Diabetic RetinopathyNCT03602989
A Multi-center Study on the Artificial Intelligence Enabled Diabetic Retinopathy Screening Based on Fundus Images
An observational study of Diabetic Retinopathy, run by Shenzhen SiBright Co., Ltd. at 3 sites in China.
Trial summary
Early detection and intervention of diabetic retinopathy (DR) is critical in preventing DR-related vision loss among type 1 (T1DM) and type 2 diabetic mellitus (T2DM) patients, currently estimated at over 100 million in China alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- AI-enabled Diabetic Retinopathy Screening Software
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 3 sitesChina
- Study dates
- 5 Jul 2018to 31 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with T1DM and T2DM under clinical setting. Invitation to volunteer
Who may be able to join
- Subject must understand the study, has chosen to participate voluntarily, and has signed informed consent
- Age 18 or older, no limitations on gender identity
- Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus
Who cannot join
- As it is difficult to obtain fundus images of satisfactory quality with small pupils, mydriasis is advisable under certain circumstances except if:
- the subject is allergic to mydriatic drugs;
- the subject's intraocular pressure (IOP) ≥ 22 mmHg;
- the subject is prone to post-dilation angle closure, pupillary block, etc.;
- The subject has refractive media opacity and/or pupil abnormalities that affect fundus examination and imaging;
- The subject has severe vitreous hemorrhage;
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- The subject has received fundus laser treatment;
- The subject has had eye surgery such as scleral buckling, vitrectomy, macular transposition, etc., BUT cataract surgery or external eye surgery are exempt from exclusion criteria;
- The subject is participating in other ophthalmic clinical trials;
- In cases when the researchers believe the subject is not suitable for taking fundus photograph, including but not limited to:
- The subject had nystagmus and could not obtain a gradable fundus photograph;
- other disqualifying condition deemed by the researcher.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Peking University People's Hospital
Beijing, Beijing Municipality
Zhongshan Ophthalmic Center
Guangzhou, Guangdong
The Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
About this study
Official title: A Prospective, Multi-center Clinical Study on the Application of An Artificial Intelligence Enabled Disease Detection Software to Diabetic Retinopathy Screening Based on Fundus Images
Early detection and intervention of diabetic retinopathy (DR) is critical in preventing DR-related vision loss among type 1 (T1DM) and type 2 diabetic mellitus (T2DM) patients, currently estimated at over 100 million in China alone. Yet the healthcare resources, particularly retinal specialists, are in short supply and unevenly distributed. In order to help address this enormous mismatch and implement population-based screening, an artificial intelligence (AI) enabled, cloud based software is developed by training a custom-built convolutional neural network.
This study is designed to evaluate the safety and efficacy of such device in detecting referable diabetic retinopathy (moderate non-proliferative DR or worse).
Read the detailed description
This prospective, multi-center clinical study is designed to validate the performance of an AI enabled software - Shenzhen SiBright AIDRScreening - in detecting referable diabetic retinopathy (RDR, defined as more than mild NPDR) among study subjects primarily by evaluating its sensitivity and specificity.
The subjects enrolled in this trial are patients with T1DM and T2DM. For those who qualify, color fundus images of each eyes are taken and then independently graded for RDR by both the device under test and a centralized reading center, which, for the purpose of this trial, is the Image Reading Center at Zhongshan Ophthalmic Center, Sun Yat-sen University (ZIRC). The grading from ZIRC serves as the gold standard to compare the device performance against.
The trial plans to enroll 1000 subjects. With a 95% confidence interval, the sensitivity is expected to be at least 85% whereas the specificity at 90% or above.
Fundus image quality assessment is performed according to the National DR Screening Imaging and Grading Guideline jointly published by Chinese Ophthalmological Society and Chinese Medical Doctor Association in 2017.
The diagnosis of RDR is based on the National DR Clinical Diagnosis and Treatment Guideline published by Chinese Ophthalmological Society in 2014.
