- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03911323
Real-world Diagnostic Effectiveness of Artificial Intelligence Algorithm in Diabetic Retinopathy Screening
A Prospective Clinical Study on the Real-world Diagnostic Effectiveness of Artificial Intelligence Algorithm in Diabetic Retinopathy Screening
Recently, artificial intelligence algorithm has made great progress in the prediction of diabetic retinopathy based on fundus images,showing very high sensitivity and specificity. However,the real-world diagnosis effectiveness of deep learning model is still unclear.
This study is designed to evaluate the clinical efficacy of such an algorithm in detecting referable diabetic retinopathy.
Study Overview
Detailed Description
This prospective clinical study is designed to evaluate the real-world diagnostic performance of an AI model in detecting referable diabetic retinopathy (RDR, defined as more than mild NPDR), by evaluating its sensitivity and specificity compared to the clinical reference standard- seven-field stereoscopic photography.
The subjects enrolled in this study are patients with T1DM or T2DM. Qualified color fundus images and seven-field stereoscopic photography images of each eyes of the subject are taken. The fundus images are graded for RDR by the algorithm under test, and seven-field stereoscopic photography images of the same eye are graded by ophthalmologist, which serving as the gold standard to compare the algorithm performance against.
The trial plans to enroll 1000 subjects. With a 95% confidence interval, the sensitivity is expected to be at least 87% whereas the specificity at 89% or above.
The quality of fundus images are assessed according to the National DR Screening Imaging and Grading Guideline published by Chinese Ophthalmological Society and Chinese Medical Doctor Association in 2017.
The grading 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 recruiting phase: recruiting qualified participants; Clinical phase: imaging and diagnosing by AI and ophthalmologist ; Statistical analysis phase: comparing two outputs; Closing phase: final report and archiving
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jiying Hu, PhD
- Phone Number: +86-1808-6481-821
- Email: 18086481821@163.com
Study Locations
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Guangdong
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Shenzhen, Guangdong, China, 518000
- Recruiting
- Shenzhen second peoples's hospital
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Contact:
- Lisha Mou, PhD
- Phone Number: +86-1589-9876-015
- Email: lishamou@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subject must understand the study, participate voluntarily, and has signed informed consent
- Age 18 or older, no limitations on gender identity
- Patients with type 1 or type 2 diabetes.
Exclusion Criteria:
- Subjects diagnosed with eye diseases other than diabetic retinopathy
- Subjects diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radioactive retinopathy or retinal vein obstruction.
- Pregnant woman, subjects with mydriatic allergy, unclear refractive medium, family history of glaucoma, or diagnosed as narrow angle
- Subjects with a history of laser therapy, retinal surgery or anti-vascular endothelial growth factor injection
- Subjects currently participating in another ophthalmic research, receiving ophthalmic research products.
- Subject who is photo-sensitivity or taking medication that causes photosensitivity
- Subjects received photodynamic therapy recently
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity
Time Frame: No more than 1 day for each subject
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To evaluate the sensitivity and specificity of the model in detecting referable DR (more than mild NPDR)
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No more than 1 day for each subject
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lisha Mou, PhD, Shenzhen Second People's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20190401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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Asociación para Evitar la Ceguera en MéxicoCompletedProliferative Diabetic Retinopathy | Severe Nonproliferative | Active Photocoagulated Diabetic RetinopathyMexico
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Asociación para Evitar la Ceguera en MéxicoUnknownProliferative Diabetic Retinopathy | Non Proliferative Diabetic RetinopathyMexico
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Asociación para Evitar la Ceguera en MéxicoUnknownNon Proliferative Diabetic Retinopathy. | Proliferative Diabetic Retinopathy.Mexico
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Valo Health, Inc.RecruitingProliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathyUnited States
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AEYE Health IncA. Stein Regulatory Affairs Consulting Ltd.RecruitingDiabetic Mellitus | Diabetic Retinopathy, DRUnited States
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Ocuphire Pharma, Inc.CompletedDiabetic Retinopathy | Diabetic Macular Edema | NPDR - Non Proliferative Diabetic Retinopathy | PDR - Proliferative Diabetic RetinopathyUnited States
-
King Khaled Eye Specialist HospitalCompletedDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathySaudi Arabia
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Retina Macula InstituteAllerganCompletedDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathyUnited States
Clinical Trials on diabetic retinopathy
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Medios Technologies Pte. LtdDiacon HospitalUnknown
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Retina Clinic, Sao Paulo, BrazilCompletedDiabetic RetinopathyBrazil
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Aalborg UniversityEnrolling by invitation
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University of Alabama at BirminghamNational Eye Institute (NEI)Recruiting
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Kyorin UniversityCompletedProliferative Diabetic RetinopathyJapan
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Shenzhen SiBright Co., Ltd.Peking University People's Hospital; Zhongshan Ophthalmic Center, Sun Yat-sen... and other collaboratorsUnknown
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Rajavithi HospitalHealth Systems Research Institute (HSRI), ThailandNot yet recruitingDiabetic Retinopathy
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Centre Hospitalier Sud FrancilienCompletedDiabetic RetinopathyFrance
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The New York Eye & Ear InfirmaryiHealthScreen IncNot yet recruitingDiabetic RetinopathyUnited States
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OrbisDeep Eye Care Foundation (DECF); Digital Diagnostics, Inc.CompletedDiabetic Retinopathy | Diabetic Macular EdemaBangladesh