Comparing Artificial Intelligence for Assisted Diagnosis of Diabetic Retinopathy

Not yet recruiting

• Conditions: Diabetic Retinopathy; Diabetic Macular Edema
• Interventions: Diagnostic Test: fundus fluorescence angiography; Diagnostic Test: fundus photography; Diagnostic Test: optical coherence tomography

• Registration Number: NCT06423274
• Lead Sponsor: Zhejiang University

Brief Summary

This study plans to compare the accuracy of artificial intelligence (AI)-assisted fundus images with other ophthalmic devices such as optical coherence tomography (OCT) and fundus fluorescence angiography (FFA) in the diagnosis of diabetic retinopathy and diabetic macular edema.

Detailed Description

This study plans to compare the accuracy of artificial intelligence (AI)-assisted fundus images with other ophthalmic devices such as optical coherence tomography (OCT) and fundus fluorescence angiography (FFA) in the diagnosis of diabetic retinopathy and diabetic macular edema.

This study was conducted as a prospective study. Participants meeting eligibility criteria will be recruited from sites staffed by trained photographers. After assessing eligibility and obtaining informed consent, fundus photographs will be taken using a non-dilated fundus camera. And optical coherence tomography or fundus fluorescence angiography will be performed.

Study Timeline

• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-15
• Study First Posted: 2024-05-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-09
• Study Start: 2024-07-10
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Diagnostic for diabetes: Type 1 diabetes of a lest 5 years of evolution; or Type 2 diabetes;
2. Obtaining informed consent;
3. Patient age 18 or above.

Exclusion Criteria

1. Patients under 18 years of age;
2. Failure to Obtain informed consent;
3. Presence of other retinal diseases;
4. A patient who has already undergone the treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
fundus fluorescence angiography	fundus fluorescence angiography	fundus fluorescence angiography in patients with diabetic retinopathy
artificial intelligence-assisted fundus photography	fundus photography	Artificial intelligence-assisted fundus photography in patients with diabetic retinopathy
optical coherence tomography	optical coherence tomography	optical coherence tomography in patients with diabetic retinopathy

Primary Outcome Measures

Name	Time	Method
The accuracy	Baseline-Month 12	Detection of DR accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography

Secondary Outcome Measures

Name	Time	Method
The accuracy	Baseline-Month 12	Detection of DME accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography

Trial Locations

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China