ClinicalTrials.gov
ClinicalTrials.gov Menu

A Multi-center Study on the Artificial Intelligence Enabled Diabetic Retinopathy Screening Based on Fundus Images

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03602989
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : August 20, 2018
Sponsor:
Collaborators:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Peking University People's Hospital
The Eye Hospital of Wenzhou Medical University
Information provided by (Responsible Party):
Shenzhen SiBright Co., Ltd.

Brief 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. 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).


Condition or disease Intervention/treatment
Diabetic Retinopathy Device: AI-enabled Diabetic Retinopathy Screening Software

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:

  1. Candidate screening phase: recruiting qualified trial subjects;
  2. Clinical phase: imaging and grading by AI and ZIRC;
  3. Statistical analysis phase: comparing two outputs;
  4. Closing phase: final report and archiving

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: AI-enabled Diabetic Retinopathy Screening Software
    Color fundus images of both eyes are captured on site before being uploaded to and analyzed by the cloud-based Artificial Intelligence software


Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with T1DM and T2DM under clinical setting. Invitation to volunteer
Criteria

Inclusion Criteria:

  1. Subject must understand the study, has chosen to participate voluntarily, and has signed informed consent
  2. Age 18 or older, no limitations on gender identity
  3. Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus

Exclusion Criteria:

  1. As it is difficult to obtain fundus images of satisfactory quality with small pupils, mydriasis is advisable under certain circumstances except if:

    1. the subject is allergic to mydriatic drugs;
    2. the subject's intraocular pressure (IOP) ≥ 22 mmHg;
    3. the subject is prone to post-dilation angle closure, pupillary block, etc.;
  2. The subject has refractive media opacity and/or pupil abnormalities that affect fundus examination and imaging;
  3. The subject has severe vitreous hemorrhage;
  4. The subject has received fundus laser treatment;
  5. 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;
  6. The subject is participating in other ophthalmic clinical trials;
  7. In cases when the researchers believe the subject is not suitable for taking fundus photograph, including but not limited to:

    1. The subject had nystagmus and could not obtain a gradable fundus photograph;
    2. other disqualifying condition deemed by the researcher.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602989


Contacts
Contact: Qimeixue Pan, B.S. +86 18565701055 qmx.pan@sibionics.com

Locations
China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China
Principal Investigator: Mingwei Zhao, M.D.         
China, Guangdong
Zhongshan Ophthalmic Center Recruiting
Guangzhou, Guangdong, China
Principal Investigator: Xiaofeng Lin, M.D.         
China, Zhejiang
The Eye Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China
Principal Investigator: Xiaozhong Xu, M.D.         
Principal Investigator: Ruzhi Deng, M.D.         
Sponsors and Collaborators
Shenzhen SiBright Co., Ltd.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Peking University People's Hospital
The Eye Hospital of Wenzhou Medical University
Investigators
Principal Investigator: Xiaofeng Lin, M.D. Zhongshan Ophthalmic Center, Sun Yat-sen University

Responsible Party: Shenzhen SiBright Co., Ltd.
ClinicalTrials.gov Identifier: NCT03602989     History of Changes
Other Study ID Numbers: AIDRScreening
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases