Diabetic RetinopathyNCT06423274
Comparing Artificial Intelligence for Assisted Diagnosis of Diabetic Retinopathy
An observational study of Diabetic Retinopathy and Diabetic Macular Edema, run by Zhejiang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy, Diabetic Macular Edema
- What is being tested?
- fundus photography, optical coherence tomography and fundus fluorescence angiography
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients under 18 years of age;
- Failure to Obtain informed consent;
- Presence of other retinal diseases;
- A patient who has already undergone the treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Hongkang Wu, MMS, 18969978676, wuhongkang@zju.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema
- Being tested
- fundus photography, optical coherence tomography, fundus fluorescence angiography
- Keywords
- diabetic retinopathy, diabetic macular edema, artificial intelligence
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fundus photographyDiagnostic test
using artificial intelligence to identify diabetic retinopathy using fundus photography
optical coherence tomographyDiagnostic test
detect diabetic retinopathy and diabetic macular edema by optical coherence tomography
fundus fluorescence angiographyDiagnostic test
detect diabetic retinopathy by fundus fluorescence angiography
| Study group | Role | What they receive |
|---|---|---|
| artificial intelligence-assisted fundus photography | Artificial intelligence-assisted fundus photography in patients with diabetic retinopathy Receives: Diagnostic Test: fundus photography | |
| optical coherence tomography | optical coherence tomography in patients with diabetic retinopathy Receives: Diagnostic Test: optical coherence tomography | |
| fundus fluorescence angiography | fundus fluorescence angiography in patients with diabetic retinopathy Receives: Diagnostic Test: fundus fluorescence angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy
Detection of DR accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography
Measured: Baseline-Month 12
Secondary outcomes (1)
The accuracy
Detection of DME accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography
Measured: Baseline-Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start10 Jul 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Hongkang, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423274
- Sponsor's protocol ID
- DR artificial intelligence
- Status last verified
- Jul 2024
- First submitted
- 9 May 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06423274
- Acronym / sponsor ID
- DR artificial intelligence
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema
- Keywords
- diabetic retinopathy, diabetic macular edema, artificial intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| artificial intelligence-assisted fundus photography | – | Diagnostic Test: fundus photographyArtificial intelligence-assisted fundus photography in patients with diabetic retinopathy |
| optical coherence tomography | – | Diagnostic Test: optical coherence tomographyoptical coherence tomography in patients with diabetic retinopathy |
| fundus fluorescence angiography | – | Diagnostic Test: fundus fluorescence angiographyfundus fluorescence angiography in patients with diabetic retinopathy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients under 18 years of age;
- Failure to Obtain informed consent;
- Presence of other retinal diseases;
- A patient who has already undergone the treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fundus photographyusing artificial intelligence to identify diabetic retinopathy using fundus photography | Diagnostic test | artificial intelligence-assisted fundus photography |
| optical coherence tomographydetect diabetic retinopathy and diabetic macular edema by optical coherence tomography | Diagnostic test | optical coherence tomography |
| fundus fluorescence angiographydetect diabetic retinopathy by fundus fluorescence angiography | Diagnostic test | fundus fluorescence angiography |
Primary outcome
The accuracy
Time frame: Baseline-Month 12
Detection of DR accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography
1 secondary outcome
The accuracy
Time frame: Baseline-Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy and Diabetic Macular Edema, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongkang Wu, MMS (+8618969978676, wuhongkang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy (time frame: Baseline-Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.