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NCT Number: NCT06423274

Comparing Artificial Intelligence for Assisted Diagnosis of Diabetic Retinopathy

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.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Macular Edema Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location contact

Hongkang Wu, MMS

CONTACT

[email protected]

18969978676

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

fundus photography

Diagnostic Test

using artificial intelligence to identify diabetic retinopathy using fundus photography

Optical coherence tomography

Diagnostic Test

detect diabetic retinopathy and diabetic macular edema by optical coherence tomography

fundus fluorescence angiography

Diagnostic Test

detect diabetic retinopathy by fundus fluorescence angiography

Primary outcomes

  1. The accuracy

    Time frame: Baseline-Month 12

    Detection of DR accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography

Secondary outcomes

  1. The accuracy

    Time frame: Baseline-Month 12

    Detection of DME accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography

Study contacts

Contact information is provided by the study sponsor or research team.

Hongkang Wu, MMS

CONTACT

[email protected]

+8618969978676

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 21, 2024
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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