Comparing Artificial Intelligence for Assisted Diagnosis of Diabetic Retinopathy

July 4, 2024 updated by: Wu Hongkang, Zhejiang University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

It is planned to include 1,000 participants in the study, all of whom will undergo fundus photography, 500 additional patients will undergo fundus fluorescence angiography, and 500 additional patients will undergo optical coherence tomography.

All participants met inclusion and exclusion criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
artificial intelligence-assisted fundus photography
Artificial intelligence-assisted fundus photography in patients with diabetic retinopathy
Diagnostic test: fundus photography
using artificial intelligence to identify diabetic retinopathy using fundus photography
optical coherence tomography
optical coherence tomography in patients with diabetic retinopathy
Diagnostic test: optical coherence tomography
detect diabetic retinopathy and diabetic macular edema by optical coherence tomography
fundus fluorescence angiography
fundus fluorescence angiography in patients with diabetic retinopathy
Diagnostic test: fundus fluorescence angiography
detect diabetic retinopathy by fundus fluorescence angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy
Time Frame: Baseline-Month 12
Detection of DR accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography
Baseline-Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy
Time Frame: Baseline-Month 12
Detection of DME accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography
Baseline-Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 10, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 9, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 4, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR artificial intelligence

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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