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

May 17, 2019 updated by: Shenzhen SiBright Co., Ltd.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Peking University People's Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • Zhongshan Ophthalmic Center
    • Zhejiang
      • Wenzhou, Zhejiang, China
        • The Eye Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with T1DM and T2DM under clinical setting. Invitation to volunteer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
No more than 1 day for each subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenzhen SiBright Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University People's Hospital
Zhongshan Ophthalmic Center, Sun Yat-sen University
The Eye Hospital of Wenzhou Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaofeng Lin, M.D., Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AIDRScreening

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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