2. Clinical Indications: Routine diabetic retinopathy screening. Hypertensive retinopathy assessment. Visual symptoms (decreased vision or metamorphopsia). Family history of retinal diseases. Routine eye examination participants. 3. Patient Status: Alert and oriented. Able to provide informed consent. Demonstrating good fixation and cooperation. Capable of providing good quality images.

Exclusion criteria

Exclusion criteria: 1. Ocular conditions: Severe media opacity (e.g., severe cataracts, corneal opacity) affecting image quality. History of ocular surgery that may affect fundus image interpretation (e.g., retinal photocoagulation). Nystagmus or other ocular motility disorders affecting image acquisition. 2. Systemic conditions: Severe systemic diseases preventing proper fundus examination compliance (e.g., severe Parkinson's disease). 3. Special populations: Pregnant or lactating women (due to potential hormonal influences). Patients with cognitive impairment (unable to provide valid informed consent).

Design outcomes

Primary

MeasureTime frame
Accuracy;Sensitivity;Specificity;F1 Score;Confusion Matrix;

Secondary

MeasureTime frame
Diagnostic Accuracy;Time Efficiency;Diagnostic Confidence;

Countries

China

Contacts

Public ContactHe Guiqin

Meizhou People's Hospital

772829270@qq.com+86 138 9077 5051

Outcome results

None listed

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