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Comparing Artificial Intelligence for Assisted Diagnosis of Diabetic Retinopathy

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Zhejiang University

Status

Not yet enrolling

Conditions

Diabetic Macular Edema
Diabetic Retinopathy

Treatments

Diagnostic Test: optical coherence tomography
Diagnostic Test: fundus photography
Diagnostic Test: fundus fluorescence angiography

Study type

Observational

Funder types

Other

Identifiers

NCT06423274
DR artificial intelligence

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

1,000 participants in 3 patient groups

artificial intelligence-assisted fundus photography
Description:
Artificial intelligence-assisted fundus photography in patients with diabetic retinopathy
Treatment:
Diagnostic Test: fundus photography
optical coherence tomography
Description:
optical coherence tomography in patients with diabetic retinopathy
Treatment:
Diagnostic Test: optical coherence tomography
fundus fluorescence angiography
Description:
fundus fluorescence angiography in patients with diabetic retinopathy
Treatment:
Diagnostic Test: fundus fluorescence angiography

Trial contacts and locations

1

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Central trial contact

Hongkang Wu, MMS

Data sourced from clinicaltrials.gov

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