A brief overview of the clinical protocol is as follows:
- Candidate screening phase: recruiting qualified trial subjects;
- Clinical phase: imaging and grading by AI and ZIRC;
- Statistical analysis phase: comparing two outputs;
- Closing phase: final report and archiving
- Conditions
- Diabetic Retinopathy
- Being tested
- AI-enabled Diabetic Retinopathy Screening Software
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-enabled Diabetic Retinopathy Screening SoftwareDevice
Color fundus images of both eyes are captured on site before being uploaded to and analyzed by the cloud-based Artificial Intelligence software
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity
To evaluate the sensitivity and specificity of the device in detecting referable DR (more than mild NPDR)
Measured: No more than 1 day for each subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start5 Jul 2018
- Primary completion30 Nov 2018
- Study completion31 Aug 2019 (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.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen SiBright Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhongshan Ophthalmic Center, Sun Yat-sen University, Peking University People's Hospital, The Eye Hospital of Wenzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Xiaofeng Lin, M.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602989
- Sponsor's protocol ID
- AIDRScreening
- Status last verified
- May 2019
- First submitted
- 17 Jul 2018
- Last updated
- 20 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Clinical Study on the Application of An Artificial Intelligence Enabled Disease Detection Software to Diabetic Retinopathy Screening Based on Fundus Images
- ClinicalTrials.gov ID
- NCT03602989
- Acronym / sponsor ID
- AIDRScreening
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shenzhen SiBright Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Zhongshan Ophthalmic Center, Sun Yat-sen University, Peking University People's Hospital, The Eye Hospital of Wenzhou Medical University
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 27 Jul 2018 (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.
Early detection and intervention of diabetic retinopathy (DR) is critical in preventing DR-related vision loss among type 1 (T1DM) and type 2 diabetic mellitus (T2DM) patients, currently estimated at over 100 million in China alone. Yet the healthcare resources, particularly retinal specialists, are in short supply and unevenly distributed. In order to help address this enormous mismatch and implement population-based screening, an artificial intelligence (AI) enabled, cloud based software is developed by training a custom-built convolutional neural network.
This study is designed to evaluate the safety and efficacy of such device in detecting referable diabetic retinopathy (moderate non-proliferative DR or worse).
Detailed description
This prospective, multi-center clinical study is designed to validate the performance of an AI enabled software - Shenzhen SiBright AIDRScreening - in detecting referable diabetic retinopathy (RDR, defined as more than mild NPDR) among study subjects primarily by evaluating its sensitivity and specificity.
The subjects enrolled in this trial are patients with T1DM and T2DM. For those who qualify, color fundus images of each eyes are taken and then independently graded for RDR by both the device under test and a centralized reading center, which, for the purpose of this trial, is the Image Reading Center at Zhongshan Ophthalmic Center, Sun Yat-sen University (ZIRC). The grading from ZIRC serves as the gold standard to compare the device performance against.
The trial plans to enroll 1000 subjects. With a 95% confidence interval, the sensitivity is expected to be at least 85% whereas the specificity at 90% or above.
Fundus image quality assessment is performed according to the National DR Screening Imaging and Grading Guideline jointly published by Chinese Ophthalmological Society and Chinese Medical Doctor Association in 2017.
The diagnosis of RDR is based on the National DR Clinical Diagnosis and Treatment Guideline published by Chinese Ophthalmological Society in 2014.
A brief overview of the clinical protocol is as follows:
- Candidate screening phase: recruiting qualified trial subjects;
- Clinical phase: imaging and grading by AI and ZIRC;
- Statistical analysis phase: comparing two outputs;
- Closing phase: final report and archiving
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with T1DM and T2DM under clinical setting. Invitation to volunteer
Key inclusion criteria (3 listed)
- Subject must understand the study, has chosen to participate voluntarily, and has signed informed consent
- Age 18 or older, no limitations on gender identity
- Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus
Key exclusion criteria (12 listed)
- As it is difficult to obtain fundus images of satisfactory quality with small pupils, mydriasis is advisable under certain circumstances except if:
- The subject has refractive media opacity and/or pupil abnormalities that affect fundus examination and imaging;
- The subject has severe vitreous hemorrhage;
- The subject has received fundus laser treatment;
- The subject has had eye surgery such as scleral buckling, vitrectomy, macular transposition, etc., BUT cataract surgery or external eye surgery are exempt from exclusion criteria;
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 |
|---|---|---|
| AI-enabled Diabetic Retinopathy Screening SoftwareColor fundus images of both eyes are captured on site before being uploaded to and analyzed by the cloud-based Artificial Intelligence software | Device | – |
Primary outcome
Sensitivity and specificity
Time frame: No more than 1 day for each subject
To evaluate the sensitivity and specificity of the device in detecting referable DR (more than mild NPDR)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
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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.
Xiaofeng Lin, M.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
3 sites 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, run by Shenzhen SiBright Co., Ltd. at 3 sites 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 12 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 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity (time frame: No more than 1 day for each subject). 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 20 May 2019.