Comparing Artificial Intelligence for Assisted Diagnosis of Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:

A Comparative Analysis of the Diagnostic Outcomes of Artificial Intelligence-assisted Fundus Photography for Diabetic Retinopathy and Diabetic Macular Edema Versus Other Imaging Devices in Ophthalmology: A Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06423274
• Other study ID #: DR artificial intelligence
• Status: Not yet recruiting
• Start date: May 10, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Zhejiang University
• Contact: Hongkang Wu, MMS
• Phone: +8618969978676
• Email: wuhongkang[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema
• Retinal Diseases

Intervention

Diagnostic Test:
• fundus photography
using artificial intelligence to identify diabetic retinopathy using fundus photography
• optical coherence tomography
detect diabetic retinopathy and diabetic macular edema by optical coherence tomography
• fundus fluorescence angiography
detect diabetic retinopathy by fundus fluorescence angiography

Locations

Country	Name	City	State
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy	Detection of DR accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography	Baseline-Month 12
Secondary	The accuracy	Detection of DME accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography	Baseline-Month 12